Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Tizanidine
Teva Pharma B.V.
M03BX; M03BX02
Tizanidine
4 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Other centrally acting agents; tizanidine
Marketed
2008-01-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ZANAFLEX 2 MG TABLETS _ _ZANAFLEX 4 MG TABLETS _ Tizanidine 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 or pharmacist - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zanaflex is and what it is used for 2. What you need to know before you take Zanaflex 3. How to take Zanaflex 4. Possible side effects 5. How to store Zanaflex 6. Contents of the pack and other information 1. WHAT ZANAFLEX IS AND WHAT IT IS USED FOR Tizanidine belongs 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZANAFLEX DO NOT TAKE ZANAFLEX: 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 Zanaflex', below) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zanaflex if you have HEART PROBLEMS such as coronary artery disease. Your doctor will check your heart function regularly using ECG. if you suffer from SEVERE WEAKNESS OF CERTAIN MUSCLES (myasthenia gravis, leading to difficulty speaking, chewing and swallowing as well as drooping eyelids) if you suffer from epilepsy. Your disease must be well-controlled with medication. if you have kidney problems. Your doctor Belgenin tamamını okuyun
Health Products Regulatory Authority 13 June 2022 CRN00CMNP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanaflex 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of tizanidine (as hydrochloride) Excipient(s) with known effect Each tablet contains 115.82 mg of lactose, anhydrous. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, biconvex, round, tablets, 9 mm in diameter, debossed “T4” on one side and quadrisected by score lines on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide 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 2 mg increasing by 2 mg increments at no less than half-weekly intervals. The optimum therapeutic response is generally achieved with a daily dose of between 12 and 24 mg, administered in 3 or 4 equally spaced doses. Single doses should not exceed 12 mg. The total daily dose should not exceed 36 mg. 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. _Discontinuingtherapy_ If therapy needs to be discontinued, particularly in patients who have been receiving high doses for long periods, the dose sho Belgenin tamamını okuyun