Clopidogrel 75 Mg Film-Coated Tablets
Package leaflet: Information for the user
Clopidogrel 75 mg film-coated tablets
clopidogrel
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 same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Clopidogrel is and what it is used for
2. What you need to know before you take Clopidogrel.
3. How to take Clopidogrel
4. Possible side effects
5. How to store Clopidogrel
6. Contents of this pack and other information
1.What clopidogrel is and what it is used for
The name of your medicine is Clopidogrel 75 mg film-coated tablets. In the rest of this leaflet your medicine is called Clopidogrel. Clopidogrel belongs 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 is 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 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 aspirin (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 aspirin or the combined use of Clopidogrel and aspirin for this condition. Your doctor should have prescribed Clopidogrel plus aspirin 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
Do not take Clopidogrel
• if you are allergic to clopidogrel or any of the other ingredient 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.
Children and adolescents
Clopidogrel is not intended for use in Children and adolescents.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel.
Warnings and precautions
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel:
• 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.
Take special care while you are taking Clopidogrel:
• 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 before giving you this medicine. They may also test you for allergy (hypersensitivity) to a group of drugs called thienopyridine. You should tell your doctor of any signs of hypersensitivity develop (swelling of the mouth and throat, skin disorders such as rashes, itching and blisters of the skin).
Other medicines and clopidogrel
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 or vice versa.
You should specifically tell your doctor if you take:
- medicines that may increase your risk of bleeding such as:
• a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,
• oral anticoagulants, heparin and other medicines used to reduce blood clotting
• ticlopidine, other antiplatelet agent,
• a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
- proton pump inhibitors used to reduce the amount of stomach acid produced.(e.g. omeprazole or esomeprazole)
- fluconazole or voriconazole, medicines to treat fungal infections,
• carbamazepine, a medicines to treat some forms of epilepsy,
- moclobemide, medicine to treat depression.
- repaglinide, medicine to treat diabetes,
- paclitaxel, medicine to treat cancer,
- efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with aspirin, a substance present in many medicines used to relieve pain and lower fever. An occasional use of aspirin (no more than 1,000 mg in a 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel with food and drinks
Clopidogrel may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to use this product during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
If you become pregnant while taking clopidogrel, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
You should not breastfeed while taking this medicine. If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Clopidogrel is unlikely to affect your ability to drive or to use machines
Medicine contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.
3. How to take clopidogrel
Always take Clopidogrel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose, including for patients with a condition called
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'atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel 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 (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 -mg tablet of clopidogrel per day described above.
You should take Clopidogrel for as long as your doctor continues to prescribe it
If you take more Clopidogrel 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
- If you forget to take a dose of Clopidogrel 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
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 pharmacist.
4. Possible side effects
Like all medicines, Clopidogrel 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, itching and blisters of the skin. These may be the signs of an allergic reaction.
• Signs of hypersensitivity reaction including swelling of the face, throat, skin rash with redness and itch difficulty breathing.
• Signs of severe skin reactions including serious illness with blistering of the skin, mouth, eyes and genitals (Stevens Johnsons Syndrome (SJS)), serious illness with blistering of the skin (Toxic epidermal necrolysis (TEN)), skin rash with blisters and fever (Acute generalised exanthematous pustulosis (AGEP)), drug rash with eosinophilia and systemic symptoms (DRESS).
The most common side effectreported 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
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 or 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 reported with Clopidogrel are:
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
• feeling sick (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)
• a feeling of dizziness or ‘‘spinning’’ (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
• generalized allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting)
• swelling in the mouth
• skin allergy
• inflammation of the mouth (stomatitis)
• decrease in blood pressure
• confusion
• hallucinations
• joint pain
• muscular pain
• changes in the way things taste
Not known
• cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, asugrel)
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store clopidogrel
- Keep this medicine out of the sight and reach of children.
- Do not use Clopidogrel after the expiry date which is stated on the carton and the blister, after EXP.. The expiry date refers to the last day of that month.
- Store in the original package.
- Do not use Clopidogrel if you notice any visible signs 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
What Clopidogrel contains
• The active substance is clopidogrel. Each film-coated tablet contains 97.854 mg of clopidogrel bisulphate equivalent to 75 mg of clopidogrel.
The other ingredients are:
• Tablet core: Mannitol E421, crospovidone, colloidal
anhydrous silica, microcrystalline cellulose macrogol 6000, hydrogenated castor oil.
• Tablet coating: Hypromellose (E464), titanium dioxide (E171),
macrogol/PEG400, iron oxide red (E172), polysorbate 80 (E433).
What Clopidogrel looks like and contents of the pack
Clopidogrel 75 mg tablets are pink coloured, circular, biconvex, film-coated tablets plain on both sides.
The tablets are packed in blister strips composed of 3-ply alu-alu laminated film and plain Aluminium foil.
Pack sizes: 30 tablets.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
This leaflet was last revised in 12/2015.
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