Desogestrel Stadafarma 75 micrograms film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desogestrel Stadafarma 75 micrograms film-coated tablets EFG

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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine is used to prevent pregnancy.

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

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

Most progestogen-only pills primarily work by preventing sperm from entering the uterus, but do not always prevent the egg from maturing, which is the main mechanism of action of combined pills. Desogestrel differs from other progestogen-only pills in that its dose 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 cannot tolerate oestrogens and by women who are breastfeeding.

One disadvantage is that you may experience irregular vaginal bleeding while taking desogestrel. You may also have no bleeding at all.

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

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

Do not take Desogestrel Stadafarma

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

Inform 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.

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

Warnings and precautions

Consult your doctor before starting to use desogestrel if:

• you have ever had breast cancer;
• you have liver cancer, since a possible 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 patches on the skin, particularly on the face); in this case, you should avoid intense exposure to sunlight or ultraviolet radiation.

Psychiatric disorders

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

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

If you use desogestrel under any of the circumstances described, 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 any 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.

The risk of breast cancer in users of progestogen-only pills such as desogestrel is believed to be similar to that in women taking combined pills, although data do not allow clear conclusions.

Breast cancers detected 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 may 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 to 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 whether or not you are taking the pill. It may also occur during pregnancy.

The risk of thrombosis is higher in users of hormonal pills than in non-users. The risk in users of progestogen-only pills such as desogestrel is believed to be lower than in users of combined pills (containing estrogens).

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or herbal products. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking desogestrel. They can advise you whether you need to take 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:

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

These include medicines 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 infections (for example, griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depression (herbal products 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 products that could reduce the effectiveness of desogestrel, you should also use a barrier contraceptive method. Since the effect of another medicine on desogestrel 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 additional contraceptive measures and, if so, for how long.

Desogestrel 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

Pregnancy

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

Breastfeeding

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

The health of infants whose mothers used desogestrel has been studied up to 7 months after birth and 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 desogestrel, consult your doctor.

Driving and use of machines

There are no indications that the use of desogestrel has any effect on alertness or concentration ability.

Desogestrel Stadafarma contains lactose and soybean oil

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

This medicine contains soybean oil. It must not be used if you are allergic to peanuts or soy.

Regular check-ups

During treatment with desogestrel, 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 leg, unexplained chest pain, difficulty breathing, or unusual cough, especially with blood-stained sputum (could indicate thrombosis);
• you have sudden, severe stomach pain or jaundice (which may indicate liver problems);
• you feel a lump in your breast (which may indicate breast cancer);
• you experience sudden or severe pain in the lower abdomen or stomach area (may indicate an ectopic pregnancy, i.e., a pregnancy outside the uterus);
• you need to remain immobile or are scheduled for surgery (consult your doctor at least four weeks in advance);
• you have unusual and 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 for taking this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Each time you start a new desogestrel 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 in the top row marked (on the back) with “WED” (Wednesday). Continue taking one tablet daily until the blister pack is empty, always following the direction indicated by the arrows. By looking at the back of the blister pack, you can easily check whether you have already taken your tablet on a given day.

Take your tablet at approximately the same time each day.

Swallow the tablet whole with water. You may experience some bleeding while using desogestrel, but you should continue taking the tablets as usual. When you finish one blister pack, you must start a new desogestrel blister pack the next day—without taking any break and without waiting for bleeding to occur.

Starting the first pack of Desogestrel Stadafarma

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

Wait for your menstrual period and take the first desogestrel tablet on the first day of your period. In this way, you do not need to take 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) during the first 7 days of treatment with the tablets.

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

You may start taking desogestrel the day after taking the last tablet of your current pack, or on the day of removal of the vaginal ring or transdermal patch (this means you do not need to have a break from tablets, ring, or patch). If your current pill contains inactive tablets, you may start taking desogestrel 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-free, ring-free, or patch-free break, 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 using another progestogen-only pill

You may discontinue your current product at any time and start taking desogestrel immediately. You will not need additional contraceptive precautions.

• If you were using an injectable, implant, or intrauterine system releasing progestogen (IUS)

Start using desogestrel at the time when your next injection would have been due, or on the day your implant or IUS is removed. Additional contraceptive precautions are not necessary.

• After childbirth

You may start desogestrel 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 desogestrel. You can find more information about breastfeeding in section “Pregnancy and breastfeeding” in point 2. Your doctor can also advise you.

• After a spontaneous abortion or an early termination of pregnancy

Your doctor will advise you.

If you forget to take Desogestrel Stadafarma

If less than 12 hours have passed since the usual time of taking the tablet, the effectiveness of desogestrel is maintained. Take the missed tablet as soon as you remember and take the following tablets at your usual time.

If more than 12 hours have passed since the usual time of taking the tablet, the effectiveness of desogestrel may have been reduced. The more consecutive tablets you miss, the greater the risk that contraceptive effectiveness has decreased. Take the last 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 starting 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 in the section above. If you vomit within 3–4 hours after taking your desogestrel tablet or have severe diarrhea, the active ingredient may not have been completely absorbed.

If you take more Desogestrel Stadafarma than you should

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

If you stop taking Desogestrel Stadafarma

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

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

4. Possible adverse effects

Like all medicines, desogestrel can cause adverse effects, although not everyone experiences them.

Seek immediate medical advice 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 described in the sections “Breast cancer” and “Thrombosis” in section 2, “What you need to know before starting to take Desogestrel Stadafarma”. Please read this section carefully for detailed information and consult your doctor immediately if necessary.

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

The following adverse effects have been reported:

• Common (may affect up to 1 in 10 women): mood changes, depressed mood, decreased sexual desire (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 1,000 women): rash, urticaria, painful purple lumps on the skin (erythema nodosum). These are skin-related 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 type of 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 Desogestrel Stadafarma

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

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

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 indicated.

The active substance poses a medium environmental risk to fish.

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

6. Contents of the pack and other information

Composition of Desogestrel Stadafarma

• The active substance is: desogestrel (75 micrograms)
• The other components are: maize starch, povidone (E1201), RRR-α-tocopher在玩家中