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1. Debunica 75 Microgram Film-Coated Tablets
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PATIENT INFORMATION SHEET: INFORMATION FOR THE USER

Debunica 75 microgram film-coated tablets Desogestrel

In this leaflet:

1.    What Debunica is and what it is used for

2.    Before you take Debunica

3.    How to take Debunica

4.    Possible side effects

5.    How to store Debunica

6.    Further information

1. WHAT DEBUNICA IS AND WHAT IT IS USED FOR

Debunica is used to prevent pregnancy. Debunica contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Debunica 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.

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. Debunica 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, Debunica provides high contraceptive efficacy. In contrast to the combined pill, Debunica can be used by women who do not tolerate oestrogens and by women who are breastfeeding.

A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Debunica. You also may not have any bleeding at all.

2. BEFORE YOU TAKE DEBUNICA

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

Do not take Debunica

•    If you are allergic to any of the ingredients of Debunica.

•    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) 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 are suspected to have a cancer that is sensitive to progestogens, such as certain types of breast cancer.

•    If you have any unexplained vaginal bleeding.

•    If you are allergic to peanut or soya.

Tell you doctor before you start to use Debunica 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 Debunica.

Take special care with Debunica

Tell your doctor before you start to use Debunica, if

•    you have ever had cancer of the breast.

•    you have liver cancer, since a possible effect of Debunica cannot be excluded.

•    you have ever had a thrombosis.

•    you have diabetes.

•    you suffer from epilepsy (see section ‘Taking other medicines’).

•    you suffer from tuberculosis (see section ‘Taking other medicines’).

•    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.

When Debunica 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.

Debunica and 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, 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 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 progestogen-only pills like Debunica 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.

Debunica and 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, 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 Debunica, is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, including medicines obtained without a prescription. Some medicines may stop Debunica from working properly.

These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and Phenobarbital) or 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.

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

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding

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

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

Driving and using machines

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

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

Use in adolescents

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

3. HOW TO TAKE DEBUNICA

Important information about some of the ingredients of Debunica

Debunica contains lactose (milk sugar) and soy bean oil.

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

When and how you should take Debunica

The Debunica 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 correspond with one tablet. Every time you start a new pack of Debunica, 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 with ‘WED’ (Wednesday). Continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows. By looking at the pill 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 Debunica, but you must continue to take your tablets as normal. When a pack is empty, you must start with a new pack of Debunica on the next day - thus without interruption and without waiting for a bleed.

When to start with the first strip Debunica

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 Debunica 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, or transdermal patch

You can start taking Debunica on the day after you take the last tablet from the present Pill pack, or on the last 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 Debunica 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-, 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 (mini-pill)

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

When changing from an injectable or implant or a progestogen-releasing intrauterine device (IUD)

Start using Debunica 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.

After having a baby

You can start Debunica between 21 and 28 days after the birth of your baby. If you start later, make sure you use during the first cycle an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before starting Debunica 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 Debunica

If you are less than 12 hours late in taking a tablet, the reliability of Debunica 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 Debunica 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 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 Debunica tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Debunica than you should

There are no mentions of seriously damaging results of taking too many Debunica pills simultaneously. Should you have taken a number of pills simultaneously, you may suffer from nausea, vomiting or vaginal blood loss. If you find out that a child has taken multiple pills, contact your doctor for advice.

If you stop taking Debunica

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Debunica can cause side effects, although not everybody gets them. Serious undesirable affects associated with the use of Debunica are described the paragraphs "Breast Cancer" and "Thrombosis" in section 2 “Before you take Debunica” 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 Debunica. 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 Debunica is decreased. In general, you need not take any action; just continue to take Debunica. If, however, bleeding is heavy or prolonged consult your doctor.

•    Common side effects (affects 1 to 10 users in 100) are: mood altered, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no menstruation, increased body weight.

•    Uncommon side effects (affects 1 to 10 users in 1,000) are: infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cyst, tiredness.

•    Rare side effects (affects 1 to 10 users in 10,000) are: rash, hives, painful blue-red skin lumps (erythema nodosum). These are skin conditions.

Apart from these side effects, breast secretion may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE DEBUNICA

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Debunica after the expiry date which is stated on the carton after ”Do not use after:” or “EXP:”. The Expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

The active substance is: desogestrel (75 microgram)

The other ingredients are: lactose monohydrate, maize starch, povidone K30, d-a-tocopherol, soybean oil, silica, colloidal anhydrous, silica, colloidal hydrated, stearic acid, hypromellose, polyethylene glycol, titanium dioxide (E 171) (see also "Important information about some of the ingredients of Debunica" in section 2).

What Debunica looks like and content of the pack

One blister pack of Debunica contains 28 white round film-coated tablets. Each carton contains 1, 3, 6 or 13 blisters.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

EFFIK

Batiment le Newton - 9-11, rue Jeanne Braconnier - 92366 Meudon la Foret France

Manufacturer

Laboratorios Leon Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n 24008 - Navatejera, Leon.

Spain

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

This leaflet was last approved on

6

Desogestrel 75 mcg

UK/H/3416-8, 4784/001/DC