Cerazette

(Desogestrel)

The active ingredient in Cerazette is desogestrel. Desogestrel is a progestogen, a man-made version of the natural sex hormone progesterone. Cerazette works mainly by stopping ovulation, which means it prevents the release of an egg from the ovaries each month. It also thickens the mucus in the cervix, making it harder for sperm to reach an egg, and changes the lining of the womb. Because it does not contain estrogen, Cerazette belongs to the group of hormonal contraceptives called progestogen-only pills and is different from the combined pill.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Cerazette. However, the following is a synopsis of the general guidelines for the use of Cerazette:

• The Cerazette pack contains 28 tablets. Take one tablet every day, at about the same time, with water.

• Take Cerazette continuously with no tablet-free break. Start a new pack the day after you finish the previous one.

• When you first take Cerazette, it is usually started on the first day of your period. If you start on days 2–5, you may need an additional contraceptive barrier method for the first 7 days.

• You may take Cerazette with or without food.

• If you forget a tablet and are more than 12 hours late, follow the missed dose instructions in the leaflet and use an additional contraceptive method as advised.

• You may notice irregular bleeding or sometimes no bleeding at all while you take Cerazette. This is common with the mini pill.

• Cerazette, like other oral contraceptives, does not protect against HIV or other sexually transmitted diseases, so a barrier method such as condoms may still be needed.

Some mild or common side effects of Cerazette include:

• Mood changes or depressed mood.
• Decreased sexual desire (low libido).
• Headache.
• Nausea.
• Acne.
• Breast pain or breast tenderness.
• Irregular bleeding, spotting, or no menstruation at all.
• Increased body weight.

Some individuals may experience serious side effects while using Cerazette. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of a blood clot (thrombosis). Symptoms include severe pain or swelling in a leg, chest pain, sudden breathlessness, or coughing up blood, which may indicate pulmonary embolism.
• Signs of liver problems, such as severe stomach pain or jaundice (yellowing of the skin or eyes).
• A suspected breast lump or changes in the breast that may suggest breast cancer.
• Sudden or severe lower abdominal pain, which could suggest ectopic pregnancy.
• Unusual, heavy vaginal bleeding.
• Signs of a serious allergic reaction, such as rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.

These are not all of the possible side effects of Cerazette. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Cerazette, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Ever had breast cancer or a cancer that grows in response to sex steroid hormones.
• Liver cancer, severe liver disease, or jaundice.
• Ever had a thrombosis or blood clot, such as deep vein thrombosis or pulmonary embolism.
• Diabetes.
• Epilepsy.
• Tuberculosis.
• High blood pressure.
• A history of chloasma (yellow-brown pigmentation of the skin, often on the face).

Have a thrombosis (blood clot) or a history of serious clotting problems.

Have jaundice or severe liver disease.

Have a known or suspected cancer that is influenced by sex steroid hormones, such as certain breast cancers.

Have unexplained vaginal bleeding.

Are pregnant or think you might be pregnant.

Are allergic to desogestrel or any of the other ingredients in Cerazette.

When you take Cerazette on the first day of your period, you are usually protected from pregnancy straight away. If you start on days 2–5 of your cycle, you will need to use an additional contraceptive barrier method, such as condoms, for the first 7 days. If you start Cerazette after using another hormonal contraceptive or after emergency contraception, follow the specific timing instructions in the leaflet or from your healthcare provider to ensure continuous birth control.

When Cerazette is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Certain epilepsy medicines (such as primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital) may stop Cerazette from working properly and can reduce its contraceptive effect.

Tuberculosis medicines (rifampicin, rifabutin) may reduce the effectiveness of Cerazette.

Some HIV medicines (ritonavir, nelfinavir, nevirapine, efavirenz) and hepatitis C medicines (boceprevir, telaprevir) may lower Cerazette levels and make this contraceptive pill less reliable.

The antifungal medicine griseofulvin and the medicine bosentan for high blood pressure in the lungs may reduce the contraceptive effect of Cerazette.

Medical charcoal can reduce the absorption of Cerazette and may make it less effective as a method of contraception.

The herbal remedy St. John’s wort may lower Cerazette levels and reduce its birth control protection.

Cerazette may increase the effect of medicines containing ciclosporine.

Cerazette may decrease the effect of lamotrigine.

The active substance and strength in Cerazette is desogestrel (75 micrograms).

It should be stored at room temperature, away from the reach of children or pets.

Cerazette is manufactured by Organon (New Zealand) Limited.

Yes, it is available from many manufacturers of generic drugs.

You can stop taking Cerazette whenever you wish. From the day you stop, you are no longer protected against pregnancy. If you do not want to become pregnant, talk to your doctor about another form of contraception or barrier method. If you stop Cerazette because you want to get pregnant, it is often suggested to wait until you have had a natural period before trying to conceive, as this can help estimate your baby’s due date.

Cerazette must not be used if you are pregnant or think you may be pregnant.

Cerazette may be used while you are breastfeeding. It does not seem to affect the production or quality of breast milk, although a small amount of desogestrel passes into breast milk.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.