CERAZET 75 micrograms FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cerazet 75 micrograms

film-coated tablets

Desogestrel

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Cerazet and what is it 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 hormones in addition to the progestogen.

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

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 during the use of Cerazet. You may also not bleed at all.

2. What you need to know before you start taking Cerazet

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

Do not take Cerazet

• if you are allergic to desogestrel or any of the other ingredients 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 had liver disease, or if you have ever had a liver tumour.
• if you have or are suspected to have a hormone-sensitive cancer, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Tell 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.

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

Warnings and precautions

Tell your doctor before starting to use Cerazet if:

? you have ever had breast cancer;

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

? you have ever had a thrombosis;

? you have diabetes;

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

? you suffer from tuberculosis (see section “Using 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 exposure to the sun or to UV radiation.

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

Breast cancer

Regularly inspect your breasts and contact your doctor as soon as possible if you notice any lump in your breasts.

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 a woman stops taking the pill, the risk decreases gradually, so that 10 years after stopping the pill the risk is the same as for women who never took the pill. Breast cancer is rare in women under 40 years of age, but the risk increases as a woman gets older. Therefore, the additional number of breast cancers diagnosed is greater the older the woman is when she stops taking the pill. The duration of use of the pill is not as important.

Of 10,000 women who have taken the pill up to 5 years and who stop taking it around the age of 20, there will be less than one additional case of breast cancer diagnosed in the next 10 years, which will be added to the 4 cases normally diagnosed in this age group. Similarly, of 10,000 women who have taken the pill up to 5 years and who stop taking it around the age of 30, there will be 5 additional cases, in addition to the 44 cases normally diagnosed. In 10,000 women who have taken the pill up to 5 years and who stop taking it around the age of 40, there will be 20 additional cases, in addition to the 160 cases normally diagnosed.

It is believed that the risk of breast cancer in users of progestogen-only pills like Cerazet is similar to that of women who take the pill, although the data do not allow clear conclusions to be drawn.

It appears that breast cancers found in women who take the pill are less advanced than breast cancers found in women who do not take the pill. It is not known whether the difference in breast cancer risk is due to the pill. It may be that women who are screened more often, so that breast cancer is detected earlier.

Thrombosis

Contact your doctor immediately if you notice any of the following 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 has formed, it can reach and block the arteries of 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 can also occur if you become pregnant.

The risk of thrombosis is greater in users of the pill than in non-users. It is believed that the risk in users of progestogen-only pills like Cerazet is lower than in users of pills that also contain oestrogens (combined pills).

Psychiatric disorders

Some women who use hormonal contraceptives like Cerazet have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and symptoms of depression, contact your doctor for further medical advice as soon as possible.

Children and adolescents

There are no clinical data available on the safety and efficacy in adolescents under 18 years of age.

Using Cerazet with other medicines

Tell your doctor if you are using or have recently used or might use other medicines or herbal products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking Cerazet. They can tell you if you need to take additional contraceptive precautions (for example, use a barrier method) and if so, for how long, or whether the use of another medicine should be changed.

Some medicines

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

These include medicines used for the treatment of:

• 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 (products containing the herbal remedy St. John's Wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazol, itraconazol, fluconazol),
• high blood pressure, angina, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that may make Cerazet less effective, you should also use a barrier method of contraception. Since the effect of another medicine on Cerazet may last up to 28 days after stopping the medicine, during this time you should also use a barrier method of contraception. Your doctor can tell you whether you need to take additional contraceptive precautions and, if so, for how long.

Cerazet may also interfere with the effect of other medicines, causing an increase in effect (e.g. medicines containing ciclosporin) or a decrease in effect (e.g. lamotrigina).

Consult your doctor or pharmacist before taking any other medicine.

Pregnancy and breastfeeding

Pregnancy

Do not use Cerazet if you are pregnant or think you might be pregnant.

Breastfeeding

Cerazet can be used during breastfeeding. Cerazet does not appear to affect milk production or the quality of breast milk. However, it has been reported that milk production decreases occasionally during the use of Cerazet. A small amount of the active substance of Cerazet passes into breast milk.

The health of children during breastfeeding for 7 months, whose mothers used Cerazet, was studied until the children were 2.5 years old. No effects on the growth or development of the children were observed.

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

Driving and using machines

There are no indications that the use of Cerazet has any effect on the ability to drive or use machines.

Cerazet contains lactose

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

Regular check-ups

During treatment with Cerazet, your doctor will ask you to have regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

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 of the blister pack, between the tablets. If you turn the blister pack over and look at the back, you will see the days of the week printed on the foil. Each day corresponds to one tablet.

Every time you start a new blister pack of Cerazet, take a tablet from the top row, but not just any tablet. For example, if you start on a Wednesday, take the tablet from the top row that is marked (on the back) “WED”. Continue taking one tablet a day until the blister pack is empty, always following the direction of the arrows. Looking at the back of the blister pack, you can easily check if you have taken your tablet on a particular day.

Take your tablet at about the same time every day, swallowing it whole with water. You may experience some bleeding during the use of Cerazet, but you should continue to take the tablets as normal. When you finish a blister pack, start a new one the next day, so without leaving a gap and without waiting for a bleed to occur.

Starting the first pack of Cerazet

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

Wait for your period to begin and take the first tablet of Cerazet on the first day of your period. This way, you do not need to take any additional contraceptive precautions.

You can also start on days 2-5 of your cycle, but in this case, make sure you also use a barrier method of contraception (e.g. condom) for the first 7 days of treatment with the tablets.

• If you are switching from a combined pill, vaginal ring or transdermal patch:

You can start taking Cerazet the day after you take the last tablet from your current pack, or the day after you remove the vaginal ring or transdermal patch (this means that you do not need to leave a gap between the tablets, ring or patch). If your current pill contains inactive tablets, you can start taking Cerazet the day after you take the last active tablet (if you are not sure, consult your doctor or pharmacist). Following these instructions, you do not need to take any additional contraceptive precautions.

You can also start the day after the pill-free interval of your current contraceptive, or the day after you remove the ring or patch, or the day after you take the last inactive tablet. If you follow these instructions, make sure you use a barrier method of contraception for the first 7 days of tablet-taking.

• If you were taking another progestogen-only pill:

You can stop taking your current pill at any time and start taking Cerazet immediately. You do not need to take any additional contraceptive precautions.

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

Start using Cerazet on the day you would have had your next injection, or on the day your implant or IUS is removed. You do not need to take any additional contraceptive precautions.

• After childbirth:

You can start using Cerazet between 21 and 28 days after giving birth. If you start later, make sure you use a barrier method of contraception for the first 7 days that you take the tablets. However, if you have already had sex, you should rule out pregnancy before starting to take Cerazet. You can find more information about breastfeeding in the 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 it has been less than 12 hourssince the time you should have taken the tablet:the efficacy of Cerazet is maintained. Take the forgotten tablet as soon as you remember and take the next tablets at the usual time.

• If it has been more than 12 hourssince the time you should have taken the tablet:the efficacy may be reduced. The more tablets you have missed, the higher the risk that the contraceptive efficacy has decreased. Take the last forgotten tablet as soon as you remember and continue with the next tablets at the usual time, using a barrier method of contraception for the next 7 days.

If you forget one or more tablets in the first week of starting treatment and have had sex in the week before forgetting the tablets, there is a possibility that you may have become pregnant. Consult your doctor.

If you have gastrointestinal disorders (e.g. vomiting, severe diarrhoea)

Follow the instructions for forgetting a tablet. If you vomit within 3-4 hours of taking your Cerazet tablet, or have severe diarrhoea, it is possible that the active substance will not have been completely absorbed.

If you take more Cerazet than you should

No serious harmful effects have been reported when taking too many Cerazet tablets at once. The symptoms that may occur are nausea, vomiting, and in girls, light vaginal bleeding. For more information, consult your doctor.

If you stop taking Cerazet

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

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

4. Possible Adverse Effects

Like all medicines, Cerazet can cause adverse effects, although not all people will experience them.

Severe adverse effects that may be associated with the use of Cerazet are explained in the sections "Breast Cancer" and "Thrombosis" in point 2. "What you need to know before starting to take Cerazet". Read this point to know the information in detail and consult your doctor immediately if you consider it necessary.

Consult your doctor immediately if you experience allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat that cause difficulty breathing or swallowing (angioedema and/or anaphylaxis).

Irregular vaginal bleeding may occur during the use of Cerazet, which can be a slight spotting that may not even require a pad or more intense bleeding, which is similar to a scarce menstruation and requires the use of sanitary protection. It may also happen that you never have bleeding. Irregular bleeding is not a sign that the contraceptive protection of Cerazet decreases. In general, you don't need to do anything, just continue taking Cerazet. However, if the bleeding is intense or prolonged, consult your doctor.

Users of Cerazet have reported the following adverse effects:

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

• mood changes, depressed mood, decreased sexual desire (libido)
• headache
• nausea
• acne
• breast pain, irregular menstruation or no menstruation
• weight gain

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

• vaginal infection
• discomfort with the use of contact lenses
• vomiting
• hair loss
• painful menstruation, ovarian cysts
• fatigue

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

• rash, hives, painful purple bumps on the skin (erythema nodosum) (these are skin effects)

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

• allergic reactions

Aside from these adverse effects, breast secretion may occur.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Cerazet

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

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

The active ingredient shows a medium environmental risk for fish.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Cerazet

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

Appearance of the Product and Packaging Content

A Cerazet blister contains 28 round film-coated tablets, white in color. The tablets are marked with the code KV over 2 on one face and ORGANON on the other. Each box contains 1, 3, 6, or 13 blisters, each packaged in a pouch.

Not all packaging sizes may be available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon,

Kloosterstraat 6,

5349 AB Oss,

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

Spain: Cerazet.

Date of the last revision of this prospectus:November 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)