Zanaflex 4mg Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Tizanidine hydrochloride

متاح من:

PCO Manufacturing Ltd.

ATC رمز:

M03BX; M03BX02

INN (الاسم الدولي):

Tizanidine hydrochloride

جرعة:

4 Base Milligrams

الشكل الصيدلاني:

Tablet

نوع الوصفة الطبية :

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

المجال العلاجي:

Other centrally acting agents; tizanidine

الوضع إذن:

Authorised

تاريخ الترخيص:

2006-02-10

نشرة المعلومات

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANAFLEX
® 2MG TABLETS
ZANAFLEX
® 4MG TABLETS
(Tizanidine)
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 ZANAFLEX is and what it is used for.
2. What you need to know before you take ZANAFLEX.
3. How to take ZANAFLEX.
4. Possible side effects.
5. How to store ZANAFLEX.
6. Contents of the pack and other information.
1. WHAT ZANAFLEX IS AND WHAT IT IS USED FOR

Tizanidine belongs to a group of medicines called
skeletal muscle relaxants.

Your medicine is used to relieve the stiffness and
restriction of muscles resulting from multiple sclerosis,
injury or diseases of the spinal cord.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZANAFLEX
DO NOT TAKE ZANAFLEX:

if you are allergic to tizanidine or any of the other
ingredients of this medicine (listed in section 6).

if you have severely impaired liver function.

if you are taking medicines such as fluvoxamine (for
depression) or ciprofloxacin (an antibiotic) (see also
‘Other medicines and Zanaflex’, below)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zanaflex

if you have kidney problems

if you have heart problems such as coronary artery
disease

if you have liver problems.
OTHER MEDICINES AND ZANAFLEX
Zanaflex must not be taken at the same time as
fluvoxamine (to treat depression) or ciprofloxacin (an
antibiotic) (see ‘Do not take Zanaflex’, above).
Tell your doctor or pharmacist if you are taking, have
recently taken or might take

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanaflex 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg of tizanidine (as hydrochloride).
Excipient with known effect: Each tablet contains lactose anhydrous.
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablets.
_Product imported from the Netherlands:_
White, circular, flat tablets, cross-scored on one side and engraved
with R L on the other side.
4 CLINICAL PARTICULARS
As per PA0749/054/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/054/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose, anhydrous
Cellulose, microcrystalline
Silica, colloidal anhydrous
Stearic acid
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 30 tablets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland