Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TIZANIDINE HYDROCHLORIDE
Cephalon UK Limited
M03BX02
TIZANIDINE HYDROCHLORIDE
2 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Other centrally acting agents
Authorised
2010-03-26
PACKAGE LEAFLET: INFORMATION FOR THE USER ZANAFLEX 2mg tablets ZANAFLEX 4mg tablets (Tizanidine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms 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. IN THIS LEAFLET: 1. What ZANAFLEX is and what it is used for. 2. Before you use ZANAFLEX. 3. How to use ZANAFLEX. 4. Possible side effects. 5. How to store ZANAFLEX. 6. Further information. 1. WHAT ZANAFLEX IS AND WHAT IT IS USED FOR The name of this medicine is ZANAFLEX. The active ingredient is tizanidine hydrochloride which belongs to a group of medicines called muscle relaxants. ZANAFLEX is used to relax muscles which have become stiff due to multiple sclerosis or other diseases affecting the spinal cord. 2. BEFORE YOU TAKE ZANAFLEX DO NOT TAKE ZANAFLEX IF YOU: - Are ALLERGIC (hypersensitive) to tizanidine hydrochloride or any of the other ingredients in ZANAFLEX. - Have liver problems. - Are taking a medicine called fluvoxamine or ciprofloxacin. ZANAFLEX is not suitable for children or the elderly. TAKE SPECIAL CARE WITH ZANAFLEX IF YOU HAVE: - An intolerance to certain sugars (lactose and cellulose). - Kidney problems. If any of the above apply to you, you should speak to your doctor before taking this medicine. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tizanidine 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tizanidine tablets containing 2mg of tizanidine as tizanidine hydrochloride. Excipients: Each tablet contains 80mg of lactose anhydrous. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets. White to off-white, circular, flat bevelled edge tablet. Cross-scored on one side with ‘A’ and ‘592’ 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 Tizanidine is indicated in adults for the 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 Tizanidine on spasticity is maximal within 2-3 hours of dosing and it has a relatively short duration of action. Tizanidine has a narrow therapeutic index and a high inter-patient variability in tizanidine plasma concentrations. 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. In controlled clinical trials efficacy was seen at doses of 8mg and above, though response varies considerably so careful titration is necessary. Since adverse events are dose-related, treatment should commence with single doses of 2mg increasing by 2mg 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 Tizanidine should not exceed 12mg and the total daily dose should not exceed 36 mg, although it is usually not necessary to exce Read the complete document