Cilostazol Galenica 100mg Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

CILOSTAZOL

Commercializzato da:

Galenica S.A. 4 Εleftherias Str., 14564, Kifissia, Greece

Codice ATC:

B01AC23

INN (Nome Internazionale):

CILOSTAZOL 100 mg

Forma farmaceutica:

TABLET

Composizione:

CILOSTAZOL 100 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTITHROMBOTIC AGENTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-12-18

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
CILOSTAZOL GALENICA 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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cilostazol Galenica is and what it is used for
2.
What you need to know before you take Cilostazol Galenica
3.
How to take Cilostazol Galenica
4.
Possible side effects
5.
How to store Cilostazol Galenica
6.
Contents of the pack and other information
1.
WHAT CILOSTAZOL GALENICA IS AND WHAT IT IS USED FOR
The active substance of Cilostazol Galenica, 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
Galenica
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 Galenica can increase the distance you
can walk without pain since it
improves the blood circulation in your legs. Cilostazol Galenica 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
Galenica.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CILOSTAZOL GALENICA
DO NOT TAKE CILOSTAZOL

Scheda tecnica

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1.
NAME OF THE MEDICINAL PRODUCT
Cilostazol Galenica100 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 Galenica 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 Galenica 100 mg tablets 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 Galenica 100 mg tablets 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
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 recommended in patients
receiving medicines that
strongly inhibit CYP3A4, for example some macrolides, azole
antifungals, protease inhibitors, or
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medicines that strongly inhibit CYP2C19, for example omeprazole (see
sect