Cerazette

Package leaflet: Information for the user

Cerazette 75 micrograms film-coated tablets

desogestrel
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cerazette is and what it is used for
2. What you need to know before taking Cerazette
3. How to take Cerazette
4. Possible side effects
5. How to store Cerazette
6. Contents of the pack and other information

1. What Cerazette is and what it is used for

Cerazette is used for the prevention of pregnancy. Cerazette contains a small amount of a female sex hormone, the progestogen desogestrel. For this reason, Cerazette is known as a progestogen-only pill (POP). Unlike the combined pill, the POP does not contain an oestrogen hormone in addition to the progestogen.
Most POPs primarily work by preventing sperm from entering the uterus, but do not always prevent the maturation of egg cells—the main action of combined-type pills. Cerazette differs from most POPs in that its dosage is high enough in most cases to prevent the maturation of egg cells. As a result, Cerazette provides high contraceptive effectiveness.
Unlike combined-type pills, Cerazette can be used by women who are intolerant to oestrogens and by women who are breastfeeding. While using Cerazette, a possible disadvantage is that vaginal bleeding may occur at irregular intervals, or there may be no bleeding at all.

2. What you should know before taking Cerazette

Cerazette, like all other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.
Do not take Cerazette

• if you are allergic to desogestrel or to any of the other ingredients of Cerazette (listed in section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
• if you have jaundice (yellowing of the skin), current or past, or severe liver disease and liver function has not yet returned to normal.
• if you have or are suspected to have a cancer sensitive to sex steroid hormones, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Inform your doctor before taking Cerazette if you have any of these conditions. Your doctor may advise you to use a non-hormonal contraceptive method.
Contact your doctor immediately if any of these conditions occur for the first time while you are taking Cerazette.
Warnings and precautions
Inform your doctor before taking Cerazette if:

• you have or have had breast cancer
• you have liver cancer, since a possible effect of Cerazette cannot be excluded
• you have ever had a thrombosis
• you suffer from diabetes
• you suffer from epilepsy (see section “Other medicines and Cerazette”)
• you suffer from tuberculosis (see section “Other medicines and Cerazette”)
• you have high blood pressure
• you have or have had chloasma (yellow-brown patches on the skin, especially on the face); in this case avoid excessive exposure to sunlight or ultraviolet radiation.

When Cerazette is used in the presence of any of the above-mentioned conditions, close medical monitoring may be necessary. Your doctor will explain what to do.
Breast cancer
Check your breasts regularly and contact your doctor as soon as possible if you notice any lump in your breast.
Breast cancer has been found slightly more often in women taking the combined oral contraceptive pill than in women of the same age who do not take it. If a woman stops taking the pill, the risk gradually decreases, so that 10 years after stopping the pill, the risk is the same as in women who have never taken it. Breast cancer is rare under the age of 40, but the risk increases with advancing age. Therefore, the number of additional cases of breast cancer diagnosed is higher the older the woman is when she stops taking the pill. The duration of pill use is less important.
For every 10,000 women who take the pill for periods up to 5 years but stop before age 20, there would be less than 1 additional case of breast cancer diagnosed up to 10 years after stopping treatment, in addition to the 4 cases normally diagnosed in women of this age. Similarly, among 10,000 women who take the pill for periods up to 5 years but stop before age 30, there would be 5 additional cases beyond the 44 normally diagnosed. In 10,000 women who take the pill for periods up to 5 years but stop before age 40, there would be 20 additional cases beyond the 160 normally diagnosed.
The risk of breast cancer in users of progestogen-only pills such as Cerazette is believed to be similar to that of women using the combined pill, but the evidence is less conclusive.
Breast cancer found in women taking the pill appears to be less advanced than that found in women not using the pill. It is not known whether the difference in breast cancer risk is due to the pill. Possibly, women who use the pill are examined more frequently, and therefore breast cancer may be diagnosed earlier. It is important to have regular breast examinations and to contact your doctor if you feel any lump in your breast.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular medical check-ups”).
Thrombosis is the formation of a blood clot that can block a blood vessel. A thrombosis may sometimes occur in the deep veins of the legs (deep vein thrombosis). If this clot detaches from the vein where it formed, it can travel to and block the pulmonary artery, causing what is known as pulmonary embolism. As a result, fatal situations may occur. Deep vein thrombosis is a rare event. It can develop independently of taking the pill and may also occur during pregnancy.
The risk is higher in women who use the pill compared to those who do not.
It is believed that the risk with progestogen-only pills such as Cerazette is lower than that observed in women using pills containing estrogens (combined pills).
Psychiatric disorders
Some women using hormonal contraceptives, including Cerazette, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
Children and adolescents
There are no data available on the efficacy and safety of Cerazette in adolescents under 18 years of age.
Other medicines and Cerazette
Inform your doctor if you are taking, have recently taken, or might take any other medicines or herbal products. Also inform any other doctors or dentists who prescribe medicines (or your pharmacist) that you are taking Cerazette, so they can determine whether additional contraceptive methods (e.g. a condom) are needed, and if so, for how long, or whether it is necessary to adjust the dose of another medicine you are taking.
Some medicines

• may affect blood levels of Cerazette
• may lead to a decrease in contraceptive effectiveness
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),
• tuberculosis (e.g., rifampicin, rifabutin),
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (e.g., boceprevir, telaprevir),
• other infectious diseases (e.g., griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depression (St. John’s wort herbal remedy),
• certain bacterial infections (e.g., clarithromycin, erythromycin),
• fungal infections (e.g., ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g., diltiazem).

If you are taking medicines or herbal products that may reduce the effectiveness of Cerazette, you must also use a barrier contraceptive method. Because the effect of other medicines on Cerazette may last up to 28 days after stopping them, you must use an additional barrier contraceptive method throughout this period. Your doctor can advise you whether you need to take additional contraceptive precautions and for how long.
Cerazette may also interfere with the action of other medicines, causing either an increase (e.g. medicines containing ciclosporin) or a decrease in effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breastfeeding
Pregnancy
Do not use Cerazette if you are pregnant or think you might be.
Breastfeeding
Cerazette can be used during breastfeeding. Cerazette does not appear to affect the quantity or quality of breast milk. However, rare cases of decreased breast milk production have been reported during use of Cerazette. A small amount of the active ingredient of Cerazette passes into breast milk.
The health of children breastfed up to 7 months of age whose mothers used Cerazette has been studied up to the age of 2.5 years. No effects on children's growth and development were observed.
If you are breastfeeding and wish to use Cerazette, contact your doctor.
Driving and using machines
There is no evidence that Cerazette affects alertness or concentration.
Cerazette contains lactose
Cerazette contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Regular medical check-ups
While using Cerazette, your doctor will advise you to return for regular medical check-ups. The frequency and type of these checks normally depend on your individual situation.
Contact your doctor as soon as possible if:

• you have severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, unusual cough, especially if accompanied by coughing up blood (possible signs of thrombosis);
• you have sudden severe stomach pain or jaundice (which may indicate possible liver problems);
• you feel a lump in your breast (which may indicate breast cancer);
• you have sudden or severe pain in the lower abdomen or stomach area (which may indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus);
• you are immobilized or require surgery (consult your doctor at least 4 weeks beforehand);
• you have unusual, heavy vaginal bleeding;
• you think you might be pregnant.

3. How to take Cerazette

When and how to take the tablets?
The Cerazette pack contains 28 tablets. Arrows between the tablets are printed on the front side of the blister. By turning the blister and looking at the back side, the days of the week are visible printed on the aluminium foil. Each day corresponds to one tablet.
Each time a new pack of Cerazette is started, take a tablet from the first row at the top of the blister. Do not start with any random tablet. For example, if you start taking tablets on Wednesday, take the tablet from the top row marked (on the back) with WED. Continue taking one tablet daily until the pack is finished, always following the direction of the arrows. By looking at the back of the blister, it is easy to check whether the tablet for a particular day has already been taken. Take the tablet at approximately the same time each day. The tablet must be swallowed whole, with a little water.
Bleeding may occur while using Cerazette; however, continue taking the tablets as usual. After finishing a pack, start the next pack the following day, without any interruption and without waiting for any bleeding.

When starting the first pack of Cerazette
If no hormonal contraceptive has been used in the previous month:
Wait for the menstrual period before starting. Take the first Cerazette tablet on the first day of menstruation. No additional contraceptive precautions are necessary.
It is also possible to start between the second and fifth day of the cycle, but in this case, it is recommended to use an additional contraceptive method (barrier method) during the first seven days of tablet intake.

Switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch:
You may start taking Cerazette the day after the last active tablet of the previous pill pack, or the day of removal of the vaginal ring or transdermal patch (meaning no pill-free, ring-free, or patch-free interval is observed). If the contraceptive being switched from includes inactive (placebo) tablets, you may start Cerazette the day after taking the last "active" tablet (in case of doubt, consult your doctor or pharmacist). If these instructions are followed, no additional contraceptive precautions are necessary.
You may start taking Cerazette no later than the day after the pill-free, ring-free, patch-free interval, or after the last inactive tablet of your current contraceptive. If following this approach, ensure to use an additional contraceptive method (barrier method) for the first 7 days of tablet intake.

Switching from another progestogen-only pill:
You may stop taking the minipill at any time and start taking Cerazette immediately. No additional contraceptive precautions are necessary.

Switching from a progestogen-releasing injection, implant, or intrauterine device (IUD):
Start using Cerazette on the day the injection is due, or on the day the doctor removes the implant or intrauterine system. No additional contraceptive precautions are necessary.

Immediately after childbirth:
You may start Cerazette between day 21 and day 28 after the birth of the baby. If you start later, ensure to use an additional contraceptive method (barrier method) until you have completed the first 7 days of tablet intake. However, if you have already had sexual intercourse, pregnancy must be excluded before starting Cerazette. For further information for breastfeeding women, see section 2 “Pregnancy and breastfeeding”. Your doctor will provide the necessary instructions.

Immediately after a spontaneous or induced abortion:
Your doctor will provide the necessary instructions.

If you forget to take Cerazette
If less than 12 hours have passed since the usual time of taking the tablet, the reliability of Cerazette remains unchanged. Take the missed tablet as soon as you remember, and take the following tablets at the usual time.

If more than 12 hours have passed, the reliability of Cerazette may be reduced. The greater the number of consecutive missed tablets, the higher the risk that contraceptive effectiveness may be reduced. Take the last missed tablet as soon as you remember, and take the following tablets as usual. For the next 7 days of tablet intake, an additional contraceptive method (barrier method) must be used. If one or more tablets were missed during the first week of starting tablet intake and sexual intercourse occurred in the previous week, pregnancy may have occurred. Consult your doctor.

If you experience gastrointestinal disturbances (e.g. vomiting or severe diarrhoea)
Follow the instructions given for missed tablets. If vomiting occurs within 3–4 hours after taking a Cerazette tablet, or if you have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Cerazette than you should
There are no reports of serious harmful effects following an overdose of Cerazette tablets taken at the same time. Symptoms that may occur include nausea, vomiting, and, in young girls, slight vaginal bleeding. For further information, consult your doctor.

If you stop taking Cerazette
You may stop taking Cerazette at any time. From the day you stop taking the pill, you are no longer protected against pregnancy.
If you have any questions about the use of Cerazette, consult your doctor or pharmacist.

4. Possible side effects

Like all other medicines, Cerazette may cause side effects, although not everyone experiences them.
Serious side effects associated with the use of Cerazette are described in section 2 “What you need to know before taking Cerazette”, subsections “Breast cancer” and “Thrombosis”. Please read this section carefully for further information and consult your doctor promptly when necessary.
You must consult your doctor immediately if you experience allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis).
During the use of Cerazette, irregular vaginal bleeding may occur. This may be only slight spotting that does not require the use of sanitary protection, or it may be heavier bleeding, more similar to a light menstruation and requiring the use of sanitary protection. It is also possible to have no bleeding at all. Irregular bleeding is not a sign that the contraceptive protection provided by Cerazette has decreased. Normally, no intervention is required and you may continue taking Cerazette; however, if bleeding is heavy or prolonged, you should consult your doctor.
Women who use Cerazette have reported the following side effects:
Common: may affect up to 1 in 10 women

• mood changes, depressed mood, decreased sex drive (libido)
• headache
• nausea
• acne
• breast pain, irregular or absent menstrual periods
• weight gain

Uncommon: may affect up to 1 in 100 women

• vaginal infection
• difficulty wearing contact lenses
• vomiting
• hair loss
• painful menstruation, ovarian cyst
• fatigue

Rare: may affect up to 1 in 1,000 women

• skin rash, urticaria, painful bluish-red subcutaneous nodules (erythema nodosum) (these are skin conditions)

Not known (frequency cannot be estimated from the available data)

• allergic reaction

In addition to these side effects, breast discharge may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cerazette

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last
day of that month.
This medicine does not require any special storage temperature. Store the blister in the original
aluminium pouch to protect the medicine from light and moisture. Use within 1 month after first
opening the pouch.
The active substance poses an environmental risk to fish.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Cerazette Contains

• The active substance is: desogestrel (75 micrograms).
• The excipients are: anhydrous colloidal silica; all-rac-α-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E171); lactose monohydrate (see also “Cerazette contains lactose” in section 2).

Description of the Appearance of Cerazette and Pack Sizes
A Cerazette blister contains 28 white, round, film-coated tablets, marked with the code KV on one side and the inscription ORGANON* on the other side. Each carton contains 1, 3, 6, or 13 blisters, each individually packed in a sachet.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Sweden, United Kingdom: Cerazette.
Spain: Cerazet.