Clopidogrel ratiopharm GmbH
clopidogrel
clopidogrel
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your 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 Clopidogrel ratiopharm GmbH is and what it is used for
What you need to know before you take Clopidogrel ratiopharm GmbH
How to take Clopidogrel ratiopharm GmbH
Possible side effects
How to store Clopidogrel ratiopharm GmbH
Contents of the pack and other information
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Clopidogrel ratiopharm GmbH contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products. Platelets (so-called thrombocytes) are very small structures, 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 ratiopharm GmbH 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 ratiopharm GmbH 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 (disturbed blood flow in arms or legs caused by vascular
occlusions) 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.
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 ratiopharm GmbH.
Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm GmbH:
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 ratiopharm GmbH:
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’).
Medicinal product no longer authorised
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.
Do not give this medicine to children because it does not work.
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 ratiopharm GmbH or vice versa.
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 or joints
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,
anti-retroviral medicines (medicines to treat HIV 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.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel ratiopharm GmbH 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 any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH. If you become pregnant while taking
Clopidogrel ratiopharm GmbH, 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.
Clopidogrel ratiopharm GmbH is unlikely to affect your ability to drive or to use machines.
Medicinal product no longer authorised
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.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel ratiopharm GmbH (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm GmbH per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel ratiopharm GmbH 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.
If you forget to take a dose of Clopidogrel ratiopharm GmbH, but remember within 12 hours of your usual time, take your tablet straight away 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.
stopping.
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.
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 2 ‘Warnings and precautions’).
Medicinal product no longer authorised
-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 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; changes in taste or loss of taste of food.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
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.
Do not store above 30 °C.
Store in the original blister in order to protect from moisture. 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 on the blister after EXP. The expiry date refers to the last day of that month.
Do not use Clopidogrel ratiopharm GmbH if you notice any visible sign of damage of blister or film-coated tablets.
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 tablet contains 75 mg of clopidogrel (as besilate).
The other ingredients are (see section 2 ‘Clopidogrel ratiopharm GmbH contains hydrogenated castor oil’):
Tablet core:
Medicinal product no longer authorised
Macrogol 6000
Cellulose, microcrystalline (E460) Crospovidone type A
Castor oil, hydrogenated
Film-coating: Macrogol 6000 Ethylcellulose (E462)
Titanium dioxide (E 171)
Clopidogrel ratiopharm GmbH 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. They are supplied in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters. Not all pack sizes may be marketed.
Archie Samuel s.r.o. Slunná 16
61700 Brno Czech Republic
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73
UAB "Sicor Biotech"
Tel: +370 5 266 02 03
Актавис ЕАД
Тел: +359 24899585
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00
Teva Denmark A/S
Tlf: +45 44 98 55 11
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +353 1963 0330
Teva Nederland B.V.
Tel: +31 800 0228 400
Teva Eesti esindus
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UAB Sicor Biotech Eesti filiaal Tel: +372 661 0801
Teva Norway AS
Tlf: +47 66 77 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 211 880 5000
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1 97 007 0
ratiopharm España, S.A.
Tél: +34 91 567 29 70
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00
Teva Santé
Tél: +33 1 55 91 78 00
Teva Pharma - Produtos Farmacêuticos, Lda
Tel: +351 21 476 75 50
Pliva Hrvatska d.o.o Tel: +385 1 37 20 000
Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24
Teva Pharmaceuticals Ireland
Tel: +353 1963 0330
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390
Sími: +358 20 180 5900
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11
Teva Italia S.r.l.
ratiopharm Oy
Tel: +39 02 89 17 98 1 Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε., Ελλάδα
Τηλ: +30 211 880 5000
Teva Sweden AB Tel: +46 42 12 11 00
UAB Sicor Biotech filiāle Latvijā
Tel: +371 67 323 666
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