Kerizet 75 micrograms film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Kerizet 75 micrograms film-coated tablets EFG

Desogestrel

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 further 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. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Kerizet is and what it is used for

Kerizet is used to prevent pregnancy. Kerizet contains a small amount of a female sex hormone, the progestogen desogestrel. For this reason, Kerizet is known as a progestogen-only pill. Unlike combined pills, the minipill does not contain oestrogen-type hormones together 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 primary action of combined pills. Kerizet differs from most progestogen-only pills in that its dose is high enough in most cases to prevent the egg from maturing. Therefore, Kerizet provides high contraceptive effectiveness.

Unlike the combined pill, Kerizet 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 Kerizet. You may also have no bleeding at all.

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

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

Do not take Kerizet

• if you are allergic to desogestrel, soy, peanut, or any of the other components of this medicine (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 ever had jaundice (yellowing of the skin) or severe liver disease and your liver is still not functioning normally.
• if you have or suspect you may have a steroid sex hormone-related cancer, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Inform your doctor before using Kerizet 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 Kerizet.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Kerizet.

Inform your doctor before starting to use Kerizet if:

• you have ever had breast cancer;
• you have liver cancer, as a possible effect of Kerizet cannot be ruled out;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see section "Use with other medicines");
• you suffer from tuberculosis (see section "Use 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, avoid intense exposure to sunlight or ultraviolet radiation.

If you use Kerizet under any of the circumstances described above, 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 greater 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. Similarly, among 10,000 women who took the pill for up to 5 years and stopped around age 30, there will be 5 additional cases on top of 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 on top of the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills such as Kerizet 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 could be that women undergo more frequent check-ups, so breast cancer is detected earlier.

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 of the lungs, causing what is known as "pulmonary embolism". This can lead to fatal outcomes. Deep vein thrombosis is rare. It can develop whether or not you are taking the pill. It can 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 Kerizet is believed to be lower than in users of pills containing estrogens (combined pills).

Psychiatric disorders

Some women using hormonal contraceptives, including Kerizet, 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 for medical advice as soon as possible.

Children and adolescents

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

Use of Kerizet with other medicines

Tell your doctor or pharmacist 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 Kerizet. 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 adjust the use of the other medicine.

Some medicines

• may affect the levels of Kerizet in the blood
• may make it less effective in preventing pregnancy
• 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 infections (e.g., griseofulvin),

• high blood pressure in the pulmonary blood vessels (bosentan),

• depressed mood (herbal products containing St. John's wort).

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

Kerizet may also interfere with the effect of other medicines, causing an increase in effect (e.g., medicines containing cyclosporine) or a decrease in effect (e.g., lamotrigine).

Consult your doctor or pharmacist before taking any medicine.

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 the quantity or quality of breast milk. However, a decrease in breast milk production has been reported rarely during use of Kerizet. A small amount of the active ingredient of Kerizet passes into breast milk.

The health of infants breastfed for 7 months by mothers using desogestrel has been studied until the children reached 2.5 years of age. No effects on growth or development of the children were observed.

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

Driving and using machines

There are no indications that the use of Kerizet produces any effect on alertness or concentration ability.

Kerizet contains lactose and soybean oil

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

If you are allergic to peanut or soy, do not use this medicine.

Regular check-ups

During treatment with Kerizet, 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 Kerizet

When and how to take Kerizet

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The Kerizet 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 Kerizet blister pack, 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 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 on a given day.

Take your tablet every day at approximately the same time.

Swallow it whole with water. You may experience some bleeding during use of Kerizet, but you should continue taking the tablets as usual. When you finish one blister pack, start a new one the next day, without leaving any rest days and without waiting for bleeding to occur.

Starting the first pack of Kerizet

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

Wait for your menstrual period and take the first Kerizet 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 treatment.

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

You may start taking Kerizet the day after taking the last tablet of your current pack, or on 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 Kerizet the day after taking the last active tablet (if you are unsure, consult your doctor or pharmacist). If you follow these instructions, additional contraceptive precautions are not 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 this approach, make sure to use an additional contraceptive method (barrier method) during the first 7 days of tablet intake.

• When switching from another progestogen-only pill

You may discontinue your current preparation at any time and start Kerizet immediately. You do not need to take additional contraceptive precautions.

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

Start using Kerizet at the time when your next injection would have been due, or on the day your implant or IUS is removed. Additional contraceptive precautions are not necessary.

• After childbirth

You may start Kerizet between days 21 and 28 after the birth of your baby. If you start later, make sure to 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 Kerizet. You can find more information about breastfeeding in section “Pregnancy and breastfeeding” in point 2. Your doctor can also advise you.

• After a spontaneous abortion or early termination of pregnancy

Your doctor will advise you.

If you forget to take Kerizet

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

• If more than 12 hours have passed since your usual time of taking the tablet, effectiveness may have been reduced. The more consecutive tablets you have missed, 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, while 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 starting 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 diarrhea)

Follow the instructions for missed tablets. If you vomit or use activated charcoal within 3–4 hours after taking your Kerizet tablet, or if you have severe diarrhea, the active ingredient may not have been completely absorbed.

If you take more Kerizet than you should

No serious harmful effects have been reported from taking too many Kerizet tablets at once. Possible symptoms include nausea, vomiting, and, in young women, slight vaginal bleeding.

For more information, consult your doctor.

If you stop taking Kerizet

You may stop taking Kerizet 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 product, consult your doctor or pharmacist.

4. Possible adverse effects

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

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

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

Irregular vaginal bleeding may occur during use of Kerizet. This may be light spotting that may not even require a sanitary pad, or heavier bleeding resembling a light menstruation, requiring sanitary protection. It may also occur that you never have bleeding. Irregular bleeding is not a sign that the contraceptive protection provided by Kerizet is reduced. In general, no action is needed—just continue taking Kerizet. However, if bleeding is heavy or prolonged, consult your doctor.

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

• Common (may affect up to 1 in 10 users): 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 users): vaginal infection, discomfort when wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cysts, fatigue.

• Rare (may affect up to 1 in 1,000 users): rash, urticaria, painful purple lumps on the skin (erythema nodosum)—these are skin-related adverse effects.

• Not known (cannot be estimated from available data): allergic reaction.

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

Reporting of adverse effects

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

5. Storage of Kerizet

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month.

Store below 30 °C. Keep in the original packaging to protect from light.

The active substance poses an environmental risk to fish.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kerizet

The active substance is desogestrel (75 micrograms). One tablet contains 75 micrograms of desogestrel.

The other components (excipients) are lactose, corn starch, povidone K30 (E1201), d-α-tocopherol, soybean oil, anhydrous colloidal silica, hydrated colloidal silica, stearic acid, hypromellose, polyethylene glycol (E1521) and titanium dioxide (E171); monohydrate lactose, soybean oil.

Appearance of the medicine and contents of the pack

One Kerizet blister contains 28 round, white, film-coated tablets. Each box contains 1, 3 or 6 blisters.

Not all pack sizes may be available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

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 under the following names:

Austria: Grystella 75 Microgram Film-coated Tablets

Spain: Kerizet 75 micrograms film-coated tablets EFG

Poland: Limetic

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

Date of the most recent review of this leaflet: May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es