Pletal 100mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Cilostazol

Διαθέσιμο από:

Otsuka Pharmaceuticals (U.K.) Ltd

Φαρμακολογική κατηγορία (ATC):

B01AC23

INN (Διεθνής Όνομα):

Cilostazol

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02060400; GTIN: 5038256000012

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

OBJECT 1
PLETAL 100 MG TABLETS
Summary of Product Characteristics Updated 05-Feb-2016 | Otsuka
Pharmaceuticals (UK) Ltd
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. Clinical particulars
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 exercis