Skip to Content

CLOPIDOGREL 75 MG FILM-COATED TABLETS

Active substance: CLOPIDOGREL HYDROGEN SULPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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 the same as yours.
If you get any side effects, talk to your doctor or pharmacist. 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 the 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
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 acetylsalicylic acid or the combined use of Clopidogrel and
acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel plus
acetylsalicylic acid 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 (hypersensitive) to clopidogrel or any of the ingredients of medicines (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.
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 are taking another type of medicine (see ‘Other medicines and Clopidogrel’)
 if you have kidney or liver disease
 if you have had an allergy or reaction to any medicine used to treat your disease.
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.
Children and adolescents

Do not give this medicine to children because it does not work.
Other medicines and Clopidogrel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. 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 medicine, usually used to treat painful and/or inflammatory
conditions of muscle or joints,
 heparin or any other medicine used to reduce blood clotting,
 a proton pump inhibitor (e.g. omeprazole or esomeprazole) for upset stomach,
 fluconazole, voriconazole, ciprofloxacin or chloramphenicol, medicines to treat bacterial and
fungal infections,
 cimetidine, medicine to treat upset stomach,
 carbamazepine or oxcarbazepine, medicines to treat some forms of epilepsy,
 ticlopidine, other antiplatelet agent
 a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine),
medicines usually used to treat depression,
 moclobemide, medicine to treat depression.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed
clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to
relieve pain and lower fever. An occasional use of acetylsalicylic acid (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 drink
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 suspect that you are pregnant, you should tell your doctor or your pharmacist
before taking clopidogrel. 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
Clopidogrel contains hydrogenated castor oil
This may cause stomach upset and diarrhoea.

3.

How to take Clopidogrel

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
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 recommended dose is one 75 mg tablet of clopidogrel per day to be taken orally with or without
food, and at the same time each day.
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 a forgotten tablet.
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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine 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.
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
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 include:
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 1,000 people)
 a feeling of dizziness or ‘‘spinning’’ (vertigo)
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
 generalised allergic reactions (for example, overall sensation of heat with sudden general
discomfort until fainting)
 swelling in the mouth
 blisters of the skin
 skin allergy
 sore mouth (stomatitis)
 decrease in blood pressure
 confusion
 hallucinations
 joint pain
 muscular pain
 changes in taste of food

In addition, your doctor may identify changes in your blood or urine test results.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via
United Kingdom,
Yellow Card Scheme,
Website: 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 this medicine 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 this medicine 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 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 (see section 2 ‘Clopidogrel contains hydrogenated castor oil’):
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
Aptil Pharma Limited
9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL

Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Limited
9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL
Distributed by
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th Floor, CP House, 97-107 Uxbridge Road,
Ealing, London W5 5TL

This leaflet was last revised in 03/2014.

Expand view ⇕

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.

Hide