TICLID FILM COATED TABLET 250MG

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

TICLOPIDINE HYDROCHLORIDE

Disponible depuis:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

TICLOPIDINE HYDROCHLORIDE

Unités en paquet:

20Tablet Tablets

Fabriqué par:

SANOFI-AVENTIS, S.A

Notice patient

_ _
_1 _
_ _
_ Consumer Medication Information Leaflet (RiMUP)_
TICLID
® FILM COATED TABLET 250MG
_ _
Ticlopidine (250mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Ticlid is used for
2. How Ticlid works
3. Before you use Ticlid
4. How to use Ticlid
5. While you are using it
6. Side effects
7. Storage and Disposal of Ticlid
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
WHAT TICLID IS USED FOR
Ticlid is used for:
- Maintenance of normal blood flow to
heart after heart bypass surgery.
- Maintenance of patency of access
sites in patients on long term
hemodialysis.
- Prevention of blood clot formation
following heart intervention procedure
(heart stent placement) in combination
with other antiplatelet medications
such as aspirin.
- Reducing risk of a new stroke in
patients who have experienced stroke
symptoms and in patients who have
had a stroke in the past. Because Ticlid
can cause life-threatening blood
problems, Ticlid should be reserved for
patients who are intolerant or allergic
to aspirin therapy or who have failed
aspirin therapy.
HOW TICLID WORKS
Ticlid contains the active substance
ticlopidine. It belongs to a group of
medicines called antiplatelet agents.
It works by reducing the ability of
blood clotting cells (platelet) to stick to
each other and to blood vessel walls.
This will lessen the ability of blood
clots forming in unwanted places such
as narrowed blood vessels.
BEFORE YOU USE TICLID
_WHEN YOU MUST NOT USE IT _
Do not take Ticlid if:
• You are allergic (hypersensitive) to
ticlopidine and/or any of the other
ingredients of Ticlid (listed in section 8
below)
• You have had blood disorders in the
past (decrease in the number of white
blood cells or decrease in the number
of platelets)
• You have any blood diseases with
prolonged bleeding time
• You have any active bleeding
problems such as stomach ulcer or
bleeding inside the brain due to rupture
of vessel.
• You have an abnormal tendency to
spontaneous often severe bleeding
(bleedi

Résumé des caractéristiques du produit

TICLID ®
Ticlopidine
Film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Ticlopidine hydrochloride ....................................................................250 mg
PHARMACEUTICAL FORM
White to off-white, round and biconvex, film-coated tablets.
CLINICAL PARTICULARS
Therapeutic indications
 Maintenance of patency of coronary artery by-pass grafts.
 Maintenance of patency of access sites in patients on chronic hemodialysis.
 Reducing risk of thrombotic stroke (fatal or non-fatal) in patients who have experienced
stroke precursors and in patients who have had a completed stroke.
 Prevention of sub-acute occlusions following coronary STENT(s) implantation.
Because Ticlid
® is associated with a risk of neutropenia/agranulocytosis, which may be life-
threatening, Ticlid® should be reserved for patients who are intolerant to aspirin therapy where
indicated to prevent stroke.
Dosage and method of administration
Adults: Oral use.
For all indications, the usual dosage is two tablets per day, to be taken with meals.
In the case of coronary stents, treatment should be instituted just before or on the day of the
endoprosthetic implantation and should be continued for 4-6 weeks at a dosage of 2 tablets per
day (500mg), concomitantly with aspirin (100-325 mg/day).
Treatment will then be continued with aspirin alone (75-100mg; maximum dose 300-325 mg).
Contraindications
This drug must never be prescribed in patients with:
 Bleeding diathesis
 Organic lesions likely to bleed: active peptic ulcer or hemorrhagic stroke in the acute
phase
 Blood diseases with prolonged bleeding time
 History of allergy to ticlopidine or to one of the ingredients in the drug
 History of blood disorders (leukopenia, thrombocytopenia or agranulocytosis).