Clopidogrel ratiopharm 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel ratiopharm 75 mg film-coated tablets EFG

clopidogrel

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Clopidogrel ratiopharm 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).

Clopidogrel ratiopharm 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 Clopidogrel ratiopharm to help prevent blood clots and reduce the risk of these serious events because:

• You have a condition that causes hardening of the arteries (also known as atherothrombosis), and
• You have previously had a myocardial infarction, 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 blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and lower fever, as well as to prevent blood clots).
• you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid to you during the first 24 hours.
• You have an irregular heartbeat, a disease called "atrial fibrillation", and you cannot take medications 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 Clopidogrel ratiopharm and acetylsalicylic acid for this disease. Your doctor will have prescribed Clopidogrel ratiopharm 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 taking Clopidogrel ratiopharm

Do not take Clopidogrel ratiopharm

• 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 in any doubt, consult your doctor before taking Clopidogrel ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting Clopidogrel ratiopharm

• If you have a risk of bleeding (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 undergone 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 medication used to treat your disease.
• If you have had a history of non-traumatic cerebral hemorrhage.

While you are taking Clopidogrel ratiopharm:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Also, inform your doctor immediately if you develop a condition (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 fatigue, confusion, yellow color in 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 formation of blood clots. For small cuts and injuries, e.g., when shaving, this is usually not important. However, if you are concerned about the bleeding, consult your doctor immediately (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.

Other medicines and Clopidogrel ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some of these medicines may affect the use of Clopidogrel ratiopharm 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, medications used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• rifampicin (used for severe infections)

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

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

Taking Clopidogrel ratiopharm with food and drinks

Clopidogrel ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant while taking Clopidogrel ratiopharm, inform 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, consult your doctor before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Clopidogrel ratiopharm contains lactose

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

Clopidogrel ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Clopidogrel ratiopharm

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel ratiopharm 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 you 300 mg or 600 mg of clopidogrel (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 ratiopharm per day as described above.

If you have experienced symptoms of a stroke that disappear 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 ratiopharm (4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm per day as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Clopidogrel ratiopharm alone or acetylsalicylic acid alone.

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

Please note that the instructions for removing the tablet from the blister pack with a peelable lid are on the outside of the box of blister packs with a peelable lid.

If you take more Clopidogrel ratiopharm than you should

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

If you forget to take Clopidogrel ratiopharm

If you forget to take a dose of Clopidogrel ratiopharm, but remember before 12 hours have passed since the time you should have taken the medication, 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 28x1 tablet format, you can check the last day you took a Clopidogrel ratiopharm tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel ratiopharm

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

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

The most common side effect reported with Clopidogrel ratiopharm is bleeding.

Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, abdomen, lungs, and joints.

If you experience prolonged bleeding while taking Clopidogrel ratiopharm

If you cut or injure yourself, it is possible that 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's ability to form clots. For minor cuts or injuries (such as when shaving), this is usually not important. However, if you have any doubts, the bleeding worsens, or you experience unexpected bleeding in unusual places in your body, you should contact 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 stomach upset

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 with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

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

Additionally, your doctor may 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, even if they are not listed in this package leaflet. You can also report side effects directly through 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 ratiopharm

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, bottle, or blister after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

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 ratiopharm Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are (see section 2 "Clopidogrel ratiopharm contains lactose" and "Clopidogrel ratiopharm contains sodium"):

• Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil, and sodium lauryl sulfate
• Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), and aluminum lake indigo carmine (E132).

Product Appearance and Package Contents

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. One side of the tablet is engraved with the number "93". The other side of the tablet is engraved with the number "7314".
• Clopidogrel ratiopharm is available in aluminum/aluminum perforated unit-dose blisters with a peelable foil or HDPE bottles with polypropylene or child-resistant polypropylene closures and silica gel as a desiccant.

Formats containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets;

• Blisters with a peelable foil or without it, containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets
• Calendar blisters without a peelable foil, containing 28 x 1 tablets
• Bottles containing 30 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

For further 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.