DESOGESTREL 75 MICROGRAMSFILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user Desogestrel 75 microgram film-tjoated tablets Desogestrel

Tead all of this leaflet carefully before you start using this medicine nformation for you. (eep this leaflet. You may Heed to read it again. »If you have any further questions, please ask your doctor or phan » This medicine has been prescribed for you only. Do not pass it on even if their symptoms ar$ the same as yours. »If you get any side effects) talk to your doctor or pharmacist. This effects not listed in this leaflet. See section 4.

recause it contains important racist. to others. It may harm them, ncludes any possible side

What is in this leaflet

• 1. What Desogestrel is and What it is used for

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

• 3. How to take Desogestrel i

• 4. Possible side effects I

• 5. How to store Desogestrel

• 6. Contents of the pack andiother information

1. what desogestrel is and what it is used for

Desogestrel is used to prevent pregnancy. I

Desogestrel contains a small amount of one type of female sex horrinone, the progestogen desogestrel. For this reason! Desogestrel is called a progestogen-orily-pill (POP).

Contrary to the combined pi|l, the POP does not contain an oestrogen hormone next to the progestogen.

Most POPs work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the primary acticin of combined pills. Desogestrel is different from most POPsiin having a dose that in most cases is High enough to prevent the egg cell from ripening. As a resujt, Desogestrel provides high contraceptive efficacy. In contrast to the combined pill, Desogestrel can be used by women who do not tolerate oestrogens and by women who are breastfeeding. I I

A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Desogestrel. You also may hot have any bleeding at all.

2. what you need to know before you take desogestrel

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

Do not take Desogestrel

• if you are allergic to desogestrel, soya, peanut or any of the other ingredients of this medicine

(listed in section 6). I I

.jj»..if.youiiave-a-thrombosis.iT­hrombosi&is-the-formation.ofat)lo­odclot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)).

• if you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver function is still not normal.
• if you have or if you are suspected of having a cancer that grows under the influence of sex-steroids, such as certain types of breast cancer.
• if you have any unexplained vaginal bleeding.

Tell your doctor before you start to use Desogestrel if any of these conditions apply to you. Your doctor may advise you to use a non-hormonal method of birth control.

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

Talk to your doctor before using Desogestrel, if

• you have ever had cancer of the breast.
• you have liver cancer, since a possible effect of Desogestrel cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines and Desogestrel’).
• you suffer from tuberculosis (see section ‘Other medicines and Desogestrel’).
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.

Psychiatric disorders:

Some women using hormonal contraceptives including <product name> have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

When Desogestrel is used in the presence of any of these conditions, you may need to be kept under close observation. Your doctor can explain what to do.

In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be less than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group. Likewise, in 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed. In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills like Desogestrel is believed to be similar to that in women who use the Pill, but the evidence is less conclusive.

Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women who do not take the Pill. It is not known whether the difference in breast cancer risk is caused by the Pill. It may be that the women were examined more often, so that the breast cancer is noticed earlier.

Thrombosis

See your doctor immediately, if you notice possible signs of a thrombosis (see also ‚Regular Checkups‘).

Thrombosis is the formation of a blood clot which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism". As a result, fatal situations may occur. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills, like Desogestrel, is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).

Children and adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years.

Other medicines and Desogestrel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or herbal products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you take Desogestrel. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long or whether the use of another medicine you need must be changed.

Some medicines:

• – can have an influence on the blood levels of Desogestrel.

• – can make it less effective in preventing pregnancy.

• – can cause unexpected bleeding.

Desogestrel

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 infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (e.g. boceprevir, telaprevir);
• or other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (the herbal remedy St. John's wort);
• certain bacterial infections (e.g. clarithromycin, erythromycin);
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole);
• high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).

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

Desogestrel may also interfere with how other medicines work, causing either an increase in effect (e.g. medicines containing ciclosporine) or a decrease in effect (e.g. lamotrigine).

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding

Desogestrel may be used while you are breast-feeding. Desogestrel does not appear to influence the production or the quality of breast milk. However, there have been infrequent reports of a decrease in breast milk production while using Desogestrel. A small amount of the active substance of Desogestrel passes over into the milk.

The health of children breast-fed for 7 months whose mothers were using Desogestrel desogestrel has been studied up to 2.5 years of age. No effects on the growth and development of the children were observed.

If you are breast-feeding and want to use Desogestrel, please contact your doctor.

Regularly check your breasts and contact your doctor as soon as possible if you feel 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 gradually decreases, so that 10 years after stopping the risk is the same as for women who have never taken the Pill. Breast cancer is rare under 40 years of age but the risk increases as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to take the Pill when she is older. How long she takes the Pill is less important.

Driving and using machines

There are no indications of any effect of the use of Desogestrel on alertness and concentration.

Desogestrel contains lactose and soya oil

Desogestrel contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you are allergic to peanut or soya, do not use this medicinal product.

BACKSIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE

Regular check-ups

When you are using Desogestrel, your doctor will tell you to return for 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 either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possibly a sign of a thrombosis).
• you have a sudden, severe stomach ache or look jaundiced (possibly a sign of liver problems);
• you feel a lump in your breast (possibly a sign of breast cancer);
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of an ectopic pregnancy, this is a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.

3. how to take desogestrelwhen and how to takedesogestrel the tablets?always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure.

The Desogestrel pack contains 28 tablets..The days of the week are printed in the blister and also arrows are printed indicating the order to take the pills Each day corresponds with one tablet.

Every time you start a new pack of Desogestrel, take a tablet from the top row. Don’t start with just any tablet. For example if you start on a Wednesday, you must take the tablet from the top row marked (on the back) with WED’. Continue to take one tablet every day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of your pack you can easily check if you have already taken a tablet on a particular day.

Take your tablet each day at about the same time. Swallow the tablet whole, with water. You may have some bleeding during the use of Desogestrel, but you must continue to take your tablets as normal. When a pack is empty, you must start with a new pack of Desogestrel on the next day -without interruption and without waiting for a bleed.

Starting your first pack of Desogestrel

When no hormonal contraceptive has been used in the past month

Wait for your period to begin. On the first day of your period take the first Desogestrel tablet. You need not take extra contraceptive precautions.

You may also start on days 2–5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

• When you change from a combined pill, vaginal ring, ortransdermal patch

You can start taking Desogestrel on the day after you take the last tablet from the present Pill pack, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring- or patch-free break). If your present Pill pack also contains inactive tablets you can start Desogestrel on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). If you follow these instructions, you need not take extra contraceptive precautions.

You can also start at the latest the day following the tablet-, ring- or patch-free break, or placebo tablet interval, of your present contraceptive. If you follow these instructions, make sure you use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

• When changing from another progestogen-only pill

You may stop taking it any day and start taking Desogestrel right away. You need not take extra contraceptive precautions.

• When changing from an Injection or implant or a progestogen-releasing intrauterine system (IUS) Start using Desogestrel when your next injection is due or on the day that your implant or your IUS is removed. You need not take extra contraceptive precautions.

• After having a baby

You can start Desogestrel between 21 and 28 days after the birth of your baby. If you start later, make sure that you use an additional barrier method of contraception until you have completed the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before starting Desogestrel use. Additional information for breast-feeding women can be found in ‚Pregnancy and Breast-feeding‘ in section 2. Your doctor can also advise you.

• After a miscarriage or a premature termination of pregnancy

Your doctor will advise you.

If you forget to take Desogestrel

If you are less than 12 hours late in taking a tablet, the reliability of Desogestrel is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual times.

If you are more than 12 hours late in taking any tablet, the reliability of Desogestrel may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and take the next tablets at the usual times. Use an additional contraceptive method (barrier method) too for the next 7 days of tablet-taking. If you missed one or more tablets in the very first week of tablet-intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice.

If you suffer from gastro-intestinal disturbances (e.g. vomiting, severe diarrhoea)

Follow the advice for missed tablets in the section above. If you vomit within 3 – 4 hours after taking your Desogestrel tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Desogestrel than you should

There have been no reports of serious harmful effects from taking too many Desogestrel tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. Formore information ask your doctor for advice.

If you stop taking Desogestrel

You can stop taking Desogestrel whenever you want. From the day you stop you are no longer protected against pregnancy.

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

4. possible side effects

Like all medicines, Desogestrel can cause side effects, although not everybody gets them.

You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to breathe.

Serious undesirable affects associated with the use of Desogestrel are described in the paragraphs „Breast Cancer“ and „Thrombosis“ in section 2 “What you need to know before you take Desogestrel" Please read this section for additional information and consult your doctor at once where appropriate.

Vaginal bleeding may occur at irregular intervals during the use of Desogestrel. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period and requires sanitary protection. You may also not have any bleeding at all. The irregular bleedings are not a sign that the contraceptive protection of Desogestrel is decreased. In general, you need not take any action; just continue to take Desogestrel. If, however, bleeding is heavy or prolonged you should consult your doctor.

How often are other possible side effects seen?

• Common (may affect up to 1 in 10 women): mood changes, depressed mood, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no menstruation, increased body weight.
• Uncommon (may affect up to 1 in 100 women): infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cyst, tiredness.
• Rare (may affect up to 1 in 1000 women): rash, hives, painful blue-red skin lumps (erythema nodosum). These are skin conditions.

5. how to store desogestrel

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

This medicinal product does not require any special storage conditions.

Do not use Desogestrel this medicine after the expiry date which is stated on the carton after „Do not use after:“. The Expi ry date refers to the last day of that month.

The active substance shows an environmental risk to fish.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

o

Contents of the pack and other information

What Desogestrel contains

The active substance is: desogestrel (75 microgram)

The other ingredients are: maize starch, povidone K30, d-a-tocopherol, silica, colloidal anhydrous, silica, colloidal hydrated, stearic acid, hypromellose, polyethylene glycol, titanium dioxide (E171), lactose monohydrate, soya oil (see also „Desogestrel contains lactose and soya oil“ in section 2).

What Desogestrel looks like and contents of the pack

One blister pack of Desogestrel contains 28 white round film-coated tablets. Each carton contains 1, 3 or 6 blisters. Not all pack sizes may be available.

Marketing Authorisation Holder

Marketing Authorisation Holder Laboratorios Leon Farma, S.A. Pol. Ind. Navatejera.

Cl La Vallina s/n

24008 – Navatejera, Leon.

Spain

Manufacturer

Laboratorios Leon Farma, S.A.

Pol. Ind. Navatejera.

Cl La Vallina s/n

24008 – Navatejera, Leon.

Spain

This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Desogestrel 75 microgram film-coated tablets

Austria: Grystella 75 Mikrogramm Fil mtabletten

France: Grystella 75 mcg

Spain: Kerizet 75 microgramos comprimidos recubiertos con pelicula EFG

Poland: Limetic E

This leaflet was last revised in March 2021 s

10 mm

202 mm

10mm

222 mm