DESOGESTREL STADA 75 micrograms tablets

2. What you need to know before you start taking Desogestrel STADA

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

Do not take Desogestrel STADA

• if you are allergicto desogestrel 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 clotin a blood vessel (e.g. 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 working normally
• if you have or suspect you may have a cancerthat is affected by sex hormones, such as certain types of breast cancer
• if you have unexplained vaginal bleeding.

Tell your doctor before using Desogestrel STADA 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 STADA.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Desogestrel STADA, especially if:

• you have ever had breast cancer
• you have had liver cancer, as it cannot be ruled out that Desogestrel STADA may have an effect; you have ever had thrombosis
• you have diabetes
• you suffer from epilepsy(see section "Taking Desogestrel STADA with other medicines")
• you suffer from tuberculosis(see section "Taking Desogestrel STADA 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, you should avoid intense exposure to the sun or ultraviolet radiation.

If you use Desogestrel STADA in any of these situations, 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 found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women 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 as women get older. Therefore, the additional number of breast cancers diagnosed is greater the older the woman is when she continues to take the Pill. The duration of use of the Pill is less important.

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 1 additional case of breast cancer diagnosed in the next 10 years, which will be added to the 4 cases normally diagnosed in this age group. Similarly, 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 Desogestrel STADA is similar to that of women who take the Pill, but the evidence is less conclusive.

It appears that breast cancers found in women who take the Pill are less advanced than breast cancers 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 possible signs of thrombosis (see also "Regular check-ups").

Thrombosis is the formation of a blood clotthat can block a blood vessel. A 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 what is known as a "pulmonary embolism". This can lead to life-threatening situations. Deep vein thrombosis is rare. It can develop when taking or not taking the Pill. It can also occur when you are pregnant.

The risk of thrombosis is greater in Pill users than in non-users. It is believed that the risk in users of progestogen-only pills like Desogestrel STADA is smaller than in users of Pills that also contain oestrogens (combined pills).

Psychiatric disorders

Some women who use hormonal contraceptives like desogestrel have reported depression or depressed mood. Depression can be severe 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.

Children and adolescents

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

Taking Desogestrel STADA with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may cause Desogestrel STADA to not work properly. These include medicines used for the treatment of:

• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIV infection (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin)
• heartburn (activated charcoal)
• depression (the herbal remedy St. John's Wort).

Your doctor will advise you if you need to take additional contraceptive precautions and for how long.

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

Pregnancy and breastfeedingIf you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

The health of children during breastfeeding for 7 months, whose mothers used other progestogen-only pills, has been studied until the children were 2.5 years old. No effects on the growth or development of the children were observed.

If you are breastfeeding and want to use Desogestrel STADA, contact your doctor.

Driving and using machines

There are no indications that the use of Desogestrel STADA has any effect on alertness or the ability to concentrate.

Desogestrel STADA contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Regular check-ups

During treatment with Desogestrel STADA, your doctor will need 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 if:

• you have severe pain or swelling in one leg, unexplained chest pain, difficulty breathing, unusual cough, especially if this is accompanied by coughing up blood (this may indicate a thrombosis);
• you have sudden severe abdominal pain or jaundice (this may indicate liver problems);
• you feel a lump in your breast(this may indicate breast cancer);
• you have sudden severe pain in the lower abdomen or stomach area (this may indicate an ectopic pregnancy, which is a pregnancy outside the uterus);
• you need to be immobilized or have surgery (consult your doctor at least 4 weeks in advance);
• you have unusual or heavy vaginal bleeding;
• you suspect you are pregnant.

3. How to take Desogestrel STADA

When and how to take the tablets

Each Desogestrel STADA 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 Desogestrel STADA blister pack, 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". Continue taking one tablet a day until the blister pack is empty, always following the direction indicated by the arrows. Looking at the back of the blister pack, you can easily check if you have taken your tablet on a particular day.

Take your tablet every day at about the same time. Swallow the tablet whole with water. You may experience some bleeding during the use of Desogestrel STADA, but you should continue to take the tablets as usual. When the blister pack is empty, start a new Desogestrel STADA blister pack the next day - so without interruption and without waiting for a bleed to occur.

Starting the first Desogestrel STADA blister pack

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

Wait for your period to begin. Take the first tablet of Desogestrel STADA on the first day of your period. 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 to use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

• Switching from a combined pill, vaginal ring, or transdermal patch

You can start taking Desogestrel STADA the day after you take the last tablet from your current blister pack, or the day of removal of the vaginal ring or transdermal patch (this means you do not need to leave a gap between the tablets, ring, or patch). If your current blister pack contains inactive tablets, you can start taking Desogestrel STADA the day after you take the last active tablet (if you are not sure, consult your doctor or pharmacist). If you follow these instructions, you do not need to take any additional contraceptive precautions.

You can also start the day after the tablet-free interval of your current contraceptive, or the interval with an inactive tablet. If you follow these instructions, make sure to use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

• Switching from another progestogen-only contraceptive

You can stop taking it at any time and start Desogestrel STADA immediately. You do not need to take any additional contraceptive precautions.

• Switching from an injectable or implant, or an intrauterine device (IUD) that releases progestogen

Start taking Desogestrel STADA at the time you would have received your next injection, or on the day you remove your implant or IUD. You do not need to take any additional contraceptive precautions.

• After having a baby

You can start taking Desogestrel STADA between 21 and 28 days after giving birth. If you start later, make sure to use an additional contraceptive method (barrier method) until you have completed the first 7 days of tablet-taking. However, if you have already had sex, you should rule out pregnancy before starting Desogestrel STADA.

You can find more information about breastfeeding in "Pregnancy and breastfeeding" in section 2. Your doctor may also advise you.

• After a miscarriage or abortion

Your doctor will advise you.

If you forget to take Desogestrel STADA

• If it has been less than 12 hourssince the usual time of tablet-taking, the efficacy of Desogestrel STADA is maintained

Take the missed tablet as soon as you remember, and take the next tablet at the usual time.

• If it has been more than 12 hourssince the usual time of tablet-taking, the efficacy may be reduced. The more tablets you have missed, the higher the risk that the contraceptive efficacy has decreased. Take the last missed tablet as soon as you remember, and continue with the next tablets at the usual time. Use an additional contraceptive method (barrier method) for the next 7 days.
• If you have missed one or more tablets during the first week of tablet-taking and have had sex the previous week, there is a possibility that you may become pregnant. Consult your doctor.

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

Follow the instructions for missed tablets in the previous section. If you vomit or use activated charcoal within 3-4 hours after taking your Desogestrel STADA tablet, or have severe diarrhoea, it is possible that the active substance has not been completely absorbed.

If you take more Desogestrel STADA than you should

No serious harmful effects have been reported when taking too many Desogestrel STADA tablets at once. The symptoms that may occur are nausea, vomiting, and in young women, slight vaginal bleeding.

For more information, consult your doctor.

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

If you stop taking Desogestrel STADA

You can stop taking Desogestrel STADA whenever you want. 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, this medicine can cause adverse effects, although not all people suffer from them.

Severe adverse effectsassociated with the use of Desogestrel STADA are described in the sections "Breast Cancer" and "Thrombosis" in section 2 "What you need to know before taking Desogestrel STADA". Read this section for additional information and consult your doctor as needed.

Irregular vaginal bleedingmay occur during the use of Desogestrel STADA. This can be just a slight spotting that may not require a pad, or more intense bleeding that resembles a scarce menstrual period and requires hygienic protection. It may also happen that you never experience bleeding. Irregular bleeding is not a sign that the contraceptive protection of Desogestrel STADA decreases. In general, you do not need to do anything, just continue taking this medicine. However, if the bleeding is intense or prolonged, consult your doctor.

Users of Desogestrel STADA have reported the following adverse effects:

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

• 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 people):

• vaginal infection
• difficulty wearing contact lenses
• vomiting
• hair loss
• painful menstruation
• ovarian cysts
• fatigue.

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

• rash, hives, blue-red and painful bumps (erythema nodosum). (these are skin diseases)

Aside from these adverse effects, breast secretion may occur.

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

Reporting 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 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 STADA

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDesogestrel STADA

The active ingredient is desogestrel. Each tablet contains 75 micrograms of desogestrel.

The other components are: lactose, all racemic forms of tocopherol, povidone, potato starch, colloidal anhydrous silica, stearic acid.

(See also "Desogestrel STADA contains lactose" in section 2).

Appearance of the Product and Package Contents

Each tablet is round, uncoated, biconvex, engraved with "152" on one side and smooth on the other. Each package of Desogestrel STADA 75 micrograms tablets contains 1, 3, 6 or 13 blisters with 28 tablets each.

Each cardboard package contains blisters packaged separately in a laminated aluminum pouch.

Packages may be marketed with or without a desiccant.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmBH.

Muthgasse 36

A-1190 Vienna

Austria

Date of the Last Revision of this Prospectus:September 2020

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/

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