Clopidogrel 1A Pharma
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 1A Pharma is and what it is used for
Before you take Clopidogrel 1A Pharma
How to take Clopidogrel 1A Pharma
Possible side effects
How to store Clopidogrel 1A Pharma
Further information
Medicinal product no longer authorised
Clopidogrel 1A Pharma 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 1A Pharma 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 1A Pharma 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 (hypersensitive) to Clopidogrel or any of the other ingredients of Clopidogrel 1A Pharma;
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 1A Pharma.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel 1A Pharma:
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 1A Pharma:
You should tell your doctor if a surgery (including dental) is planned.
Medicinal product no longer authorised
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 1A Pharma is not intended for use in children or adolescents.
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 1A Pharmaor 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 medicine used to reduce blood clotting
a proton pump inhibitor (e.g, omeprazole) for upset stomach
fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections
cimetidine, medicine to treat upset stomach
fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression
carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy
ticlopidine, other antiplatelet agent.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel 1A Pharma 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 1A Pharma may be taken with or without food.
It is preferable not to use this product during pregnancy and breast-feeding.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel 1A Pharma. If you become pregnant while taking Clopidogrel 1A Pharma, consult your doctor immediately as it is recommended not to take Clopidogrel while you are pregnant.
While taking Clopidogrel 1A Pharma, consult your doctor about the breast-feeding of a baby. Ask your doctor or pharmacist for advice before taking any medicine.
Clopidogrel 1A Pharma is unlikely to affect your ability to drive or to use machines.
Medicinal product no longer authorised
Clopidogrel 1A Pharma contains hydrogenated castor oil which may cause stomach upset or diarrhoea.
Always take Clopidogrel 1A Pharma exactly as your doctor has told you. You should 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 1A Pharma (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Clopidogrel 1A Pharma per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel 1A Pharma 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 1A Pharma, 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 the forgotten individual doses.
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Clopidogrel 1A Pharma 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 ‘Take special care with Clopidogrel 1A Pharma’).
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 ‘Take special care with
Clopidogrel 1A Pharma’).
Medicinal product no longer authorised
Side effects may occur with certain frequencies, which are defined as follows:
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.
-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.
-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.
Store in the original blister in order to protect from moisture. Keep out of the reach and sight of children.
Do not use Clopidogrel 1A Pharma 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 1A Pharma if you notice any visible sign of damage of blister or film-coated tablets.
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 tablet contains 75 mg of Clopidogrel (as besilate).
Medicinal product no longer authorised
The other ingredients are:
Tablet core:
Macrogol 6000
Cellulose, microcrystalline (E460) Crospovidone type A
Castor oil, hydrogenated
Film-coating: Macrogol 6000 Ethylcellulose (E462)
Titanium dioxide (E 171)
Clopidogrel 1A Pharma 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. They are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters. Not all pack sizes may be marketed.
Acino Pharma GmbH Am Windfeld 35
83714 Miesbach Germany
Acino AG
Am Windfeld 35
83714 Miesbach Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1
39179 Barleben Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
D-82041 Oberhaching Allemagne/Duitsland Tél/Tel: + 49 89 6138825 – 0
D-82041 Oberhaching Allemagne/Deutschland Tél/Tel: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
Medicinal product no longer authorised
D-82041 Oberhaching
Германия
Teл.: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Németország
Tel.: + 49 89 6138825 - 0
D-82041 Oberhaching Německo
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Il-Ġermanja
Tel: + 49 89 6138825 - 0
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S info.sandoz-dk@sandoz.com
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching
Duitsland
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Tel: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Tyskland
Tlf: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Saksamaa
Tel: + 49 89 6138825 – 0
1A Pharma GmbH
Eduard-Kittenberger-Gasse 56 A-1235 Wien
Tel: + 43 (0)1 480 56 03
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching
Γερμανία
Τηλ: + 49 89 6138825 – 0
1A Pharma GmbH Sp. Z.o.o. ul. Grojecka 22/24 lok. 49/50 02-021 Warszawa
Tel: + 48 22 213 11 45
ACOST Comercial Generic Pharma, S.L C/ Ferraz 10, 1º izdq
E-28008 Madrid
Tel.: + 34 91 548 84 04
1Apharma – Produtos Farmacêuticos S.A Alameda da Beloura
Edifício 1, 2º andar - Escritório 15 P-2710-693 Sintra
Tel: + 351 21 924 19 19
1 A Pharma GmbH Keltenring 1 + 3
Medicinal product no longer authorised
D-82041 Oberhaching Allemagne
Tél: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Germania
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Germany
Tel: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Nemčija
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Þýskaland
Sími: + 49 89 6138825 - 0
D-82041 Oberhaching Nemecko
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching
Germania
Tel: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching
Saksa
Puh/Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching
Γερμανία
Τηλ: + 49 89 6138825 - 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Tyskland
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Vācija
Tel: + 49 89 6138825 - 0
D-82041 Oberhaching Germany
Tel: + 49 89 6138825 – 0
1 A Pharma GmbH Keltenring 1 + 3
D-82041 Oberhaching Vokietija
Tel: + 49 89 6138825 - 0
Detailed information is available on the European Medicines Agency website:
Medicinal product no longer authorised