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Package leaflet: Information for the user Xanthadu 0.02 mg/3 mg film-coated tablets Ethinylestradiol/Drospirenone

What is in this leaflet:

1.    What Xanthadu is and what it is used for

2.    What you need to know before you take Xanthadu

3.    How to take Xanthadu

4.    Possible side effects

5.    How to store Xanthadu

6.    Contents of the pack and other information

1.    What Xanthadu is and what is used for

•    Xanthadu is a contraceptive pill and is used to prevent pregnancy.

•    Each of the 24 pink tablets contain a small quantity of two different female hormones, namely drospirenone and ethinylestradiol.

•    The 4 white tablets contain no active substances and are also called placebo tablets.

•    Contraceptive pills that contain two hormones are called “combination” pills.

2.    What you need to know before you take Xanthadu

Do not take Xanthadu

•    if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other organs

•    if you have (or have ever had) a heart attack or stroke

•    if you have (or have ever had) a disease that can be an indicator of a heart attack in the future (for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects).

•    if you have a disease that may increase the risk of a clot in the arteries. This applies to the following diseases:

o diabetes with damaged blood vessels o very high blood pressure

o a very high level of fat in the blood (cholesterol or triglycerides)

•    if you have a disturbance of blood clotting (for example, protein C deficiency)

•    if you have (or have ever had) a certain form of migraine (with so-called focal neurological symptoms)

•    if you have (or have ever had) liver disease and your liver function is still not normal

•    if your kidneys are not working well (renal failure)

•    if you have (or have ever had) a tumour in the liver

•    if you have (or have ever had) or if you are suspectedof having breast cancer or cancer of the genital organs

•    if you have any unexplained bleeding from the vagina

• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredientsofof this medicine (listed in section 6). This may cause itching, rash or swelling

Warnings and precautions

In some situations you need to take special care while using Xanthadu or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, you must inform your doctor before starting to use Xanthadu. Also, if any of the following conditions develops or worsens while you are using Xanthadu you must consult your doctor:

•    if a close relative has or has ever had breast cancer

•    if you have a disease of the liver or the gallbladder

•    if you have diabetes

•    if you have depression

•    if you have Crohn's disease or inflammatory bowel disease (ulcerative colitis)

•    if you have a blood disease called HUS (haemolytic uremic syndrome) that causes kidney damage

•    if you have a blood disease called sickle cell anaemia

•    if you have epilepsy (see page 5 "Xanthadu and using other medicines")

•    if you have a disease of the immune system, called SLE (systemic lupus erythematosus)

•    if you have adisease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash withblisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham's chorea)

•    if you have or have ever had golden brown pigment patches (chloasma), so called "pregnancy patches", especially on the face. If this is the case, avoid direct exposure to sunlight or ultraviolet light.

•    If you have hereditary angioedema, products containingoestrogensmay cause or worsen the symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx, and/or difficulty swallowing or hives together with difficulty breathing.

Xanthadu and venous and arterial blood clots

The use of any combinationpill, including Xanthadu, increases a woman’s risk of developing a venous bloodclot (venous thrombosis) compared with women who do not take any contraceptive pill.

The risk of venous thrombosis in users of combination pills increases:

•    with increasing age

•    if you are overweight

•    if one of your close relatives had a blood clotin the leg, lung (pulmonary embolism),or other organ at a young age

•    if you must have surgery, if you have had a serious accident or if you are immobilised for a long time. It is important to tell your doctor in advance that you are using Xanthadu as the treatment may have to be stopped. Your doctor will tell you when to start Xanthadu again. This is usually about two weeks after you are back on your feet.

Your chances of having a blood clot are increased by taking the pill.

-    Of 100,000 women who are not on the pill and not pregnant, about 5-10 may have a blood clot in a year.

-    Of 100,000 women taking a pill like Xanthadu, 30-40 may have a blood clot in a year, the exact number is unknown.

-    Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.

A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.

The level of risk may vary according to the type of pill you take. Discuss with your doctor the available options.

The use of combinationpills has been connected with an increase of the risk of an arterial blood clot (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).

The risk of an arterial blood clotin users ofcombinationpills increases:

•    if you smoke. You are strongly advised to stop smoking when you use Xanthadu, especially if you are older than 35 years.

•    if you have high levels of blood cholesterol or triglycerides

•    if you are overweight

•    if one of your close relatives had a heart attack or stroke at a young age

•    if you have high blood pressure

•    if you suffer from migraine

•    if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm)

Xanthaduand cancer

Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women oncombination pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping thecombination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign livertumours, and in even fewer cases malignant liver tumourshave been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Xanthadu, you may have unexpected bleeding (bleeding outside the placebo days). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.

What you must do if no bleeding occurs during the placebo days

If you have taken all the pink active tablets correctly, you have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Only start the next strip if you are sure that you are not pregnant.

Other medicines and Xanthadu

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Xanthadu. They can tell you if you need to take additional contraceptives precautions (for example condoms)

and if so, for how long._

Some medicines can make Xanthadu less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

• medicines used for the treatment of

o epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

o tuberculosis (for example, rifampicin)

o HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as grisoefulvin, penicillin, tetracyline)

o high blood pressure in the blood vessels in the lungs (bosentan)

•    the herbal remedy St. John’s wort

Xanthadu may influence the effect of other medicines, e.g.

•    medicines containing ciclosporin

•    the anti-epilepticlamotrigine (this could lead to an increased frequency of seizures)

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

Xanthadu with food and drink

Xanthadu may be taken with or without food, if necessary with a small amount of water. Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal contraceptives can affect the results of some tests.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, you must not take Xanthadu. If you become pregnant while taking Xanthadu you must stop immediately and contact your doctor. If you want to become pregnant, you can stop taking Xanthadu at any time (see also “If you want to stop taking Xanthadu”).

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

Breast-feeding

Use of Xanthadu is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.

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

Driving and using machines

There is no information suggesting that use of Xanthadu affects driving or use of machines. Xanthadu contains lactose.

If you cannot tolerate certain sugars, contact your doctor before you take Xanthadu.

3. How to take Xanthadu

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Each blister contains 24 active pink tablets and 4 white placebo tablets.

The two differently coloured tablets of Xanthadu are arranged in order. A strip contains 28 tablets.

Take one tablet of Xanthadu every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.

Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet for the last 4 days. You must then start a new strip straight away (24 pink and then 4 white tablets). There is therefore no gap between two strips.

Because of the different composition of the tablets it is necessary to begin with the first tablet on the upper left and that you take the tablets every day. For the correct order, follow the direction of the arrows on the strip.

Preparation of the strip

To help you keep track, there are 7 stickers each with 7 days of the week for each strip of Xanthadu. Choose the week sticker that starts with the day you begin taking the tablets.For example, if you start on a Wednesday, use the week sticker that starts with “WED”.

Stick the corresponding strip in the upper left hand corner of the pack, on the "Start" position. There is now a day indicated above every tablet and you can see whether you have taken a certain pill. The arrows show the order you are to take the pills.

During the 4 days when you are taking the white placebo tablets (the placebo days), bleeding should begin (so-called withdrawal bleeding). This usually startson the 2^nd or 3^rd day after the last pink active tablet of Xanthadu. Once you have taken the last white tablet, you should start with the following strip, whether your bleeding has stopped or not. This means that you should start everystrip on the same day of the week, and that the withdrawal bleed should occur on the same days each month.

If you use Xanthadu in this manner, you are protected against pregnancy also during the 4 days when you are taking a placebo tablet.

When can you start with the first strip?

•    If you have not used a contraceptive with hormones in the previous month

Begin with Xanthadu on the first day of the cycle (that is, the first day of your period). If you start Xanthadu on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

•    Changing from a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch

You can start Xanthadu preferably on the day after the last active tablet (the last tablet containing the active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill finish (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.

•    Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablettaking.

•    After a miscarriage

Follow the advice of your doctor.

•    After having a baby

You can start Xanthadu between 21 and 28 days after having a baby. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first 7 days of Xanthadu use.

If, after having a baby, you have had sex before starting Xanthadu (again), you must first be sure that you are not pregnant or you must wait until your next period.

•    If you are breast-feeding and you want to start Xanthadu (again) after having a baby Read the section on "Breast-feeding", page 6.

Ask your doctor what to do if you are not sure when to start.

If you take more Xanthadu than you should

There are no reports of serious harmful results of taking too many Xanthadu tablets.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.

If you have taken too many Xanthadu tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Xanthadu

The last 4 tablets in the 4^th row of the stripare placebo tablets. If you forget to take one of these tablets, this will have no effect on the reliability of Xanthadu. Throw away the forgotten placebo tablet.

If you forget a pink, active tablet (tablets 1-24 of your blister-strip) you must do the following:

•    If you are less than 24 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.

•    If you are more than 24 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a pink tablet at the beginning or at the end of the strip. Therefore, you should keep the following rules (see also the diagram on page 9):

•    More than one tablet forgotten in this strip Contact your doctor.

One tablet forgotten between days 1 - 7 (first row)

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you must realize that there is a risk of pregnancy. In that case, contact your doctor.

•    One tablet forgotten between days 8 - 14 (second row)

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

•    One tablet forgotten between days 15 - 24 (third or fourth row)

You can choose between two possibilities:

1.    Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets on this strip, throw them away, and start the next strip (the starting day will be different).

Most likely, you will have a period at the end of the second strip - while taking the white placebo tablets - but you may have light or menstruation-like bleeding during the second strip.

2.    You can also stop the active pink tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, record the day on which you forgot your tablet). If

you want to start a new strip on the day you always start, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

•    If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the placebo days, this may mean that you are pregnant. You must contact your doctor before you start the next strip.

What todo in case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking an active pink tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, you must take another pink tablet from a reserve strip as soon as possible. If possible take it within 24 hours of when you normally take your pill. If this is not possible or 24 hours have passed, you should follow the advice given under "If you forget to take Xanthadu", page 8.

Delaying your period: what you need to know

Even if it is not recommended, you can delay your period by not taking the white placebo tablets from the 4^th row and going straight to a newstrip of Xanthadu and finish it. You may experience light or menstruation-like or bleeding while using this second strip. Finish this second strip by taking the 4 white tablets from the 4^th row. Then start your next strip.

You might ask your doctor for advice before deciding to delay your menstrual period.

Changing the first day of your period: what you need to know

If you take the tablets according to the instructions, then your period will begin during the placebo days. If you have to change this day, reduce the number of placebo days - when you take the white placebo tablets - (but never increase them - 4 is the maximum!). For example, if you start taking the placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. You may not have any bleeding during this time. You may then experience light or menstruation-like bleeding.

If you are not sure what to do, consult your doctor.

If you want to stop taking Xanthadu

You can stop taking Xanthadu whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Xanthadu and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.

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

4. Possible side effects

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

The following is a list of the side effects that have been linked with the use of Xanthadu:

•    Common side effects (may affect up to 1 in 10 people):

o mood swings o headache o nausea

o breast pain, problems with your periods, such as irregular periods, absence of periods

•    Uncommon side effects (may affect up to 1 in 100 people):

o depression, nervousness, sleepiness o dizziness, “pins and needles” o migraine, varicose veins, increased blood pressure

o    stomach ache, vomiting, indigestion, intestinal gas, inflammation of the stomach,

diarrhoea

o acne, itching, rash

o aches and pains, for instance back pain, limb pain, muscle cramps

o    vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps,

uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flushes, inflammation of the vagina (vaginitis), problems with your periods, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear, decreased interest in sex o lack of energy, increased sweating, fluid retention o weight increase

•    Rare side effects (may affect up to 1 in 1,000 people):

o candida (a fungal infection)

o anemia, increase in the number of platelets in the blood o allergic reaction o hormonal (endocrine) disorder

o increased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood o failure to experience an orgasm, insomnia o giddiness, tremor

o eye disorders, for instance inflammation of the eyelids, dry eyes o abnormally rapid heartbeat o    inflammation of a vein, nosebleed, fainting

o enlarged abdomen, bowel disorder, feeling bloated, stomach hernia, fungal infection of the mouth, constipation, dry mouth

o pain of bile ducts or the gallbladder, inflammation of the gallbladder o yellow brown patches on the skin, eczema, hair loss, acne-like inflammation of the skin, dry skin, lumpy inflammation of the skin, excessive hair growth, skin disorder, stretch marks on the skin, skin inflammation, light-sensitive skin inflammation, skin nodules. o difficult or painful sex, inflammation of the vagina (vulvovaginitis), bleeding following intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant lumps in the breast, abnormal growth on the mucosal surface of the neck of the womb, shrinkage or wasting of the lining of the womb, ovarian cysts, enlargement of the womb o feeling generally unwell o weight loss

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (rash with target-shaped reddening or sores).

Reporting of side effects

If you get any side effects, talk to your doctor orpharmacist. 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 storeXanthadu

Keep Xanthadu out of the sight and reach of children.

Store below 30°C.

Expiry date

Do notuse this medicine after the expiry date which is stated on the packaging after ”Do not use after:” or ”EXP:”. The expiry date refers to the last day of that month.

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 Xanthadu contains

• The active substances are ethinylestradiol and drospirenone.

Each pink active film-coated tablet contains 0.02 milligram ethinylestradiol and 3 milligram drospirenone.

The white film-coated tablets do not contain active substances.

•    The other ingredients are

Pink active film-coated tablets: lactose monohydrate, pregelatinized starch (maize), povidone K-30 (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572), poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

White inactive film-coated tablets: lactose anhydrous, povidone K-30 (E1201), magnesium stearate (E572), poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc (E553b).

What Xanthadu looks like and contents of the pack

• Each blister of Xanthadu contains 24 pink, active film-coated tabletsin the 1^st, 2^nd, 3^rd and 4^th rows of the strip and 4 white placebo film-coated tablets in row 4.

•    Xanthadu tablets, both the pink and the white, are film-coated tablets; the core of the tablet is coated.

•    Xanthadu is available in boxes of 1, 3, 6 and 13 blister strips, each containing 28 (24+4) tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder

Laboratorios Liconsa, S.A.

Gran Via Carlos 98

7th floor , Barcelona, E-08028, Spain.

Manufacturer

Laboratorios Leon Farma, S.A.

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

Spain

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

Xanthadu 0,02 mg/3 mg, filmomhulde tabletten Xanthadu 0,02 mg/3 mg potahovane tablety Xanthadu

Vylespi 0,02 mg/3 mg, comprime pellicule

Xanthadu 0.02 mg /3 mg

Xanthadu

Xanthadu 3 mg/ 0,02 mg comprimate filmate Xanthadu

Xanthadu 0,02 mg/3 mg filmsko oblozene tablete Xanthadu 0,02/3 mg filmom obalene tablety Xanthadu 0.02 mg /3 mg, film-coated tablets

This leaflet was last approved in: December 2013

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