Cilostazol 100mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Cilostazol

Disponible des:

Focus Pharmaceuticals Ltd

Codi ATC:

B01AC; B01AC23

Designació comuna internacional (DCI):

Cilostazol

Dosis:

100 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Platelet aggregation inhibitors excl. heparin; cilostazol

Estat d'Autorització:

Not marketed

Data d'autorització:

2014-08-22

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cilostazol 100mg Tablets are and what they are used for
2. What you need to know before you take Cilostazol 100mg Tablets
3. How to take Cilostazol 100mg Tablets
4. Possible side effects
5. How to store Cilostazol 100mg Tablets
6. Contents of the pack and other information
1. WHAT CILOSTAZOL 100MG TABLETS ARE AND WHAT THEY ARE USED FOR
Cilostazol 100mg Tablets contains the active substance Cilostazol.
Cilostazol 100mg 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 100mg 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 100mg Tablets 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-sty

Fitxa tècnica

Health Products Regulatory Authority
21 December 2018
CRN008PC4
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
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 with a diameter of 8.6mm and
a break-mark.
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
taken 30 minutes before breakfast and the evening meal. Taking
cilostazol with food
has been shown to increase the maximum plasma concentrations (Cmax) 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 improved.
Health Products Regulatory Authority
21 December 2018
CRN008PC4
Page 2 of 13
Patients receiving treatment with Cilostazol should continue with
their lifestyle
modifications (smoking cessation and exercise), and pharmacological
interventions
(such as