Document: Desogestrel Orifarm film-coated tablet ENG PL change

• Desogestrel Orifarm film-coated tablet PL
• Desogestrel Orifarm film-coated tablet ENG PL

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Package leaflet: Information for the user

Desogestrel Orifarm 75microgram film-coated tablets

Desogestrel

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, pharmacist or nurse.

• 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

Desogestrel Orifarm is used to prevent pregnancy. It contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Desogestrel Orifarm is called a progestogen-only-pill (POP), or a mini-pill. Contrary to the combined pill, the POP or mini-pill does not contain an oestrogen hormone next to the progestogen.

Desogestrel Orifarm is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Desogestrel Orifarm provides high contraceptive efficacy.

Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the primary action of combined pills.

In contrast to the combined pill, Desogestrel Orifarm can be used by women who do not tolerate oestrogens and by women who are breast feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Desogestrel Orifarm. You also may not have any bleeding at all.

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

Do not take Desogestrel Orifarm

• if you are allergic to 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 clot in a blood vessel (e.g. of the legs (deep venous thrombosis) that can among others migrate into the lungs and cause a 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 are suspected to have a cancer that is sensitive to 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 Orifarm 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 Orifarm.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Desogestrel Orifarm.

Take special care with Desogestrel Orifarm:

• if you have ever had breast cancer.

• if you have liver cancer, since a possible effect of Desogestrel Orifarm on liver cancer cannot be excluded.

• if you have ever had a thrombosis.

• if you suffer from epilepsy (see section 2 "Other medicines and Desogestrel Orifarm").

• if you suffer from tuberculosis (see section 2 "Other medicines and Desogestrel Orifarm").

• if you have high blood pressure.

• if 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.

When Desogestrel Orifarm 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.

Breast cancer

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. 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 the age until which the woman continues to take the pill is higher. How long she takes the pill is less important.

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 progesteron-only pills like Desogestrel Orifarm is believed to be similar to that in women who use the pill, but 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 check-ups").

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, fatalsituations 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 of getting a thrombosis is higher in pill-users than in non-users. The risk with progesteron-only pills like Desogestrel Orifarm is believed to be lower than in users of pills that also contain oestrogens (combined pills).

Children and adolescents

The safety and efficacy of desogestrel in adolescents below 18 years has not been established.

Other medicines and Desogestrel Orifarm

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

Some medicines may stop Desogestrel Orifarm from working properly. These include medicines used for the treatment of :

• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital)

• tuberculosis (e.g. rifampicin)

• HIV infections (e.g. ritonavir), or other infectious diseases (e.g. griseofulvin)

• stomach upset (medical charcoal)

• depressive moods (the herbal remedy St. John’s wort)

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.

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

Desogestrel Orifarm with food and drink

You can take Desogestrel Orifarm with or without food and drink. Swallow the tablet with water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not use Desogestrel Orifarm if you are pregnant, or think you might be pregnant. If you become pregnant during treatment with Desogestrel Orifarm you should stop taking this medicine.

Breast-feeding

Desogestrel Orifarm may be used while you are breast-feeding. Desogestrel Orifarm does not influence the production or the quality of breast milk. However, a small amount of the active substance of Desogestrel Orifarm passes over into the milk.

The health of children breast-fed for 7 months whose mothers were using 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 Orifarm, please contact your doctor.

Driving and using machines

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

Desogestrel Orifarm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Regular check-ups

When you are using Desogestrel Orifarm, 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 of either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possibly indicating a thrombosis)

• you have a sudden, severe stomach ache or look jaundiced (possibly indicating liver problems)

• you feel a lump in your breast (possibly indicating breast cancer)

• you have a sudden or severe pain in the lower abdomen or stomach area (possibly indication 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

Always take this medicine exactly as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

When and how to take the tablets?

The Desogestrel Orifarm pack contains 28 tablets. Arrows are printed on the front side of the pack between the tablets. If you turn over your pack, and look at the back side, you will see the days of the week printed on the foil. Each day corresponds with one tablet. Every time you start a new pack of Desogestrel Orifarm, take a tablet from the top row. For example if you start on a Wednesday, you must take the tablet from the top row marked (at the back) with "Wed". Continue to take one tablet a day until the pack is empty, always follow the direction indicated by the arrows. By looking at the back of your pack you can easily check if you have already taken your 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 vaginal bleeding during the use of Desogestrel Orifarm, but you must continue to take your tablets as normal. When a pack is empty, you must start with a new pack of Desogestrel Orifarm on the next day - thus without interruption and without waiting for a bleed.

Starting your first pack of Desogestrel Orifarm

Wait for your period to begin. On the first day of your period take the first Desogestrel Orifarm 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.

You can start taking Desogestrel Orifarm 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 interval). If your present pill pack contains both active and inactive tablets you can start Desogestrel Orifarm 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 on the day following the tablet-, ring-, patch-free interval, or after the intake of the inactive tablets 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.

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

Start using Desogestrel Orifarm when your next injection is due or on the day that your implant or your IUD is removed. You need not take extra contraceptive precautions.

You can start Desogestrel Orifarm between 21 to 28 days after the birth of your baby. If you start later, make sure you use an additional contraceptive method (barrier method) until you have completed the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before starting Desogestrel Orifarm use. Additional information for breast-feeding women can be found in ‘Pregnancy and breast-feeding’ in section 2. Your doctor can also advise you.

Your doctor will advise you.

If you take more Desogestrel Orifarm than you should

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

If you forget to take Desogestrel Orifarm

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

• If you are more than 12 hours late in taking any tablet, the reliability of Desogestrel Orifarm 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. This means that you possibly take 2 tablets on one day. 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 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 or use medical charcoal within 3-4 hours after taking your Desogestrel Orifarm tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you stop taking Desogestrel Orifarm

You can stop taking Desogestrel Orifarm 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 medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Serious undesirable effects associated with the use of Desogestrel Orifarm are described in the paragraphs "Breast cancer" and "Thrombosis" in section 2 "What you need to know before you take Desogestrel Orifarm". 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 Orifarm. 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 Orifarm is decreased. In general, you need not take any action. Just continue to take Desogestrel Orifarm. If, however, bleeding is heavy or prolonged you should consult your doctor.

Users of desogestrel have reported the following side effects:

Common: may affect up to 1 in 10 people:

Mood altered, decreased sexual drive (libido), depressed mood, headache, nausea, acne, breast pain, irregular or no menstruation, increased body weight.

Uncommon: may affect up to 1 in 100 people:

Infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cyst, tiredness.

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

Rash, hives, painful blue-red skin lumps (erythema nodosum) (these are skin conditions).

Apart from these side effects, breast secretion may occur.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desogestrel Orifarm

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30C.

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 protect the environment.

6. Contents of the pack and other information

What Desogestrel Orifarm contains

The other ingredients are: lactose monohydrate (see also “Desogestrel Orifarm contains lactose“ in section 2), maize starch, povidone PVP K-30, stearic acid, all-rac-alpha-tocopherol, silica, colloidal anydrous, hypromellose, macrogol, talc, titanium dioxide (E171).

What Desogestrel Orifarm looks like and contents of the pack

Desogestrel Orifarm tablets are white to off white, circular, biconvex film-coated tablets without embossing.

One blister pack of Desogestrel Orifarm contains 28 film-coated tablets. Each carton contains 1, 3 or 6 blister packs, each separately packed in a sachet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orifarm Generics A/S

Energivej 15

DK-5260 Odense S

Denmark

info@orifarm.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden, Norway, Denmark: Desogestrel Orifarm

This leaflet was last revised in 2015-10-02