What does it contain?

Each strip of Cerazette contains 28 white round tablets marked with the letters KV above 2 on one side and Organon * on the other. Each film coated tablet contains:

• active ingredient: desogestrel (75 microgram)
• other ingredients: silica, colloidal anhydrous; α -tocopherol; lactose monohydrate; maize starch; povidone; stearic acid. Each film coated tablet is covered with a thin coating of hypromellose; macrogol 400; talc and titanium dioxide (E 171).

Cerazette comes in a pack of 3 strips. Each strip is sealed in a foil sachet.

How does it work?

Cerazette contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Cerazette is called a progestogen-only-pill (POP), or a minipill. Unlike the combined pill, the POP or mini-pill does not contain an oestrogen hormone but only a progestogen. Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the primary action of combined pills. Cerazette is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Cerazette provides high contraceptive efficacy. In contrast to the combined pill, Cerazette can be used by women who do not tolerate estrogens and by women who are breast-feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Cerazette. You also may not have any bleeding at all.

Why is it used?

To prevent pregnancy.

Before you start to use Cerazette

If Cerazette is used in the presence of any of the conditions listed below, you may need to be kept under close observation. Your doctor can explain to you what to do. Therefore, if any of these apply to you, tell your doctor before starting to use Cerazette:

• you have or have had cancer of the breast;
• you have cancer of the liver;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy;
• you suffer from tuberculosis;
• 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.

Potentially serious conditions

Decreased Bone Mass

Estrogens are important to maintain the strength of your bones. During the use of Cerazette, the concentration in your blood of the natural estrogen estradiol is comparable to the concentration seen in the first half of your natural cycle but is decreased in comparison with the second half of the natural cycle. It is not known whether this has an effect on the strength of your bones.

 

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the Pill.

Breast cancer is rare under 40 years of age but the risk increases as the woman gets older.

Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, this reduces the risk, so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancers seem less likely to have spread when found in women who take the Pill, than in women who do not take the Pill.

It is not certain whether the Pill causes the increased risk of breast cancer. It may be that women taking the Pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill, but by the age at which she is using the pill. This is because the risk of breast cancer strongly increases as a woman gets older.

In every 10,000 women who take the combined Pill for up to 5 years but stop taking it by the time they are aged 20, it is estimated that less than 1 additional case of breast cancer would be found up to 10 years afterwards, compared to the 4 cases diagnosed in 10,000 women in this age group who have never taken the Pill. For 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases found up to 10 years afterwards (in addition to the 44 cases of breast cancer found in 10,000 women in this age group who have never taken the Pill). In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases found up to 10 years afterwards (in addition to 160 cases of breast cancer found in 10,000 women in this age group who have never taken the Pill).

The estimated risk in women who take progestagen-only Pills such as Cerazette is possibly of a similar magnitude as that found in users of the combined Pill. The possible extra risk of being diagnosed with breast cancer has to be weighed against the known benefits of taking the progestagen-only Pill.

Thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called 'pulmonary embolism'. People do not always fully recover from a thrombosis, and very rarely, they are fatal. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. It has been suggested, on the basis of statistical evidence, that the risk of developing thrombosis is slightly greater in women who take the Pill than in those who do not. However, such associations are less clear with progestagen-only Pills. Risk factors for deep venous thrombosis include obesity, having a member in your family who has suffered from venous thrombosis at a young age and having varicose veins. The risk of deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (e.g. you are in bed after an accident or you have a plaster cast on a broken leg). If any of these conditions apply to you before you decide to take Cerazette or while you are taking Cerazette you must discuss them with your doctor.

Signs and symptoms of blood clots are given in the section 'When should you contact your doctor'.

Other Medicines

Some medicines may stop the pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, hydantoins, barbiturates, carbamazepine, felbamate, oxcarbamazepine), tuberculosis (e.g. rifampicin, rifabutin), HIV infection (ritonavir), fungal infections (griseofulvin), medical charcoal used for stomach upset and products containing St. Johns Wort (hypericum perforatum). Always tell the doctor, who prescribes Cerazette, which medicines you are already using.

Pregnancy

Cerazette must not be used by women who are pregnant,or who think they may be pregnant.

Breast feeding

Cerazette does not influence the production or the quality of breast milk. Small amounts of the active substance in Cerazette are found in breast milk. As a result, 0.01 to 0.05 microgram per kg body weight per day may be ingested by the baby, but there are no indications of any risk. Tell your doctor if your baby shows any signs or symptoms which you think might be related to the use of Cerazette.

Ability to Drive

There are no indications of any effect of the use of Cerazette on alertness and concentration.

WHEN SHOULD YOU CONTACT YOUR DOCTOR

Regular check-ups

When you are using Cerazette, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

Contact your doctor immediately if:

• you notice possible signs of a thrombosis (e.g. severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when accompanied by blood spitting);
• you have a sudden, severe stomach ache or jaundice (indicating possible liver problems);
• you feel a lump in your breast;
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.

When and how to take the tablets?

Each strip of Cerazette contains 28 tablets. Arrows are printed on the front side of the strip, between the tablets. If you turn the strip over, next to each tablet is printed the day of the week each tablet should be taken. Take your tablet at about the same time each day. Swallow each tablet whole, with water. Each time you start a new strip of Cerazette, take a tablet in the top row. For example if you start on a Wednesday, you should take the tablet from the top row marked WED. You should continue to take one tablet a day until the strip is empty, always following the direction indicated by the arrows. In this way you can easily check whether you have taken your daily tablet. You may have some bleeding during the use of Cerazette (see Undesirable Effects), but you must continue to take your tablets as normal. When a strip is empty, you must start with a new pack of Cerazette on the next day - without interruption and without waiting for a bleed. You can stop taking Cerazette whenever you want. From the day you stop you are no longer protected against pregnancy.

Starting your first pack of Cerazette

If you are not using hormonal contraception at present (or in the past month)

Wait for your period to begin. On the first day of your period take the first Cerazette tablet, additional contraceptive precautions are not necessary. If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet taking.

When you change from a combined pill (COC)

Start Cerazette on the day after the last active tablet of the COC, additional contraceptive precautions are not necessary.

When you change from a mini-pill (POP), injection, implant or hormonal IUS.

Switch on any day from another mini pill. Start Cerazette the day an implant or IUS is removed or the day your next injection would be due, additional contraceptive precautions are not necessary.

If you have a baby or abortion.

Start immediately after first trimester abortion, additional contraceptive precautions are not necessary. After delivery or second trimester abortion, start before periods return. If more then 21 days have elapsed, pregnancy must be ruled out and an additional barrier method of contraception should be used for the first 7 days.

If you forget to take one or more tablets

If you are more than 12 hours late:

Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two tablets in one day. This is not harmful. (If you have forgotten more than one tablet you don't need to take the earlier missed ones). You are not protected against pregnancy. 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 are more than 12 hours late taking your tablet and have had sex it is safe to use emergency contraception, please consult your pharmacist or doctor.

If you are less than 12 hours late:

Take the tablet as soon as you remember, and take the next one at the usual time. The contraceptive action of Cerazette is maintained.

If you missed one or more tablets in the first week of tablet intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Ask your doctor for advice.

If you vomit or use medical charcoal

If you vomit or use medical charcoal within 3 - 4 hours after taking your Cerazette tablet, the active ingredient may not have been completely absorbed. Follow the advice for missed tablets.

If too many Cerazette tablets are taken (overdose)

There have been no reports of serious harmful effects from taking too many Cerazette tablets at one time. Symptoms that may occur are nausea, vomiting and, in women or girls, slight vaginal bleeding. For more information ask your doctor for advice.