Zoely 2,5 mg/1,5 mg comprimidos recubiertos con pelicula

Package Leaflet: Information for the User

Zoely 2.5mg/1.5mg film-coated tablets

Nomegestrol acetate / Estradiol

This medicinal product is subject to additional monitoring. Reporting of side effects on this product will be governed by the national requirements.You can help us by reporting any side effects you experience. See the end of section4 for how to report side effects.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of venous and arterial thromboembolism, especially in the first year or when restarting use of a CHC after a break of 4weeks or more.
• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section2 “Blood clots”).

Read this leaflet carefully before you start usingthismedicinal product, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicinal product has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours.
• Ifyouexperienceside effects, consult your doctor, pharmacist or nurse, even if they are not mentioned in this leaflet.

1.What is Zoely and for what it is used

2.What you need to know before you start using Zoely

3.How to use Zoely

4.Possible side effects

5.Storage of Zoely

6.Contents of the pack and additional information

Zoely is a contraceptive pill used to prevent pregnancy.

• 24 white film-coated tablets, are active tablets containing a small amount of two different female hormones. These are nomegestrol acetate (a progestogen) and estradiol (an estrogen).
• The four yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
• Contraceptive pills that contain two different hormones, such as Zoely, are called "combined pills".
• Estradiol, the estrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle..
• Nomegestrol acetate, the progestogen in Zoely, is derived from progesterone, a hormone, that is produced by the ovaries during a menstrual cycle.

When Not to Use Zoely

You should not use Zoely if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs.

• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you will be immobile for a long time (see section 2 “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries.

• severe diabetes with vascular damage;
• very high blood pressure;
• very high levels of fat in your blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have had) pancreatitis (inflammation of the pancreas) related to high levels of fat in your blood.

• If you have (or have had) a serious liver disease and your liver is not functioning normally.

• If you have (or have had) a benign or malignant liver tumor.
• If you have (or have had) or may have breast cancer or cancer of the reproductive organs.

• If you have any vaginal bleeding without an apparent cause.
• If you are allergic to estradiol, nomegestrol acetate or any of the other components of this medication (including those listed in section 6).

If any of these conditions appear for the first time while taking Zoely, stop taking it immediately and consult your doctor. Meanwhile, use a non-hormonal contraceptive. See also “General Notes” in section 2, above.

When to Have Special Care with Zoely

Inform Your Doctor If You Suffer Any of the Following Conditions.

If the condition develops or worsens while using Zoely, you should also inform your doctor.

• If you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, or difficulty swallowing, or rashes, accompanied by difficulty breathing. Medications containing estrogens can induce or worsen the symptoms of angioedema.
• If a close relative has or has had breast cancer.
• If you have epilepsy (see section 2, “Use of Zoely with Other Medications”).

• If you have liver disease (for example, jaundice) or gallbladder disease (for example, gallstones).
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in your blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or are immobile for a long time (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Zoely after delivery.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you experience a condition that occurred for the first time or worsened during pregnancy or with the use of sex hormones; for example: sudden hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disorder characterized by sudden body movements), angioedema (hereditary). (See section 2, “When to Consult Your Doctor”.)
• If you have (or have had) melasma (brown or dark patches on the skin, especially on the face). In that case, avoid excessive exposure to the sun or ultraviolet light.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Zoely increases your risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (known as “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of developing a blood clot that is harmful due to Zoely is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Zoely, your risk of developing a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in your leg or lung (DVT or PE) with Zoely is small.

• Of every 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato, about 5-7 will develop a blood clot in a year.
• We do not yet know how the risk compares with Zoely and a combined hormonal contraceptive containing levonorgestrel.
• The risk of developing a blood clot will vary depending on your personal medical history (see “Factors that Increase Your Risk of a Blood Clot” below).

Factors that Increase Your Risk of a Blood Clot in a Vein

The risk of developing a blood clot with Zoely is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited blood clotting disorder.
• If you need surgery or are immobile for a long time due to an injury or illness, or if you have your leg immobilized. You may need to stop taking Zoely for several weeks before surgery or while you have limited mobility. If you need to stop taking Zoely, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth recently.

The risk of developing a blood clot increases the more conditions you have.

Long-distance flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Zoely.

If any of the conditions listed above change while you are using Zoely, for example, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to Zoely is very small, but it may increase:

•With age (over about 35 years).

•If you smoke.You are advised to stop smoking when using a hormonal contraceptive like Zoely. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.

•If you are overweight.

•If you have high blood pressure.

•If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.

•If you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides).

•If you have migraines, especially migraines with aura.

•If you have a heart condition (valve disorder, a rhythm disorder called atrial fibrillation).

•If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of developing a blood clot may be increased even further.

If any of the conditions listed above change while you are using Zoely, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined pills, but it is not known whether this is caused by the combined pills. For example, tumors may be detected more frequently in women taking combined pills because they are examined more frequently by their doctor. After stopping the combined pill, the increased risk decreases gradually.

It is essential that you have your breasts checked regularly and consult your doctor if you notice any lump. You should also inform your doctor if a close relative has or has had breast cancer (see section 2, “When to Have Special Care with Zoely”).

In rare cases, benign (non-cancerous) liver tumors have been reported in women taking combined pills, and even in rare cases, malignant (cancerous) liver tumors have been reported. Contact your doctor if you experience severe abdominal pain.

Cervical cancer is caused by a human papillomavirus (HPV) infection. It has been reported that it occurs more frequently in women who use the pill for more than 5 years. It is not known whether this observation is due to the use of hormonal contraceptives or other factors, such as differences in sexual behavior.

Laboratory Tests

If you have any blood or urine tests, inform your doctor that you are taking Zoely, as it may affect the results of some tests.

Children and Adolescents

We do not have data on the safety and efficacy in girls under 18 years old.

Use of Zoely with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to take any other medication, including those purchased without a prescription and herbal medications.

You should also inform any other doctor or dentist who prescribes another medication (or the pharmacist who dispenses the medication) that you are taking Zoely. They may tell you if you need to take additional barrier contraceptive precautions and, if so, for how long.

• There are medications that can make Zoely less effective in preventing pregnancy or cause unexpected bleeding. These include medications for treating the following diseases:

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

• tuberculosis (e.g. rifampicin);

• HIV infection (e.g. ritonavir, nevirapine, nelfinavir, efavirenz);
• other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan).

• The medicinal herb called St. John's Wort may also make Zoely less effective. If you want to use St. John's Wort products while taking Zoely, you should consult your doctor first.
• Some medications can increase the levels of Zoely's active ingredients in the blood. The effectiveness of the pill is maintained, but inform your doctor if you are taking medications for treating fungal infections that contain ketoconazole.
• Zoely may also interfere with the function of other medications, such as the antiepileptic drug lamotrigine.

Pregnancy and Breastfeeding

Women who are pregnant or think they may be pregnant should not use Zoely. If you become pregnant while taking Zoely, stop taking it and contact your doctor.

If you want to stop taking Zoely because you want to become pregnant, see section 3, “If You Interrupt Treatment with Zoely”.

We do not generally recommend using Zoely during breastfeeding. If you want to use the pill while breastfeeding, consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machinery

Zoely has no or negligible effect on your ability to drive or operate machinery.

Zoely Contains Lactose

Zoely contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

When and how to take the tablets

The Zoely blister contains 28 tablets: 24 white tablets with active ingredients (numbers 1 to 24) and four yellow tablets without active ingredients (numbers 25 to 28).

Each time you start a new Zoely blister, take the white active tablet, identified with the number 1, in the top left corner (see “Start”).

Choose one of the seven stickers with day indicators, the one in the gray column that starts with your start day. For example, if you start on a Wednesday, use the sticker that indicates “WED”. Attach it to the blister, just above the row of white active tablets, where it says “Place the day of the week sticker here”. This allows you to check if you have taken your daily tablet.

Take one tablet a day, approximately at the same time; if necessary, with a little water.

Follow the direction of the arrows on the blister, so use the white active tablets first, and then the yellow placebo tablets.

Your menstruation will start during the four days you take the yellow placebo tablets (this menstruation is called withdrawal bleeding). It usually starts two to three days after the last white active tablet and may not have finished before starting the next blister.

Start taking the next blister immediately after the last yellow tablet, even if your menstruation has not finished. This means that you will always start a new blister on the same day of the week, and also that you will have your menstruation approximately the same days every month.

Some users may not have menstruation every month while taking the yellow tablets. If you have taken Zoely every day according to these instructions, it is unlikely that you are pregnant (see also section 3, “If you have missed one or two periods”).

Start of your first Zoely package

If you have not used any hormonal contraceptive in the previous month

Start taking Zoely on the first day of your cycle (i.e., the first day of your menstruation). Zoely will act immediately.

You do not need to use any additional contraceptive method.

If you switch from another combined hormonal contraceptive (combined pill, vaginal ring, or transdermal patch)

You can start taking Zoely on the day after taking the last tablet of your current pill package (this means there is no interruption in taking the tablets). If your current pill package also contains inactive tablets (placebo), you can start Zoely on the day after taking the last active tablet (if you are not sure which one, ask your doctor or pharmacist).

You can also start later, but never after the day after stopping taking your current pills (or the day after the last inactive tablet of your current pill). If you use a vaginal ring or a transdermal patch, it is best to start taking Zoely on the day you remove the ring or patch.

You can also start, at the latest, the day you would have started using the next ring or patch.

If you follow these instructions, you do not need to use any additional contraceptive method.

If you switch from a pill that only contains progestogen (mini-pill)

You can stop taking the mini-pill on any day and start taking Zoely the next day.

However, if you have sex, make sure to use a barrier contraceptive method during the first seven days you take Zoely.

If you switch from a progestogen-only injectable, implant, or intrauterine system medicated with hormone

Start using Zoely when it is time for your next injection or the day the implant or intrauterine system is removed.

However, if you have sex, make sure to use a barrier contraceptive method during the first seven days you take Zoely.

After having a baby

You can start taking Zoely between 21 and 28 days after giving birth. If you start after the 28th day, you should use a barrier contraceptive method during the first seven days you use Zoely. If, after giving birth, you have had sex before starting to take Zoely, make sure you are not pregnant or wait until your next menstruation. If you want to start taking Zoely after giving birth and are breastfeeding, also read section 2 “Pregnancy and breastfeeding”.

If you are unsure when to start, consult your doctor.

After a spontaneous or induced abortion

Follow your doctor's advice.

If you take more Zoely than you should

There have been no reports of serious side effects from taking too many Zoely tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. If a child has taken Zoely, ask your doctor for advice.

If you forgot to take Zoely

The following advice only refers to the white active tablets you forgot to take.

If you vomit or have intense diarrhea

If you vomit within three or four hours after taking a white active tablet, or if you have intense diarrhea, the active ingredients of your Zoely tablet may not have been fully absorbed by your body. This situation is similar to forgetting to take a white active tablet. After vomiting or having diarrhea, you should take, as soon as possible, a white active tablet from a spare blister. If possible, take it within 24 hours after the usual time you take the pill. Take the next tablet at the usual time. If this is not possible or if more than 24 hours have passed, you should follow the recommendation under “If you forgot to take Zoely”. If you have intense diarrhea, consult your doctor.

The yellow tablets are placebo and do not contain active ingredients. If you vomit or have intense diarrhea within three to four hours after taking a yellow tablet, the reliability of Zoely is maintained.

If you want to delay your menstruation

You can delay your menstruation by not taking the yellow placebo tablets and going straight to a new Zoely blister. You may experience light bleeding or bleeding similar to menstruation while using this second blister. When you want your menstruation to start during the second blister, stop taking the white active tablets and start taking the yellow placebo tablets. After finishing the four yellow placebo tablets from the second blister, start with the next blister (the third).

If you want to change the start day of your menstruation

If you take the tablets according to the instructions, your menstruation will start during the days you take the placebo. If you need to change this day, reduce the number of days you take the placebo, i.e., when you take the yellow placebo tablets (but never increase it; the maximum is four). For example, if you start taking the placebo on a Friday and want to change it to a Tuesday (three days earlier), you should start a new blister three days earlier than usual. You may not experience bleeding during the shortened period when you take the yellow placebo tablets. While using the next blister, you may experience oligomenorrhea (spots or streaks of blood) or intermenstrual bleeding during the days you take the white active tablets.

If you are unsure what to do, consult your doctor.

If you have unexpected bleeding

With all combined pills, during the first months, you may experience irregular vaginal bleeding (oligomenorrhea or intermenstrual bleeding) between periods. You may need to use a sanitary protection, but continue taking the tablets as usual. The irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after a few months). If the bleeding continues, becomes heavy, or starts again, consult your doctor.

If you have missed one or more periods

In clinical studies with Zoely, it has been observed that it is possible that you may not have your regular menstrual period after the 24th day.

• If you have taken the tablets correctly, have not vomited or had intense diarrhea, and have not taken any other medication, then it is very unlikely that you are pregnant. Continue taking Zoely as usual. Also, see section 3, “If you vomit or have intense diarrhea”, or section 2, “Use of Zoely with other medications”.
• Ifyouhave not taken the tablets correctly or if your expected menstruation is missing twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next Zoely blister until your doctor has confirmed that you are not pregnant.

If you interrupt treatment with Zoely

You can stop taking Zoely at any time. If you do not want to become pregnant, ask your doctor about other contraceptive methods first.

If you have stopped taking Zoely because you want to become pregnant, it is recommended that you wait until you have had a natural menstruation before trying to conceive. This will help you determine when the baby will be born.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due to Zoely, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism [VTE]) or blood clots in the arteries (arterial thromboembolism [ATE]). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to use Zoely”.

The following side effects have been associated with the use of Zoely:

Very common(may affect more than 1 in 10people):

• acne;
• changes in menstruation (e.g., absence or irregularity);

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

• decreased libido, depression or depressive mood, mood changes;
• headache or migraine;
• feeling sick (nausea);
• heavy menstruation, breast pain, pelvic pain;
• weight gain.

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

• increased appetite, fluid retention (edema);
• migraines;
• abdominal swelling;
• increased sweating, hair loss, itching, dry skin, oily skin;
• heaviness in the limbs;
• regular but scanty menstruation, larger breasts, breast lump, milk production while not pregnant, premenstrual syndrome, pain during sex, vaginal or vulvar dryness, uterine cramps;
• irritability;
• increased liver enzymes.

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

• harmful blood clots in a vein or artery, for example:
• • in a leg or foot (i.e., DVT);
  • in a lung (i.e., PE);
  • heart attack;
  • stroke;
  • transient ischaemic attack (TIA) or temporary symptoms similar to a stroke;
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).

• decreased appetite;
• increased libido;
• attention disorder;
• dry eyes, intolerance to contact lenses;
• dry mouth;
• brown-golden pigmentation spots, especially on the face; excessive hair growth
• bad vaginal odor, vaginal or vulvar discomfort;
• hunger;
• bile duct disease.

Adverse reactions (hypersensitivity) have been reported in users of Zoely, but their frequencycannot be estimated from the available data.

For more information on changes in menstruation (e.g., absent or irregular) as a possible side effect during the use of Zoely, see section3, “When and how to take the tablets”,“If you experience unexpected bleeding”and “If you have stopped having one or more menstruations”.

Reporting of side effects

If you experienceany type ofside effect, consultyour doctor, pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet.Also, you can report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister and on the box, after EXP/CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Unused combined pills (including Zoely tablets) should not be flushed down the toilet or municipal sewer system. The hormonal active principles of the tablet may have harmful effects if they reach the aquatic environment. Return them to the pharmacy or dispose of them in a safe manner, in accordance with local regulations.This will help protect the environment..

Composition of Zoely

• The active principle(s) is/are: nomegestrol acetate and estradiol.
  White film-coated active tablets: each tablet contains 2.5mg of nomegestrol acetate and 1.5mg of estradiol (as hemihydrate).
  Yellow film-coated placebo tablets: the tablet does not contain active principles.
• The other components are:
  Tablet core (white film-coated active tablets and yellow film-coated placebo tablets):
  monohydrate lactose (see section2, “Zoelycontains lactose”), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and anhydrous colloidal silica.
  Tablet coating (white film-coated active tablets):
  polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol3350 and talc (E553b).
  Tablet coating (yellow film-coated placebo tablets):
  polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol3350, talc (E553b), yellow iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

The active film-coated tablets (tablets) are white and round, and have the code “ne” on both faces.

The placebo film-coated tablets are yellow and round, and have the code “p” on both faces.

Zoely is presented in blisters of 28tablets (24white film-coated active tablets and 4yellow film-coated placebo tablets), packaged in a carton.

Pack sizes: 28, 84, 168 and 364tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorisation and manufacturer responsible

Holder of the marketing authorisation

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer responsible

Organon (Ireland) Limited

Drynam Road

Swords

Co. Dublin

Ireland

Delpharm Lille S.A.S.

Parc d’Activités Roubaix-Est

22 Rue de Toufflers

CS 50070,

59452 LYS-LEZ-LANNOYFrance

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow

Poland

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.