Nuvaring instructions for use, contraindications, side effects, reviews. NovaRing contraceptive: instructions, side effects

vaginal ring 2.7 mg + 11.7 mg: pack. 1 or 3 pcs. Reg. No.: P N015411/01

Clinico-pharmacological group:

Hormonal contraceptive for intravaginal administration

Release form, composition and packaging

vaginal ring smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 PC. - aluminum foil waterproof bags (1) - cardboard packs.
1 PC. - aluminum foil waterproof bags (3) - cardboard packs.

Description of the active ingredients of the drug Novaring ®»

pharmachologic effect

Combined hormonal contraceptive preparation containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.

The contraceptive effect of NovaRing ® is due to the combination various factors, the most important of which is the suppression of ovulation.

Efficiency

AT clinical research it was found that the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NovaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95 % CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to Pearl Index values ​​obtained from comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).

Against the background of the use of the drug NovaRing ®, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug. In addition, high-dose COCs (0.05 mg ethinyl estradiol) reduce the risk of developing ovarian cysts, inflammatory diseases pelvic organs, benign changes mammary glands and ectopic pregnancy. It is not entirely clear whether low-dose hormonal contraceptives similar benefits.

The nature of bleeding

Comparison of bleeding patterns over one year in 1000 women who used NovaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing ® compared with COCs . In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing®.

Effect on bone mineral density

Comparative two-year study of the effect of NovaRing (n=76) and non-hormonal intrauterine device(n=31) showed no effect on mineral density bone tissue among women.

Children

Indications

- contraception.

Dosing regimen

NovaRing ® is injected into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina; after a week break, a new ring is introduced. For example: if the NovaRing ® ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00; on the next Wednesday, a new ring is introduced.

Bleeding associated with the cessation of the drug usually begins 2-3 days after the removal of NovaRing ® and may not completely stop until the moment when a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NovaRing ® should be administered on the first day of the cycle (i.e. the first day of menstruation). It is allowed to install the ring on the 2nd-5th days of the cycle, however, in the first cycle, in the first 7 days of using NovaRing ®, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NovaRing ® should be administered on the last day of the free interval in taking combined hormonal contraceptives (tablets or patch). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle.

The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-based contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking mini-pills can switch to the use of NovaRing ® on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman should use barrier method contraception during the first 7 days after the introduction of the ring.

After an abortion in the first trimester of pregnancy

The use of NuvaRing ® can be started immediately after an abortion. In this case, there is no need for additional application other contraceptives. If the use of NovaRing ® immediately after an abortion is undesirable, the use of the ring should be carried out in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, a woman is recommended alternative method contraception.

After childbirth or abortion in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing ® is started in more than late dates, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing ®. However, if sexual intercourse has already taken place during this period, then it is necessary to first exclude pregnancy or wait for the first menstruation before using NovaRing ®.

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid losing the contraceptive effect in case of deviation from the regimen, the following recommendations should be followed.

Extension of the break in the use of the ring

If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. How longer break the higher the chance of pregnancy. If pregnancy is ruled out, insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, may be used for the next 7 days.

If the ring has been temporarily removed from the vagina

If a the ring remained outside the vagina less than 3 hours, contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If a the ring was out of the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.

If a the ring has been outside the vagina for more than 3 hours during the third week of its use, the contraceptive effect may be reduced. The woman should discard this ring and choose one of two methods:

1. Immediately install a new ring. Keep in mind that a new ring can be used within the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting of blood or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after removing the previous ring. This option should only be selected if the ring has not been previously broken during the first 2 weeks.

Extended use of the ring

If the drug NovaRing ® was used no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week off from using the ring, and then introduce a new ring. If NovaRing ® remained in the vagina more than 4 weeks, then the contraceptive effect may worsen, therefore, before the introduction of a new ring, pregnancy must be excluded.

To change the time of onset of menstrual bleeding

To postpone (prevent) menstrual-like withdrawal bleeding, you can enter a new ring without a week break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Further, after the usual weekly break, you should return to the regular use of NovaRing ®.

To bear the onset of bleeding on another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the break in ring use, the more likely there is to be no bleeding after ring removal and bleeding or spotting while the next ring is in use.

Ring damage

In rare cases, when using NuvaRing ®, a rupture of the ring was observed. The core of the NovaRing ® ring is solid, so its contents remain intact and hormone secretion does not change significantly. If the ring breaks, it usually falls out of the vagina. If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a loss of NovaRing ® from the vagina, for example, when it was inserted incorrectly, when removing a tampon, during intercourse, or against a background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ® ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have inadvertently injected NovaRing ® into the urethra. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

The safety and efficacy of NuvaRing for adolescents under the age of 18 have not been studied.

Rules for using NuvaRing ®

A woman can independently insert NovaRing ® into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NovaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it must be rinsed with warm (not hot) water and inserted into the vagina immediately.

To remove the ring, you can pick it up index finger or squeezing between the index and middle fingers, pull out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Side effect

When using the drug, there may be side effects meeting with different frequency: often (≥1/100), infrequently (<1/100, ≥1/1 000), редко (<1/1000, ≥1/10 000).

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Local partner reactions include reports of local penile reactions.

3 Data from an observational cohort study: ≥1/10,000 -<1/1000 женщин-лет.

Contraindications

- venous thrombosis (including history), including thromboembolism;

- arterial thrombosis (including history), including cerebrovascular accident, myocardial infarction and / or precursors of thrombosis, including angina pectoris, transient ischemic attack;

- heart defects with thrombogenic complications;

- predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant);

- migraine with focal neurological symptoms in history;

- diabetes mellitus with vascular damage;

- pronounced or multiple risk factors for venous or arterial thrombosis;

- pancreatitis (including history), in combination with severe hypertriglyceridemia;

- severe liver disease, until the normalization of its function;

- liver tumors, malignant or benign (including history);

- established or suspected hormone-dependent malignant tumors (for example, genital or breast);

- vaginal bleeding of unknown etiology;

- pregnancy (including intended);

- hypersensitivity to any of the active or auxiliary substances of the drug NovaRing ®.

In the event of any of the above conditions, you should immediately stop using the drug.

FROM caution the drug should be prescribed in the presence of any of the diseases, conditions or risk factors listed below; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing®:

- the presence of diseases in a family history (venous thrombosis and embolism and / or arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age);

- prolonged immobilization, major surgery, any surgery on the lower extremities or serious injury;

- obesity (body mass index more than 30 kg / m 2);

- thrombophlebitis of superficial veins;

- smoking (especially in women over 35 years old);

- dyslipoproteinemia;

- valvular heart disease;

- atrial fibrillation;

- arterial hypertension;

- diabetes;

- acute or chronic liver dysfunction;

- jaundice and / or itching caused by cholestasis;

- cholelithiasis;

- porphyria;

- systemic lupus erythematosus;

- hemolytic-uremic syndrome;

- Sydenham's chorea (small chorea);

- hearing loss due to otosclerosis;

- (hereditary) angioedema;

- chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);

- sickle cell anemia;

- chloasma;

- conditions that make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In case of exacerbation of diseases, worsening of the condition, or the occurrence of any of the listed conditions for the first time, you should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Pregnancy and lactation

NovaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and delivery.

Pregnancy

The use of the drug NovaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known if this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that NovaRing ® is administered into the vagina, the concentrations of contraceptive hormones inside the uterus when using NovaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used the drug NovaRing ® during a clinical study are not described.

breastfeeding period

The use of the drug NovaRing ® during breastfeeding is not indicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites can be excreted in milk, but there is no evidence of their negative effect on the health of children.

Application for violations of liver function

Contraindicated in severe liver disease (before the normalization of function indicators).

Application for children

The safety and efficacy of NovaRing ® for adolescents under the age of 18 has not been studied.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ®. In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. The increased risk is less than in pregnancy, where the risk is 5-20 per 10,000 YL (pregnancy data are based on actual length of pregnancy in standard studies; based on a 9-month pregnancy, the risk is 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, women using the drug NuvaRing ® are at a greater risk of developing VTE, similar to that of women using COCs (adjusted risk ratio is presented in the table below). The large prospective observational study TASC (Transatlantic Active Cardiovascular Safety Study) assessed the risk of VTE in women who started using NovaRing ® or COCs, switched to NovaRing ® or COCs from other contraceptives or resumed use drug NuvaRing ® or COC, in a population of typical users. Women were followed up for 24-48 months. The results showed a similar level of risk of developing VTE in women using NovaRing ® (frequency 8.3 cases per 10,000 LL) and in women using COCs (frequency 9.2 cases per 10,000 LL). For women using COCs, with the exception of desogestrel, gestodene and drospirenone, the incidence of VTE was 8.9 cases per 10,000 VL.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 YL, while in women, those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing ®, compared with the risk of developing VTE in women using COCs

1 Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Based on age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known when using COCs. It is not known whether these cases are associated with the use of COCs.

Possible symptoms of venous or arterial thrombosis may include pain in one leg and/or swelling; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" abdomen.

Risk factors for the development of venous thrombosis and embolism:

- age;

- the presence of diseases in a family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting any hormonal contraceptive;

- prolonged immobilization, major surgery, any surgery on the lower extremities or serious injury. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;

- with obesity (body mass index more than 30 kg / m 2);

— possibly thrombophlebitis of superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

— age;

— smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);

— dyslipoproteinemia;

— obesity (body mass index over 30 kg/m2);

— hypertension;

— migraine;

— heart valve disease;

— atrial fibrillation;

— the presence of diseases in a family history (arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives.

Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (eg Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.

Women using CHCs should be advised to contact their doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives. It remains unclear how this effect is associated with the use of NovaRing®.

A meta-analysis of the results of 54 epidemiological studies revealed a small increase (1.24) in the relative risk of developing breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. An increased risk of developing breast cancer may be
due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women taking COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing ® if the symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives have a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If during the use of the drug NovaRing ® there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of the drug NovaRing ®.

During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic - uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic violations of liver function may serve as a basis for discontinuation of the drug NovaRing ® until the normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of the drug NovaRing ®.

Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing®, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NovaRing ®.

The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have inadvertently inserted the NovaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

Cases of vaginitis during the use of the drug NovaRing ® are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NovaRing ®, as well as evidence of the effect of the use of the drug NovaRing ® on the effectiveness of the treatment of vaginitis.

Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination/consultation

Before you prescribe the drug NovaRing ® or resume its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NovaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing ® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Reduced cycle control

During the use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the drug NovaRing ®, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on male sexual partners due to absorption through the tissues of the penis have not been studied.

Laboratory research

Use of contraceptive steroids may interfere with certain laboratory findings, including biochemical parameters of liver, thyroid, adrenal, and kidney function, plasma levels of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, and carbohydrate metabolism and indicators of coagulability and fibrinolysis. Indicators, as a rule, change within normal values.

Influence on the ability to drive vehicles and control mechanisms

Based on information about the pharmacodynamic properties of the drug NovaRing ® , it can be expected that it does not affect the ability to drive vehicles and work with mechanisms.

Considering the pharmacodynamic properties of NovaRing ® , its effect on the ability to drive a car and use complex equipment is not expected.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described.

Alleged symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

drug interaction

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 2 ° to 8 ° C. Shelf life - 3 years.

drug interaction

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure.

The following interactions with combined oral contraceptives are described in the literature in general.

Possible interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones. Interactions with the following drugs have been established: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with NovaRing ® or choose another method of contraception. During the concomitant use of drugs that cause the induction of microsomal liver enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of the drug NovaRing ® slightly affected the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (except amoxicillin and doxycycline) should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be inserted immediately without the usual interval.

Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of NovaRing®. With the combined use of suppositories with antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

To exclude a possible interaction, it is necessary to study the instructions for use of other drugs.

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when the tampon is removed.

Today it is more than wide. Each woman, having received the advice of a specialist, can choose the remedy that suits her both for health reasons and for personal wishes. Many today prefer to use the Nuvaring vaginal ring. What is its fundamental advantage over other drugs? Do doctors' reviews and instructions for use allow using the Nuvaring ring for endometriosis? What are the main contraindications? What do the reviews say about it? Read the details in this article.

Compound

What is included in the composition of such a contraceptive as the Nuvaring ring? Instructions, expert reviews report that each ring contains 11.7 milligrams of etonogestrel and 2.7 milligrams of ethinyl estradiol, as well as some additional components. That is why the remedy in question is called a contraceptive with an incredibly low content of hormones. This significantly reduces the risk of any side effects characteristic of other hormonal contraceptives.

Indications for use

Instructions for use, reviews of the Nuvaring ring recommend using it as a contraceptive. It, of course, is hormonal, however, the doses of hormones contained in the agent in question are so small that the negative effect of such hormone replacement therapy should practically not be felt. However, its effectiveness is in no way diminished by this. Moreover, the Nuvaring ring instructions for use, reviews of practicing gynecologists recommend using for some time to those patients who plan pregnancy for a certain period, but it does not occur. In this case, pregnancy may occur against the background of the withdrawal of the hormonal drug. When using contraceptives, there is a significant suppression of ovarian function by hormonal agents. After the drug is discontinued, the appendages begin to work in full force and ovulation occurs, which gives the woman a chance to become pregnant in this or the next cycle.

Side effects

As patients' reviews of the Nuvaring ring say, side effects may occur with some frequency. A number of women do not feel them at all, while others suffer from them throughout the entire time of using the drug. How can you tell which group you belong to? A qualified medical practitioner should be consulted. So, what are the side effects of the NovaRing ring, expert reviews? The most commonly reported reactions are:

• Increased fatigue, weakness.
• Dizziness.
• Headache.
• Depressed, depressed state.
• Unreasonable anxiety.
• emotional lability.
• Migraine-like headache or migraine itself.
• Cystitis.
• Vaginitis.
• Increase in body weight.
• Nausea.
• Decreased libido.
• Vomit.
• Quincke's edema.
• Difficulties in sexual intercourse that are directly related to the placement of the ring.
• Chair disorder.
• Hives.
• Dysmenorrhea.
• Cervicitis.
• Skin itching.
• Pain in the epigastric region.
• Vaginal discharge.
• Enlargement and sensitivity of the mammary glands.

It is important to remember: in order not to experience side effects and not get pregnant, the Nuvaring ring is strongly recommended by gynecologists to use it only as directed by the doctor and only according to the instructions. If you still experience one of the conditions listed above, immediately contact a specialist who can adjust the use of a contraceptive.

Mode of application

The drug in question is intended to be administered intravaginally. It is quite possible to do it yourself. To do this, just take a comfortable position for you. It can be anything: lying down, standing, raising one leg, sitting. In order to start using the agent in question, it is necessary to compress it and insert it into the vagina. There is no exact position in which the ring must be inside in order to maintain the contraceptive effect. The only condition is the personal physical and psychological comfort of the patient. Therefore, the ring should be placed so as not to cause discomfort to a woman, including during intercourse. Once the ring has been inserted, it can remain inside the vagina for up to three weeks. If the ring is accidentally removed from the vagina (for example, while a woman is removing a tampon), it must be rinsed with warm water and reinserted immediately. After twenty-one days (the day of the week must be the same as when the remedy was first introduced), the ring must be removed. If a woman still wants to use contraceptives, then after seven days she inserts a new ring. During these seven days, menstrual-like bleeding must begin (usually this happens two to three days after the previous ring has been removed). The next remedy should be administered according to the schedule, not focusing on the end of the described bleeding.

Do not use Nuvaring if pregnancy is suspected. First rule out the existence of this condition. If in the previous menstrual cycle the patient did not use contraceptives that contain hormones, then the ring must be inserted on one of the first five days of the cycle. Over the next week, you should also use additional contraceptives, in particular, barrier ones (for example, condoms). If, however, hormone-containing contraceptives were still used in the previous menstrual cycle, then the ring should be inserted on the first day after the prescribed seven-day break or the next day after the last placebo pill was taken (taking placebo pills for some drugs of this kind replaces the break ).

What can be said about those who in the previous cycle used mini-pills or other hormone-containing drugs that contain only progestogens (the same applies to intrauterine devices containing progestogen)? You can use the agent in question on the same day that you received the last dose of the hormone, whether it was the removal of an intrauterine device or an injection of progestogens. In the first week, it is important to use a barrier method of contraception, since when switching from progestogen contraceptives to the Nuvaring ring, the risk of pregnancy remains in the first seven days.

If an abortion was performed in the first trimester of pregnancy, then the contraceptive in question can be used immediately after the procedure (there is no need to use any other methods of contraception). If an abortion was performed in the second trimester, a miscarriage occurred or childbirth occurred, then it is advised to use the Nuvaring ring only starting from the fourth week after the incident. If the use of this contraceptive is started later, condoms must be used for the next week.

What if the patient forgot to insert the ring after a seven-day break? She should do it as soon as possible. However, for the next seven days, it is important to use additional barrier methods of contraception, such as condoms or a vaginal diaphragm. What if the ring was accidentally removed from the vagina? If it was outside the genital tract for more than three hours, then its contraceptive effect decreased significantly. The ring must be reinserted immediately. However, it is also important to use barrier methods of contraception (eg condoms) for the next week. If this week is the third since the start of the use of this ring, then it is important to ensure that it has been in the vagina for more than twenty-one days since its first introduction. The next remedy must be entered a day after the end of the use of the previous one.

If the patient for some reason did not remove the agent in question in due time, then it is important to remember that it remains effective only for four weeks after it was first introduced. After the woman has remembered that it is necessary to remove the ring, this should be done immediately. After a break of one day, you can enter a new agent. If the ring has been used for more than four weeks and there has been unprotected intercourse after that, it is important to rule out pregnancy before starting the next ring.

If you have taken the required seven-day break between periods of application of the remedy in question, but the expected menstrual bleeding does not begin, then it is important to exclude pregnancy (by examination by a specialist) before inserting a new ring. You can do a home pregnancy test or take a blood test for hCG.

As the reviews say, some people use the Nuvaring vaginal ring to change the time of menstruation. To do this, you can simply reduce the number of days between using the next ring by as many days as necessary for the desired shift in menstruation. If the break is short enough, chances are high that natural monthly bleeding will not start at all. However, this means that minor spotting may begin during the next cycle.

In order to delay menstruation, the patient can start using the next ring without taking the required seven-day break. When the next ring is inserted, one should not be surprised at the slight bleeding that may appear throughout the next cycle. This is the body's reaction to the existing hormonal background. Further, it is important to enter the rings, observing all the necessary seven-day breaks.

To prevent other people from coming into contact with your used ring, it should be carefully packaged in a bag and disposed of immediately with other household waste.

Contraindications

The contraceptive ring "Novaring" reviews of doctors recommend that not everyone use it. So, for example, there are a number of contraindications, in the presence of which a woman should avoid the method of contraception in question. Among them are the following:

• personal intolerance to one or more components of this vaginal ring;
• the presence of a tumor in the liver (even if it was in history);
• violation of the functioning of the liver;
• hormone-dependent malignant tumors (even if there is only suspicion of their existence);
• thrombosis, including history;
• diabetes mellitus with vascular complications;
• thromboembolism (including the risk of its development);
• pancreatitis with hypertriglyceridemia;
• vaginal bleeding of unknown origin;
• migraine with neurological reactions;
• when pregnancy is suspected.

However, this is not yet a complete list. Among other things, you should be careful when prescribing the contraceptive in question to patients who suffer from sickle cell anemia, obesity, Crohn's disease, arterial hypertension, ulcerative colitis, epilepsy, chloasma, uterine fibromyoma, heart valve disease, fibrocystic mastopathy, atrial fibrillation, systemic lupus erythematosus, dyslipoproteinemia, congenital hyperbilirubinemia, diseases of the hepatobiliary system, hemolytic uremic syndrome.

Particular caution should also be exercised by women who smoke, whose age exceeds thirty-five years, as well as those patients who have been lying down for a long time. It is also important to be careful for those who suffer from diseases that affect the introduction of the ring into the vaginal area and may contribute to its loss. These may include a hernia of the bladder, prolapse of the cervix, a hernia of the rectum, pronounced stool disorders.

Pregnancy

It is important to remember that the Nuvaring ring is an instruction, reviews of gynecologists categorically forbid women to use it not only during pregnancy, but also if pregnancy is suspected. Before you start using a new ring (which, by the way, must be changed every month), it is important to exclude pregnancy with the help of an examination by a qualified specialist if there was a risk of pregnancy in the previous month (cycle) (for example, unprotected intercourse). Also, doctors' reviews of the Nuvaring ring are forbidden to be used at a time when a woman is breastfeeding her baby. It is possible to resume its use only after the mother stops breastfeeding, so that the use of contraception does not affect the child in any way.

Overdose

And what happens if the Nuvaring ring is used in the wrong way? The consequences (reviews describe them in all colors) can be the most unpleasant. As a rule, they occur when using artificially high dosages of the drug in question. What are the symptoms in this case? There may be bleeding from the vagina, the development of nausea and vomiting. As experts report on the contraceptive ring "Novaring", there is no one specific antidote that would get rid of all the unpleasant symptoms at once. Treatment will be prescribed exclusively symptomatic. If you notice the appearance of at least one of the conditions listed above, it is important to immediately contact your doctor, who will prescribe therapy, and will also be able to figure out whether you should continue to use the contraceptive in question.

Or frequently asked questions about the NovaRing hormonal ring, which the doctor hears at every appointment.

What is NuvaRing?

is an elastic ring that is inserted deep into the vagina. The system is installed in the first days of the menstrual cycle and remains in the genital tract for 21 days. The contraceptive ring contains the female sex hormones estrogen and progesterone. These substances are gradually released and enter the bloodstream, blocking ovulation and making pregnancy impossible. Hormones also make cervical mucus viscous so that nimble sperm do not penetrate and do not fulfill their intended purpose.

To date, the NuvaRing vaginal ring is considered one of the most effective contraceptives with a minimum amount of hormones. This fact makes the system popular with both young women and older ladies. What should you know about NovaRing and how to use this contraceptive correctly?

Who is NuvaRing suitable for?

The contraceptive ring is a good choice for different categories of women:

• Young and nulliparous, having one sexual partner.
• After childbirth and completion of breastfeeding.
• In the premenopausal period (in the absence of a chronic pathology that can become a contraindication).

Why is NuvaRing better than birth control pills?

The vaginal ring has three clear advantages over similarly formulated COCs:

• The estrogen dosage is lower than in any hormonal pills.
• The drug does not pass through the gastrointestinal tract and does not affect digestion.
• You do not need to remember to take pills every day - just enter the ring once and forget about it for 21 days.

Can NuvaRing be used for breastfeeding mothers?

Instructions for use of the contraceptive ring do not recommend the use of NuvaRing during lactation. You should wait until the end of breastfeeding and only then put the ring. Nursing mothers can use mini-pills (pure progestin preparations) as contraception. Don't forget about condoms.

Can a woman put a contraceptive ring herself or should she go to the doctor?

NuvaRing is simple, convenient and affordable. Any woman can easily insert the ring on her own. To do this, you need to take a comfortable position - squatting, standing or lying down - and insert the ring as deep as possible. If you have any difficulties, you can make an appointment to see a doctor. The doctor will introduce the ring, after which he will tell the patient in detail how to do this at home.

Can a man feel the ring during sex?

No, NuvaRing is not felt at all during intercourse.

Can a woman feel the vaginal ring?

No, if the NuvaRing is placed correctly, it will not be felt in the vagina.

Why doesn't the ring fall out?

NuvaRing, inserted deeply, is securely fixed in the vagina by the muscles. In addition, the ring lies horizontally in the genital tract, as if on a shelf, and the probability of its falling out is extremely low.

Can the ring fall out?

Rarely, but it does happen. In this case, you need to wash the ring with warm or cool water and gently insert it back into the vagina. The contraceptive effect does not suffer if less than 3 hours have passed since the ring fell out.

The ring fell out, but I did not have time to quickly return it to its place. What to do?

If more than 3 hours have passed after the ring fell out or was removed, you need to act according to the scheme:

1. If such a problem happened on the 1st or 2nd week of using the NovaRing ring, you need to return it to its place as soon as possible. The contraceptive effect of the drug is reduced, and for some time the woman will not be protected from unwanted pregnancy. It is recommended to additionally use a condom for the next 7 days.
2. If the ring falls out in the 3rd week of use, it must be discarded and a new one inserted immediately. In this case, there will be no menstrual-like bleeding, but scanty spotting may be noted. This is normal, no need to panic. The ring is removed after the prescribed 21 days, then a break is made for 7 days and a new drug is introduced.
3. If a woman does not want to immediately put a new ring, she can wait for withdrawal bleeding and enter NuvaRing after 7 days. This option is possible only when the ring has never fallen out during the first two weeks. If the problem has occurred before, see point 2.

Is it possible to remove the ring from the vagina during sex?

Yes, but it makes no sense, because NuvaRing is not felt by either a woman or a man. If the ring was nevertheless removed, it must be returned within 2-3 hours and no later.

Can the NuvaRing fall too deep?

No, the birth control ring is securely attached to the vagina. It will not fall into the uterus, since the entrance to the reproductive organ is blocked by a closed pharynx. The ring has nowhere to go from the woman's genital tract, and even during sex, it will not penetrate too deeply.

Can NuvaRing be left in the vagina for 4 weeks?

This is acceptable because the contraceptive effect of the system lasts up to 28 days. After 4 weeks, the ring must be removed: the level of hormones drops, and the woman loses her protection against unwanted pregnancy.

Can NuvaRing be frozen?

The birth control ring can be stored in the refrigerator for up to 12 hours. It is not recommended to freeze the system in the freezer. If you need to take a contraceptive with you (for example, when traveling to another city), use a special cooler bag.

Can menses be cancelled?

Yes, you can insert a new ring without a week break. Menstruation will not come, but spotting bleeding in the middle of the cycle is possible. A new ring can be left in the vagina for 21 days (according to the usual scheme).

How to postpone the date of menstruation when using the NovaRing ring?

Very simple: you just need to introduce a new ring not after 7 days, but, for example, 5 or 6 after the removal of the previous one. It is important to know: the shorter the break, the higher the likelihood of spotting in the middle of the cycle.

Can a contraceptive ring be used by girls under the age of 18?

The safety of NuvaRing in adolescents has not been studied. Internal consultation of the doctor is necessary.

Should I use the ring if there is a uterine prolapse?

With this pathology, NuvaRing may fall out. It is recommended to use other means of contraception.

Why can't you drink antibiotics if there is a ring?

This is not entirely true. If the doctor has prescribed antibiotics, they should be taken. The problem is that when using some antibiotics (in particular ampicillin and tetracycline), there is a decrease in the contraceptive effect. While a woman is taking antibiotics, she should additionally use condoms - for the entire period of treatment and for 7 days after completion of the course of therapy.

Can the NuvaRing break?

Yes, this is possible. The risk of ring rupture increases with the simultaneous use of vaginal suppositories against a fungal infection (thrush). During treatment, you need to additionally use condoms and monitor the condition of NuvaRing.

Can the birth control ring be used with tampons?

Yes, the use of tampons does not affect the functionality of NuvaRing. In rare cases, the ring may fall out after the tampon is removed.

Does NuvaRing lead to cervical cancer?

It is believed that the main cause of cervical cancer is the human papillomavirus (HPV), but not the use of hormonal contraceptives. Statistics show that women who use NovaRing are more likely to develop cervical cancer, but gynecologists attribute this to regular check-ups with a doctor and annual testing (a smear for oncocytology). It is worth noting that in this situation, the disease is usually detected in the early stages, when it is much easier to cure it.

How fast can I get pregnant after removing the NuvaRing?

Restoration of fertility occurs within 1-3 months after discontinuation of the drug. This means that a woman can become pregnant already in the first cycle after removing the ring. In some cases, the conception of a child occurs after 3-12 months.

How does the menstrual cycle change after the insertion of the vaginal ring?

After the introduction of NovaRing, a gradual release of hormones begins. The menstrual cycle becomes monotonous. The level of own hormones remains stable. Menstruation, as a rule, becomes less abundant, their duration decreases. Menstrual-like bleeding on the background of NovaRing comes every 28 days strictly according to the schedule.

How much does NuvaRing cost?

The average price for a contraceptive ring is about 1000 rubles.

NovaRing (vaginal rings. sachet N1) Netherlands N.V. Organon

Brand name: NovaRing

International name: Etonogestrel + Ethinylestradiol

Manufacturer: N.V. Organon

Country: Netherlands

Packing vaginal rings 1 pc., sachet (1) - packs of cardboard

Registration number П N015411/01

Date of registration 25.12.2003

Description (Vidal 2008):

NuvaRingR (NuvaRingR)

Representation:

ORGANON ATX code: G02BB01

Registration certificate holder:

ethinylestradiol + etonogestrel

Release form, composition and packaging

The vaginal ring is smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.

ethinylestradiol 2.7 mg

Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate, purified water.

1 PC. - aluminum foil bag (1) - cardboard boxes.

Clinico-pharmacological group: Hormonal contraceptive for intravaginal administration

Registration Nos.:

# vaginal ring 11.7 mg + 2.7 mg: 1 pc. - P No. 015411/01, 25.12.03 PPR

Description of the drug is based on officially approved instructions for use and approved by the manufacturer for the 2006 edition.

pharmachologic effect| Pharmacokinetics | Indications | Dosing regimen | Side effect| Contraindications | Special Instructions | Overdose | Drug interaction | Storage conditions and expiration dates

pharmachologic effect

Hormonal contraceptive for intravaginal use containing estrogen - ethinyl estradiol and progestogen - etonogestrel. Etonogestrel, a derivative of 19-nortestosterone, binds to progesterone receptors in target organs.

The contraceptive effect of NovaRing is based on various mechanisms, the most significant of which is inhibition of ovulation. The Pearl Index of NuvaRing is 0.765.

In addition to the contraceptive effect, the drug has a positive effect on the menstrual cycle. Against the background of its use, the cycle becomes more regular, menstruation is less painful, with less bleeding, which in turn can help reduce the frequency of iron deficiency. In addition, there is evidence to reduce the risk of endometrial cancer and ovarian cancer.

Pharmacokinetics

Suction

Etonogestrel released from NovaRing is rapidly absorbed by the vaginal mucosa. Cmax etonogestrel, equal to approximately 1700 pg / ml, is achieved approximately one week after the introduction of the ring. Serum concentration fluctuates slightly and slowly reaches the level of 1400 pg / ml after 3 weeks. Absolute bioavailability is about 100%.

Distribution

Metabolism

breeding

The decrease in serum etonogestrel concentration is biphasic. T1 / 2 α-phase is about 29 hours. Etonogestrel and its metabolites are excreted in the urine and bile in a ratio of 1.7:1. T1 / 2 metabolites about 6 days.

Ethinylestradiol

Suction

Ethinylestradiol released from NovaRing is rapidly absorbed by the vaginal mucosa. Cmax is about 35 pg / ml, is reached by the 3rd day after the introduction of the ring and decreases to 18 pg / ml after 3 weeks. The absolute bioavailability is about 56%, which is comparable to oral bioavailability.

Metabolism

Ethinylestradiol is initially metabolized by aromatic hydroxylation to form a variety of hydroxylated and methylated metabolites, which are present both in the free state and as glucuronide and sulfate conjugates. Serum clearance is about 3.5 l / h.

breeding

The decrease in the concentration of ethinylestradiol in serum is biphasic. T1 / 2 α-phase is characterized by large individual differences, and, on average, is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3:1. T1 / 2 metabolites is about 1.5 days.

Indications

Contraception.

Dosing regimen

NuvaRing is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina. After a week break, a new ring is introduced. Bleeding associated with the cessation of the drug usually begins 2-3 days after the removal of NuvaRing and may not completely stop until the next ring needs to be started.

If hormonal contraceptives were not used in the previous menstrual cycle, NuvaRing should be administered between the 1st and 5th day of the menstrual cycle, but no later than the 5th day of the cycle, even if the woman has not completed her menstrual bleeding. During the first 7 days of the first cycle of NovaRing, additional use of barrier methods of contraception is recommended.

When switching from taking combined oral contraceptives, NovaRing should be administered no later than the day following the interval in taking the drug. If the combined oral contraceptive also contains inactive tablets (placebo), then NovaRing should be administered no later than the day following the last placebo tablet.

When switching from progestin contraception (mini-pill, implant or injectable contraception) or progestogen-releasing intrauterine devices (IUDs), NuvaRing should be administered on any day (if the patient took mini-pill), the day after removal of the implant or IUD, and with injectable contraception - on the day when the next injection is needed. In all these cases, an additional barrier method of contraception should be used during the first 7 days of using NovaRing.

After an abortion in the first trimester of pregnancy, you can start using NuvaRing immediately after the abortion. In this case, there is no need for additional use of other contraceptives. If the use of NovaRing immediately after an abortion is undesirable, then the use of the ring should be carried out in the same way as if hormonal contraceptives were not used in the previous cycle.

After childbirth or an abortion in the second trimester of pregnancy, NuvaRing should be started within the 4th week after childbirth or abortion. If the use of NovaRing is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing. However, if sexual intercourse has already taken place during this period, you must first exclude pregnancy or wait for the first menstruation before using NovaRing.

The contraceptive effect and cycle control may be impaired if the patient violates the recommended regimen. To avoid losing the contraceptive effect in case of deviation from the regimen, the following recommendations should be followed:

In the event of an extended interruption in the use of the ring, a new ring should be placed in the vagina as soon as possible. Additionally, a barrier method of contraception must be used for the next 7 days. If during the break in the use of the ring there were sexual contacts, the possibility of pregnancy should be considered. The longer the break, the higher the risk of pregnancy.

If the ring was accidentally removed and left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible. If the ring has been outside the vagina for more than 3 hours, the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible, after which it should be permanently in the vagina for at least 7 days, and an additional barrier method of contraception should be used during these 7 days. If the ring was outside the vagina for more than 3 hours during the third week of its use, then its use should be extended beyond the prescribed three weeks (until the end of 7 days after the re-insertion of the ring). After that, the ring should be removed, and a new one placed after a week break. If the removal of the ring from the vagina for more than 3 hours occurs during the first week of using the ring, the possibility of pregnancy should be considered.

In the case of prolonged use of the ring, but not longer than 4 weeks, the contraceptive effect is preserved. You can take a week break and then place a new ring. If NuvaRing has been in the vagina for more than 4 weeks, the contraceptive effect may decrease, and pregnancy must be excluded before using a new NuvaRing ring.

If the patient does not adhere to the recommended regimen and then there is no bleeding caused by ring removal within a week of ring use, pregnancy must be excluded before using a new vaginal ring.

To delay the onset of menstruation, you can start using a new ring without a week break. The next ring should also be used within 3 weeks. This may cause bleeding or spotting. Further, after the prescribed weekly break, you should return to the regular use of NuvaRing.

To shift the onset of menstruation to another day of the week from the day that falls on the current scheme of using the ring, you can shorten the upcoming break in the use of the ring by as many days as necessary. The shorter the break in the use of the ring, the higher the likelihood of the absence of bleeding that occurs after the removal of the ring, and the occurrence of untimely bleeding or spotting during the period of use of the next ring.

Rules for using NovaRing

The patient can independently insert NovaRing into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NuvaRing in the vagina is not decisive for the contraceptive effect of the ring. After insertion, the ring must remain in the vagina continuously for 3 weeks. If it is accidentally removed (for example, when removing a tampon), the ring must be rinsed with warm water and immediately placed in the vagina. To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina.

Side effect

From the side of the central nervous system: headache, migraine, depression, emotional lability, dizziness, anxiety, fatigue.

From the digestive system: nausea, abdominal pain, diarrhea, vomiting.

From the endocrine system: decreased libido, soreness, tension and enlargement of the mammary glands, dysmenorrhea, increase or decrease in body weight.

From the reproductive system: vaginal discharge ("leucorrhea"), vaginitis, cervicitis.

From the urinary system: urinary tract infections (including cystitis).

Local reactions: loss of the ring, discomfort during intercourse in women and men, sensation of a foreign body in the vagina.

Contraindications

Venous or arterial thrombosis / thromboembolism (including history);

Thrombosis risk factors (including history);

Migraine with focal neurological symptoms;

Diabetic angiopathy;

Pancreatitis (including history) in combination with a high degree of hypertriglyceridemia (LDL concentration more than 500 mg / dl);

Severe liver disease (before normalization of function indicators);

Tumors of the liver (benign or malignant, including in history);

Hormone-dependent malignant tumors (established or suspected, for example, tumors of the genital organs or mammary glands);

Vaginal bleeding of unknown etiology;

Pregnancy or suspicion of it;

lactation period;

Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for diabetes mellitus, obesity (body mass index over 30 kg / m2), arterial hypertension, atrial fibrillation, heart defects, dyslipoproteinemia, liver or gallbladder diseases, Crohn's disease or ulcerative colitis, sickle cell anemia, systemic lupus erythematosus , hemolytic uremic syndrome, epilepsy, smoking in combination with age over 35 years, with prolonged immobilization, major surgical interventions, fibrocystic mastopathy, uterine fibroids, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), chloasma (avoid exposure to ultraviolet rays), as well as conditions that make it difficult to use the vaginal ring (cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation).

Application for violations of liver function

Contraindicated in severe liver disease (before the normalization of function indicators).

special instructions

Before prescribing NovaRing, a detailed patient history should be collected, as well as a medical examination should be carried out, taking into account contraindications and warnings. During the period of application of NuvaRing, the examination should be repeated at least 1 time per year. The frequency and list of studies should be selected individually for each patient, but in any case, special attention should be paid to control of blood pressure, examination of the mammary glands, abdominal organs and small pelvis, including cytological examination of the cervix and appropriate laboratory tests.

The effectiveness of NovaRing may be reduced in case of non-compliance with the regimen or the concomitant use of other drugs.

If it is necessary to use drugs against the background of the use of NovaRing, which may affect the contraceptive effect of the ring, you should use a barrier method of contraception in addition to the use of NovaRing or choose another method of contraception. When taking inducers of microsomal liver enzymes while using NuvaRing, a barrier method of contraception should be used during the course of taking concomitant drugs and for 28 days after stopping their use. While taking antibiotics (excluding rifampicin and griseofulvin), you should use the barrier method for at least 7 days after stopping the course of antibiotic therapy. If the course of therapy with concomitant drugs continues for more than 3 weeks of using the ring, the next ring is placed immediately, without a weekly break.

The use of contraceptive steroids may affect certain laboratory findings, including biochemical parameters of liver, thyroid, adrenal, and kidney function, plasma levels of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulation and fibrinolysis. Indicators, as a rule, change within normal values.

Against the background of pregnancy or taking oral hormonal contraceptives, conditions such as herpes pregnant, hearing loss, chorea, porphyria may occur.

The patient should be informed that NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

During the use of NuvaRing, irregular bleeding (minor discharge or sudden bleeding) may occur.

Some women do not bleed during the break from ring use. If NuvaRing has been used as recommended, it is unlikely that the woman is pregnant. In case of deviation from the recommended regimen and the absence of bleeding from discontinuation of the drug, or in the absence of bleeding 2 times in a row, the presence of pregnancy should be excluded.

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on sexual partners through their absorption through the skin of the penis have not been studied.

Overdose

Cases of overdose are unknown.

Expected overdose symptoms: nausea, vomiting, vaginal bleeding.

Treatment: carry out symptomatic therapy. There are no antidotes.

drug interaction

Interactions between hormonal contraceptives and other medicinal products may result in breakthrough bleeding and/or loss of the contraceptive effect.

With the simultaneous use of NovaRing with drugs that induce microsomal liver enzymes (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, St. John's wort), the metabolism of sex hormones increases and the contraceptive effect of NovaRing decreases.

The effectiveness of NuvaRing may also be reduced while taking some antibiotics, such as penicillins and tetracyclines. These drugs reduce the enterohepatic circulation of estrogen, which leads to a decrease in the concentration of ethinyl estradiol.

The effect on the contraceptive effect and safety of NovaRing antifungal drugs and spermicidal agents administered intravaginally is not known. No direct interactions of etonogestrel with co-administered ztinyl estradiol have been found.

Terms and conditions of storage

NuvaRing should be stored out of the reach of children at a temperature of 2° to 8°C.

Terms of dispensing from pharmacies

NuvaRing is available by prescription.

NuvaRing is a flexible contraceptive ring (diameter 54 mm, ring shell thickness 4 mm). In the form of a ring, you can see the ring only in the package, because when inserted into the vagina, it adapts to the individual contours of the woman's body and occupies the optimal position. The ring is soft, it does not violate sexual harmony and does not reduce the sensitivity of partners. The ring does not interfere with playing sports, actively moving, swimming, running. Most women claim that NuvaRing is very convenient to use.

The principle of operation of Nuvaring

Hormones (estrogen and progestogen) in microdoses, smaller than even in any microdosed birth control pill, daily come from the ring directly into the uterus and ovaries, without penetrating into other organs. They prevent the release of the egg from the ovary and fertilization, so pregnancy is impossible.

Hormones begin to be released from the ring located in the vagina, under the influence of body temperature. You should be aware that under various conditions, the temperature of the human body can fluctuate in the range from 34°C to 42°C. Fluctuations in this range do not affect the effectiveness of NovaRing.

Rice. one. The location of the NovaRing ring in the vagina.

The shell of the ring is made of hypoallergenic material and consists of a complex system of membranes that allow a strictly defined amount of hormones to be released daily. Regardless of any individual characteristics of a woman, the dose of hormones released per day is always strictly the same (15 micrograms of estrogen and 120 micrograms of progestogen).

Through the mucous membrane of the vagina, they enter the bloodstream. There is no primary passage through the liver and gastrointestinal tract. This allows to achieve high efficiency (more than 99%). The ability to conceive is fully restored within a month after stopping the use of NovaRing.

The main advantage of NovoRing is that you cannot gain weight, there is no effect on blood clotting (varicose veins of the lower extremities) and liver function. All these side effects, unfortunately, are present in one way or another in contraceptive pills. Also, the hormones from NovaRing do not reduce the level of tissue testosterone, so the ring does not reduce libido and sensations during orgasm.

How to use NovoRing?

One hormonal ring is designed for one menstrual cycle. A woman inserts it into the vagina from the 1st to the 5th day of the menstrual cycle. NuvaRing is comfortably placed inside and remains in the vagina for 21 days (3 weeks), on the 22nd day the ring is removed. A week later, on day 8, a new one is introduced.

NuvaRing does not require any special position in the vagina. The flexible and elastic ring itself will take the optimal position, adapting to the individual contours of the woman's body.

Be sure to consult a gynecologist to assess the possibility of using this method of contraception. The doctor will teach you how to insert the ring correctly, as well as tell you about the scheme for switching from birth control pills to NovaRing.

ATTENTION!!!
The NuvaRing hormone ring does not protect against sexually transmitted diseases. Therefore, a prerequisite for its use is the presence of one permanent sexual partner, and the absence of both genital infections.