Cilostazol Sandoz 100mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

CILOSTAZOL

Disponibil de la:

Hexal Pharma GmbH Stella-Klein-Low-Weg 17, 1020 Wein, Austria

Codul ATC:

B01AC23

INN (nume internaţional):

CILOSTAZOL 100 mg

Forma farmaceutică:

TABLET

Compoziție:

CILOSTAZOL 100 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTITHROMBOTIC AGENTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-09-24

Prospect

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

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cilostazol Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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 dose of cilostazol is 100 mg twice a day.
Cilostazol Sandoz 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
medicines that strongly inhibit CYP2C19, for example omeprazole (see
sections 4.4