Clopidogrel DURA
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 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, please talk to
your doctor or pharmacist. See section 4.
What Clopidogrel dura is and what it is used for
What you need to know before you take Clopidogrel dura
How to take Clopidogrel dura
Possible side effects
How to store Clopidogrel dura
Contents of the pack and other information
Medicinal product no longer authorised
Clopidogrel dura contains clopidogrel and 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 dura 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 dura 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 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 dura.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel dura:
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.
While you are taking Clopidogrel dura:
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.
Medicinal product no longer authorised
Do not give this medicine to children because it does not work.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some other medicines may influence the use of Clopidogrel dura 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.
It is preferable not to take this medicine during pregnancy .
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel dura. If you become pregnant while taking Clopidogrel dura, 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 breastfeed, talk to your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Clopidogrel dura is unlikely to affect your ability to drive or to use machines.
This may cause stomach upset and diarrhoea.
Always take this medicine exactly as your doctor or pharmacist 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 dura per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel dura for as long as your doctor continues to prescribe it.
Medicinal product no longer authorised
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
If you forget to take a dose of Clopidogrel dura, 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 have any further questions 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.
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 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 ‘Warnings and precautions’).
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, sensation of tingling and numbness.
Rare side effect (may affect up to 1 in 1000 people): Vertigo.
Very rare side effects (may affect up to 1 in 10,000 people):
Medicinal product no longer authorised
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 the national reporting system listed in Appendix V. 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.
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 (see section 2 ‘Clopidogrel Dura contains hydrogenated castor oil’)
Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron
oxide (E172), talc and macrogol 3000.
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.
Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
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 SAS
Tel: +33 4 37 25 75 00 (France)
Medicinal product no longer authorised
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan bvba/sprl
Tél/Tel: + 0032 2 658 61 00 (Belgium)
Mylan Kft
Tel: 36 1 8026993
Mylan AB
Tel: + 46 8-555 227 50
George Borg Barthet Ltd Tel: +356 21244205
Mylan dura GmbH
Tel: + 49-(0) 6151 9512 0
Mylan B.V
Tel: + 31 (0)33 2997080
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan AB
Tlf: + 46 8-555 227 50 (Sverige)
Generics Pharma Hellas ΕΠΕ
Τηλ: +30 210 9936410
Arcana Arzneimittel GmbH
Tel: +43 1 416 24 18
Mylan Pharmaceuticals, S.L tel: + 34 93 3786400
Mylan Sp.z.o.o
Tel: +48 22 5466400
Mylan SAS
Mylan, Lda.
Tel: +33 4 37 25 75 00 Phone: + 00351 21 412 7200
Generics [UK] Ltd Tel: +44 1707 853000
Mylan SAS
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)
Icepharma hf
Sími: + 354 540 8000
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)
Medicinal product no longer authorised
Detailed information is available on the European Medicines Agency website: .