CLOPIDOGREL HEC PHARM 75 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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 your 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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet

• 1. What Clopidogrel HEC Pharm is and what it is used for

• 2. What you need to know before you take Clopidogrel HEC Pharm

• 3. How to take Clopidogrel HEC Pharm

• 4. Possible side effects

• 5. How to store Clopidogrel HEC Pharm

• 6. Contents of the pack and other information

1. what clopidogrel hec pharm is and what it is used for

Clopidogrel HEC Pharm contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Clopidogrel HEC Pharm is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel HEC Pharm to help prevent blood clots and reduce the risk of these severe events because:

• – You have a condition of hardening of arteries (also known as atherosclerosis), and

• – You have previously experienced a heart attack, stroke or have a condition known as

peripheral arterial disease, or

• – You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

• – You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel HEC Pharm and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel HEC Pharm plus acetylsalicylic acid if

you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

2. what you need to know before you take clopidogrel hec pharm- if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).

• – If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.

• – If you suffer from severe liver disease.

If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel HEC Pharm.

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel HEC Pharm:

• if you have a risk of bleeding such as

• – a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer). – a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).

• – a recent serious injury.

• – a recent surgery (including dental).

• – a planned surgery (including dental) in the next seven days.

• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
• if you have kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat your disease.

While you are taking Clopidogrel HEC Pharm:

• You should tell your doctor if a surgery (including dental) is planned.
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).
• Your doctor may order blood tests.

Children and adolescents

Do not give this medicine to children because it does not work.

Other medicines and Clopidogrel HEC Pharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some other medicines may influence the use of Clopidogrel HEC Pharm or vice versa.

You should specifically tell your doctor if you take

• – medicines that may increase your risk of bleeding such as:

o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

o heparin or any other injectable medicine used to reduce blood clotting,

o ticlopidine, other antiplatelet agent,

o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

• – omeprazole or esomeprazole, medicines to treat upset stomach,

• – fluconazole or voriconazole, medicines to treat fungal infections,

• – efavirenz, or other anti-retroviral medicines (used to treat HIV infections),

• – carbamazepine, a medicine to treat some forms of epilepsy,

• – moclobemide, medicine to treat depression,

• – repaglinide, medicine to treat diabetes,

• – paclitaxel, medicine to treat cancer,

• – opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain).

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel HEC Pharm in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Clopidogrel HEC Pharm with food and drink

Clopidogrel HEC Pharm may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel HEC Pharm. If you become pregnant while taking Clopidogrel HEC Pharm, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breast-feed while taking this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

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

Driving and using machines

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

Clopidogrel HEC Pharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Clopidogrel HEC Pharm contains hydrogenated castor oil This may cause stomach upset or diarrhoea.

3. how to take clopidogrel hec pharm

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

The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel HEC Pharm per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel HEC Pharm (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel HEC Pharm per day as described above.

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

If you take more Clopidogrel HEC Pharm than you should

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take Clopidogrel HEC Pharm

If you forget to take a dose of Clopidogrel HEC Pharm, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

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

For the 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel HEC Pharm by referring to the calendar printed on the blister.

If you stop taking Clopidogrel HEC Pharm

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

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 may be due to rare decrease of some blood cells.
• signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions’).
• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

The most common side effect reported with Clopidogrel HEC Pharm is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel HEC Pharm

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).

Other side effects include:

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

Diarrhoea, abdominal pain, indigestion or heartburn.

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

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

Rare (may affect up to 1 in 1000 people):

Vertigo, enlarged breasts in males.

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

Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.

Not known (frequency cannot be estimated from the available data):

Allergic reactions with chest or abdominal pain, persistent low blood sugar symptoms.

In addition, your doctor may identify changes in your blood or urine test results.

Reporting of side effects

If you get 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 Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store clopidogrel hec pharm

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 on the blister, after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

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 to protect the environment.

6. contents of the pack and other information the active substance is clopidogrel. each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

• The other ingredients are (see section 2 ‘Clopidogrel HEC Pharm contains lactose’ and ‘Clopidogrel HEC Pharm contains hydrogenated castor oil’):

What Clopidogrel HEC Pharm looks like and contents of the pack

Clopidogrel HEC Pharm are pink round film-coated tablets, debossed “C17” on one side and blank on the other side. Clopidogrel HEC Pharm is supplied in cardboard cartons containing 28, 30, 50, 84 and 100 tablets in OPA/Aluminium/PVC blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin, Germany

Tel.: 030–3300 7721

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin

Germany

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

This leaflet was last revised in 06/2020.