CLOPIDOGREL 75 mg FILM-COATED TABLETS
Clopidogrel
Read all of this leaflet carefully before you start taking this medicine.
- 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. 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 gets 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
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, smaller than red or white blood cells, 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 arteries (also known as atherosclerosis), and
- You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease
Clopidogrel which is contained in Clopidogrel Tablets may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
Before You Take Clopidogrel Tablets
Do not take Clopidogrel Tablets:
- If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Tablets (listed in section 6 'What Clopidogrel Tablets contain')
- 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 (ischemic stroke) which occurred within the last seven days
- if you are taking another type of medicine (see 'Taking other medicines')
- 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 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
- You should tell your doctor or pharmacist if you notice any side effect not listed in section 4 'POSSIBLE SIDE EFFECTS' or if you notice that a side effect gets serious
Clopidogrel Tablets are not intended for use in children or adolescents.
Taking other medicines:
Some other medicines may influence the use of clopidogrel or vice versa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The use of oral anticoagulants (medicines used to reduce blood clotting) with clopidogrel is not recommended.
You should specifically tell your doctor if you take a non steroidal anti-inflammatory drug, usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or any other medicine used to reduce blood clotting, or if you take a proton pump inhibitor (e.g, omeprazole) for upset stomach.
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 use this product during pregnancy and breast-feeding.
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.
While taking Clopidogrel Tablets, consult your doctor about the breast-feeding of a baby.
Ask your doctor or pharmacist 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 of Clopidogrel Tablets:
Clopidogrel Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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 75 mg tablet 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 the nearest 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 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 the forgotten individual doses.
If you stop taking Clopidogrel Tablets:
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Clopidogrel Tablets 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 '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 (affects 1 to 10 patients in 100) reported with Clopidogrel 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 'Take special care with Clopidogrel Tablets').
Other side effects reported with Clopidogrel are:
Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, abnormal touch sensation.
Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.
Very rare side effects (affects less than 1 patient in 10,000): 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.
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.
The medicinal product does not require any special storage conditions.
Do not use Clopidogrel Tablets if you notice any visible sign 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 to protect the environment.
Further Information
What Clopidogrel Tablets contain
- The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
- The other ingredients are:
Core: Cellulose, microcrystalline, hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid (type 50), talc
Coating: Hypromellose (E464), iron oxide red (E172), lactose monohydrate, triacetin (E1518), titanium dioxide (E171)
What Clopidogrel Tablets look like and contents of the pack
Clopidogrel film-coated tablets are pink, round and biconvex.
They are supplied in PVC/PE/PVDC-Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 14, 28, 30, 50, 84, 90 or 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Clopidogrel 75mg Filmtabletten
United Kingdom: Clopidogrel 75mg film coated tablets
This leaflet was last approved in September 2009.
PT350502 / 2805527/2
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