Cilostazol 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cilostazol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

B01AC23

INN (International Name):

Cilostazol

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060400; GTIN: 5025903016267

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PLETAL® 100MG TABLETS / CILOSTAZOL 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.
This medicine is available as either of the above names but will be
referred to as Pletal throughout the following
atient information leaflet.
p
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.
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
ome blood cells called platelets inside your vessels.
s
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

Summary of Product characteristics

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
Cilostazol 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cilostazol 100 mg.
Excipients with known effect
Sorbitol E420: contains 40mg of Sorbitol E420 per tablet dose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White or almost white, round, flat tablet marked with C100
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cilostazol 100mg Tablets are 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).
Cilostazol 100mg Tablets are for second-line use, in patients in whom
lifestyle
modifications (including stopping smoking and [supervised] exercise
programmes)
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 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 improved.
Patients
receiving
treatment
with
Cilostazol
should
continue
with
their
lifestyle modifications (smoking cessation and exercise), and
pharmacological
interventions (such as lipid lowering and anti-platelet treatment) to
reduce the
risk
of
cardiovascular
events.
Cilostazol
is
not
a
substitute
for
such
treatments.
Reduction of the dose to 50mg twice daily
is