Zanaflex 4 mg Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Tizanidine

متاح من:

Teva Pharma B.V.

ATC رمز:

M03BX; M03BX02

INN (الاسم الدولي):

Tizanidine

جرعة:

4 milligram(s)

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:

Marketed

تاريخ الترخيص:

2008-01-25

نشرة المعلومات

1
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. Your doctor

خصائص المنتج

Health Products Regulatory Authority
13 June 2022
CRN00CMNP
Page 1 of 8
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 115.82 mg of lactose, anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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
4.1 THERAPEUTIC INDICATIONS
Treatment of spasticity associated with multiple sclerosis or with
spinal cord injury or disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The effect of tizanidine on spasticity is maximal within 2-3 hours of
dosing and it has a relatively short duration of action. The
timing and frequency of dosing should therefore be tailored to the
individual, and tizanidine should be given in divided doses,
up to 3-4 times daily, depending on the patient's needs. There is
considerable variation in response between patients so careful
titration is necessary. Care should be taken not to exceed the dose
producing the desired therapeutic effect.
It is usual to start with a single dose of 2 mg increasing by 2 mg
increments at no less than half-weekly intervals. The optimum
therapeutic response is generally achieved with a daily dose of
between 12 and 24 mg, administered in 3 or 4 equally spaced
doses. Single doses should not exceed 12 mg. The total daily dose
should not exceed 36 mg.
Adverse events (see section 4.8) may occur at therapeutic doses but
these can be minimised by slow
titration so that in the large majority of patients they are not a
limiting factor.
_Discontinuingtherapy_
If therapy needs to be discontinued, particularly in patients who have
been receiving high doses for long periods, the dose
sho