Pletal 100mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Cilostazol

Tersedia dari:

Lexon (UK) Ltd

Kode ATC:

B01AC23

INN (Nama Internasional):

Cilostazol

Dosis:

100mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02060400

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
PLETAL® 100MG TABLETS
CILOSTAZOL

THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING. THIS WILL
ALLOW QUICK IDENTIFICATION OF NEW SAFETY INFORMATION. YOU CAN HELP
BY REPORTING ANY SIDE EFFECTS YOU MAY GET. SEE THE END OF SECTION 4
FOR HOW TO REPORT SIDE EFFECTS.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Pletal 100mg Tablets but will be referred
to
as Pletal throughout the remainder of the leaflet.
IN THIS LEAFLET:
1. What Pletal is and what it is used for
2. Before you take Pletal
3. How to take Pletal
4. Possible side effects
5. How to store Pletal
6. Contents of the pack and other information
1. WHAT PLETAL IS AND WHAT IT IS USED FOR
Pletal belongs to a group of medicines called phosphodiesterase type 3
inhibitors.
It has several actions which include widening of some blood vessels
and
reducing the clotting activity (clumping) of some blood cells called
platelets inside your vessels.
You have been prescribed Pletal for "intermittent claudication".
Intermittent claudication is the cramp-like pain in your legs when you
walk and is caused by insufficient blood supply in your legs. Pletal
can
increase the distance you can walk without pain since it improves the
blood circulation in your legs. Cilostazol is only recommended for
patients whose symptoms have not improved sufficiently after making
life-style modifications (such as stopping smoking and increasing
exercise) and after other appropriate interventions. It is important
that
you continue the modifications you have made to your life-style whi

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report
any suspected adverse reactions. See section 4.8 for how to report
adverse reactions.
1
NAME OF THE MEDICINAL PRODUCT
Pletal 100 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 100 mg of cilostazol.
For a full list of excipients, see section 6.1
.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat faced tablets debossed with “OG30” on one side.
4.1
THERAPEUTIC INDICATIONS
Pletal is indicated for the improvement of the maximal and pain-free
walking
distances in patients with intermittent claudication, who do not have
rest pain and who
do not have evidence of peripheral tissue necrosis (peripheral
arterial disease Fontaine
stage II).
Pletal is for second-line use, in patients in whom lifestyle
modifications (including
stopping smoking and [supervised] exercise programs) and other
appropriate
interventions have failed to sufficiently improve their intermittent
claudication
symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage of cilostazol is 100 mg twice a day. Cilostazol
should be
taken 30 minutes before breakfast and the evening meal. Taking
cilostazol with food
has been shown to increase the maximum plasma concentrations (C
max
) of cilostazol,
which may be associated with an increased frequency of adverse
reactions.
Cilostazol should be initiated by physicians experienced in the
management of
intermittent claudication (see also section 4.4).
The physician should reassess the patient after 3 months of treatment
with a view to
discontinuing cilostazol where an inadequate effect is observed or
symptoms have not
been improved.
Patients receiving treatment with cilostazol should continue with
their life-style
modifications (smoking cessation and exercise), and pharmacological
interventions
(such as lipid lowering and antiplatelet treatment) to reduce the risk