DESOPOP 75 micrograms FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Desopop 75 micrograms film-coated tablets EFG

Desogestrel

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Desopop and what is it used for
2. What you need to know before taking Desopop
3. How to take Desopop
4. Possible side effects
5. Storage of Desopop
6. Package contents and additional information

1. What is Desopop and what is it used for

Desopop is used to prevent pregnancy.

Desopop contains a small amount of a type of female sex hormone, the progestogen desogestrel. For this reason, Desopop is known as a progestogen-only pill, or mini-pill.

Unlike combined pills, the progestogen-only pill or mini-pill does not contain estrogen hormones along with the progestogen.

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

Unlike the combined pill, Desopop can be taken by women who cannot tolerate estrogens and women who are breastfeeding. A disadvantage is that it may cause irregular vaginal bleeding during use of Desopop. It may also not cause bleeding.

2. What you need to know before taking Desopop

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

Do not take Desopop

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

Tell your doctor before using Desopop if any of these circumstances apply to 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 Desopop.

Warnings and precautions

Tell your doctor before starting to use Desopop if:

• you have ever had breast cancer;
• you have liver cancer, as it cannot be ruled out that Desopop may have an effect;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see section "Other medications and Desopop");
• you suffer from tuberculosis (see section "Other medications and Desopop");
• you have high blood pressure;
• you have or have had chloasma (yellow-brown patches on the skin, particularly on the face); in this case, you should avoid intense sun exposure or ultraviolet radiation.

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

Breast cancer

Regularly examine your breasts 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 do not take 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 higher the older the age at which the pill was stopped. The duration of pill use is not as important.

Out of 10,000 women who have taken the pill for up to 5 years and stop taking it around the age of 20, there will be less than one additional case of breast cancer observed up to 10 years after stopping the pill, which will be added to the 4 cases normally diagnosed in this age group. Similarly, out of 10,000 women who have taken the pill for up to 5 years and 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 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 Desopop is similar to that of women taking the pill, although the data does not allow for clear conclusions to be drawn.

The breast cancers found in women taking the pill seem to be less advanced than the breast cancers found in women who do not take it. It is not known if the difference in breast cancer risk is due to the pill. It may be that women are monitored more frequently, 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 whether or not you are 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 progestogen-only pills like Desopop is lower than in users of pills that contain estrogens (combined pills).

Psychiatric disorders

Some women using hormonal contraceptives like Desopop 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

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

Other medications and Desopop

Tell your doctor if you are taking, have recently taken, or may need to take any other medication or herbal remedies. Also, inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are taking Desopop. They can inform you if you need to take any additional contraceptive measures (e.g., use condoms) and if so, for how long, or if you need to modify the use of the other medication.

Some medications

• may affect Desopop levels in the blood
• may make Desopop less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital), tuberculosis (e.g., rifampicin, rifabutin),
• HIV infections (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),
• depressive mood (products containing the herbal remedy 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 medications or herbal remedies that may make Desopop less effective, you should also use a barrier contraceptive method. Since the effect of another medication on Desopop can last up to 28 days after stopping the medication, during that time, you should use the additional barrier method. Your doctor can inform you if you need to take any additional contraceptive measures and if so, for how long.

Desopop may also interfere with the effect of other medications, causing an increase in effect (e.g., medications containing cyclosporin) or a decrease in effect (e.g., lamotrigine).

Consult your doctor or pharmacist before taking any medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use Desopop if you are pregnant or think you may be pregnant.

Breastfeeding

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

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

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

Driving and using machines

There is no indication that the use of Desopop has any effect on alertness or concentration.

Desopop contains lactose and soybean oil

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Do not use this medication if you are allergic to peanuts or soy.

Regular checks

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

Contact your doctor as soon as possible in the following cases:

• you have severe pain or swelling in one leg, unexplained chest pain,
• difficulty breathing, unusual cough, especially with bloody sputum (may indicate a thrombosis);
• you have sudden, severe stomach pain or jaundice (may indicate liver problems);
• if you find a lump in your breasts (which may indicate breast cancer);
• if you experience sudden, severe pain in the lower abdomen or stomach area (may indicate an ectopic pregnancy, i.e., a pregnancy outside the uterus);
• if you need to be immobilized or have surgery(consult your doctor at least 4 weeks in advance);
• if you have unusual, heavy vaginal bleeding;
• if you suspect you are pregnant.

3. How to take Desopop

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

When and how to take Desopop

The Desopop 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 Desopop 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 from the top row 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 given day.

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

Starting the first pack of Desopop

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

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

You can also start on days 2 to 5 of your cycle, but in this case, make sure to use a complementary contraceptive method (barrier method, condom) while taking the first 7 days of treatment with the tablets.

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

You can start taking Desopop the day after taking the last tablet from your current pack or the day of removal of the vaginal ring or transdermal patch (this means you do not need to leave a pill-free period). If your current pill contains inactive tablets, you can start taking Desopop the day after taking the last active tablet (if you are unsure, 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 period or with inactive tablets of your current contraceptive. If you follow these instructions, make sure to use a complementary contraceptive method (barrier method) while taking the first 7 days of tablets.

• If you were taking another progestogen-only pill

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

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

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

• After childbirth

You can start Desopop between 21 and 28 days after giving birth. If you start later, make sure to use a complementary contraceptive method (barrier method) during the first 7 days you take the tablets. However, if you have already had sexual intercourse, you should rule out pregnancy before starting to take Desopop. You can find more information about breastfeeding in the "Pregnancy and breastfeeding" section in point 2. Your doctor can also advise you.

• After an abortion

Your doctor will advise you.

If you forget to take Desopop

• If it has been less than 12 hourssince the usual time of taking the tablet, the efficacy of Desopop is maintained. Take the forgotten tablet as soon as you remember and the following tablets at the usual time.
• If it has been more than 12 hourssince the usual time of taking the tablet, the efficacy may be reduced. The more consecutive tablets you have forgotten, the greater the risk that the contraceptive efficacy has decreased. Take the last forgotten tablet as soon as you remember and continue with the following tablets at the usual time, using a complementary contraceptive method (barrier method) for the next 7 days.

If you forget one or more tablets in the first week of 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 experience gastrointestinal disorders (e.g., vomiting, severe diarrhea)

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

If you take more Desopop than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you stop taking Desopop

You can stop taking Desopop whenever 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe adverse effects that may be associated with the use of Desopop are explained in the sections "Breast Cancer" and "Thrombosis" in point 2. "What you need to know before you start taking Desopop". 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 Desopop, which can be a slight spotting that may not even require a pad or more intense bleeding, which resembles 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 Desopop decreases. In general, you don't need to do anything, just continue taking Desopop. However, if the bleeding is intense or prolonged, consult your doctor.

Users of desogestrel 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

Uncommon (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 10,000 women):

• rash, hives, purple and painful 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 Desopop

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

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

This medicine does not require special storage conditions.

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 at 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 Desopop

• The active ingredient is desogestrel. Each tablet contains 75 micrograms of desogestrel.
• The other components (excipients) are: lactose monohydrate, cornstarch, povidone K30, d-α-tocopherol, soybean oil, anhydrous colloidal silica, hydrated colloidal silica, stearic acid, hypromellose, polyethylene glycol, and titanium dioxide (E171) (see also "Desopop contains lactose" in section 2).

Appearance of the Product and Packaging Content

A Desopop blister pack contains 28 film-coated, round, white tablets. Each box contains 1, 3, 6, or 13 blister packs.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

C/ La Vallina s/n

24193 Navatejera, León

Spain

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

Spain: Desopop 75 micrograms film-coated tablets EFG

France: DESOPOP 75 micrograms, film-coated tablet

Belgium: DESOPOP 75 micrograms, film-coated tablet

Date of the last revision of this prospectus: November 2021.

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/.