Clopidogrel 75mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Clopidogrel

Fáanlegur frá:

Consilient Health Ltd

ATC númer:

B01AC04

INN (Alþjóðlegt nafn):

Clopidogrel

Skammtar:

75mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02090000; GTIN: 5391512450762

Upplýsingar fylgiseðill

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• 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, talk to your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Clopidogrel 75 mg film-coated tablets are and what
they are used for
2. What you need to know before you take Clopidogrel 75 mg
film-coated tablets
3. How to take Clopidogrel 75 mg film-coated tablets
4. Possible side effects
5. How to store Clopidogrel 75 mg film-coated tablets
6. Contents of the pack and other information
The product name is Clopidogrel 75 mg film-coated tablets but will
be referred to as Clopidogrel throughout this leaflet. 1.
WHAT CLOPIDOGREL 75 MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Clopidogrel 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 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 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, or
• You have experienced a severe type of chest pain known as
‘unstable angina’

Vara einkenni

OBJECT 1
CLOPIDOGREL 75 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Consilient
Health Ltd
1. Name of the medicinal product
Clopidogrel 75 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 75 mg clopidogrel (as hydrochloride).
Excipient with known effect:
Each film-coated tablet contains 13.00 mg hydrogenated castor oil. For
the full list of excipients, see
section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink, round and slightly convex film-coated tablets.
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 syndrome (unstable angina
or non