Cilostazol Labormed 100mg Tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

CILOSTAZOL

Доступна з:

Labormed Pharma SA 44B Theodor Pallady Blvd., 3rd District, Bucharest, Romania

Код атс:

B01AC23

ІПН (Міжнародна Ім'я):

CILOSTAZOL 100 mg

Фармацевтична форма:

TABLET

Склад:

CILOSTAZOL 100 mg

Тип рецепту:

POM

Терапевтична области:

ANTITHROMBOTIC AGENTS

Статус Авторизація:

Withdrawn

Дата Авторизація:

2013-09-24

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE
USER
CILOSTAZOL LABORMED 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. See section 4.
WHAT IS THIS LEAFLET
1.
What Cilostazol Labormed is and what it is used for
2.
What do you need to know before you take Cilostazol Labormed
3.
How to take Cilostazol Labormed
4.
Possible side effects
5.
How to store Cilostazol Labormed
6.
Contents of the pack and other information
1. WHAT CILOSTAZOL LABORMED IS AND WHAT IT IS USED FOR
Cilostazol Labormed 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 Labormed 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 Labormed 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 y

Характеристики продукта

1
Version 9.1, 06/2015
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 Labormed 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 Labormed 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 Labormed 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 Labormed 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 co