Clopidogrel Qualimed
clopidogrel
Clopidogrel
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. 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.
What Clopidogrel Qualimed is and what it is used for
Before you take Clopidogrel Qualimed
How to take Clopidogrel Qualimed
Possible side effects
How to store Clopidogrel Qualimed
Further information
Medicinal product no longer authorised
Clopidogrel Qualimed 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 Qualimed 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 Qualimed 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.
if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Qualimed;
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 Qualimed.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Qualimed:
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.
While you are taking Clopidogrel Qualimed:
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.
Clopidogrel Qualimed is not intended for use in children or adolescents.
Medicinal product no longer authorised
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 Qualimed 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 injectable medicine used to reduce blood clotting,
-omeprazole, esomeprazole or cimetidine, medicines to treat for 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.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel Qualimed may be taken with or without food.
It is preferable not to take 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 Qualimed. If you become pregnant while taking Clopidogrel Qualimed, 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.
Clopidogrel Qualimed is unlikely to affect your ability to drive or to use machines.
Always take Clopidogrel Qualimed 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 of Clopidogrel Qualimed per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel Qualimed for as long as your doctor continues to prescribe it.
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Medicinal product no longer authorised
If you forget to take a dose of Clopidogrel Qualimed, 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 dose.
For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Qualimed by referring to the calendar printed on the blister.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Clopidogrel Qualimed 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)
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 Qualimed’).
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.
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 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 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 Qualimed’).
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.
Medicinal product no longer authorised
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.
Keep out of the reach and sight of children.
Do not use Clopidogrel Qualimed 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.
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.
The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil
Film-coating: hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol.
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.
Boxes of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.
Boxes of 30x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Not all pack sizes may be marketed.
Qualimed, 117 allee des Parcs, 69 800 Saint Priest, France
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Mylan bvba/sprl
Tél/Tel: + 0032 2 658 61 00
Mylan bvba/sprl
Tél/Tel: + 0032 2 658 61 00 (Belgium)
Medicinal product no longer authorised
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan Kft
Tel: 36 1 8026993
George Borg Barthet Ltd Tel: +356 21244205
Mylan ApS
Tlf: + 45 3694 4568
Mylan B.V
Tel: + 31 (0)33 2997080
Mylan dura GmbH
Tel: + 49-(0) 6151 9512 0
Mylan AB
Tlf: + 46 8-555 227 50 (Sverige)
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Arcana Arzneimittel GmbH Tel: +43 1 416 24 18
Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 9936410
Mylan Sp.z.o.o
Tel: +48 22 5466400
Mylan Pharmaceuticals, S.L tel: + 34 93 3786400
Mylan, Lda.
Phone: + 00351 21 412 7200
Qualimed
Mylan SAS
Tel: +33 4 37 25 75 00 Tel: +33 4 37 25 75 00 (France)
Mc Dermott Laboratories Ltd Tel: + 1800 272 272
Allphar +353 1 4041600
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Actavis Group PTC ehf Sími: + 354 5503300
Mylan sr.o
Tel: +421 2 32 604 901
Mylan S.p.A
Tel: + +39/02-61246921
Mylan OY
Puh/Tel: + 358 9-46 60 03
Pharmaceutical Trading Co Ltd Τηλ: +35 7 24656165
Mylan AB
Tel: + 46 8-555 227 50
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Generics [UK] Ltd trading as Mylan Tel: +44 1707 853000
Mylan SAS
Medicinal product no longer authorised
Tel: +33 4 37 25 75 00 (France)
Detailed information is available on the European Medicines Agency website: