Cilostazol 100mg Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

CILOSTAZOL

Beschikbaar vanaf:

Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands

ATC-code:

B01AC23

INN (Algemene Internationale Benaming):

CILOSTAZOL 100 mg

farmaceutische vorm:

TABLET

Samenstelling:

CILOSTAZOL 100 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTITHROMBOTIC AGENTS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2013-10-02

Bijsluiter

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
CILOSTAZOL 100 MG TABLETS
CILOSTAZOL
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 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.
WHAT IS IN THIS LEAFLET
1. What Cilostazol is and what it is used for
2. What do you need to know before you take Cilostazol
3. How to take Cilostazol
4. Possible side effects
5.
How to store Cilostazol
6. Contents of the pack and other information
1.
WHAT CILOSTAZOL IS AND WHAT IT IS USED FOR
Cilostazol 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 Cilostazol 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. Cilostazol 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 whilst taking
cilostazol.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CILOSTAZOL
DO NOT TAKE CILOSTAZOL

if you are allergic (hypersensitive) to Cilostazol or any of the other
ingredients of this
medicine (listed in section 6)

if you have the c

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cilostazol 100 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 100 mg of cilostazol.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
Cilostazol 100 mg tablets are white round tablets scored in one side,
with an approximate diameter of
8 mm.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cilostazol 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).
Cilostazol 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 of cardiovascular events.
Cilostazol is not a substitute for
such treatments.
Reduction of the dose to 50 mg twice daily is recomme