Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tizanidine hydrochloride
Dowelhurst Ltd
M03BX02
Tizanidine hydrochloride
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200
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 Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tizanidine 4mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4mg tablet contains: 4 mg tizanidine (as 4.576mg tizanidine hydrochloride) Excipient with known effect: 200mg of lactose, anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Tizanidine Tablets are white, round tablets. Tizanidine 4 mg Tablets are scored and marked ‘N 63’ on the other side. The 4mg tablet can be divided 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 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 treatme Les hele dokumentet