ZYLLT 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zyllt 75 mg film-coated tablets EFG

clopidogrel

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 or pharmacist.

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

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Zyllt and what is it used for
2. What you need to know before you take Zyllt
3. How to take Zyllt
4. Possible side effects
5. 5 Storage of Zyllt
6. Contents of the pack and further information

1. What is Zyllt and what is it used for

Zyllt contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that clump together to form blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis).

Zyllt is given to adults to prevent blood clots (thrombi) in blood vessels (arteries) that have become hardened (a process known as atherothrombosis), which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Zyllt to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition that leads to hardening of the arteries (also known as atherosclerosis), and
• you have previously had a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or
• you have had a severe type of chest pain known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore adequate blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).

you have an irregular heartbeat, a condition called "atrial fibrillation", and you cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Zyllt and acetylsalicylic acid for this condition. Your doctor will have prescribed Zyllt plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take Zyllt

Do not take Zyllt

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• If you have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before taking Zyllt.

Warnings and precautions

Before starting treatment with Zyllt, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding because:

• you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• you have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).

• you have recently had a serious injury.

• you have recently had surgery (including dental surgery).

• • you are going to have surgery (including dental surgery) in the next seven days.
• If you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medicine used to treat your disease.

During treatment with Zyllt:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Tell your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bleeding under the skin that can appear as red spots), accompanied or not by unexplained extreme tiredness, confusion, yellow color of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, the bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood from forming clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children because it is not effective.

Other medicines and Zyllt

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Zyllt or vice versa.

You must specifically tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:
• • oral anticoagulants, medicines used to decrease blood clotting,
  • non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
  • heparin, or any other injectable medicine used to decrease blood clotting,
  • ticlopidine, another antiplatelet agent,
  • a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medicines of the same type), medicines used to treat depression,
• omeprazole or esomeprazole, medicines used to treat stomach upset,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infections,
• carbamazepine, a medicine used to treat some forms of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• antiretrovirals (medicines used to treat HIV infection).

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Zyllt in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and reduce fever. A dose of acetylsalicylic acid given occasionally (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Zyllt with food and drinks

Zyllt can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Zyllt. If you become pregnant while taking Zyllt, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

You should not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Zyllt is unlikely to affect your ability to drive or use machines.

Zyllt contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Zyllt

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Zyllt tablet per day, taken orally with or without food and at the same time each day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Zyllt (4 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Zyllt tablet per day as described above.

You should take Zyllt for as long as your doctor continues to prescribe it.

If you take more Zyllt than you should

Contact your doctor or go to the nearest hospital emergency department, as there is a higher risk of bleeding.

If you forget to take Zyllt

If you forget to take a dose of Zyllt, but remember before 12 hours have passed since the time you should have taken the medicine, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zyllt

Do not stop your treatment unless your doctor tells you to. Consult your doctor or pharmacist before stopping this medicine.

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

4. Possible side effects

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

Consult your doctor immediately if you experience:

• Fever, signs of infection, or extreme tiredness. These symptoms may be due to a rare decrease in some blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 "Warnings and precautions").
• Swelling of the mouth or skin disorders such as rash and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Zyllt is bleeding.

Bleeding may occur in the stomach or intestine, bruising, bleeding (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Zyllt

If you cut or injure yourself, the bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood from forming clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

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

Diarrhea, abdominal pain, indigestion, or heartburn.

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

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

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

Dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (such as a feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zyllt

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from light and moisture.

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

6. Package Contents and Additional Information

Zyllt Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are: lactose (see section "Zyllt contains lactose"), microcrystalline cellulose, pregelatinized corn starch, macrogol 6000, and hydrogenated castor oil in the tablet, and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc, and propylene glycol in the film coating.

Appearance of Zyllt and Package Contents

Film-coated tablets are pink, round, and slightly convex.

Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90, and 100 film-coated tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

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