Package leaflet: Information for the user Feanolla 75 microgram 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 Family Planning Nurse.

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

•    If 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.

What is in this leaflet

1.    What Feanolla is and what it is used for

2.    What you need to know before you take Feanolla

3.    How to take Feanolla

4.    Possible side effects

5.    How to store Feanolla

6.    Contents of the pack and other information

1.    What Feanolla is and what it is used for

•    Feanolla is used to prevent pregnancy.

•    There are 2 main kinds of hormone contraceptive.

-    The combined pill, “The Pill”, which contains 2 types of female sex hormone, an oestrogen and a progestogen

-    The progestogen-only pill, POP or mini-pill, which doesn’t contain an oestrogen.

•    Feanolla is a progestogen-only-pill (POP), or a mini-pill.

•    Feanolla contains a small amount of one type of female sex hormone, the progestogen desogestrel.

•    Most POPs or minipills 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 main way that combined pills work.

•    Feanolla is different from other mini-pills in having a dose that in most cases prevents the egg cell from ripening. As a result, Feanolla is a highly effective contraceptive.

•    In contrast to the combined pill, Feanolla 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 Feanolla. On the other hand you may not have any bleeding at all.

2.    What you need to know before you take Feanolla

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

Do not take Feanolla if:

•    you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).

•    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)).

•    you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver is still not working normally.

•    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.

•    you have any unexplained vaginal bleeding.

If any of these conditions apply to you, tell your doctor before you start to use Feanolla. Your doctor may advise you to use a non-hormonal method of birth control. If any of these conditions appear for the first time while using Feanolla, consult your doctor immediately.

Warnings and precautions

Before you start Feanolla tell your doctor or family planning nurse, if you:

•    have ever had breast cancer.

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

•    have ever had a thrombosis.

•    have diabetes.

•    suffer from epilepsy (See section ‘Other medicines

and Feanolla’).

•    have tuberculosis (See section ‘Other medicines and Feanolla’).

•    have high blood pressure.

•    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 Feanolla 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

•    It is important to regularly check your breasts and you should 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, this reduces the risk, so that 10 years after stopping the Pill, 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.

•    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.

•    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 Feanolla 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 certain whether the Pill causes the increased risk of breast cancer. 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 athrombosis (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”. A pulmonary embolism can cause chest pain, breathlessness, collapse or even death.

•    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 Feanolla is believed to be lower than in users of Pills that also contain oestrogens (combined pills)

Other medicines and Feanolla Tell your doctor, pharmacist, or Family Planning Nurse if you are taking, have recently taken or might take any other medicines or herbal products.This includes medicines obtained without a prescription. Some medicines may stop Feanolla from working properly. These include medicines used for the treatment of:

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

•    tuberculosis (e.g. rifampicin)

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

•    stomache upset (medical charcoal)

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

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long. Feanolla 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, breast-feeding and fertility

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 Feanolla if you are pregnant, or think you may be pregnant.

Breast-feeding

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

The health of children who were breast-fed for 7 months while their mothers were using desogestrel has been studied up until they were 2¹/2 years of age. No effects on the growth and development of the children were observed.

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

Fertility

There is no evidence to suggest any short or long term infertility effects following the use of this medicine. However, in patients receiving similaroral contraceptive products, temporary infertility after discontinuance of treatment has been seen occasionally.

Driving and using machines

Feanolla has no known effect on the ability to drive or use machines

Feanolla contains lactose

Feanolla contains lactose (milk sugar). Please contact your doctor before taking Feanolla if you have been told by your doctor that you are intolerant to some sugars.

Use in adolescents

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

Regular Check-ups

When you are using Feanolla, 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 notice possible signs of a blood clot (e.g. severe pain or swelling in either of your legs) unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood)

•    you have a sudden, severe stomach ache or jaundice (you may notice yellowing of the skin, the whites of the eyes, or dark urine, possibly a sign of liver problems)

•    you feel a lump in your breast

•    you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of an ectopic pregnancy - 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 Feanolla

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

When and how to take the tablets

Each strip of Feanolla contains 28 tablets - 4 weeks supply.

•    Take your tablet each day at about the same time. Swallow the tablet whole, with water.

•    Arrows are printed on the front of the strip, between the tablets. The days of the week are printed on the back of the strip. Each day corresponds with one tablet.

•    Every time you start a new strip of Feanolla, 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 your tablet on a particular day.

•    You may have some bleeding during the use of Feanolla, (See Section 4 - Side Effects) but you must continue to take your tablets as normal.

•    When a strip is empty, you must start with a new strip of Feanolla on the next day - without interruption and without waiting for a bleed.

Starting your first pack of Feanolla

If you are not using hormonal contraception at

present (or in the past month)

Wait for your period to begin. On the first day of your period take the first Feanolla tablet. Additional contraceptive precautions are not necessary.

If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet-taking.

When you change from a combined pill (COC), vaginal ring, or transdermal patch.

If you have a tablet-, ring- or patch-free break

•    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 barrier method of contraception for the first 7 days of tablet-taking.

If you don’t have a tablet-, ring- or patch-free break

•    Start taking Feanolla 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 Feanolla 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, additional contraceptive precautions are not necessary.

When you change from another progestogen-only pill (mini-pill)

Switch on any day from another mini pill. Additional contraceptive precautions are not necessary.

When you change from an injection, implant or a hormonal IUS

Start using Feanolla when your next injection is due or on the day that your implant or you IUS is removed. Additional contraceptive precautions are not necessary.

After you have a baby

You can start Feanolla between 21 to 28 days after the birth of your baby.

If you start later, make sure that during the first cycle you use an additional barrier method of contraception for the first 7 days of tablet-taking. However, if you have already had sex, checkthatyou are not pregnant before starting Feanolla. Information for breastfeeding women can be found in section 2 “What you need to know before you take Feanolla” in the paragraph “Pregnancy, breast-feeding and fertility”. Your doctor can also advise you.

After a miscarriage or an abortion Your doctor will advice you.

If you forget to take Feanolla If you are less than 12 hours late:

•    Take the missed tablet as soon as you remember and take the next one at the usual time.

Feanolla will still protect you from pregnancy.

If you are more than 12 hours late:

•    If you are more than 12 hours late in taking any tablet, you may not be completely protected against pregnancy. The more consecutive tablets you have missed, the higher the risk that you might fall pregnant.

•    Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two in one day. This is not harmful. (If you have forgotten more than one tablet you don’t need to take the earlier missed ones). Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next 7 days.

•    If you are more than 12 hours late taking your tablet and have had sex it is safe to use emergency contraception; please consult your pharmacist or doctor.

•    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, you may fall pregnant. Ask your doctor for advice.

If you vomit or use medical charcoal

If you vomit, or use medical charcoal within 3 - 4 hours after taking your Feanolla tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed. Follow the advice for forgotten tablets in the section above.

If you take more Feanolla 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.

For more information ask your doctor for advice.

If you stop taking Feanolla

You can stop taking Feanolla 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, this medicinecan cause side effects, although not everybody gets them.

Tell your doctor if you notice any unwanted effect, especially if severe or persistent.

Serious side effects associated with the use of desogestrel are described in section 2 “What you need to know before you take Feanolla”. Please read this section for additional information on ‘Breast cancer’ and ‘Thrombosis’, and consult your doctor at once where appropriate.

Vaginal bleeding may occur at irregular intervals

while using Feanolla. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. You may need to use tampons or sanitary towels. You may also not have any bleeding at all. Irregular bleeding is not a sign that Feanolla is not working. In general, you need not take any action; just continue to take Feanolla. If bleeding is heavy or prolonged you should consult your doctor.

How often are other possible side effects seen? Common (affecting less than 1 in 10 women)

•    mood changes

•    depressed mood

•    decreased sexual drive (libido)

•    headache

•    nausea

•    acne

•    breast pain

•    irregular or no periods

•    weight increase.

Uncommon (affecting less than 1 in 100 women)

•    infection of the vagina

•    difficulties in wearing contact lenses

•    vomiting, hair loss

•    painful periods

•    ovarian cysts

•    tiredness

Rare (affecting less than 1 in 1000 women)

•    skin conditions such as: rash, hives, painful blue-red skin lumps (erythema nodosum)

•    breast secretion or leakage may occur

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.

If 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.

5.    How to store Feanolla

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

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

This medicinal product does not require any special storage conditions.

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

6.    Contents of the pack and other information

What Feanolla contains

•    The active substance is desogestrel. One (1) film-coated tablet contains 75 micrograms of desogestrel.

•    The other ingredients are:

Tablet core: Lactose monohydrate, Allrac a

Tocopherol (E307), Povidone K30, Silica colloidal anhydrous, Talc (E553b), Maize starch, Stearic acid, Magnesium stearate (E470b)

Film-coating: Hypromellose (HPMC2910, E464), Titanium dioxide (E171), Macrogol 400 (PEG 400) What Feanolla looks like and contents of the pack

Feanolla are white, round, biconvex, film-coated tablets, plain on both the sides. Feanolla film-coated tablets are packed in blister strips. Each blister contains 28 tablets

Feanolla is available in packs of 28 (1x28), 84 (3x28) and 168 (6x28) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited

Victoria Court

Bexton Road

Knutsford

Cheshire

WA160PF

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names: Germany:    Feanolla 75    Mikrogramm

Filmtabletten

Italy:    Feanolla 75    microgrammi

compresse rivestite con film Spain:    Feanolla 75    microgramos

comprimidos recubiertos con pelola

United Kingdom: Feanolla 75    microgram film-

coated tablets

This leaflet was last revised in July 2014

ID#: 238713