Clopidogrel 75mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Clopidogrel

Dostupné s:

Milpharm Ltd

ATC kód:

B01AC04

INN (Mezinárodní Name):

Clopidogrel

Dávkování:

75mg

Léková forma:

Tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 02090000

Informace pro uživatele

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 or nurse.
-
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 or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Clopidogrel is and what it is used for
2.
What you need to know before you take
Clopidogrel
3.
How to take Clopidogrel
4.
Possible side effects
5.
How to store Clopidogrel
6.
Contents of the pack and other information 1. WHAT CLOPIDOGREL IS AND WHAT IT IS 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’ 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

Charakteristika produktu

OBJECT 1
CLOPIDOGREL 75 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Jun-2018 | Aurobindo
Pharma - Milpharm 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 of clopidogrel (as clopidogrel
bisulfate).
Excipients(s) with known effect: Each film-coated tablet contains 2.88
mg lactose monohydrate and 5.2
mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink coloured, round [diameter 9 mm], biconvex, bevel edge,
film-coated tablets debossed with 'E' on one
side and '34' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
_Secondary 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 elderly
Clopidogrel should be given as a si