DESOGESTREL STADAFARMA 75 MICROGRAMS FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Desogestrel Stadafarma 75 micrograms film-coated tablets EFG

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Desogestrel Stadafarma and what is it used for

This medicine is used to prevent pregnancy.

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

Unlike combined pills, the progestogen-only pill does not contain oestrogen hormones in addition to the progestogen.

Most progestogen-only pills work mainly by preventing sperm from entering the uterus, but they do not always prevent the egg from ripening, which is the main action of combined pills. Desogestrel is different from other progestogen-only pills because it has a dose that is high enough to prevent the egg from ripening in most cases. Therefore, desogestrel provides high contraceptive efficacy. Unlike the combined pill, desogestrel can be taken by women who do not tolerate oestrogens and by women who are breast-feeding.

A disadvantage is that you may have irregular vaginal bleeding during the use of desogestrel. You may also not have any bleeding.

2. What you need to know before you take Desogestrel Stadafarma

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

Do not take Desogestrel Stadafarma

• if you are allergic to desogestrel, soya, peanut or 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 severe liver disease and your liver is not yet working normally.
• if you have or are suspected to have a sex-hormone sensitive cancer, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

Tell your doctor before using desogestrel if any of these conditions apply to you. Your doctor may recommend that you use a non-hormonal method of birth control.

Consult your doctor immediately if any of these conditions occur for the first time while using desogestrel.

Warnings and precautions

Consult your doctor before starting to use desogestrel if:

• you have ever had breast cancer;
• you have liver cancer, as the effect of desogestrel cannot be ruled out;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see section “Other medicines and Desogestrel Stadafarma”);
• you suffer from tuberculosis (see section “Other medicines and Desogestrel Stadafarma”);
• you have high blood pressure;
• you have or have had chloasma (yellowish-brown pigmentation on the skin, particularly on the face); in this case you should avoid prolonged exposure to the sun or to UV radiation.

Psychiatric disorders

Some women using hormonal contraceptives like desogestrel have reported depression or depressed mood. Depression can be serious and sometimes may lead to suicidal thoughts.

If you experience mood changes and symptoms of depression, contact your doctor for further medical advice as soon as possible.

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

Breast cancer

Regularly inspect your breasts and contact your doctor as soon as possible if you notice any lump in your breasts. Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If you stop taking the pill, the risk decreases gradually, so that 10 years after stopping the pill the risk is the same as for women who have never taken the pill. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, the additional number of breast cancers diagnosed is higher among older women. The duration of use of the pill 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 extra case of breast cancer found up to 10 years after stopping the pill, in addition to the 4 cases normally found 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 extra cases, in addition to the 44 cases normally found in this age group. Out of 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 extra cases, in addition to the 160 cases normally found in this age group.

It is believed that the risk of breast cancer in users of progestogen-only pills like desogestrel is similar to that of women who take the pill, although the data do not allow firm conclusions to be drawn.

It appears that the breast cancers found in women who take the pill are less advanced than those found in women who do not take the pill. It is not known whether the difference in breast cancer risk is due to the pill. It may be that women who take the pill are examined more often, so that breast cancer is detected earlier.

Thrombosis

Contact your doctor immediately if you notice any of the following 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 has formed, it can reach and block the arteries of the lungs, causing a so-called “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 users of the pill than in non-users. It is believed that the risk in users of progestogen-only pills like desogestrel is smaller than in users of pills that also contain oestrogens (combined pills).

Children and adolescents

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

Other medicines and Desogestrel Stadafarma

Tell your doctor or pharmacist if you are using or have recently used or might use other medicines or herbal products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking desogestrel. They can tell you if you need to take additional contraceptive precautions (such as a condom) and if so, for how long, or whether the use of another medicine should be changed.

Some medicines:

• may influence the levels of desogestrel in the blood
• may make desogestrel less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used for the treatment of:

• 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 infectious diseases (e.g. griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressive moods (products containing the herbal remedy St. John’s Wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazol, itraconazol, fluconazol),
• high blood pressure, angina or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that may make desogestrel less effective, you should also use a barrier method of contraception. Since the effect of another medicine on desogestrel may last up to 28 days after stopping the medicine, during this time you should also use a barrier method. Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.

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

Consult your doctor or pharmacist before taking any medicine.

Pregnancy and breast-feeding

Pregnancy

Do not use desogestrel if you are pregnant or think you might be pregnant.

Breast-feeding

Desogestrel can be used during breast-feeding. Desogestrel does not seem to affect milk production or the quality of the milk. However, it has been reported that desogestrel may cause a decrease in milk production in rare cases. A small amount of the active substance of desogestrel passes into the breast milk.

The health of breast-fed children whose mothers were using desogestrel has been studied for 7 months, until the children were 2.5 years old. No effects on the growth and development of the children were found.

If you are breast-feeding and want to use desogestrel, consult your doctor.

Driving and using machines

There are no indications that the use of desogestrel has any effect on the ability to drive or use machines.

Desogestrel Stadafarma contains lactose and soya oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains soya oil. It should not be used if you are allergic to peanut or soya.

Regular check-ups

During treatment with desogestrel, your doctor will ask you to have regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

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

• you have severe pain or swelling in one leg, unexplained chest pain, difficulty breathing, unusual cough, especially coughing up blood (this could be a sign of a thrombosis);
• you have sudden severe abdominal pain or jaundice (this could indicate liver problems);
• you feel a lump in your breast (this could indicate breast cancer);
• you have sudden severe pain in the lower abdomen or stomach area (this could indicate an ectopic pregnancy, i.e. a pregnancy outside the womb);
• you need to stay in bed or are to be operated on (consult your doctor at least 4 weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect you are pregnant.

3. How to take Desogestrel Stadafarma

When and how to take Desogestrel Stadafarma

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

The blister of desogestrel contains 28 tablets. The days of the week are printed on the blister and there are arrows printed indicating the order in which you should take the tablets. Each day corresponds to one tablet.

Every time you start a new blister of desogestrel, take a tablet from the top row. Do not start with any tablet. For example, if you start on a Wednesday, you should take the tablet from the top row that is marked (on the back) with “WED” (Wednesday). Continue taking one tablet every day until the blister is empty, always following the direction indicated by the arrows. Looking at the back of the blister, you can easily check if you have already taken your tablet on a particular day.

Take your tablet at about the same time every day.

Swallow the tablet whole with water. You may experience some bleeding during the use of desogestrel, but you should continue to take the tablets as normal. When you finish a blister, start a new blister of desogestrel the next day - without leaving a gap and without waiting for a bleed.

Starting the first pack of Desogestrel Stadafarma

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

Wait for your period to begin and take the first tablet of desogestrel on the first day of your period. This way, you are protected against pregnancy immediately. You do not need to take any additional contraceptive precautions.

You can also start on days 2-5 of your cycle, but in this case, make sure you also use a barrier method of contraception (such as a condom) for the first 7 days of tablet-taking.

• When changing from a combined pill, vaginal ring or patch

You can start taking desogestrel the day after you take the last tablet from your current pack, or the day after you remove the vaginal ring or patch (this means you do not need to have a pill-free break from your previous pill, ring or patch). If your current pill is a pill that has inactive tablets, you can start taking desogestrel the day after you take the last active tablet (if you are not sure, 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 break from your current pill, ring or patch, or the day after you take the last inactive tablet from your current pill. If you follow these instructions, make sure you also use a barrier method of contraception for the first 7 days of tablet-taking.

• If you were taking another progestogen-only pill

You can stop taking your current pill and start taking desogestrel at any time. You do not need to take any additional contraceptive precautions.

• If you were using an injectable, implant or intrauterine system (IUS) that releases progestogenStart using desogestrel on the day you would have your next injection or on the day your implant or IUS is removed. You do not need to take any additional contraceptive precautions.

• After childbirth

You can start using desogestrel between 21 and 28 days after giving birth. If you start later than this, make sure you also use a barrier method of contraception for the first 7 days of tablet-taking.

However, if you have already had sex, you must make sure you are not pregnant before you start taking desogestrel. You can find more information about breast-feeding in the section “Pregnancy and breast-feeding” in point 2. Your doctor may also advise you.

• After a miscarriage or abortion

Your doctor will advise you.

If you forget to take Desogestrel Stadafarma

If it has been less than 12 hourssince the time you should have taken your tablet, the contraceptive protection of desogestrel is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual time.

If it has been more than 12 hourssince the time you should have taken your tablet, the contraceptive protection of desogestrel may be reduced. The more tablets you have missed, the greater the risk that the contraceptive protection of desogestrel is reduced. Take the most recently missed tablet as soon as you remember and take the next tablets at the usual time, and use a barrier method of contraception for the next 7 days. If you miss one or more tablets in the first week of tablet-taking and have had sex in the week before missing the tablets, you may be pregnant. Consult your doctor.

If you have gastrointestinal disorders (e.g. vomiting, severe diarrhoea)

Follow the instructions for a missed tablet in the section above. If you vomit within 3-4 hours of taking your desogestrel tablet, or have severe diarrhoea, it is possible that the active substance will not have been completely absorbed.

If you take more Desogestrel Stadafarma than you should

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

If you stop taking Desogestrel Stadafarma

You can stop taking desogestrel at any time you like. From the day you stop taking it, you will no longer be protected against pregnancy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, desogestrel can cause adverse effects, although not all people experience them.

Consult your doctor immediately if you experience symptoms of angioedema, such as (i) swelling of the face, tongue, or pharynx; (ii) difficulty swallowing; or (iii) hives and difficulty breathing.

Serious adverse effects that may be associated with the use of desogestrel are explained in the sections "Breast Cancer" and "Thrombosis" in point 2. "What you need to know before taking Desogestrel Stadafarma". Read this point to know the information in detail and consult your doctor immediately if you consider it necessary.

Irregular vaginal bleeding may occur during the use of desogestrel, which can be a slight spotting that may not even require a pad or more intense bleeding, similar to a scarce menstruation, which 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 desogestrel decreases. In general, you don't need to do anything, just continue taking desogestrel. However, if the bleeding is intense or prolonged, consult your doctor.

The following adverse effects have been reported:

• Frequent (may affect up to 1 in 10 women): mood changes, depressed mood, decreased sexual desire (libido), headache, nausea, acne, breast pain, irregular or absent 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 1,000 women): rash, hives, painful purple bumps on the skin (erythema nodosum). These are skin effects.

• Frequency not known (frequency cannot be estimated from 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 is not listed 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. Storage of Desogestrel Stadafarma

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C. Store in the original blister packaging to protect it from light.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

The active ingredient shows a medium environmental risk for fish.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in 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. Package Contents and Additional Information

Composition of Desogestrel Stadafarma

• The active ingredient is: desogestrel (75 micrograms)
• The other components are cornstarch, povidone (E1201), RRR-α-tocopherol (E307), silica, anhydrous colloidal (E551), colloidal hydrated silica (E551), stearic acid (E570), hypromellose (E464), macrogol, titanium dioxide (E171), lactose monohydrate, soybean oil (see also "Desogestrel Stadafarma contains lactose and soybean oil" in section 2).

Appearance of the Product and Package Contents

A blister pack of Desogestrel Stadafarma contains 28 film-coated tablets.

The tablets are round, with a diameter of approximately 5 mm. Each package contains 1, 3, 6, or 13 blister packs.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios Leon Farma, S.A.

C/ La Vallina s/n, Polígono Industrial Navatejera

24193, Villaquilambre, León

Spain

or

STADA Arzneimittel AG

Stadastraße 2 -18, Bad Vilbel

61118

Germany

or

Centrafarm Service B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

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

Netherlands: Desogestrel Centrafarm 0,075 mg, filmomhulde tabletten

Denmark: Desonor

Sweden: Desonor 75 mikrogram tabletter

Finland: Desonor 75 mikrog tabletit

Spain: Desogestrel STADAFARMA 75 micrograms film-coated tablets EFG

Date of the last revision of this prospectus:April 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)