Clopidogrel STADA 75 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingrédients actifs:

CLOPIDOGRELWATERSTOFSULFAAT SAMENSTELLING overeenkomend met ; CLOPIDOGREL

Disponible depuis:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

Code ATC:

B01AC04

DCI (Dénomination commune internationale):

CLOPIDOGRELWATERSTOFSULFAAT COMPOSITION corresponding to ; CLOPIDOGREL

forme pharmaceutique:

Filmomhulde tablet

Composition:

CASTOROLIE, GEHYDREERD ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171),

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Clopidogrel

Descriptif du produit:

Hulpstoffen: CASTOROLIE, GEHYDREERD; CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MANNITOL (D-) (E 421); TITAANDIOXIDE (E 171);

Date de l'autorisation:

2016-12-21

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL STADA 75 MG, FILMOMHULDE TABLETTEN
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 your 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 [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] 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).
[Product name] 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 [Product name] 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 hav

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Clopidogrel STADA 75 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect
Each
film-coated
tablet
contains
5.2 mg
castor
oil,
hydrogenated
and
2.8 mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
[Product name] are pink coloured, round, biconvex, bevelled edged
film-coated tablets with
9 mm diameter.
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.
_In patients with moderate to high-risk Transient Ischaemic Attack
(TIA) or minor Ischaemic _
_Stroke (IS) _
Clopidogrel in combination with ASA is indicated in:
•
Adult patients with moderate to high-risk TIA (ABCD2
1
score ≥ 4) or minor IS (NIHSS
2
≤ 3) within 24 hours of either the TIA or IS event.
_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
1
Age, Blood pressure, Clinical features, Duration, and Diabetes
mellitus diagnosis
2
National Institutes of Health Stroke Sca