Minerva 0,035 mg/2 mg Tablets

MINERVA - 35 is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. These include patients with polycystic ovary syndrome, who require treatment for these symptoms. MINERVA - 35 is a hormonal contraceptive (the “Pill”). Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate as well. You should only take MINERVA - 35, if your doctor considers that other anti-acne treatments, including topical treatments and antibiotics, are inappropriate. Each of the 21 beige coated tablet contains the hormones ethinylestradiol and cyproterone acetate.

General notes Before you can begin taking MINERVA - 35, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests. In this leaflet, several situations are described where you should stop using MINERVA - 35, or where the reliability of MINERVA - 35 may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method.

Do not use rhythm or temperature methods. These methods can be unreliable because MINERVA - 35 alters the monthly changes of body temperature and cervical mucus. MINERVA - 35 does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take MINERVA - 35 Do not use MINERVA - 35 if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use MINERVA - 35:

• if you are allergic (hypersensitive) to ethinylestradiol, cyproterone acetate or any of the other ingredients in MINERVA - 35. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that may be an indicator of a heart attack in the future (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke’ (transient ischaemic attack)
• if you have (or have ever had) a migraine, with visual disturbances, speech disability or weakness or numbness in part of your body.
• if you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions:
• diabetes affecting your blood vessels.
• very high blood pressure.
• a very high level of fat in your blood (cholesterol or triglycerides)
• if you have problems with blood clotting (e.g. protein C deficiency)
• if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally
• if you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, or any combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
• if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• if you have (or have ever had) a benign or malignant tumour of the liver
• if you have any unexplained bleeding from the vagina
• if you are using another hormonal contraceptive
• if you are pregnant or think you might be pregnant
• if you are breast-feeding

If any of these conditions appear for the first time while using MINERVA - 35, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures. See also ‘General notes’.

MINERVA - 35 is not for use in men.

MINERVA - 35 is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. The dose regimen of MINERVA - 35 is similar to the regimen of most of the usual contraceptive Pills. Thus, the same administration rules must be considered. The irregular intake of MINERVA - 35 can lead to intermenstrual bleedings and could lessen the therapeutic and contraceptive reliability. The MINERVA - 35 pack contains 28 tablets. Follow the direction of the arrows until all 28 tablets have been taken. Take your tablet at about the same time each day, with some liquid if necessary. Usually a period will start while you are taking tablets from the silver section (i.e. on day 2 - 3 after the last hormone-containing beige MINERVA - 35 tablet). Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days every month.

When can you start with the first pack? If you have not used a contraceptive with hormones during the previous month Wait for your next period to occur. Start with MINERVA - 35 on the first day of the cycle (= 1st day of bleeding) from the silver section of the pack and select the right tablet for that day of the week (e.g. “M O” for Monday). During the first cycle, you must use extra protective measures (for example, a condom) for the first 14 days of MINERVA - 35 use.

Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch. You can start taking MINERVA - 35 the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains hormone-free tablets you can start MINERVA - 35 on the day after taking the last tablet containing hormones (if you are not sure which this is, ask your doctor or pharmacist). In case you have used a vaginal ring or transdermal patch, start using MINERVA - 35 on the day of removal of the last ring or patch of a cycle pack. If you follow these instructions, it is not necessary to use an additional contraceptive method.

Changing from a progestogen-only method (progestogen-only pill, injection, implant or a progestogen-releasing intrauterine system ‘IUS’). You may switch from the progestogen-only pill any day (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) during the first 14 days of MINERVA - 35 use.

After a miscarriage. Follow the advice of your doctor, but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking.

After having a baby. If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking MINERVA - 35. Sometimes it is possible to start sooner. Your doctor will advise you, but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking. If, after having a baby, you have had sex before starting MINERVA - 35, be sure that you are not pregnant or wait until the next menstrual period.

If you take more MINERVA - 35 than you should There are no reports of serious harmful effects of taking too many MINERVA - 35 tablets. If you take several hormone-containing tablets at once, you may feel sick or vomit or may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.

If you have taken too many MINERVA - 35 tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take MINERVA - 35 Depending on the day of the cycle on which one tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom. In case of doubt, contact your doctor.

If you forgot to take any of the 7 hormone-free larger white tablets, you should proceed with your next tablet at the normal time and discard the forgotten hormone-free larger white tablet(s) to avoid any confusion. If you forgot the last tablet of your current pack it is important that you still take the first tablet from the next pack at the correct time.

The following advice refers to the beige tablets (those containing hormones): If you are less than 12 hours late when taking a beige tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets again at the usual time. If you are more than 12 hours late in taking any beige tablets your protection against pregnancy may be reduced. The more beige tablets you have forgotten, the greater the risk that the protection from pregnancy is reduced. There is a particularly high risk of becoming pregnant if you miss beige tablets at the beginning, right after the larger white tablets, or at the end (the last of the 21 beige tablets). If a beige tablet has been missed for more than 12 hours, use extra contraceptive precautions (barrier method) for the next 7 days.

More than one tablet forgotten in a pack: Contact your doctor. Do not take more than 2 beige tablets on a given day, to make up for missed pills. If you have forgotten beige tablets in a pack, and you do not have the expected bleeding that should start while taking tablets from the silver section of your pack, you may be pregnant. Contact your doctor before you start the next pack.

What to do if you vomit or have severe diarrhoea If you vomit or have severe diarrhoea after taking any of the beige tablets, the active ingredients in that tablet may not have been completely absorbed. If you vomit within 3 to 4 hours after taking your tablet, this is like missing a tablet. Therefore, follow the advice under ‘If you forget to take MINERVA - 35’. If you have severe diarrhoea, please contact your doctor. Vomiting or diarrhoea while taking the 7 hormone-free larger white tablets at the end of your blister does not have an influence on the contraceptive reliability.

For how long MINERVA - 35 should be used? The length of use depends on the severity of your symptoms and their response to treatment. In general, treatment should be carried out over several months. Acne and seborrhoea usually respond sooner than hirsutism. It is recommended to take MINERVA - 35 for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence, weeks or months after discontinuation of tablet-taking, treatment with MINERVA - 35 may be resumed. In case of a restart of MINERVA - 35 (following a 4 week or greater pill free interval), the increased risk of VTE should be considered (see also section ‘MINERVA - 35 and blood clots’).

If you stop taking MINERVA - 35 You can stop taking MINERVA - 35 at any time. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking MINERVA - 35 and wait for a menstrual period before starting to try to become pregnant. You will be able to calculate the expected delivery date more easily.

MINERVA - 35 can have side effects. Not all side effects reported for MINERVA - 35 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MINERVA - 35, please consult your health care provider for advice.

Frequent side effects:

• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness

Less frequent side effects:

• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex or increased interest in sex
• breast enlargement
• vaginal discharge
• breast discharge
• rash
• urticaria (hives)
• erythema nodosum or multiforme (skin disorders)
• venous blood clot
• contact lens intolerance
• allergic reactions (hypersensitivity)
• weight loss

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MINERVA - 35.

Keep this medicine out of the sight and reach of children. Store at or below 30 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).