Zanaflex 4 mg Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Tizanidine

Commercializzato da:

PCO Manufacturing Ltd.

Codice ATC:

M03BX; M03BX02

INN (Nome Internazionale):

Tizanidine

Dosaggio:

4 milligram(s)

Forma farmaceutica:

Tablet

Area terapeutica:

Other centrally acting agents; tizanidine

Data dell'autorizzazione:

2021-05-21

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANAFLEX
® 2 MG TABLETS
ZANAFLEX
® 4 MG 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, 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 HEART PROBLEMS such as coronary artery
disease. Your doctor will check your heart function regularly
using ECG.
•
if you suffer from SEVERE WEAKNESS OF CERTAIN MUSCLES
(myasthenia gravis, leading to difficulty speaking, chewing
and swallowing as well as drooping eyelids)
•
if you suffer from epilepsy. Your disease must be well-
controlled with medication.
•
if you have kidney problems. Y

Scheda tecnica

Health Products Regulatory Authority
24 November 2022
CRN00D72L
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanaflex 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of tizanidine (as hydrochloride).
Excipient(s) with known effect
Each tablet contains lactose, anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Germany:_
White to off-white, biconvex, round, tablets, 9 mm in diameter,
debossed "T4" on one side and quadrisected by score lines on
the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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
Cellulose, microcrystalline
Stearic acid
Silica, colloidal anhydrous
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Health Products Regulatory Authority
24 November 2022
CRN00D72L
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister PVC/PVDC/Aluminium.
Blister packs of 120 tablets in outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/474/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21
st
May 2021
10 DATE OF REVISION OF THE TEXT
November 2022