Patient leaflet - Clopidogrel DURA
What Clopidogrel Dura is and what it is used for
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:
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- You have a condition of hardening of arteries (also known as atherosclerosis), and
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- You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease.
2. What you need to know before you take Clopidogrel Dura
Do not take Clopidogrel dura
- 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.
Warnings and precautions
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
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– a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
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– a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
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– a recent serious injury
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– a recent surgery (including dental)
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– 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.
Children and adolescents
Do not give this medicine to children because it does not work.
Other medicines and Clopidogrel Dura
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
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– oral anticoagulants, medicines used to reduce blood clotting,
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– a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory
conditions of muscle or joints,
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– heparin, or any other injectable medicine used to reduce blood clotting,
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– omeprazole, esomeprazole or cimetidine, medicines to treat for upset stomach,
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– fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,
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– fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,
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– carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,
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– 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.
Pregnancy and breast-feeding
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.
Driving and using machines
Clopidogrel dura is unlikely to affect your ability to drive or to use machines.
Clopidogrel dura contains hydrogenated castor oil
This may cause stomach upset and diarrhoea.
3. How to take Clopidogrel Dura
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.
If you take more Clopidogrel dura 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 dura:
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 stop taking Clopidogrel dura:
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 :
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- fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
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- 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’).
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- 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 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 dura
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’).
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, 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):
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.
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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clopidogrel Dura
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.
6. Contents of the pack and other information
What Clopidogrel dura contains
The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
The other ingredients are:
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- Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A),
macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Dura contains hydrogenated castor oil’)
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- Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
What Clopidogrel dura 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 Holder
Mylan dura GmbH, WittichstraBe 6, D-64295 Darmstadt, Germany
Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 0032 2 658 61 00 | Lietuva Mylan SAS Tel: +33 4 37 25 75 00 (France) |
| Efc^rapufl Mylan SAS Tel: +33 4 37 25 75 00 (France) | Luxembourg/Luxemburg Mylan bvba/sprl Tei/’iel: + 0032 2 658 61 00 (Belgium) |
| Ceská republika MylanPharmaceuticals s.r.o. Tel: +420 274 770 201 Danmark Mylan AB Tel: + 46 8–555 227 50 | ^Magyarorszag Mylan Kft Tel: 36 1 8026993 Malta George Borg Barthet Ltd Tel: +356 21244205 |
| Deutschland Mylan dura GmbH Tel: + 49-(0) 6151 9512 0 | Nederland Mylan B.V Tel: + 31 (0)33 2997080 |
| Eesti Mylan SAS Tel: +33 4 37 25 75 00 (France) | Norge Mylan AB Tlf: + 46 8–555 227 50 (Sverige) |
| EMáSa Generics Pharma Hellas EnE Tql: +30 210 9936410 | Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 24 18 |
| España Mylan Pharmaceuticals, S.L tel: + 34 93 3786400 | Polska Mylan Sp.z.o.o Tel: +48 22 5466400 |
| France Mylan SAS | Portugal Mylan, Lda. |
Tel: +33 4 37 25 75 00
Hrvatska
Generics [UK] Ltd
Tel: +44 1707 853000
Ireland
Mc Dermott Laboratories Ltd
Tel: + 1800 272 272
Allphar +353 1 4041600
Island
Icepharma hf
Simi: + 354 540 8000
Italia
Mylan S.p.A
Tel: + +39/02–61246921
Knnpog
Pharmaceutical Trading Co Ltd
Tql: +35 724656165
Latvija
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Phone: + 00351 21 412 7200
România
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Slovenija
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Slovenska republika
Mylan sr.o
Tel: +421 2 32 604 901
Suomi/Finland
Mylan OY
Puh/Tel: + 358 9–46 60 03
Sverige
Mylan AB
Tel: + 46 8–555 227 50
United Kingdom
Generics [UK] Ltd
Tel: +44 1707 853000
This leaflet was last revised in MM/YYYY.
Detailed information is available on the European Medicines Agency website: .
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