Contrezin 3 mg/0.03 mg Film-Coated Tablets

CONTREZIN is a combined oral contraceptive (“the combined tablet”) consisting of 21 light yellow tablets with active ingredients and 7 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, CONTREZIN is considered a low-dose oral contraceptive.

CONTREZIN is used:

• to prevent pregnancy.

Do not take CONTREZIN if you:

• are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (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.
• 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
• 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
• have inflammation of the liver (hepatitis C) and are taking the medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or medicine containing glecaprevir/ pibrentasvir (see also in section “Other medicines and CONTREZIN ”).

Warnings and precautions

Tell your doctor or health care provider before starting CONTREZIN if:

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 CONTREZIN pack contains 28 tablets (21 active tablets and 7 inactive tablets). The first course of CONTREZIN 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. If you start CONTREZIN during the latter part of the week, the first cycle may be slightly shortened.

Starting your first pack of CONTREZIN:

When no hormonal contraceptive has been used in the past month:

Start taking CONTREZIN on the first day of your cycle, i.e. the first day of menstrual bleeding. Take the tablet marked with that day of the week from the silver section of the pack. For example, if your period starts on a Friday, take the tablet marked “FR”. Then take 1 tablet every day following the directions shown by the arrows. During the first cycle an additional barrier method is recommended for the first 7 days of tablet-taking.

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

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

• Allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching)
• Rash or itching,
• Fainting

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Depressive mood,
• headache,
• migraine,
• nausea,
• menstrual disorders,
• intermenstrual bleeding,
• breast pain,
• breast tenderness,
• leucorrhoea,
• vaginal moniliasis
• stomach pain
• blood in the urine
• increased body weight

Less frequent side effects:

• Asthma,
• hypersensitivity,
• an increased sex drive,
• decreased sex drive,
• hearing problems (hypoacusis),
• hypertension,
• hypotension ,
• Blood clots in the veins
• Blood clots in the arteries
• vomiting,
• diarrhoea,
• acne,

• 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).