Package Leaflet: Information for the user

Kerizet 75 micrograms film-coated tablets EFG

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 are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

1. What is Kerizet and what is it used for

2. What you need to know before you take Kerizet

3. How to take Kerizet

4. Possible side effects

5. Storage of Kerizet

6. Contents of the pack and other information

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

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

Unlike the combined pill, Kerizet 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 Kerizet. It could also not bleed.

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

Do not take Kerizet

• if you are allergic to desogestrel, soy, peanuts, or any of the other components of this medication (listed in section 6).
• if you have a blood clot. A blood clot is the formation of a 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 suspect you may have a sex steroid-related cancer, such as certain types of breast cancer.
• if there is any unexplained vaginal bleeding.

Inform your doctor before using Kerizet 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 Kerizet.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kerizet.

Inform your doctor before starting to use Kerizet if:

• you have had breast cancer;
• you have liver cancer, as it cannot be ruled out that Kerizet may have an effect;
• you have had a blood clot;
• you have diabetes;
• you have epilepsy (see section “Use of other medications”);
• you have tuberculosis (see section “Use of other medications”);
• 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 use Kerizet in any of the described situations, you must remain under medical supervision. Your doctor may explain what you should do.

Breast cancer

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

Breast cancer has been observed at 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 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 age at which the pill was stopped. The duration of use of the pill is not as important.

Of every 10,000 women who have taken the pill for up to 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 for 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 for 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 progestin-only pills like Kerizet is similar to that of women taking combined pills, although the data do not allow for clear conclusions.

It appears that the breast cancers found in women taking the pill are less extensive 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 monitored, 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 off from the veins where it formed, it can reach and block the arteries of the lungs, causing what is known as “pulmonary embolism.” This can lead to fatal situations. 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 progestin-only pills like Kerizet is lower than in users of combined pills that contain estrogen.

Mental health disorders

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

Children and adolescents

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

Use of Kerizet with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication or herbal remedies. Also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Kerizet. They can inform you if you need to use 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 medication.

Some medications

• may affect the levels of Kerizet in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

These include medications 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 medications or herbal remedies that may make Kerizet less effective, you should also use a barrier contraceptive method. Since the effect of another medication on Kerizet can last up to 28 days after stopping the medication, 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 for how long.

Kerizet can also interfere with the effect of other medications, causing an increase in effect (for example, medications with cyclosporine) or a decrease in effect (for example, lamotrigine).

Consult your doctor or pharmacist before taking any medication.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Breastfeeding

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

A study was conducted on the health of children in breastfeeding for 7 months, whose mothers used desogestrel, until the children were 2.5 years old. No effects were observed on the growth or development of the children.

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

Driving and operating machines

There is no indication that the use of Kerizet produces any effect on alertness and concentration.

Kerizet contains lactose and soy oil

Kerizet contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

If you are allergic to peanuts or soy, do not use this medication.

Regular checks

During treatment with Kerizet, 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 Kerizet

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The blister of Kerizet contains 28 tablets. There are arrows printed on the front face of the blister, between the tablets. If you turn the blister over and look at the back face, you will see the days of the week printed on the sheet. Each day corresponds to a tablet.

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

Take your tablet each day approximately at the same hour.

Swallow it whole with water. Some bleeding may occur during the use of Kerizet, but you should continue taking the tablets normally. When you finish a blister, start a new one the next day, so without leaving any day of rest and without waiting for bleeding to appear.

Starting the first package of Kerizet

• When not using hormonal contraception in the previous month

Wait for your period and on the first day of the period, take the first tablet of Kerizet.

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 Kerizet the day after taking the last tablet of the current package or the day the vaginal ring or transdermal patch is removed (this means you do not have to leave a period of rest from the tablets, ring, or patch). If your current pill contains inactive tablets, you can start taking Kerizet 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 rest period 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.

• When switching from another progestin-only pill

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

• When switching from an injectable, implant, or intrauterine system (IUS) releasing progestin

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

• After childbirth

You can start with Kerizet 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 sexual intercourse, you must rule out pregnancy before starting to take Kerizet. You can find more information about breastfeeding in the section “Pregnancy and breastfeeding” in point 2. Your doctor can also advise you.

• After a spontaneous abortion or premature interruption of pregnancy

Your doctor will advise you.

If you forgot to take Kerizet

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

• If more than 12 hours have passed since the usual time of taking, the efficacy may have been reduced. The more consecutive tablets you have forgotten, the greater the risk that the contraceptive efficacy has decreased. Take the last missed tablet as soon as you remember and continue with the following tablets at your usual time, using an additional contraceptive method (barrier method) during the next 7 days.

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

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

Follow the instructions for missed tablets. If you vomit or use activated charcoal within 3-4 hours after taking your Kerizet tablet or have intense diarrhea, it may not have been fully absorbed.

If you take more Kerizet than you should

No serious adverse effects have been described for taking too many Kerizet tablets at once. The symptoms that may occur are nausea, vomiting, and in young women, slight vaginal bleeding.

For more information, consult your doctor.

If you interrupt the treatment with Kerizet

You can stop taking Kerizet 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 doubts about the use of this product, consult your doctor or pharmacist.

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

Severe side effects associated with the use of Kerizet are explained in the sections “Breast Cancer” and “Thrombosis” in point 2. “What you need to know before starting to take Kerizet.” Read this point for detailed information and consult your doctor immediately if you consider it necessary.

You should see your doctor immediately if you experience allergic reactions (hypersensitivity), including facial swelling, lips, tongue, and/or throat that cause difficulty breathing or swallowing

(angioedema and/or anaphylaxis).

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

Users of desogestrel have reported the following side effects:

• Frequent(may affect up to 1 in 10 users): mood changes, depressed mood, decreased libido, headaches, nausea, acne, breast pain, irregular or absent menstruation, weight gain.

• Infrequent(may affect up to 1 in 100 users): vaginal infection, discomfort with contact lens use, vomiting, hair loss, painful menstruation, ovarian cysts, fatigue.

• Rare(may affect up to 1 in 1,000 users): rash, urticaria, painful and purple skin bumps (erythema nodosum), are skin side effects.

• Unknown (cannot be estimated from available data): allergic reaction

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

Reporting of side effects

If you experience any type of

side effect, consult your doctor, pharmacist, or nurse, 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month.

Kerizet does not require special storage conditions.

The active substance poses an environmental risk to fish.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Kerizet

The active ingredient is desogestrel (75 micrograms). A tablet contains 75 micrograms of desogestrel.

The other components (excipients) are lactose, cornstarch, povidone K30(E1201),d-α-tocopherol, soybean oil, colloidal anhydrous silica, hydrated colloidal silica, stearic acid, hypromellose, polyethylene glycol (E1521) and titanium dioxide (E 171); lactose monohydrate, soybean oil.

Appearance of the product and content of the packaging

A blister pack of Kerizet contains 28 round tablets coated with a film and white in color. Each box contains 1, 3 or 6 blister packs.

Not all packaging sizes may be available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n

24193 - Villaquilambre, León.

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Grystella 75 Mikrogramm Filmtabletten

Spain: Kerizet 75 micrograms film-coated tablets EFG

Poland: Limetic

United Kingdom (Northern Ireland): Desogestrel 75 microgram film-coated tablets

Last review date of this leaflet: May 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es