Clopidogrel 75mg Film-Coated Tablets
1. WHAT CLOPIDOGREL 75 MG FILM-COATED TABLETS AREANDWHATTHEYAREUSEDFOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOPIDOGREL 75 MG FILM-COATED TABLETS
CONSILIENT HEALTH u*
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clopidogrel 75 mg film-coated tablets
Clopidogrel hydrochloride
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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
What is in this leaflet:
1. What Clopidogrel 75 mg film-coated tablets are and what they are used for
2. What you need to know before you take Clopidogrel 75 mg film-coated tablets
3. How to take Clopidogrel 75 mg film-coated tablets
4. Possible side effects
5. How to store Clopidogrel 75 mg film-coated tablets
6. Contents of the pack and other information
The product name is Clopidogrel 75 mg film-coated tablets but
will be referred to as Clopidogrel throughout this leaflet.
Clopidogrel belongs 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 is taken by adults 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.
Do not take Clopidogrel
• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients 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.
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:
• ifyouhaveariskofbleedingsuchas
- 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'Taking other medicines').
• 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 orTTP) 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. Flowever, 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 the see'Possible side effects'section of this leaflet or if you notice that a side effect gets serious.
Children and adolescents
Do not give this medicine to children because it does not work.
Other medicines and Clopidogrel
Some other medicines may influence the use of Clopidogrel or vice versa. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
You should specifically tell your doctor if you take
• medicines that may increase your risk of bleeding such as:
- 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 orjoints,
- heparin or any other injectable medicine 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,
• omeprazole or esomeprazole medicines to treat upset stomach,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
• carbamazepine, a medicine to treat some forms of epilepsy,
• moclobemide, medicine to treat depression,
• repaglinide, medicine to treat diabetes,
• paclitaxel, medicine to treat cancer.
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and reduce fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel with food and drink
Food/meals have no influence. Clopidogrel may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to take this product during pregnancy.
3. HOW TO TAKE CLOPIDOGREL 75 MG FILM-COATED TABLETS
4. POSSIBLE SIDE EFFECTS
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 breast-feed while taking this medicine.
If you are breast-feeding or planning to breast-feed, 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 or diarrhoea.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose, including for patients with a condition called '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.
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 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 guestions on the use of this medicine, ask your doctor or pharmacist.
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 a 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 and itching, blisters of the skin. These may be the signs of an allergic reaction.
The most common side effect 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 slightly 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 of no concern. However, if you are concerned by your bleeding,
5. HOW TO STORE CLOPIDOGREL 75 MG FILM-COATED TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
you should contact your doctor straightaway (see section 2 'Warnings and precautions').
Other side effects include
Common side effects (may affect up to 1 in 10 people): diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, abnormal touch sensation.
Rare side effect (may affect up to 1 in 1,000 people): vertigo, enlarged breasts in males.
Very rare side effects (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, taste disorders.
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 or pharmacist.
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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture and light.
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.
What Clopidogrel contains
The active substance is clopidogrel. Each film-coated tablet contains 75 mg clopidogrel (as hydrochloride).
The other ingredients are (see section 2' Clopidogrel contains hydrogenated castor oil'):
• Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil.
• Film-coating: red iron oxide (E172), yellow iron oxide (E172) and opadry II HP white 85F28751 containing polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 (polyethyleneglycol) and talc.
What Clopidogrel looks like and contents of the pack
The film-coated tablets are pink, round and slightly convex. Boxes of 7,14, 28,30,50,56,84,90 and 100 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorisation Number
PL 24837/0028
Marketing Authorisation Holder
Consilient Health Ltd., 5th Floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland.
Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6,
8501 Novo mesto, Slovenia.
This leaflet was last revised in December 2015.
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