Contrez Film-Coated Tablets

CONTREZ is a combined oral contraceptive (“the combined tablet”) consisting of 24 pink tablets with active ingredients and 4 white inactive tablets. Each active tablet contains a small amount of two different female hormones. These are drospirenone (a progesterone) and ethinylestradiol (an oestrogen). Because of the small amounts of hormones, CONTREZ is considered a low-dose oral contraceptive.

CONTREZ is used:

• to prevent pregnancy.
• for the treatment of moderate acne vulgaris in women seeking oral contraception.
• for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control.

Do not take CONTREZ if you:

• are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of CONTREZ (listed in section 6). This may cause itching, rash or swelling.
• have (or had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs.
• know you have a disorder affecting your blood clotting (for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, or antiphospholipid antibodies).
• Have (or had) a blood clot in your arteries (arterial thromboembolism).
• need an operation or if you are off your feet for a long time (see section ‘Blood clots’).
• have ever had a heart attack or stroke.
• have (or had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms).
• have any of the following diseases that may increase your risk of a clot in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia (a condition that can lead to arterial damage and blood clots in your blood vessel).
• have (or had) a type of migraine called ‘migraine with aura’.
• have (or had) a liver disease and your liver function is still not normal.
• kidneys are not working well (renal failure).
• have (or had) a tumour in the liver.
• have (or had) or if you are suspected of having breast cancer or cancer of the genital organs.
• have any unexplained bleeding from the vagina.

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is: The CONTREZ pack contains 28 tablets (24 active tablets and 4 inactive tablets). The first course of CONTREZ is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday) The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once you have selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 or 3 after starting the inactive tablets and may not have finished before the next pack is started. Each subsequent pack is started in the silver section the day after the last tablet of the current pack.

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

If any of the following happens, stop taking CONTREZ and tell your doctor immediately or go to the casualty department at your nearest hospital:

• ‘Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing’,
• Rash or itching,
• Fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to CONTREZ. You may need urgent medical attention or hospitalisation.

• Keep out of reach and sight of children.

• Store at or below 30ºc.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).