מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tizanidine hydrochloride
Actavis UK Ltd
M03BX02
Tizanidine hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200; GTIN: 5012617018601
AAAE5293 Tizanidine Hydrochloride 2mg & 4mg 120 Tablets PIL - UK item no: AAAE5293 print proof no: 2 origination date: 06.11.12 originated by: SA revision date: 15.11.12 revised by: sa dimensions: 145 x 480 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 06.11.12 supplier: Niche Generics Ltd technically app. date: 07.11.12 min pt size: TECHNICAL APPROVAL TIZANIDINE 2MG AND 4MG TABLETS 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1 WHAT TIZANIDINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 FURTHER 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 BEFORE YOU TAKE DO NOT TAKE TIZANIDINE TABLETS IF YOU • are ALLERGIC (hypersensitive) to tizanidine or to any of the ingredients in your medicine • have SEVERELY IMPAIRED LIVER function • are taking medicines such as FLUVOXAMINE (for depression) or CIPROFLOXACIN (an antibiotic) (see also ‘Taking other medicines’) TAKE SPECIAL CARE WITH TIZANIDINE TABLETS Check with your doctor before taking Tizanidine tablets if you have: • KIDNEY problems • HEART problems such as coronary artery disease • LIVER problems. TAKING OTHER MEDICINES Tizanidine tablets must not be taken at the same time as fluvoxamine (to treat depression) or ciprof קרא את המסמך השלם
OBJECT 1 TIZANIDINE 2MG TABLETS Summary of Product Characteristics Updated 17-Mar-2016 | Accord-UK Ltd 1. Name of the medicinal product Tizanidine 2mg Tablets 2. Qualitative and quantitative composition Each 2mg tablet contains: 2mg tizanidine (as 2.288mg tizanidine hydrochloride) Excipient with known effect: 100mg of lactose, anhydrous For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. Tizanidine Tablets are white, round tablets. Tizanidine 2mg Tablets are marked 'N 62' on one side. 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 treatmen קרא את המסמך השלם