Package Leaflet: Information for the User

Desogestrel Stadafarma 75 micrograms Film-coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as 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 others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking 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

This medication 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 progestin-only pill.

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

Most progestin-only 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. Desogestrel is different from other progestin-only pills as it has a dose that is high enough in most cases to prevent the egg from maturing. Therefore, desogestrel provides high contraceptive efficacy. Unlike the combined pill, desogestrel 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 desogestrel. It could also not bleed.

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

Do not take Desogestrel Stadafarma

· if you are allergic to desogestrel, soy, peanuts, 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 (for example, in the legs (deep vein thrombosis) or 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 suspect you may have a sex steroid-related cancer, such as certain types of breast cancer.

· if there is any unexplained vaginal bleeding.

Inform your doctor before using desogestrel 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 desogestrel.

Warnings and precautions

Consult your doctor before starting to use desogestrel if:

· you have had breast cancer;

· you have liver cancer, as the effect of desogestrel cannot be ruled out;

· you have had a thrombosis;

· you have diabetes;

· you have epilepsy (see section “Other medications and Desogestrel Stadafarma”);

· you have tuberculosis (see section “Other medications and Desogestrel Stadafarma”);

· 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.

Mental health disorders

Some women who use hormonal contraceptives like desogestrel have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts.

If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

If you use desogestrel in any of the described situations, you should 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 lumps 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 woman is when she stops taking the pill. The duration of use of the pill is not as important.

Of every 10,000 women who have taken the pill for up to 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 for up to 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 for up to 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 progestin-only pills like desogestrel 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 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 occur while taking or not 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 progestin-only pills like desogestrel is lower than in users of combined pills (pills containing both estrogen and progestin).

Children and adolescents

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

Other medications and Desogestrel Stadafarma

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications or herbal remedies. Also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking desogestrel. They can inform you if you need to use 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 desogestrel in the blood

- may make itless effective in preventing pregnancy

- may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example, primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, 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),
• fungus 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 desogestrel less effective, you should also use a barrier contraceptive method. Since the effect of another medication on desogestrel 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.

Desogestrel can also interfere with the effect of other medications, causing an increase in effect (for example, medications containing cyclosporine) or a decrease in effect (for example, lamotrigine).

Consult your doctor or pharmacist before taking any medication.

Pregnancy and lactation

Pregnancy

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

Lactation

Desogestrel can be used during lactation. Desogestrel 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 desogestrel. A small amount of the active principle of desogestrel passes into breast milk.

A study was conducted on the health of infants for 7 months, whose mothers used desogestrel, 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 desogestrel, consult your doctor.

Driving and operating machinery

No indications have been found that the use of desogestrel produces any effect on alertness and concentration.

Desogestrel Stadafarma contains lactose and soy oil

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

This medication contains soy oil. Do not use it in case of allergy to peanuts or soy.

When and how to take Desogestrel Stadafarma

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

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

Each time you start a new desogestrel blister, 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 marked (behind) with "MIE" (Wednesday). Continue taking one tablet a 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 given day.

Take your tablet approximately at the same hour every day.

Swallow the tablet whole with water. You may experience some bleeding during the use of desogestrel, but you should continue taking the tablets normally. When you finish a blister, you should start a new desogestrel blister the next day - without leaving any day off and without waiting for bleeding to appear.

Start of the first package of Desogestrel Stadafarma

• When not using hormonal contraception in the previous month

Wait for your period and on the first day of the period, take the first desogestrel tablet. 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 a complementary contraceptive method (barrier method) during the first 7 days of treatment with the tablets.

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

You can start taking desogestrel the day after taking the last tablet from 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 pills, ring, or patch). If your current pill contains inactive tablets, you can start taking desogestrel the day after taking the last active tablet (if 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 pills, ring, or patch or with inactive tablets from your current contraceptive. If you follow these instructions, make sure to use a complementary contraceptive method (barrier method) during the first 7 days of taking the tablets.

• When taking another pill with only progestogen

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

• When using an injectable, implant, or intrauterine system (IUS) releasing progestogenStart using desogestrel 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 desogestrel between days 21 and 28 after the birth of the baby. 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 desogestrel. You can find more information about breastfeeding in the "Pregnancy and breastfeeding" section in point 2. Your doctor can also advise you.

• After a spontaneous or premature abortion

Your doctor will advise you.

If you forgot to take Desogestrel Stadafarma

If more than 12 hours have passed since the usual time to take the tablet, the effectiveness of desogestrel may have been reduced. The more consecutive tablets you have forgotten, the greater the risk that the contraceptive effectiveness has decreased. Take the last forgotten tablet as soon as you remember it and continue with the next tablets at your usual time, also using a complementary contraceptive method (barrier method) during the next 7 days. If you forget one or more tablets in the first week of starting 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, intense diarrhea)

Follow the instructions for forgotten tablets in the previous section. If you vomit within 3-4 hours after taking your desogestrel tablet or have intense diarrhea, it may be that the active ingredient has not been fully absorbed.

If you take more Desogestrel Stadafarma than you should

No serious adverse effects have been described by taking too many desogestrel 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 Desogestrel Stadafarma

You can stop taking desogestrel 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, ask your doctor or pharmacist.

Like all medications, desogestrel may cause side effects, although not everyone will 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) urticaria and difficulty breathing.

Severe side effects associated with the use of desogestrel are explained in the sections “Breast Cancer” and “Thrombosis” in point 2. “What you need to know before starting to take Desogestrel Stadafarma”. Read this point for detailed information and consult your doctor immediately if necessary.

Irregular vaginal bleeding may occur during the use of desogestrel, which can 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 desogestrel has decreased. In general, you do not need to do anything, just continue taking desogestrel. However, if the bleeding is heavy or prolonged, consult your doctor.

The following side effects have been reported:

• Frequent(may affect up to 1 in 10 women): mood changes, depressed mood, decreased libido, headaches, nausea, acne, breast pain, irregular or absent menstruation, weight gain.

• Infrequent(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, urticaria, painful and purple skin bumps (erythema nodosum). These 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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 your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desogestrel Stadafarma

- The active ingredient is: desogestrel (75 micrograms)

- The other components are cornstarch, povidone (E1201), RRR-α-tocopherol (E307), silica, colloidal anhydrous (E551), 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).

Aspect of the product and content of the packaging

A blister of Desogestrel Stadafarma contains 28 round tablets coated with a film.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Laboratorios Leon Farma, S.A.

C/ La Vallina s/n, Industrial Estate Navatejera

24008, 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 with 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 microgramos comprimidos recubiertos con película EFG

Date of the last review of this prospect: April 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )