Cerazette 28 tablets

Trade Name:

Cerazette 

28 tablets

Composition:

Desogestrel 75 mcg

Inactive ingredients:

Silica, colloidal anhydrous, all- rac-a-tocopherol, lactose monohydrate, maize starch, povidone, stearic acid, hypromellose, macrogol 400, talc and titanium dioxide

Properties:

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 mini-pill. Contrary to combined pills, mini-pills do not contain an estrogen hormone next to the progestogen. Most mini-pills work primarily by preventing the sperm cells from entering the womb but, unlike combined pills, they do not always prevent an egg cell from ripening.

Cerazette is distinct from other mini-pills because, like combined pills, in most cases it does prevent the egg cells 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 oestrogens and by women who are breastfeeding..

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.

Indications:

Prevention of pregnancy.

When Cerazette is taken correctly (without missing tablets), the chance of becoming pregnant is very low.  Cerazette, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Dosage and administration:

-The Cerazette pack contains 28 tablets. Arrows are printed on the front side of the pack, between the tablets. If you turn over your pack, and look at the back side, you will see the days of the week printed on the foil. Each day corresponds to one

tablet. Every time you start a new pack of Cerazette, take a tablet from the top row. Continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of your pack you can easily check if you have already taken your tablet on a particular day. 

-Take your tablet each day at about the same time. 

-Swallow the tablet whole, with water. 

-You may have some bleeding during the use of Cerazette, but you must continue to take your tablets as normal. When a pack is empty, you must start with a new pack of Cerazette on the next day – thus 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.

-On the first day of your period take the first Cerazette® tablet. You need not take extra contraceptive precautions.

You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method for the first 7 days of tablet-taking in the first cycle.

-When you change from a combined pill, vaginal ring, or transdermal patch, you can start taking Cerazette on the day after you take the last tablet from your present contraceptive pack, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring-, or patch-free break). If your present contraceptive pack also contains inactive tablets you can start Cerazette on the day after taking the last active tablet (if you are not sure which this is, ask your doctor. If you follow these instructions, it is not necessary to use an additional contraceptive method.

-You can also start at the latest the day following the tablet-, ring-, patch-free break, or placebo tablet interval, of your present contraceptive. If you follow these instructions, make sure you use during the first cycle an additional contraceptive method for the first 7 days of tablet-taking.

-When you change from another progestogen-only pill (mini-pil), you may stop taking it any day and start taking Cerazette right away. You need not take extra contraceptive precautions.

-When you change from an injectable or implant or a progestogen-releasing intrauterine device (IUD), start using Cerazette® when your next injection is due or on the day that your implant or your IUD is removed. You need not take extra contraceptive precautions.

-If you have just had a baby, you can start Cerazette between 21 and 28 days after the birth of your baby. If you start later, make sure you use during the first cycle an additional contraceptive method for the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before starting Cerazette use. 

-After miscarriage or an abortion, your doctor will advise you.

-If you forget to take one or more tablets

If you are less than 12 hours late in taking a tablet, the reliability of Cerazette is maintained. Take the missed tablet as soon as you remember and take the next tablet at the usual time.

-If you are more than 12 hours late taking any tablet, the reliability of Cerazette may be reduced. The more consecutive tablets you have missed the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and take the next tablet at the usual time. Use a condom too for the next 7 days of tablet-taking. 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. Ask your doctor for advice.

-If you vomit within 3-4 hours after taking your Cerazette tablet or have severe diarrhea, the active ingredient may not have been completely absorbed.  If you have severe diarrhea, please contact your doctor.

-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. -You can stop taking Cerazette at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.

-If you stop using Cerazette because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.

Side effects:

Like all medicines, Cerazette can cause side effects, although not everybody gets them. 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 Cerazette.

• Common: 

-Mood altered, decreased libido-

-Headache

-Nausea

-Acne

-Breast pain, irregular or no menstruation

-Increased body weight

• Uncommon:

-Infection of the vagina

-Difficulties in wearing contact lenses

-Vomiting

-Hair loss

-Painful menstruation, ovarian cyst

-Tiredness

• Rare:

Rash, hives, painful blue- red skin lumps (erythema nodosum)  Apart from these side effects, breast secretion may occur.

In addition, allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis) have been reported.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Contraindications:

Do not use Cerazette® if you have any of the conditions

listed below:

• If you have a thrombosis;
• If you have jaundice (yellowing of the skin) or severe liver disease;
• If you have a cancer that grows under the influence of sex steroid hormones;
• 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 Cerazette.

Warnings and precautions:

• Inform your doctor if any of the following conditions apply to you:

-You have or have had breast cancer;

-You have liver cancer;

-You have ever had a thrombosis;

-You have diabetes;

-You suffer from epilepsy;

-You suffer from tuberculosis;

-You have high blood pressure;

-You have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face):

• 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.

• Every woman is at risk of breast cancer whether or not she takes oral contraceptives. Breast cancer has been found slightly more often in women who take the oral contraceptives than in women of the same age who do not take them.

• Tell your doctor if you are taking or have recently taken any other medicines or herbal products, including medicines obtained without a prescription.

Some medicines may stop Cerazette® from working properly. These include:

-epilepsy medicines (e.g..primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),

-tuberculosis medicines (e.g., rifampicin, rifabutin),

-HIV infection medicines (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)

-Hepatitis C virus infection medicines(e.g., boceprevir, telaprevir),

-other infectious diseases medicines (e.g., griseofulvin),

-high blood pressure in the blood vessels of the lungs medicines (bosentan),

-stomach upset medicines (medical charcoal)

-depressive moods medicines (the herbal remedy St. John’s wort)

• If you are taking medicines herbal products that might make Cerazette® less effective, a barrier contraceptive method should also be used. Since effect of another medicine on Cerazette may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive for that long.

• Vaginal bleeding may occur at irregular intervals during the use of Cerazette. This may be just slight staining which may not even require a pad, or heavy bleeding, which looks rather like a scanty period and requires sanitary protection. You may also not have any bleeding at all.

The irregular bleedings are not a sign that the contraceptive protection of Cerazette® is decreased. In general, you need not take any action; just continue to take Cerazette. However, if bleeding is heavy or prolonged, consult your doctor.

• During the use of all low-dose hormonal contraceptives, small fluid-filled sacs may develop in the ovaries. These are called ovarian cysts. They usually disappear on their own. Sometimes they cause mild abdominal pain. Only rarely, they may lead to more serious problems.

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

Cerazette does not influence the production or the quality of breast milk. However, a small amount of the active substance of Cerazette passes over into the milk. If you are breastfeeding and want to use Cerazette, please contact your doctor.

• If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Cerazette.
• 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 as soon as possible if:

-you notice possible signs of a thrombosis (e.g. severe pain or swelling in the legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood);

-you have a sudden, severe stomach ache or look jaundiced (indicating possible liver problems);

-you feel a lump in your breast;

-you have a sudden or severe pain in the lower part of your belly or the stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb):

-you are to be immobilized (for example being confined to bed) or are to have surgery, consult your doctor at least four weeks in advance;

-have unusual, heavy vaginal bleeding:

-you suspect that you are pregnant.

Storage:

Store between 2°C to 30°C, protected from light and moisture. 

Package:

Carton box holds 1 blister of 28 white round tablets.