Tizanidine 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tizanidine hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

M03BX02

INN (International Name):

Tizanidine hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10020200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TIZANIDINE 2MG AND 4MG 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, pharmacist or
nurse.
• 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 or
nurse. This includes any possible
side effects not listed in this leaflet, See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT TIZANIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIZANIDINE TABLETS
3.
HOW TO TAKE TIZANIDINE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TIZANIDINE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TIZANIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
•Tizanidine tablets belong 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIZANIDINE TABLETS
DO NOT TAKE TIZANIDINE TABLETS:
• 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 Tizanidine tablets’,
below).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Tizanidine
tablets:
• if you have KIDNEY problems
• if you have HEART problems such as coronary artery disease
• if you have LIVER problems.
OTHER MEDICINES
AND TIZANIDINE TABLETS
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
Tizanidine tablets must not be taken at t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tizanidine 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2mg tablet contains:
2mg tizanidine (as 2.288mg tizanidine hydrochloride)
Excipient with known effect: 100mg of lactose, anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Tizanidine Tablets are white, round tablets.
Tizanidine 2mg Tablets are marked ‘N 62’ on one side.
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 2mg increasing by 2mg
increments at no less
than half-weekly intervals. The optimum therapeutic response is
generally achieved
with a daily dose of between 12 and 24mg, administered in 3 or 4
equally spaced
doses. Single doses should not exceed 12mg. The total daily dose
should not exceed
36mg.
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.
Discontinuing therapy
If therapy needs to be discontinued, particularly in patients who have
been receiving
high doses for long periods, the dose should be decreased slowly (see
section 4.4).
Elderly
Experience in the elderly is limited and use of tizanidine is not
recommended unless
the benefit of treatment clearly outweighs the risk. Pharmacokinetic
data suggest that
re