Desopop 75 micrograms film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desopop 75 micrograms film-coated tablets EFG

Desogestrel

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because 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 the leaflet

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

1. What Desopop is and what it is used for

Desopop is used to prevent pregnancy.

Desopop contains a small amount of a 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 oestrogen-type hormones in addition to the progestogen.

Most progestogen-only pills or mini-pills primarily work by preventing sperm from entering the uterus, but do not always prevent the egg from maturing, which is the main action of combined pills. Desopop differs from other progestogen-only pills in that its dose is high enough in most cases to prevent the egg from maturing. Therefore, Desopop provides high contraceptive effectiveness.

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

2. What you need to know before starting Desopop

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

Do not take Desopop

• if you are allergic to desogestrel, peanuts, or soy, or to any of the other ingredients 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 had jaundice (yellowing of the skin) or severe liver disease and your liver is still not functioning normally.
• if you have or are suspected of having a steroid hormone-related cancer, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Inform your doctor before using Desopop 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 Desopop.

Warnings and precautions

Inform your doctor before starting to use Desopop if:

• you have ever had breast cancer;
• you have liver cancer, as a possible effect of Desopop cannot be ruled out;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see section “Other medicines and Desopop”);
• you suffer from tuberculosis (see section “Other medicines and Desopop”);
• you have high blood pressure;
• you have or have had chloasma (brownish-yellow patches on the skin, particularly on the face); in this case, avoid intense exposure to sunlight or ultraviolet radiation.

If you use Desopop under any of the described circumstances, 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 number of additional diagnosed breast cancers is higher 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. Likewise, among 10,000 women who took the pill for up to 5 years and stopped around age 30, there will be 5 additional cases compared to the 44 cases normally diagnosed. Among 10,000 women who took the pill for up to 5 years and stopped around age 40, there will be 20 additional cases compared to the 160 cases normally diagnosed.

It is believed that the risk of breast cancer in users of progestogen-only pills such as Desopop is 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 that 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 and block the arteries in 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 during pregnancy.

The risk of thrombosis is higher in users of contraceptive pills than in non-users. It is believed that the risk in users of progestogen-only pills such as Desopop is lower than in users of pills containing estrogens as well (combined pills).

Psychiatric disorders

Some women using hormonal contraceptives such as Desopop have reported depression or a 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 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 of age.

Other medicines and Desopop

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines or herbal remedies. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Desopop. 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 modify the use of the other medicine.

Some medicines

• can affect the blood levels of Desopop,
• can make it less effective in preventing pregnancy,
• can cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (for example, primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital), tuberculosis (for example, rifampicin, rifabutin),
• HIV infections (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 pulmonary vessels (bosentan),
• depression (herbal remedies containing 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 remedies that could reduce the effectiveness of Desopop, a barrier contraceptive method should also be used. Since the effect of another medicine on Desopop may last up to 28 days after stopping the medicine, a 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.

Desopop may also interfere with the effect of other medicines, causing an increase in effect (for example, medicines containing cyclosporine) or a decrease in effect (for example, lamotrigine).

Consult your doctor or pharmacist before taking any medicine.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

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

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

Driving and using machines

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

Desopop contains lactose and soybean oil

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

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

Regular check-ups

During treatment with Desopop, 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.

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

• you have severe pain or swelling in one of your legs, unexplained chest pain,
• difficulty breathing, unusual cough, especially accompanied by bloody sputum (could indicate thrombosis);
• sudden and severe stomach pain or jaundice (which may indicate liver problems);
• if a lump is found in your breasts (which may indicate breast cancer);
• if you experience sudden or severe pain in the lower abdomen or stomach area (could indicate an ectopic pregnancy, i.e., a pregnancy outside the uterus);
• if you are to remain immobile or require surgery (consult your doctor at least four weeks in advance);
• if you have unusual and heavy vaginal bleeding;
• if you suspect you are pregnant.

3. How to take Desopop

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, 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 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 Desopop blister pack, take a tablet from the top row, but not any tablet at random. 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 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 for a given day.

Take your tablet at approximately the same time each day, swallowing it whole with water. Bleeding may occur while using Desopop, but you should continue taking the tablets as usual. When you finish one 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 Desopop

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

Wait for your menstrual period and take the first Desopop 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 taking the tablets.

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

You may start taking Desopop the day after taking the last tablet of your current pack, or on the day of removal of the vaginal ring or transdermal patch (meaning you do not need a tablet-, ring-, or patch-free break). If your current pill contains inactive tablets, you may start Desopop the day after taking the last active tablet (if you are unsure, consult your doctor or pharmacist). By following 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 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 progestogen-only pill

You may stop your current product at any time and start Desopop immediately. You do not need additional contraceptive precautions.

• If you were using a progestogen injection, implant, or intrauterine system (IUS)

Start using Desopop at the time you are due for your next injection, or on the day your implant or IUS is removed. Additional contraceptive precautions are not necessary.

• After childbirth

You may start Desopop 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 taking the tablets. However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Desopop. More information about breastfeeding can be found in section “Pregnancy and breastfeeding” under point 2. Your doctor can also advise you.

• After an abortion

Your doctor will advise you.

If you forget to take Desopop

• If less than 12 hours have passed since the usual time of taking the tablet, the effectiveness of Desopop is maintained. Take the missed tablet as soon as you remember, and take the following tablets at the usual time.
• If more than 12 hours have passed since the 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, using an additional contraceptive method (barrier method) for the next 7 days.

If you miss one or more tablets during the first week of 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 within 3–4 hours after taking your Desopop tablet or have severe diarrhea, the active ingredient may not have been completely absorbed.

If you take more Desopop than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

No serious harmful effects have been reported from taking too many Desopop tablets at once. Possible symptoms include nausea, vomiting, and slight vaginal bleeding in girls. For more information, consult your doctor.

If you stop taking Desopop

You may stop taking Desopop 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 medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Seek immediate medical attention if you experience allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis).

Irregular vaginal bleeding may occur during use of Desopop. This may be light spotting, which may not even require a sanitary pad, or heavier bleeding resembling a light menstrual period, requiring sanitary protection. It may also occur that you do not have any bleeding at all. Irregular bleeding is not a sign that the contraceptive protection of Desopop is reduced. In general, no action is needed; simply continue taking Desopop. However, if bleeding is heavy or prolonged, consult your doctor.

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

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

• 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 women):

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

Rare (may affect up to 1 in 10,000 women):

• rash, urticaria, painful purple lumps on the skin (erythema nodosum) (these are skin effects)

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

• allergic reactions

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

Reporting of adverse effects

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

5. Storage of Desopop

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.

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

The active substance poses a medium environmental risk for fish.

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

6. Contents of the pack and other information

Composition of Desopop

• The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel.
• The other components (excipients) are: monohydric lactose, corn starch, 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 contents of the pack

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

Only certain pack 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 medicinal product 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 microgrammes, comprimé pelliculé

Belgium: DESOPOP 75 microgrammes, comprimé pelliculé

Date of the most recent review of this leaflet: November 2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.