ZANAFLEX Tablets 4 Milligram
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
30-05-2024
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Virkt innihaldsefni:
TIZANIDINE HYDROCHLORIDE
Fáanlegur frá:
G & A Licensing Limited
Skammtar:
4 Milligram
Lyfjaform:
Tablets
Leyfisdagur:
2008-09-26
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanaflex 4 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zanaflex tablets containing 4 mg of tizanidine as hydrochloride.
Contains Lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Greece:_
White to off-white, circular, flat tablets, cross-scored on one side and embossed with ‘R’ and ‘L’.
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
For oral administration.
The effect of Zanaflex 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 Zanaflex should be given
in divided doses, up to 3-4 times daily, depending on the patient's needs. In controlled clinical trials efficacy was seen
at doses of 8 mg and above, though response varies considerably so careful titration is necessary. Since adverse events
are dose-related, treatment should commence with single doses of 2 mg increasing by 2 mg increments at no less than
half-weekly intervals. Care should be taken not to exceed the dose producing the desired therapeutic effect.
Single doses of Zanaflex should not exceed 12 mg and 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 Undesirable Effects)
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
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