Cerazette

• Contraception
• ‘Mini pill’: contains only one hormone
• Highly effective
• Can be used by women who are breastfeeding

Cerazette is used to prevent pregnancy. It contains a small amount of one type of female sex hormone, the progestogen desogestrel. Cerazette is commonly referred to as a mini pill or progestogen-only pill (POP). Contrary to the combined pill, which contains two types of female sex hormone (an oestrogen and a progestogen), Cerazette doesn’t contain an oestrogen. Therefore, Cerazette can be used by women who are breastfeeding.

Most mini pills work primarily by preventing the sperm cells from entering the womb. But they do not always prevent the egg cell from ripening, which is the main way that combined pills work. Cerazette is different from most mini pills in having a dose that in most cases prevents the egg cell from ripening. As a result, Cerazette is a highly effective contraceptive.

Cerazette is taken daily. The tablets can be taken with or without food.

Each strip of Cerazette contains 28 tablets. Take one tablet every day. Arrows are printed on the front of the strip, between the tablets. The days of the week are printed on the back of the strip. Each day corresponds with one tablet. By looking at the back of your pack you can easily check if you have already taken your tablet on a particular day. This way, you won't miss a tablet.

When a strip is empty, you must start with a new strip of Cerazette on the next day. Cerazette does not have a pill-free week. Vaginal bleeding may occur at irregular intervals while using Cerazette. You may also not have any bleeding at all. Irregular bleeding is not a sign that Cerazette is not working.

It is important to take your tablet each day at about the same time to ensure it is effective.

Check the package leaflet to see when to start your first pack of Cerazette. For example, when changing from another contraceptive or after you have had a baby.

Taken too much/forgot to take/stop taking Cerazette

If you have taken more Cerazette tablets than you should, contact your doctor or pharmacist immediately.

Forgot to take Cerazette?

• If you are less than 12 hours late Cerazette will still protect you from pregnancy. Take the missed tablet as soon as you remember and take the next one at the usual time.
• If you are more than 12 hours late Cerazette can be less effective. The more consecutive tablets you have missed, the higher the risk that you might fall pregnant. Take a tablet as soon as you remember and take the next one at the usual time. Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next seven days. If you missed one or more tablets in the very first week of starting the strip and
• had intercourse in the week before missing the tablets, you may fall pregnant. Ask your doctor for advice.
• If you have digestive issues (such as vomiting or severe diarrhoea), follow the advice for forgotten tablets in the section above. If you vomit within three to four hours after taking your Cerazette tablet, have taken activated charcoal, or have severe diarrhoea, the active ingredient may not have been completely absorbed.

You can stop taking Cerazette whenever you want. From the day you stop you are no longer protected against pregnancy.

Cerazette is not suitable for everyone. Do not take this pill if:

• You are allergic to any of the ingredients in Cerazette (see section ‘What Cerazette contains').
• You are pregnant or think you may be pregnant.
• You have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel
• e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have, or have had, jaundice (yellowing of the skin) or severe liver disease and your
• liver is still not working normally.
• You have or are suspected of having a cancer that grows under the influence of sex steroids, such as certain types of breast cancer.
• You have any unexplained vaginal bleeding.

If any of these conditions apply to you, tell your doctor before you start to use Cerazette. Your doctor may advise you to use a non-hormonal method of birth control.

If any of these conditions appear for the first time while using Cerazette, consult your doctor immediately.

When should this medicine be used with caution?

When Cerazette is used in the presence of any of the following conditions, you may need to be kept under close observation. Talk to your doctor or pharmacist before taking Cerazette if:

• You have ever had breast cancer.
• You have liver cancer.
• You have ever had a thrombosis.
• You have diabetes.
• You suffer from epilepsy.
• You have tuberculosis.
• You have high blood pressure.
• You have, or have had, chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face). If so, avoid too much exposure to the sun or ultraviolet radiation.

Pregnancy and breastfeeding

Pregnancy

Do not use Cerazette if you are pregnant or think you may be pregnant.

Breastfeeding

Consult a doctor. Cerazette may be used while you are breastfeeding. Cerazette does not appear to influence the production or the quality of breast milk.

A small amount of the active substance of Cerazette passes over into the milk. There are no known harmful effects on the nursing infant when it is used by breastfeeding mothers. For more information, see the package leaflet.

Other medicines and Cerazette

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or herbal products. This includes medicines that do not require a prescription.

Some medicines can make Cerazette less effective in preventing pregnancy. These include medicines used for the treatment of:

• Epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital).
• Tuberculosis (e.g., rifampicin, rifabutin).
• HIV infections (e.g., ritonavir) or other infectious diseases (e.g., griseofulvin).
• Digestive symptoms (activated charcoal).
• Depressive moods (herbal remedies containing St. John’s Wort).

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.

Cerazette may also interfere with how other medicines work, causing either an increase in effect

(e.g., medicines containing ciclosporin) or a decrease in effect.

Medicines can cause side effects, although some people may not experience any. The following are some of the side effects that have been reported after use of Cerazette:

Common:

• Mood changes, depressed mood.
• Decreased sexual drive (libido).
• Nausea.
• Acne.
• Breast pain.
• Irregular and/or menstruation.
• Weight gain.

Uncommon:

• Infection of the vagina.
• Difficulties in wearing contact lenses.
• Vomiting.
• Hair loss.
• Painful menstruation.
• Ovarian cyst.
• Tiredness.

For a list of rare side effects, please see the package leaflet. See the package leaflet for further information on serious side effects such as thrombosis and certain types of cancer. Consult a doctor if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

The active substance is desogestrel (75 microgram).

The other ingredients are: colloidal anhydrous silica, all-rac-α-tocopherol, maize starch, povidone, stearic acid, hypromellose, macrogol 400, talc, titanium dioxide (E171), lactose monohydrate.

The manufacturer of Cerazette is:

N.V. Organon Postbus 20
5340 BH Oss
The Netherlands

Or:

Organon (Ireland) Limited Drynam Road
P.O. Box 2857
Swords
Co. Dublin
Ireland

Read the package leaflet before use.