Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TIZANIDINE HYDROCHLORIDE
G & A Licensing Limited
2 Milligram
Tablets
2008-09-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanaflex 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zanaflex tablets containing 2 mg of tizanidine as hydrochloride. Contains Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets _Product imported from Greece:_ White to off-white, circular, flat tablets, cross-scored on one side and embossed with 'Z' and 'O'. 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 Zanaflex Read the complete document