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CLOPIDOGREL DEXCEL 75 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOPIDOGREL 75 mg FILM-COATED TABLETS
Clopidogrel

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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
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 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.
2. 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 (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
• 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:
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
- oral anticoagulants (medicines used to reduce blood clotting).
- a non steroidal anti-inflammatory drug, 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 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.

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Pregnancy and breast-feeding:
It is preferable not to use 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 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 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 (e.g. lactose), contact your doctor before taking this medicine.
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 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 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
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 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 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 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 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 effect : 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.
Do not store above 25 oC.
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.
6. 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:
Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
This leaflet was last approved in June 2011.
1204000019V-324-Add

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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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