Cilostazol Pharmacare 100mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CILOSTAZOL

Available from:

Pharmacare Srl Via Marghera, 29 20149, Milan, Italy

ATC code:

B01AC23

INN (International Name):

CILOSTAZOL 100 mg

Pharmaceutical form:

TABLET

Composition:

CILOSTAZOL 100 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-04-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CILOSTAZOL PHARMACARE 100 MG 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 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 THIS LEAFLET
:
1. What Cilostazol Pharmacare 100 mg tablets is and what it is used
for
2. What do you need to know before you take Cilostazol Pharmacare 100
mg tablets
3. How to take Cilostazol Pharmacare 100 mg tablets
4. Possible side effects
5. How to store Cilostazol Pharmacare 100 mg tablets
6. Contents of the pack and other information
1. WHAT CILOSTAZOL PHARMACARE 100 MG TABLETS IS AND WHAT IT IS USED
FOR
Cilostazol Pharmacare 100 mg tablets 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 Pharmacare 100 mg tablets 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 Pharmacare 100 mg
tablets can increase the
distance you can walk without pain since it improves the blood
circulation in your legs. Cilostazol
Pharmacare 100 mg tablets is only recommended for patients whose
symptoms have not improved
sufficient

Summary of Product characteristics

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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 Pharmacare 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
Pharmacare 100
mg tablets should be taken 30 minutes before breakfast and the evening
meal. Taking
Cilostazol Pharmacare 100 mg tablets 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 Pharmacare 100 mg tablets 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
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improved.
Patients
receiv