This combination tablet is indicated for:

• As an oral contraceptive

• Treatment of moderate acne vulgaris

• Treatment of premenstrual dysphoric disorder (PMDD)

This contains two active ingredients – Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinylestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein (HDL). Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone-binding globulin increase, which is useful for binding and inactivating endogenous androgens.

To achieve maximum contraceptive effectiveness, tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pill tablet of the upper row and have to continue daily for 24 consecutive days. After completion of the pill tablet, the white tablet should be taken from day 25 to day 28. Withdrawal bleeding usually starts on days 2-3 after starting the white tablets, but do not stop taking white tablets even if your menstruation has already started. Each subsequent new pack is started on the day after the last white tablet of the previous pack.

No preceding hormonal contraceptive use in the past month. Tablet taking has to start on day 1 of the woman's menstrual cycle. The woman should be instructed to take the first active tablet (light pill) from the upper row of this tablet according to the direction, and in this case no additional methods of contraception are required. Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

Changing from another combined hormonal pill or vaginal ring or transdermal patch: In case of a combined hormonal pill, the woman should start with the first active tablet of the upper row on the day after the last active tablet of her previous combined oral contraceptive (COC). In case a vaginal ring or transdermal patch has been used, the woman should start using this tablet preferably on the day of removal.

Changing from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (or from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method (e.g., condom) for the first 7 days of tablet-taking.

Following first-trimester abortion: The woman may start immediately, and in this case no need to take an additional contraceptive method.

Following delivery or second-trimester abortion: Women are advised to start on day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman is advised to additionally use a barrier method (e.g., condom) for the first 7 days of tablet-taking.

Administration

Management of Missed Tablets: Missed white pills from the last row of the blister are placebo tablets and thus can be disregarded. But if you forgot to take a light pill tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally, you should use some other method of contraception (like a condom) for the next 7 days. If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) until your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the light pill tablet of the top row of a fresh pack from the first day of your next menstruation.

If you have missed a period after taking the tablet: If you have taken all of your pills at the right time and you have not vomited or used other medicines, then you are very unlikely to be pregnant. Continue to take the tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked that you are not pregnant.

How to Delay a Period: To delay a period, women should continue with another new pack of this tablet just after finishing the active (light pill) pack of the present pack (that is, no need to take the white placebo tablets of the present pack). The extension can be carried on for as long as wished until the end of the active (light pill) pack of the second pack. When women wish their period to begin, just stop tablet-taking. While using the second pack, a woman may have some breakthrough bleeding or spotting. Start your next pack after the usual 4-day white inactive tablet interval.

Advice in case of Vomiting: If vomiting occurs within 3–4 hours after taking a light pill (active tablet), absorption may not be complete. In such an event, the advice concerning management of missed tablets is applicable. The woman must take the extra active tablet (light pill) needed from a backup pack after vomiting.

Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce the efficacy of the oral contraceptive. Examples of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir, and barbiturates. Certain antibiotics including ampicillin, other penicillins, and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet and other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal backup method of contraception be used in addition to the regular intake of this tablet.

This tablet should not be used:

• Known or suspected pregnancy
• If you have heart disease, clotting of blood in the vein
• If you suffer from liver disease or jaundice
• If you suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
• The presence or a history of venous or arterial thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, or of a cerebrovascular accident)
• History of migraine with focal neurological symptoms
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumors (benign or malignant)
• Undiagnosed vaginal bleeding
• Hypersensitivity to any of the components of this preparation

Different types of tablets suit different types of women. At the initial stage, some women may experience side effects like dizziness, headache, breast pain, nausea, or unscheduled uterine bleeding. These symptoms may occur in >3% of users. After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, rash, yellow skin, or a rise in blood pressure, take immediate advice from your doctor.

Use during pregnancy: This tablet is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use of this tablet, the preparation must be withdrawn immediately. For women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.

Use during lactation: Lactation may be influenced by combined pills as they may reduce the quantity and change the composition of breast milk. Therefore, the use of estrogen-containing combined pills should generally not be recommended until the nursing mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk.

If any circulatory disorder (e.g., myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury, etc.) or other risk factors (e.g., smoking, obesity, hypertension, dyslipidemia, migraine, atrial fibrillation, etc.) are present, the benefits of combined oral contraceptive (COC) use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation, or first appearance of any of these conditions or risk factors after taking the pill, the woman should contact her physician. The physician should then decide on whether its use should be discontinued.

Pediatric Use: This product is only indicated after menarche. There are no data suggesting the need for dosage adjustment.

Use in the Elderly: This product is not indicated after menopause.

Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms.

Oral Contraceptive Preparations

Do not store above 30°C. Keep away from light and out of reach of children.