Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tizanidine hydrochloride
Viatris UK Healthcare Ltd
M03BX02
Tizanidine hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200; GTIN: 5016695461007
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TIZANIDINE 2 MG TABLETS TIZANIDINE 4 MG 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 is and what it is used for 2. What you need to know before you take Tizanidine 3. How to take Tizanidine 4. Possible side effects 5. How to store Tizanidine 6. Contents of the pack and other information 1. WHAT TIZANIDINE IS AND WHAT IT IS USED FOR Your tablets contain the active substance tizanidine, which belongs to a group of medicines called muscle relaxants. Tizanidine acts on your central nervous system and can help to relieve painful muscle spasms and cramping and tightness of muscle due to multiple sclerosis or other disease or injury affecting the spinal cord. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIZANIDINE DO NOT TAKE TIZANIDINE: • if you are allergic to tizanidine or any of the other ingredients of this medicine (listed in section 6) • if you have severe liver problems • if you are taking medicines such as fluvoxamine (for depression) or ciprofloxacin (an antibiotic) (See ' Other medicines and Tizanidine ' ) Tizanidine is not suitable for children or the elderly. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tizanidine: • if you have kidney problems. • if you have liver problems. Your doctor will decide if you need blood tests to check that your liver is working properly. OTHER MEDICINES AND TIZANIDINE Tell your doctor or pharmacist if you are taking, have recently taken or Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tizanidine 2 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of tizanidine (as hydrochloride). Excipient with known effect: Each tablet contains 24.012 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, 7 mm flat bevel edged tablet marked with “TI” and “2” on either side of a bisecting score line on one side and “G” 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 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 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 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) 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 patients _ Experience with the use of tizanidine in the elderly is limited, therefore use is not recommended in elderly patients unless the benefit of treatment clearly outweighs the risk. Pharmacokinetic data suggest that renal clearance in the elderly may be decr Prečítajte si celý dokument