Package Leaflet: Information for the User

Cerazet 75 micrograms

Coated tablets

Desogestrel

Read this leaflet carefully before you start taking this medicine,because 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 onlyaloneand should not be given to others, even if they have the same symptoms, as it may harm them.
• Ifyouexperienceside effectsconsult your doctor or pharmacist evenifthey are not listed in this leaflet.See section 4.

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

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

Unlike the combined pill, Cerazet can be taken by women who do not tolerate estrogens and women who are breastfeeding. A disadvantage is that it could have irregular vaginal bleeding during the use of Cerazet. It could also not bleed.

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

Do not take Cerazet

• if you are allergic to desogestrel orany other component ofCerazet (including those 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 jaundice (yellow discoloration of the skin) or severe liver disease and the liver is not functioning normally.
• if you have or have had a cancer related to sex steroids, such as certain types of breast cancer.
• if there is any unexplained vaginal bleeding.

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

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

Warnings and precautions

Inform your doctor before starting to use Cerazet if:

?you have had breast cancer;

?you have liver cancer, as it cannot be ruled out that Cerazet may have an effect;

?you have had a thrombosis;

?you have diabetes;

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

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

?you have high blood pressure;

?you have or have had melasma (yellow-brown skin discoloration, particularly on the face); in this case, avoid intense exposure to the sun or ultraviolet radiation.

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

Breast cancer

Have your breasts examined regularly and contact your doctor as soon as possible if you notice any lump in your breasts.

Breast cancer has been observed with a slightly higher frequency in women taking the pill than in women of the same age who are not taking it. If the woman stops taking the pill, the risk decreases gradually, so that 10 years after stopping the pill, the risk is the same as that of women who have never taken it. Breast cancer is rare before the age of 40, but the risk increases as the 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 every 10,000 women who have taken the pill until 5 years and who stop taking it around the age of 20, there will be fewer than one additional case of breast cancer observed 10 years after stopping the pill, which will be added to the 4 cases normally diagnosed in this age group. Similarly, of 10,000 women who have taken the pill until 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 until 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 pills with only progestogen like Cerazet is similar to that of women taking the pill, although the data do not allow for clear conclusions.

It appears that the breast cancers found in women taking the pill are less widespread than the breast cancers found in women who are not taking it. The cause of the difference in breast cancer risk is unknown. It may be that women are more frequently checked, so that breast cancer is detected earlier.

Thrombosis

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

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 reach and block the arteries of the lungs, causing what is known as “pulmonary embolism”, which can be fatal. Deep vein thrombosis is rare. It can develop while taking or not taking the pill. It can also occur if you become pregnant.

The risk of thrombosis is higher in pill users than in non-users. It is believed that the risk in users of pills with only progestogen like Cerazet is lower than in users of combined pills.

Mental health disorders

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

Children and adolescents

No clinical data are available on the safety and efficacy in adolescents under 18 years.

Use of Cerazet with other medicines

Inform your doctorif you are using or have used recently ormay have to useother medicines or herbal medicines.Also inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking Cerazet. They can inform you if you need to take additional contraceptive measures (for example, the use of condoms) and if necessary, for how long, or if you need to modify the use of the other medicine.

Some medicines

• may affect the levels of Cerazet in the blood
• may make itless 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 infectious diseases (for example griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressed mood (products containing the medicinal plant 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 medicines that may make Cerazet less effective, you should also use a barrier contraceptive method. Since the effect of another medicine on Cerazet may last up to 28days after stopping the medicine, you will need to use the additional barrier contraceptive method during that time. Your doctor can inform you if you need to take 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, medicines with ciclosporin) 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 milk production or milk quality. However, with rare frequency, a decrease in milk production has been reported during the use of Cerazet. A small amount of the active ingredient in Cerazet passes into breast milk.

A study was conducted on the health of children in breastfeeding for 7 months, whose mothers used Cerazet, 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 operating machinery

No indication of the use of Cerazet producing any effect on alertness and concentration has been found.

Cerazet contains lactose

This medicine contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

Regular checks

During treatment with Cerazet, your doctor will require you to undergo regular checks. In general, the frequency and characteristics of these checks will depend on your personal situation.

When and how to take Cerazet

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 a tablet.

Each 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, you should take the tablet 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 already taken your tablet on a particular day.

Take your tablet approximately at the same time every day, swallowing it whole with water. You may experience some bleeding during the use of Cerazet, but you should continue taking the tablets as usual. When you finish a blister pack, start a new one the next day, without leaving any days off and without waiting for bleeding to appear.

Starting the first pack of Cerazet

• When you have not used hormonal contraception in the past month:

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

You can 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 treatment with the tablets.

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

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

You can also start the day after the break without tablets, ring, or patch, or with inactive tablets of your current contraceptive. If you follow these instructions, make sure to use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

• If you were taking another progestin-only pill:

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

• If you used an injectable, implant, or intrauterine system (IUS) releasing progestin:

Start using Cerazet at the time you should receive the next injection or the day the implant or IUS is removed. You will not need to take additional contraceptive precautions.

• After childbirth:

You can start with Cerazet between days 21 and 28 after the birth of the baby. If you start later, make sure to use an additional contraceptive method (barrier method) during the first 7 days you take the tablets. However, if you have already had sex, you should rule out pregnancy before starting Cerazet. You can find more information about breastfeeding in the section “Pregnancy and breastfeeding” in point 2.Your doctor may also advise you.

• After an abortion:

Your doctor will advise you.

If you forgot to take Cerazet

• If less than 12 hours have passed since the usual time for taking the tablet, the efficacy of Cerazet is maintained.Take the missed tablet as soon as you remember and the next tablets at the usual time.

• If more than 12 hours have passed since the usual time for taking the tablet, the efficacy may have been reduced.Cuantos más comprimidos consecutivos haya olvidado, el riesgo de que la eficacia anticonceptiva haya disminuido es mayor. Take the last missed tablet as soon as you remember and continue with the next tablets at your usual time, using also an additional contraceptive method (barrier method) during the 7 days following.

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

If you experience gastrointestinal disorders (e.g. vomiting, intense diarrhea)

Follow the instructions for the case of missed tablets. If you vomit within 3-4 hours after taking your Cerazet tablet or have intense diarrhea, it may be that the active ingredient has not been fully absorbed.

If you take more Cerazet than you should

No severe adverse effects have been described for 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 interrupt the treatment with Cerazet

You can stop taking Cerazet at any time you want. 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 medication, consult your doctor or pharmacist.

Like all medications, Cerazet may cause side effects, although not everyone will experience them.

Severe side effects associated with the use of Cerazet are explained in the sections “Breast Cancer” and “Thrombosis” in point 2. “What You Need to KnowBeforeStarting toTake Cerazet”. Read this point for detailed information and consult your doctor immediately if you consider it necessary.

Consult your doctor immediately if you experienceallergic reactions(hypersensitivity), including facial swelling, lips, tongue, and/or throat that cause difficulty breathing or swallowing (angioedema and/or anaphylaxis).

Cerazet may cause irregular vaginal bleeding during use, which can be a light spotting that may not even require a pad or a more intense bleeding that resembles a light period and requires the use of sanitary protection. It may also occur that you never experience bleeding. Irregular bleeding is not a sign that Cerazet's contraceptive protection has decreased. In general, you do not need to do anything, just continue taking Cerazet. However, if the bleeding is heavy or prolonged, consult your doctor.

Users of Cerazet have reported the following side effects:

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

• mood changes, depressed mood, decreased libido
• headache
• nausea
• acne
• breast pain, irregular or absent menstruation
• weight gain

Less frequent (may affect up to 1 in 100women):

• vaginal infection
• eye irritation with contact lens use
• diarrhea
• hair loss
• painful menstruation, ovarian cysts
• edema

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

• eruption, urticaria, painful and purple skin bumps (erythema nodosum) (skin effects)

Unknown frequency (frequency cannot be estimated from available data):

• allergic reactions

In addition to these side effects, breast secretion may occur.

Reporting of side effects:

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

Keepthis medicationout of the sight and reach ofchildren.

Do not usethis medicationafter the expiration date that appears on the packaging after the CAD abbreviation. The expiration dateis the last day of the month indicated.

This medication does not require any special storage temperature. Storethe blisterin theoriginal packaging to protect it from light and moisture. Use it within 1 month from the date of the first opening of the packaging.

The active ingredient poses a moderate environmental risk to fish.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cerazet

• The active ingredient is desogestrel (75 micrograms)
• The other components (excipients) are anhydrous colloidal silica, all- rac - ? - tocopherol, cornstarch, 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 content of the container

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

Not all container sizes may be available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing:

N.V. Organon,

Kloosterstraat 6,

5349 AB Oss,

Netherlands

This medication is authorized in the member states of the European Economic Area with 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 review of this prospectus: November 2020.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )