Clopidogrel-Splendris 75mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-08-2018
Summary of Product characteristics
(SPC)
09-11-2017
Active ingredient:
Clopidogrel hydrogen sulphate
Available from:
Splendris Pharmaceuticals GmbH
ATC code:
B01AC; B01AC04
INN (International Name):
Clopidogrel hydrogen sulphate
Dosage:
75 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Platelet aggregation inhibitors excl. heparin; clopidogrel
Authorization status:
Not marketed
Authorization date:
2009-09-18
Patient Information leaflet
1
HERTFORDSHIRE AL10 9UL
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL-SPLENDRIS 75 MG FILM-COATED TABLETS
clopidogrel
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 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 IS IN THIS LEAFLET
1.
What Clopidogrel-Splendris is and what it is used for
2.
What you need to know before you take Clopidogrel-Splendris
3.
How to take Clopidogrel-Splendris
4.
Possible side effects
5
How to store Clopidogrel-Splendris
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL-SPLENDRIS IS AND WHAT IT IS USED FOR
Clopidogrel-Splendris contains clopidogrel and 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-Splendris 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-Splendris 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 ‘myocardi
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel-Splendris 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipient with known effect:
Each film-coated tablet contains 12 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to almost white, round, biconvex film-coated tablets.
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 single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
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