Tizanidine 2mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Tizanidine hydrochloride

Saadav alates:

Teva UK Ltd

ATC kood:

M03BX02

INN (Rahvusvaheline Nimetus):

Tizanidine hydrochloride

Annus:

2mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 10020200; GTIN: 5017007032403

Infovoldik

PHARMA CODE
PHARMA CODE
PHARMA CODE
PHARMA CODE
TEMPLATE
ZINC Ref:
EAS4220C LEA TIZANIDINE 2MG AND 4MG TAB TUK DEB
6 OCTOBER 2021
Version:
3
Colours Used:
Length:
Width:
Depth:
280 MM
160 MM
-
UK & Ireland Artwork Department
BLACK
TIZANIDINE 2 MG OR 4 MG 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.
1. What Tizanidine is and what it is used for
2. What you need to know before you take
Tizanidine
3. How to take Tizanidine
4. Possible side effects
5. How to store Tizanidine
6. Contents of the pack and other information
WHAT TIZANIDINE IS AND WHAT IT IS
USED FOR
Tizanidine belongs to a group of drugs called
skeletal muscle relaxants.
Tizanidine is used to relieve the stiffness and
restriction of muscles resulting from multiple
sclerosis, injury or diseases of the spinal cord.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TIZANIDINE
DO NOT TAKE TIZANIDINE:
• if you are allergic to tizanidine
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
• if you have severe liver problems
• if you are taking medicines such as
FLUVOXAMINE (for depression) or
CIPROFLOXACIN (an antibiotic) (see ‘Other
medicines and Tizanidine’)
• if you have rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose
malabsorption.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE YOU START TO TAKE
THIS MEDICINE IF YOU:
• have kidney problems
• have liver problems.
OTHER MEDICINES AND TIZANIDINE
TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF
THE FOLLOWING:
• any

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tizanidine 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of tizanidine (as 2.290 mg tizanidine
hydrochloride).
Excipient(s) with known effect:
Each tablet contains 57.910 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex, round, tablets, debossed “T2” on one
side and scoreline
on the other.
The scoreline 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
For oral administration
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 total daily dose should not exceed 36 mg, although it is usually
not necessary to
exceed 24 mg daily. Secondary pharmacological effects (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.
_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
renal clearance in the elderly may be in some cases significantly
decreased by up to
three fold. Caution is therefore indicated when using t