Cilostazol 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cilostazol

Available from:

Viatris UK Healthcare Ltd

ATC code:

B01AC23

INN (International Name):

Cilostazol

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060400; GTIN: 5016695005829

Patient Information leaflet

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Barcode Info
Description
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Superceded Affiliate Item Code
TrackWise PR No.
MA No.
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Sign-offs
2063361
PL 04569/
1426-1427
Adamed - (Pabianice, PL)
TBC
N/A
400523727; 400523726
2
United Kingdom
103463455/0020
N/A
20:05
11 Feb 20
160 x 520 mm
Affiliate Item Code
v3/Jul 2017
Cilostazol_50mg_100mg_56
Leaflet
2063361
1900097
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Black
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PACKAGE LEAF
LET: INFORMATION FOR THE PATIENT
TABLETS
TABLETS
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 is and what it is used for
2. What you need to know before you
take Cilostazol
3. How to take Cilostazol
4. Possible side effects
5. How to store Cilostazol
6. Contents of the pack and other information
1. WHAT CILOSTAZOL IS AND WHAT IT IS USED FOR
Cilostazol belongs to a group of medicines
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 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 can
increase the distance you can walk without
pain since it impr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cilostazol 50 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of cilostazol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, flat-faced, round tablets, debossed with “50”
on one side with an
approximate diameter of 7mm.
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 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 and 4.5).
Older people
There are no special dosage requirements for the elderly.
Pae