Package Insert:Information for the User

Desopop 75 micrograms Film-Coated Tablets

Desogestrel

Read this package insert carefully before starting to take this medicine,because it contains important information for you.

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

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor, or pharmacist, evenifthey are not listed in this package insert. See section 4.

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-type hormones along with the progestogen.

Most progestogen-only pills or mini-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. Desopop is different from other progestogen-only pills since it has a dose that is high enough in most cases to prevent the egg from maturing. Therefore, Desopop provides high contraceptive efficacy.

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

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 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 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 Desopop 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 Desopop.

Warnings and precautions

Inform your doctor before starting to use Desopop if:

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

If you use Desopop 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 examined regularly 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 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 Desopop 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 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 likely to have regular check-ups, 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”, which can be fatal. Deep vein thrombosis is rare. It can develop while taking or not taking the pill. It can also appear 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 Desopop is lower than in users of combined pills.

Mental health disorders

Some women who use 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 safety and efficacy in adolescents under 18 years of age.

Other medications and Desopop

Inform your doctor 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 Desopop. 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 medication.

Some medications

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

These include medications used to treat:

• epilepsy (for example, primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, 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),
• depression (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 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, 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.

Desopop may 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 and breastfeeding

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

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 milk production or quality. However, with rare frequency, a decrease in milk production has been reported during the use of Desopop. Asmall amount of the active ingredient in Desopop passes into breast milk.

A study was conducted on the health of children in breastfeeding for 7 months, whose mothers used Desopop, 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 Desopop, consult your doctor.

Driving and operating machines

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

Desopop contains lactose and soy oil

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

Do not use this medication in case of allergy 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.

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

When and how to take Desopop

The blister of Desopop 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 foil. Each day corresponds to a tablet.

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

Starting the first package of Desopop

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

Wait for your period to arrive and on the first day of the period, take the first tablet of Desopop. In this way, you will 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) 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 of the current package or the day the vaginal ring or transdermal patch is removed (this means you do not need to leave a period of rest from the tablets, ring, or patch). 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 will 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) while taking the first 7 days of tablet treatment.

• When taking another progestin-only pill

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

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

Start using Desopop 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 Desopop 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 should rule out pregnancy before starting to take Desopop. You can find more information about breastfeeding in the section “Pregnancy and breastfeeding” in point 2. Your doctor can also advise you.

• After an abortion

Your doctor will advise you.

If you forgot to take Desopop

• If more than12 hourshave passed since the usual time for taking the tablet, the efficacy of Desopop is maintained. Take the missed tablet as soon as you remember it and the following tablets at the usual time.
• If more than12 hourshave passed since the usual time for taking the tablet, 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 it and continue with the following tablets at your usual time, using an additional contraceptive method (barrier method) during the 7 days following.

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 have become 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 Desopop tablet or have intense 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you interrupt the treatment with Desopop

You can stop taking Desopop 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 medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects associated with the use of Desopop are explained in the sections “Breast Cancer” and “Thrombosis” in point 2. “What you need to know before starting to take Desopop.” Read this point to get detailed information 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 may 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 have bleeding. Irregular bleeding is not a sign that the contraceptive protection of Desopop has decreased. In general, you do not need to do anything, just continue taking Desopop. 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 women):

• Changes in mood, depressed mood, decreased libido (sex drive)
• Headaches
• Nausea
• Acne
• Breast pain, irregular or absent menstruation
• Weight gain

Less frequent (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, purple and painful skin lesions (erythema nodosum) (are 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 leaflet. You can also report them directly through the Spanish System for 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 medicine.

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

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

This medication does not require special conditions for conservation.

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 SIGRE collection 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 Desopop

• The active principle 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 contents of the packaging

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

Only some packaging sizes may be marketed.

Marketing authorization holder

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

C/ La Vallina s/n

24193 Navatejera, León

Spain

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

Spain: Desopop 75 microgram tablets, film-coated EFG

France: DESOPOP 75 microgrammes, coated tablet

Belgium: DESOPOP 75 microgrammes, coated tablet

Last review date of this leaflet: November 2021.

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