Clopidogrel 75mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Clopidogrel

Διαθέσιμο από:

Sandoz Ltd

Φαρμακολογική κατηγορία (ATC):

B01AC04

INN (Διεθνής Όνομα):

Clopidogrel

Δοσολογία:

75mg

Φαρμακοτεχνική μορφή:

Tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02090000; GTIN: 5050650062038

Αρχείο Π.Χ.Π.

CLOPIDOGREL 75 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Jan-2015 | Sandoz
Limited
1. Name of the medicinal product
Clopidogrel 75 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel
hydrochloride).
Excipients with known effect:
Each film-coated tablet contains 7.50 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink colored, film-coated, round shaped tablets, plain on both sides.
4. Clinical particulars
4.1 Therapeutic indications
_Prevention of atherothrombotic events_
Clopidogrel is indicated in:
• Adult patients suffering from myocardial infarction (from a few
days until less than 35 days), ischaemic
stroke (from 7 days until less than 6 months) or established
peripheral arterial disease.
• Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave myocardial
infarction), including patients undergoing a stent placement following
percutaneous coronary
intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination
with ASA in medically treated
patients eligible for thrombolytic therapy.
_Prevention of atherothrombotic and thromboembolic events in atrial
fibrillation _
In adult patients with atrial fibrillation who have at least one risk
factor for vascular events, are not
suitable for treatment with Vitamin K antagonists (VKA) and who have a
low bleeding risk, clopidogrel
is indicated in combination with ASA for the prevention of
atherothrombotic and thromboembolic events,
including stroke.
For further information please refer to section 5.1.
4.2 Posology and method of administration
Posology
• Adults and older people
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
− Non-ST segment elevation acute coronary syndro