Clopidogrel 75mg film-coated Tablets

Clopidogrel (as hydrochloride)

Read all of this leaflet carefully before you start to take this medicine.

  • Keep this leaflet. You may need to read it again while you are receiving your treatment.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  1. What Clopidogrel Tablets are and what they are used for
  2. Before you take Clopidogrel Tablets
  3. How to take Clopidogrel Tablets
  4. Possible side effects
  5. How to store Clopidogrel Tablets
  6. Further information

1. WHAT CLOPIDOGREL TABLETS ARE AND WHAT THEY ARE USED FOR

Clopidogrel Tablets belong 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 Tablets are taken 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 Tablets to help prevent blood clots and reduce the risk of these severe events because:

  • You have a condition of hardening of the arteries (also known as atherosclerosis), and
  • You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease.

2. BEFORE YOU TAKE CLOPIDOGREL TABLETS

Do not take Clopidogrel Tablets:

  • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients in Clopidogrel Tablets
  • 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 Tablets.

Take special care with Clopidogrel Tablets:

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

  • 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.

While you are taking Clopidogrel Tablets:

  • 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

Clopidogrel Tablets are not intended for use in children or adolescents.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some other medicines may influence the use of Clopidogrel Tablets or vice versa.

You should specifically tell your doctor if you take

  • oral anticoagulants, medicines used to reduce blood clotting
  • a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints
  • heparin or any other injectable medicine used to reduce blood clotting
  • omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach
  • fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines used to treat bacterial and fungal infections
  • fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression
  • carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy
  • ticlopidine, other antiplatelet agent.

Taking Clopidogrel Tablets with food and drink

Clopidogrel Tablets 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 Tablets. If you become pregnant while taking Clopidogrel Tablets, 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 pharamcist for advice before taking any medicine.

Driving and using machines

Clopidogrel Tablets are unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients in Clopidogrel Tablets

This medicine contains hydrogenated castor oil, which may cause stomach upsets and diarrhoea.

3. HOW TO TAKE CLOPIDOGREL TABLETS

Always take Clopidogrel Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one 75mg tablet of Clopidogrel per day to be taken orally with or without food, and at the same time each day.

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

If you take more Clopidogrel Tablets than you should

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

If you forget to take Clopidogrel Tablets

If you forget to take a dose of Clopidogrel Tablets, but remember within 12 hours of your usual time, take your tablet straight away 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 the forgotten individual doses.

If you stop taking Clopidogrel Tablets

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 product, ask your doctor or pharamcist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clopidogrel Tablets can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

  • very common (affects more than 1 user in 10)
  • common (affects 1 to 10 users in 100)
  • uncommon (affects 1 to 10 users in 1,000)
  • rare (affects 1 to 10 users in 10,000)
  • very rare (affects less than 1 user in 10,000)
  • not known (frequency cannot be estimated from the available data)

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 ‘Take special care with Clopidogrel Tablets’)
  • 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 Tablets 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 Tablets

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 ‘Take special care with Clopidogrel Tablets).

Other side effects reported with Clopidogrel Tablets are:

  • Common side effects: Diarrhoea, abdominal pain, indigestion or heartburn.
  • Uncommon side effects: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
  • Rare side effects: Vertigo.
  • Very rare side effects: jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CLOPIDOGREL TABLETS

Keep out of the reach and sight of children.

Do not use Clopidogrel Tablets after the expiry date which is stated on the carton and on the blister, after EXP.

This medicine does not require any special storage conditions. Do not use Clopidogrel Tablets 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. These measures will help protect the environment.

6. FURTHER INFORMATION

What Clopidogrel Tablets contain

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

The other ingredients are: macrogol 6000, microcrystalline cellulose, low substituted hydroxypropyl cellulose, glycerol dibehenate, and castor oil hydrogenated in the tablet core and opadry II (containing iron oxide red (E172), macrogol 4000, polyvinyl alcohol, titanium dioxide (E171) and talc) in the tablet coating.

What Clopidogrel Tablets look like and the contents of the pack

Clopidogrel Tablets are round, pink tablets with bevelled edges. They are supplied in blister strips in a cardboard outer container in pack sizes of 28, 30, 50 and 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

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

  • UK: Clopidogrel 75mg Film-Coated Tablets
  • Ireland: Clopidogrel 75mg Film-Coated Tablets
  • Germany: Clopidogrel 75mg Filmtabletten
  • Poland: Clopidogrel 75mg Tabletki Powlekane
  • Cyprus: Clopidogrel 75mg Film-Coated Tablets
  • Malta: Clopidogrel 75mg Film-Coated Tablets
  • France: Clopidogrel 75mg comprimé pelliculé

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

  • Product name: Clopidogrel 75mg Tablets
  • Reference number: PL 29831/0415

This is a service provided by the Royal National Institute of Blind People.

For the Republic of Ireland please call +353 52 6186000

This leaflet was last approved in 02/2011.

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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