Mercilon ® 0,15 mg/0,02 mg Tablets

MERCILON is a combined oral contraceptive (‘the combined Pill’) used to prevent pregnancy.

Do not take MERCILON:

• If you have, or have had in the past a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs.
• If you have or have had a heart attack or stroke in the past.
• If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
• If you have a disturbance of blood clotting (e.g., protein C deficiency).
• If you need major surgery (e.g., an operation) and your ability to move around is limited for a long period of time (see The Pill and Thrombosis).
• If you have (had) a type of migraine called “migraine with aura”.
• If you have diabetes mellitus with blood vessel damage.
• If you have a serious risk factor, or several risk factors for developing thrombosis, this may also be a reason why you cannot use MERCILON (see The Pill and Thrombosis).
• If you have or have had pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood.
• If you have jaundice (yellowing of the skin) or have (had) severe liver disease and your liver is not yet working normally.
• If you have or have 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 had a liver tumour.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant.
• If you are allergic to any of the ingredients of MERCILON.

Do not use MERCILON if you have Hepatitis C and are taking the combination medicine regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see Other medicines and MERCILON).

When and how to take the tablets

The MERCILON pack contains 28 white tablets: 21 large tablets with the active substances and 7 small tablets without active substances. On the pack, each tablet is marked with the day of the week on which it is to be taken. One tablet is to be taken daily for 28 consecutive days. Take your tablet at about the same time each day, with some liquid if necessary. The first tablet should be taken from the blister in the green section of the calendar pack marked with the appropriate day of the week. Follow the direction of the arrows until all 28 tablets have been taken. A period should begin during the 7 days that you use the placebo tablets (the withdrawal bleed). Usually, it will start on day 2 to 3 after the last large tablet. Start taking your next pack immediately after the last placebo tablet, 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, each month.

Starting your first pack of MERCILON

When no hormonal contraceptive has been used in the past month

Start taking MERCILON on the first day of your cycle i.e., the first day of menstrual bleeding. Take a tablet marked with that day of the week, starting in the green section of the calendar pack. For example, if your period starts on a Friday, take the tablet marked Friday in the green section of the calendar pack. Then follow the days in order in the direction of the arrows. MERCILON will work immediately. You do not need to use an additional contraceptive method. You may also start on days 2 to 5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

MERCILON can have side effects. Not all side effects reported for MERCILON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MERCILON, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by the Pill.

Serious Side Effects

Serious reactions associated with the use of the Pill, as well as the related symptoms, are described in the sections The Pill and Thrombosis and The Pill and Cancer. Please read these sections for additional information and consult your doctor at once where appropriate.

Other Possible Side Effects

The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.

• Common (occurring in more than one per 100 users): depressed mood, mood changes, headache, nausea, abdominal pain, breast pain, breast tenderness, increase or decrease in body weight
• Uncommon (occurring in more than one per 1000 users but not more than one per 100 users): fluid retention, decreased or increased sexual drive, migraine, vomiting, diarrhoea, rash, hives, breast enlargement
• Rare (occurring in less than one per 1000 users): hypersensitivity reactions, blood clot in a vein, blood clot in an artery, contact lens intolerance, erythema nodosum, erythema multiforme (these are skin conditions), breast secretion, vaginal secretion.
• Unknown (frequency cannot be estimated from the available data): suicidal thoughts/behaviour and suicide

Store at 2 to 30 °C. Protect from light and moisture. Keep all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).