Cerazet 75 micrograms film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cerazet 75 micrograms

film-coated tablets

Desogestrel

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Cerazet is and what it is used for

Cerazet is used to prevent pregnancy. Cerazet contains a small amount of a type of female sex hormone, the progestogen desogestrel. For this reason, Cerazet is known as a progestogen-only pill. Unlike combined pills, the progestogen-only pill does not contain oestrogen-type hormones along with the progestogen.

Most progestogen-only pills work mainly by preventing sperm from entering the uterus, but do not always prevent the egg from maturing, which is the main action of combined pills. Cerazet is different from other progestogen-only pills because it has a dose that in most cases is high enough to prevent the egg from maturing. Therefore, Cerazet provides high contraceptive effectiveness.

Unlike the combined pill, Cerazet can be taken by women who do not tolerate oestrogens and by women who are breastfeeding. A disadvantage is that you may experience irregular vaginal bleeding while using Cerazet. You may also have no bleeding at all.

2. What you need to know before starting to take Cerazet

Cerazet, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted infections.

Do not take Cerazet

• if you are allergic to desogestrel or to any of the other components of Cerazet (listed in section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [for example, in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
• if you have or have previously had jaundice (yellowing of the skin) or severe liver disease and your liver is still not functioning normally.
• if you have or are suspected of having a steroid sex hormone-related cancer, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Inform your doctor before using Cerazet if any of these conditions apply to you. Your doctor may recommend that you use a non-hormonal method of birth control.

Contact your doctor immediately if any of these conditions occur for the first time while you are using Cerazet.

Warnings and precautions

Inform your doctor before starting to use Cerazet if:

? you have ever had breast cancer;

? you have liver cancer, as a possible effect of Cerazet cannot be ruled out;

? you have ever had a thrombosis;

? you have diabetes;

? you suffer from epilepsy (see section “Use of Cerazet with other medicines”);

? you suffer from tuberculosis (see section “Use of Cerazet with other medicines”);

? you have high blood pressure;

? you have or have had chloasma (yellowish-brown patches on the skin, particularly on the face); in this case, you should avoid intense exposure to sunlight or ultraviolet radiation.

If you use Cerazet under any of the described circumstances, you should remain under medical supervision. Your doctor can explain what you should do.

Breast cancer

Examine your breasts regularly and contact your doctor as soon as possible if you notice a lump in your breasts.

Breast cancer has been observed slightly more frequently in women taking the 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 risk is the same as in women who have never taken it. Breast cancer is rare before the age of 40, but the risk increases as a woman gets older. Therefore, the additional number of diagnosed breast cancers is higher the older the woman is when she stops taking the pill. The duration of pill use is less important.

Among 10,000 women who took the pill for up to 5 years and stopped around age 20, there will be fewer than one additional case of breast cancer observed up to 10 years after stopping the pill, added to the 4 cases normally diagnosed in this age group. Likewise, among 10,000 women who took the pill for up to 5 years and stopped around age 30, there will be 5 additional cases compared to the 44 cases normally diagnosed. In 10,000 women who took the pill for up to 5 years and stopped around age 40, there will be 20 additional cases compared to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills such as Cerazet is believed to be similar to that in women taking combined oral contraceptives, although data do not allow clear conclusions.

The breast cancers found in women taking the pill appear to be less advanced than those found in women not taking the pill. It is unknown whether the difference in breast cancer risk is due to the pill. It may be that women taking the pill undergo more frequent check-ups, leading to earlier detection of breast cancer.

Thrombosis

Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular check-ups”).

Thrombosis is the formation of a blood clot that can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from the veins where it formed, it can travel to and block the arteries in the lungs, causing what is known as a “pulmonary embolism,” which can be fatal. Deep vein thrombosis is rare. It can develop whether or not you are taking the pill. It may also occur during pregnancy.

The risk of thrombosis is higher in users of oral contraceptives than in non-users. The risk in users of progestogen-only pills such as Cerazet is believed to be lower than in users of combined oral contraceptives (which contain estrogens).

Psychiatric disorders

Some women using hormonal contraceptives such as Cerazet have reported depression or depressed mood. Depression can be severe and may sometimes 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 clinical data available on the safety and efficacy in adolescents under 18 years of age.

Use of Cerazet with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines or herbal products. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Cerazet. They can advise you whether you need to use additional contraceptive measures (for example, use of condoms), and if so, for how long, or whether you need to modify the use of the other medicine.

Some medicines:

• may affect the levels of Cerazet in the blood,
• may make it less effective in preventing pregnancy,
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (for example, primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
• tuberculosis (for example, rifampicin, rifabutin),
• HIV infection (for example, ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (for example, boceprevir, telaprevir),
• other infections (for example, griseofulvin),
• high blood pressure in the pulmonary blood vessels (bosentan),
• depressive mood (herbal products containing St. John’s wort),
• certain bacterial infections (for example, clarithromycin, erythromycin),
• fungal infections (for example, ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina, or certain heart rhythm disorders (for example, diltiazem).

If you are taking medicines or herbal products that could reduce the effectiveness of Cerazet, a barrier contraceptive method should also be used. Since the effect of another medicine on Cerazet may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during that time. Your doctor can advise you whether you need additional contraceptive measures and, if so, for how long.

Cerazet may also interfere with the effect of other medicines, causing an increase in effect (for example, cyclosporine) or a decrease in effect (for example, lamotrigine).

Consult your doctor or pharmacist before taking any medicine.

Pregnancy and breastfeeding

Pregnancy

Do not use Cerazet if you are pregnant or suspect you may be pregnant.

Breastfeeding

Cerazet can be used during breastfeeding. Cerazet does not appear to affect the quantity or quality of breast milk. However, a decrease in breast milk production has been reported infrequently during use of Cerazet. A small amount of the active ingredient of Cerazet passes into breast milk.

The health of breastfed infants whose mothers used Cerazet has been studied up to 7 months of breastfeeding and followed until the children were 2.5 years old. No effects on growth or development of the children were observed.

If you are breastfeeding and wish to use Cerazet, consult your doctor.

Driving and use of machines

There is no indication that the use of Cerazet affects alertness or concentration ability.

Cerazet contains lactose

This medicine contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Regular check-ups

During treatment with Cerazet, your doctor will require you to undergo regular check-ups. In general, the frequency and nature of these check-ups will depend on your individual circumstances.

3. How to take Cerazet

When and how to take Cerazet

The Cerazet blister pack contains 28 tablets. There are arrows printed on the front side of the blister, between the tablets. If you turn the blister over and look at the back side, you will see the days of the week printed on the foil. Each day corresponds to one tablet.

Each time you start a new Cerazet blister, take a tablet from the top row, but not any tablet. For example, if you start on a Wednesday, you should take the tablet in the top row marked (on the back) “WED”. Continue taking one tablet daily until the blister is empty, always following the direction of the arrows. By looking at the back of the blister, you can easily check whether you have already taken your tablet for a given day.

Take your tablet at approximately the same time each day, swallowing it whole with water. You may experience some bleeding while using Cerazet, but you should continue taking the tablets as usual. When you finish one blister, start a new one the next day, without leaving any tablet-free interval and without waiting for bleeding to occur.

Starting the first pack of Cerazet

• If you have not used hormonal contraception in the previous month:

Wait for your menstrual period and take the first Cerazet tablet on the first day of your period. In this way, you do not need to use additional contraceptive precautions.

You may also start on days 2 to 5 of your cycle, but in this case, make sure to use an additional contraceptive method (barrier method, condom) during the first 7 days of tablet use.

• When switching from a combined oral contraceptive, vaginal ring, or transdermal patch:

You may start taking Cerazet the day after taking the last tablet of your current pack or the day of removal of the vaginal ring or transdermal patch (this means you do not need to leave a tablet-, ring-, or patch-free interval). If your current pill contains inactive tablets, you may start Cerazet the day after taking the last active tablet (if you are unsure, consult your doctor or pharmacist). By following these instructions, no additional contraceptive precautions are necessary.

You may also start the day after the tablet-, ring-, or patch-free interval or after the inactive tablets of your current contraceptive. If you follow these instructions, ensure you use an additional contraceptive method (barrier method) during the first 7 days of tablet intake.

• If you were using another progestogen-only pill:

You may stop your current preparation at any time and start Cerazet immediately. You will not need additional contraceptive precautions.

• If you were using an injectable, implant, or intrauterine system releasing progestogen (IUS):

Start using Cerazet at the time you would receive your next injection or on the day your implant or IUS is removed. No additional contraceptive precautions are necessary.

• After childbirth:

You may start Cerazet between days 21 and 28 after the birth of your baby. If you start later, ensure you use an additional contraceptive method (barrier method) during the first 7 days of tablet intake. However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Cerazet. You can find more information about breastfeeding in section “Pregnancy and breastfeeding” in point 2. Your doctor can also advise you.

• After an abortion:

Your doctor will advise you.

If you forget to take Cerazet

• If less than 12 hours have passed since the usual time of taking the tablet, the effectiveness of Cerazet is maintained. 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 since the usual time of taking the tablet, effectiveness may have been reduced. The more consecutive tablets you miss, the greater the risk that contraceptive effectiveness has decreased. Take the most recently missed tablet as soon as you remember and continue taking the following tablets at your usual time, also using an additional contraceptive method (barrier method) for the next 7 days.

If you miss one or more tablets during the first week of treatment and have had sexual intercourse during the week before missing the tablets, there is a possibility you may be pregnant. Consult your doctor.

If you experience gastrointestinal disturbances (e.g., vomiting, severe diarrhoea)

Follow the instructions for missed tablets. If you vomit within 3–4 hours after taking your Cerazet tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Cerazet than you should

No serious harmful effects have been reported from taking too many Cerazet tablets at once. Possible symptoms include nausea, vomiting, and, in girls, slight vaginal bleeding. For further information, consult your doctor.

If you stop taking Cerazet

You may stop taking Cerazet at any time. From the day you stop taking it, you will no longer be protected against pregnancy.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Cerazet may cause adverse effects, although not everyone experiences them.

Serious adverse effects that may be associated with the use of Cerazet are described in the sections “Breast cancer” and “Thrombosis” in section 2, “What you need to know before starting to take Cerazet”. Please read this section carefully for detailed information and consult your doctor immediately if necessary.

Seek immediate medical attention 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).

Irregular vaginal bleeding may occur during use of Cerazet. This may be light spotting that may not even require a sanitary pad, or heavier bleeding resembling a light menstruation that requires sanitary protection. It may also happen that you do not have any bleeding at all. Irregular bleeding is not a sign that the contraceptive protection provided by Cerazet is reduced. In general, no action is needed other than continuing to take Cerazet. However, if the bleeding is heavy or prolonged, consult your doctor.

The following adverse effects have been reported by users of Cerazet:

Frequent (may affect up to 1 in 10 women):

• mood changes, depressed mood, decreased sex drive (libido)
• headache
• nausea
• acne
• breast pain, irregular menstruation or absence of menstruation
• weight gain

Uncommon (may affect up to 1 in 100 women):

• vaginal infection
• discomfort when wearing contact lenses
• vomiting
• hair loss
• painful menstruation, ovarian cysts
• fatigue

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

• rash, urticaria, painful purple lumps on the skin (erythema nodosum) (skin reactions)

Frequency not known (frequency cannot be estimated from available data):

• allergic reactions

In addition to these adverse effects, breast milk secretion may occur.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cerazet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Keep the blister pack in the original sachet to protect it from light and moisture. Use within 1 month from the date of first opening of the sachet.

The active substance poses a medium environmental risk to fish.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cerazet

• The active substance is desogestrel (75 micrograms).
• The other components (excipients) are anhydrous colloidal silica, all-rac -?-tocopherol, maize starch, povidone, stearic acid, hypromellose, macrogol 400, talc and titanium dioxide (E 171); lactose monohydrate (see also “Cerazet contains lactose” in section 2).

Appearance of the product and contents of the pack

A Cerazet blister pack contains 28 round, film-coated white tablets. The tablets are marked with the code KV over 2 on one side and ORGANON? on the other. Each carton contains 1, 3, 6 or 13 blisters, each packed in an individual pouch.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon,

Kloosterstraat 6,

5349 AB Oss,

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany, Austria, Belgium, Denmark, Finland, Greece, Ireland, Italy, Luxembourg, Norway, The Netherlands, Portugal, United Kingdom, Sweden: Cerazette.

Spain: Cerazet.

Date of the most recent review of this summary: November 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)