Clopidogrel Aspirin 75 mg Film-Coated Tablets

CLOPIDOGREL ASPIRIN 75/75 mg PD contains the active substances clopidogrel and acetylsalicylic acid (aspirin), which belongs to a group of medicines called antiplatelet medicines. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping in some types of blood vessels, antiplatelet medicines reduce the chances of blood clots forming (a process called atherothrombosis). CLOPIDOGREL ASPIRIN 75/75 mg PD is used to treat adult patients who have suffered with angina (a severe type of chest pain), or who have had a heart attack by preventing blood clots forming and reducing the risk of further atherothrombotic events (such as stroke, heart attack, or death).

Do not take CLOPIDOGREL ASPIRIN 75/75 mg PD:

• if you are hypersensitive (allergic) to clopidogrel, acetylsalicylic acid (aspirin) or to any of the ingredients of CLOPIDOGREL ASPIRIN 75/75 mg PD (see section 6)
• if you are allergic to other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) usually used to treat painful and/or inflammatory conditions of muscles and joints
• if you have been diagnosed with mastocytosis (a condition where certain immune cells, called mast cells, build up under the skin and/or in the bones) as taking CLOPIDOGREL ASPIRIN 75/75 mg PD may cause a severe hypersensitivity (allergic) reaction
• if you have a history of gastrointestinal bleeding, gastrointestinal ulcer or gastrointestinal perforation related to previous use of an NSAID
• if you have a medical condition that is currently causing bleeding such as a stomach ulcer, haemophilia or bleeding within the brain or bowel or a history of such a condition
• if you are under the age of 18 years
• if you have a medical condition that includes the combination of asthma, nasal discharge (runny nose) and polyps (a type of growth in the nose)
• if you have heart problems which can cause shortness of breath or ankle swelling (heart failure)
• if you suffer from severe liver disease
• if you suffer from severe kidney disease
• if you suffer from a dysfunction of, or reduction in, blood platelets which increases risk of bleeding and bruising (thrombocytopenia)
• if you are pregnant or breastfeeding your baby.

Do not share medicines prescribed for you with any other person. Always use CLOPIDOGREL ASPIRIN 75/75 mg PD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Adults: The usual dose is one tablet of CLOPIDOGREL ASPIRIN 75/75 mg PD per day to be taken orally with a glass of water, with or without food. You should take your medicines at the same time each day. You should take CLOPIDOGREL ASPIRIN 75/75 mg PD for as long as your doctor continues to prescribe it.

Children: CLOPIDOGREL ASPIRIN 75/75 mg PD is not prescribed for children. Your doctor will tell you how long your treatment with CLOPIDOGREL ASPIRIN 75/75 mg PD will last. Do not stop treatment early.

CLOPIDOGREL ASPIRIN 75/75 mg PD can have side effects. Not all side effects reported for CLOPIDOGREL ASPIRIN 75/75 mg PD are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using CLOPIDOGREL ASPIRIN 75/75 mg PD, please consult your healthcare provider for advice.

The most frequent side effect which has been seen with CLOPIDOGREL ASPIRIN 75/75 mg PD is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleed, 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 ASPIRIN 75/75 mg PD: If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way CLOPIDOGREL ASPIRIN 75/75 mg PD works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself or shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straight away (see section 2).

Store all medicines out of reach of children. Store at or below 25 °C. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).