Marvelon

Oral contraception.

When considering the appointment of the drug Marvelon®, individual risks in each woman should be taken into account, especially the risk of developing venous thromboembolism (VTE), as well as the risk of developing VTE with the use of Marvelon® and other combined hormonal contraceptives.

The tablets should be taken in the order indicated on the package, approximately daily at the same time, with a small amount of liquid, if necessary. For 21 consecutive days take 1 tablet. Each subsequent pack is taken after a 7-day pill-free period, during which bleeding usually occurs. Usually, it begins on the 2-3rd day after the last tablet and can continue until the next pack.

Hormonal contraceptives have not been used in the previous month (last month).

The use of pills begins on the first day of a woman's natural cycle (ie, on the first day of menstrual bleeding). You can start the treatment from 2-5 days, but in this case, it is recommended to use the barrier method of contraception during the first 7 days of the first cycle of tablet use.

Transfer from another combination hormonal contraceptive (combined oral contraceptive (PDA), vaginal ring or transdermal patch).

It is preferable for the woman to start using Marvelon® the next day after the last active tablet (last tablet containing the active substances) of the previous PDA, but not later than the day after the break in the tablet or after the inactive tablet of the previous COC. If a vaginal ring or transdermal patch is used, a woman should start using Marvelon® preferably on the day of removal, but not later than the next day.

If the previous method of contraception was used correctly and systematically, and the woman is quite sure that she is not pregnant, she can also switch from another combination hormonal contraceptive to any day of the cycle.

The hormone-free contraceptive-free period should not be longer than recommended.

Switching from progestogen-only drugs (mini-pills, injections or implants) or from the intrauterine system (IUD) that releases progestogen.

A woman may start using Marvelon® any day after stopping the mini-pill (in the case of an implant or IUD - on the day of his/her removal, in the case of injection - on the day of the next injection). In all these cases, the woman must use the barrier method during the first 7 days of the tablet.

After first trimester abortion.

A woman can start using the drug immediately after an abortion. In this case, there is no need to use additional contraception.

After delivery or abortion in the second trimester.

Women are advised to start on the 21st or 28th day after delivery or second trimester abortion. If you start using the drug later, it is recommended that you use the barrier method within the first 7 days of using the tablet. In any case, if you have had sexual intercourse during this period, you should either eliminate the pregnancy or wait for the first menstrual period before using the PDA.

What to do if you miss a tablet

If the woman is late with the next tablet for less than 12 hours, the birth control effect of the drug is not reduced. The woman should take the pill as soon as she remembers it and continue to use it at the usual time.

If the woman is late with the next tablet for more than 12 hours, contraceptive protection may be reduced. In this case, there are two basic rules:

1. Do not stop using the pill for more than 7 days.
2. After initiation of the tablets, adequate inhibition of the hypothalamus-pituitary-ovarian axis is achieved within 7 days of continuous use.

Accordingly, the following tips should be followed in everyday life:

 Week 1.

A woman should take the last missed pill as soon as she mentions a pass, even if she has to take two pills at a time. She continues to take the pill at the usual time. In addition, a barrier method of contraception, such as a condom, should be used within the next 7 days. If you have had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more tablets are missed and the closer they are to the normal pill-free period, the greater the risk of pregnancy.

Week 2.

A woman should take the last missed pill as soon as she mentions a pass, even if she has to take two pills at a time. She continues to take the pill at the usual time. If a woman misses the previous pill for the missed tablet for 7 days, then additional contraception is not needed. However, otherwise, or if more than one tablet is missed, within the next
Additional contraception methods should be used for 7 days.

Week 3.

The risk of reduced reliability increases with the approach of the pill break. However, following a certain pattern of use of pills can reduce the contraceptive protection. If one of the following options is followed, it will not be necessary to use additional contraceptives, provided that the woman has taken the pill correctly for 7 days prior to admission. If this is not the case, then the woman should follow the first of the following options and use additional precautionary methods for the next 7 days.

1. A woman should take the last missed pill as soon as she mentions a pass, even if she has to take two pills at the same time. She continues to take the pill at the usual time. The next pack should be started immediately after the previous pack, ie there should be no break between packs. It is unlikely that a woman will start bleeding withdrawal before the end of the second package of the drug, although the process of pill use may be "smeared" or sudden bleeding.
2. A woman may also stop using the pills from the packaging she is using. In this case, the break should be 7 days, including days of missing the tablets; tablets should be started with the next pack.

If a woman missed another pill and during the first planning period without the pill, there was no bleeding, she may have become pregnant.

Recommendations in the case of gastrointestinal disorders.

In case of severe gastrointestinal disorders, the absorption of the drug may be incomplete and additional contraceptive measures should be taken. If vomiting occurs no later than 3-4 hours after using the tablet, the recommendations for missed tablets should be followed. If a woman does not want to change her usual pattern of pills, she must take an extra pill (s) from another pack.

How to change or delay the onset of menstruation.

To delay the onset of menstruation, a woman should simply continue to take the pills from the next pack and not take breaks. If desired, any delay may be made within the number of tablets of the second package until they are finished. Sudden short-term bleeding or "smearing" may occur during a woman's delay. After the next scheduled 7-day pill-free period, regular intake of pills resumes.

In order to move the onset of menstruation to another day of the week as opposed to the normal cycle when not using Marvelon®, a woman may be advised to shorten the pill-free period by the required number of days. The smaller this period, the greater the likelihood of no bleeding cancellation and the occurrence of "lubrication" and short-term bleeding during the use of subsequent packaging (as with the delay of menstruation).

• Combined hormonal contraceptives (CCGs) cannot be used in the presence of any of the following conditions.
• Presence or risk of venous thromboembolism (VTE).
• Venous thromboembolism - the presence of VTE now (undergoing treatment with anticoagulants) or in history (eg deep vein thrombosis (DVT) or pulmonary embolism (ELS).
• Known or acquired hereditary risk factors for venous thromboembolism, such as resistance to activated protein C (including Leiden's factor V), deficiency of antithrombin III, deficiency of protein C, deficiency of protein S.
• Extensive surgery with prolonged immobilization.
• High risk of venous thromboembolism due to the presence of multiple risk factors.
• Presence or risk of arterial thromboembolism (ATE)
• Arterial thromboembolism - the presence of arterial thromboembolism now or in history (eg, myocardial infarction) or a prodromal condition (eg, angina).
• Cerebrovascular disease is the presence of a stroke, a history of a stroke or prodromal condition (for example, transient ischemic cerebral circulation).
• Known hereditary or acquired tendency to develop arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
• Migraine history with focal neurological symptoms.
• High risk of developing arterial thromboembolism due to the presence of multiple risk factors or one serious risk factor:

1. Diabetes with vascular complications;
2. Severe hypertension;
3. Severe dyslipoproteinemia.

• Presence of systemic lupus erythematosus now or in history.
• Pancreatitis or previously transmitted pancreatitis, which is associated with high hypertriglyceridemia.
• Presence or history of severe liver disease (until liver function indicators return to normal).
• Presence or history of liver tumors (benign or malignant).
• Estrogen dependent tumors identified or suspected.
• Vaginal bleeding of unknown etiology.
• Pregnancy is established or possible.
• Hypersensitivity to any active or auxiliary ingredient.

Marvelon® is contraindicated for use with a combination hepatitis C virus regimen containing ombitasvir/paritransformation/ritonavir with or without dasabuvir.

Active ingredients: desogestrel, ethinylestradiol;

1 tablet contains 0.150 mg of desogestrel and 0.030 mg of ethinyl estradiol.

Excipients: potato starch; silicon dioxide is colloidal anhydrous; alpha-tocopherol; stearic acid; povidone; lactose, monohydrate.

Tablets

Basic physicochemical properties: round, biconvex, white tablets, ORGANON * printed on one side, TR/5 inscribed on the other.

Packaging. 21 tablets in a blister, 1 blister per sachet, 3 sachets per carton.

Store in the original package at a temperature not exceeding 30 ° C, out of the reach of children.

N.V. Organon, Netherlands

№1438 dated 24.06.2019