CLOPIDOGREL ZENTIVA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Zentiva 75 mg Film-Coated Tablets

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

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

1. What Clopidogrel Zentiva is and what it is used for

Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel Zentiva is given to adults to prevent blood clots (thrombi) in the blood vessels (arteries) that supply the brain and heart, a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel Zentiva 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
• previously had a heart attack, stroke, or have a condition known as peripheral arterial disease, or
• experienced a severe form of chest pain known as "unstable angina" or "heart attack". For the treatment of this condition, your doctor may need to insert a stent in the obstructed or narrowed artery to restore proper blood flow. Your doctor may also have prescribed aspirin (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).
• experienced symptoms of a stroke that disappeared within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer aspirin to you during the first 24 hours.
• have an irregular heartbeat, a condition called "atrial fibrillation", and 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 aspirin or the combined use of Clopidogrel Zentiva and aspirin for this condition. Your doctor will have prescribed Clopidogrel Zentiva plus aspirin if you cannot take "oral anticoagulants" and do not have a high risk of major bleeding.

2. What you need to know before you take Clopidogrel Zentiva

Do not take Clopidogrel Zentiva:

• if you are allergic (hypersensitive) 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, tell your doctor before taking Clopidogrel Zentiva.

Warnings and precautions

Before starting treatment with Clopidogrel Zentiva, tell your doctor if you:

• have a 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 makes you prone 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.

• have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
• have liver or kidney disease.
• have had an allergy or reaction to any medicine used to treat your condition.
• have had a non-traumatic brain hemorrhage.

During treatment with Clopidogrel Zentiva:

• 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 (bruises) under the skin that can appear as red spots, with or without unexplained extreme tiredness, confusion, yellow color of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• 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.

Taking Clopidogrel Zentiva with other medicines

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 Clopidogrel Zentiva or vice versa.

You must 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 drugs of the same type), medicines used to treat depression,
• rifampicin (used for severe infections)

• omeprazole or esomeprazole, medicines to treat stomach discomfort,
• fluconazole or voriconazole, medicines to treat bacterial and fungal infections,
• efavirenz, or other antiretroviral medicines (used to treat HIV infections),
• carbamazepine, a medicine to treat some forms of epilepsy,
• moclobemide, a medicine for depression,
• repaglinide, a medicine for diabetes,
• paclitaxel, a medicine for cancer,
• opioids: if you are being treated with clopidogrel, you should tell your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to reduce cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed Clopidogrel Zentiva in combination with aspirin, a substance present in many medications used to relieve pain and reduce fever. A dose of aspirin given occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Zentiva with food and drinks

Clopidogrel Zentiva 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 should tell your doctor or pharmacist before taking Clopidogrel Zentiva. If you become pregnant while taking Clopidogrel Zentiva, you should tell 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, you should tell your doctor before taking this medicine.

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

Driving and using machines

Clopidogrel Zentiva is unlikely to affect your ability to drive or use machines.

Clopidogrel Zentiva contains lactose

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

Clopidogrel Zentiva contains hydrogenated castor oil

This may cause stomach upset and diarrhea.

3. How to take Clopidogrel Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

The recommended dose, even for patients with a condition known as "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Zentiva 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 heart attack), your doctor may prescribe you 300 mg or 600 mg of Clopidogrel Zentiva (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel Zentiva per day, as described above.

If you have experienced symptoms of a stroke that disappeared within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you 300 mg of Clopidogrel Zentiva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel Zentiva per day, as described above, with aspirin for 3 weeks.

After that, your doctor will prescribe either Clopidogrel Zentiva alone or aspirin alone.

You should take Clopidogrel Zentiva for as long as your doctor prescribes it.

If you take more Clopidogrel Zentiva 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 Clopidogrel Zentiva

If you forget to take a dose of Clopidogrel Zentiva, 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.

In the 7, 14, 28, and 84 tablet formats, you can check the last day you took a Clopidogrel Zentiva tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Zentiva

Do not stop taking your treatment unless your doctor tells you to.Contact your doctor or pharmacist before stopping treatment with 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.

Contact 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), with or without 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 may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Zentiva is bleeding. Bleeding may occur in the stomach or intestine, bruising, hematoma (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 or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Zentiva

If you cut or injure yourself, 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 cuts 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:

Frequent 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, feeling of 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 (e.g., feeling of heat throughout the body 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, talk to your doctor or pharmacist. 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. Storage of Clopidogrel Zentiva

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 refers to the last day of the month.

See the storage conditions in the carton.

Store below 30°C when Clopidogrel Zentiva is presented in PVC/PVDC/aluminum blisters. When Clopidogrel Zentiva is presented in any aluminum blister, it does not require special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

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

Clopidogrel Zentiva Composition

The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other components are (see section 2 "Clopidogrel Zentiva contains lactose" and "Clopidogrel Zentiva contains hydrogenated castor oil"):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose.
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464),
• triacetin (E1518), red iron oxide (E172), titanium dioxide (E171).
• Varnish: carnauba wax.

Product Appearance and Package Contents

Clopidogrel Zentiva 75 mg film-coated tablets (tablets) are round, biconvex, pink, and engraved with the number "75" on one side and the number "1171" on the other. Clopidogrel Zentiva is available in cardboard boxes of:

• 7, 14, 28, 30, 50, 84, 90, and 100 tablets in PVC/PVDC/Aluminum or Aluminum/Aluminum blisters,
• 50x1 tablets in PVC/PVDC/Aluminum blisters or unit-dose perforated aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturers:

Sanofi Winthrop Industrie

1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France.

or

Delpharm Dijon

6, Boulevard de l’Europe, F - 21800 Quétigny, France

or

S.C. Zentiva S.A.

B-dul Theodor Pallady nr. 50, sector 3,

032266 Bucharest

Romania

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of the Last Revision of this Leaflet: <{MM/AAAA}>

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