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• leaflet MAH BRAND_PL 46055-0002

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PACKAGE lFaFlET: INFORMATION FOR~THE USFr^_

I    Desomono 75 microgram film-coated tablets

Desogestrel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have any further questions, askyourdoctororpharmacistornurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of llness are the same as yours.

•    Ifyou get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in thisleaflet. See section 4.

What is in this leaflet:

|1.    What Desomono is and what it is used for    I

|2.    What you need to know before you take Desomono    I

3.    How to take Desomono    I

4.    Possible side effects    ,

l5. How to store Desomono

|6. Contents of the pack and other information

1.    WHAT IS DESOMONO AND WHAT IS IT USED FOR

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

^ost POPs or minipills work primarily by preventing the sperm cells from entering the womb but do not always preventi the egg cell from ripening, which is the primary action of combined pills. Desomono 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, Desomono provides high contraceptive efficacy.

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESOMONO

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

Do not take Desomono

ifyou are allergic desogestrel or any of the other ingredients of this medicine (listed in section 6). ifyou 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 nod normal.

ifyou have or are suspected to have a cancer that is sensitive to sex-steroids, such as certain types of breast cancer.

• ifyou have any unexplained vaginal bleeding.

Tell your doctor before you start to use Desomono 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 Desomono.

Warnings and precautions

[Talk to your doctor or pharmacist before taking Desomono, if

•    you have ever had breast cancer.

•    you have Iiver cancer, since a possible effect of Desomono 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 Desomono 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.

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Breast cancer

•    Regularly checkyour breasts and contactyour doctor as soon as possible ifyou 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, I not take the Pill. If women stop taking the Pill, the risk gradually decreases, so that 10 years after stopping the risk is the I    same as for women who have never taken the Pill. Breast cancer is rare under 40 years of age but the risk increases as¹

I    the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if the age until which thel

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

I    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 Desomono 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 womenl 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 thatthq women were examined more often, so that the breast cancer is noticed earlier I

Thrombosis

pee your doctor immediately, if you notice possible signs of a thrombosis (see also "When should you contact yourl doctor?

thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep ^eins 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,

peep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen ifl you become pregnant.

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

Other medicines and Desomono

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

Some medicines may stop Desomono from working properly. These include medicines used for the treatment of-

•    epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamateand 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 ifyou need to take additional contraceptive precautions and if so, for how long.

Desomono 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

Breast-feeding

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

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'normal. When a pack is empty, you must start with a new pack of Desomono on the next day - thus without interruption and without waiting for a bleed.

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Starting your first pack of Desomono

• 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 Desomono 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 example a condom) for the first 7 days of tablet-taking.

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

You can start taking Desomono on the day after you take the last tablet from the present Pill pack, or on the day of removal bf your vaginal ring or patch (this means no tablet-, ring- or patch-free break). If your present Pill pack also contains¹ linactive tablets you can start Desomono on the day after taking the last active tablet (if you are not sure which this is, ask lyour doctor or pharmacist). Ifyou follow these instructions, you need not take extra contraceptive

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

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•    When changing from another progestogen-only pill (mini-pill).

You may stop taking it any day and start taking Desomono 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 Desomono 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.

Vou can start Desomono between 21 to 28 days after the birth of your baby. Ifyou 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, ir lintercourse has already occurred, pregnancy should be excluded before starting Desomono use. Additional information' for breast-feeding women can be found in "Pregnancy and Breastfeeding" in section 2. Yourdoctorcan alsoadviseyou

•    After a miscarriage or an abortion.

Your doctor will advise you.

Ifyou forget to take Desomono

•    Ifyou are less than 12 hours late in taking a tablet, the reliability of Desomono is maintained.

Take the missed tablet as soon as you remember and take the next tablets at the usual times.

•    Ifyou are more than 12 hours late in taking any tablet, the reliability of Desomono may be reduced.

The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Take the¹ last missed tablet as soon as you remember and take the next tablets at the usual times. This means that you possibly take 2 gablets on one day. Use an additional contraceptive method (barrier method, such as condoms) 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 beforq missing the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice.

Ifyou 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 afterl taking your Desomono tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

Ifyou take more Desomono than you should

There have been no reports of serious harmful effects from taking too many Desomono tablets atone time. Symptoms that¹ |may occur are nausea, vomiting and, in young girls, slight vaginal bleeding. For more information ask your doctor foi^ advice.

Ifyou stop taking Desomono

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

Ifyou have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

perious undesirable effects associated with the use of Desomono are described in the paragraphs "Breast cancer" and ^Thrombosis" in section 2 "Before you take Desomono". Please read this section for additional information and consult your doctor at once where appropriate.

Paginal bleeding may occur at irregular intervals during the use of Desomono. This may be just slight staining which may hot even require a pad, or heavier bleeding, which looks rather like a scanty period and requires sanitary protection. You¹ pay also not have any bleeding at all. The irregular bleedings are not a sign that the contraceptive protection of pesomono is decreased. In general, you need not take any action; just continue to take Desomono. If, however, bleeding is heavy or prolonged you should consult your doctor.

Users of another desogestrel-only pill have reported the following side effects:

Common may affect up to 1 in 10 people	Uncommon may affect up to 1 in 100 people	Rare may affect up to 1 in 1,000 people
mood altered, depressed mood, decreased sexual drive	infection of the vagina rash,	hives, painful blue-red skin (libido) lumps (erythema nodosum) (these are skin conditions)
headache	difficulties in wearing contact lenses
nausea	vomiting
acne	hair loss
breast pain, irregularorno menstruation	painful menstruation, ovarian cyst
increased body weight	tiredness

Apart from these side effects, breast secretion may occur.

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

Reporting of side effects

Jf you get any side effects talk to your doctor, pharmacist or Family Planning Nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the national Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE DESOMONO

Keep this medicine out ofthesightand reach of children.

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

Do not store above 30°C.

Store in the original foil pouch to protect from moisture.

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 Desomono contains

The active substance is Desogestrel.

Each film coated tablet contains 75 microgram desogestrel.

The other ingredients are alpha-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400; titaniuml dioxide (E 171); lactose monohydrate.    |