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TIZAGELAN is a brand name for Tizanidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Spasms of the skeletal muscles - associated with static and functional disorders of the spine (cervical and lumbar syndromes) - after surgical interventions on the musculoskeletal system, e.g. herniated disc or joint disorders of the hip. Spasticity due to neurological disorders, such as - multiple sclerosis, chronic…
Verbatim from this product's MHRA label. Tap a section to expand.
Tizanidine has a narrow therapeutic index and a high inter-patient variability in tizanidine plasma concentrations. Therefore, it is important to adjust the dose individually. A low starting dose of 2 mg three times daily can reduce the risk of side effects.
The dose should be increased gradually and with caution according to the individual patient’s need and the therapeutic response. Posology Spasms of the skeletal muscles The recommended dose is 2-4 mg 3 times daily. In severe cases, an extra dose of 2-4 mg may be given, preferably late in the evening to reduce the sedative effect.
Spasticity due to neurological disorders The initial daily dose should not exceed 6 mg in 3 divided doses. This dose may be increased in steps by 2-4 mg at intervals of half or full week. The optimum therapeutic response is usually achieved with a daily dose of between 12 and 24 mg, divided into 3-4 equal doses throughout the day.
The total daily dose should not exceed 36 mg. Special populations Paediatric population The safety and efficacy of tizanidine in children and adolescents under 18 years have not been established. Limited data are available. 8). Elderly Experience with tizanidine in the elderly is limited.
In this patient group the starting dose should be as low as possible and it should be increased in small increments, according to tolerability and efficacy. Renal impairment In patients with renal impairment (CLCR < 25 mL/min) treatment should be started with 2 mg once daily with slow titration to achieve the effective dose.
Dosage increases should be in increments of no more than 2 mg according to tolerability and effectiveness. If efficacy has to be improved, it is advisable to slowly increase the once-daily dose before increasing the frequency of administration.
2). 3). Only limited data are available in this patient group. 2). 8). Tizanidine should be used with caution in patients with mild and moderate hepatic impairment. The starting dose should be as low as possible and it should be increased in small increments, according to tolerability and efficacy.
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. 4). Method of administration Oral use.
a. Summary of the safety profile Many adverse effects have been found to be dose related and slow titration of doses appears to reduce the frequency of occurrence. With low doses, such as those recommended for the relief of painful muscle spasms, somnolence, fatigue, dizziness, dry mouth, decreased blood pressure, nausea, gastrointestinal disturbances, and increased hepatic enzymes have been reported, usually as mild and transient adverse reactions.
With the higher doses recommended for the treatment of spasticity, the adverse reactions reported with low doses are more frequent and more pronounced, but seldom severe enough to require discontinuation of treatment. b. Tabulated list of adverse reactions The table below shows the frequencies of adverse reactions which have been reported in clinical trials and post-marketing experience.
The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (frequency cannot be estimated from available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System organ class Very common Common Uncommon Not known Infections and infestations Infections Rhinitis Pharyngitis Immune system disorders Hypersensitivity reactions including anaphylaxis, angioedema and urticaria(1) Psychiatric disorders Sleep disorders Insomnia Confusion(1) Nervousness Hallucinations(1) Nervous system disorders Somnolence Drowsiness(2) Dizziness(2) Fatigue(2) Headache Ataxia Dyskinesia Dysarthria Syncope(1) Vertigo(1) Eye disorders Accommodation disorder Blurred vision(1) Cardiac disorders Bradycardia Tachycardia QT prolongation(1) Vascular disorders Hypotension(2) Gastrointestinal disorders Dry mouth(2) Gastrointestinal disturbances(2) Nausea(2) Vomiting Abdominal pain Constipation Hepatobiliary disorders Hepatitis(1) Hepatic failure(1) Skin and subcutaneous tissue disorders Pruritus(1) Rash(1) Dermatitis(1) Musculoskeletal and connective tissue disorders Muscular weakness Renal and urinary disorders Pollakiuria Urinary tract infection General disorders and administration site conditions Anorexia Asthenia(1) Withdrawal syndrome(1) Flu-like illness Investigations Blood pressure decreased Hepatic enzymes increased (1) Adverse reactions reported in post marketing experience (2) With slow upward titration of the dose of tizanidine, these effects are usually not severe enough to require discontinuation of treatment.
3). 5). Concomitant use should be avoided unless the necessity for tizanidine therapy is clinically evident. In such a case, tizanidine should be used with caution. Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension.
Syncope has been reported in the post marketing setting. The chance of significant hypotension may possibly be minimised by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement.
5). Withdrawal syndrome Withdrawal adverse reactions include rebound hypertension, tachycardia, and hypertonia. To minimise the risk of these reactions, particularly in patients who have been receiving high doses (20 to 28 mg daily) for long periods (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 to 4 mg per day).
Hepatic impairment Since hepatic dysfunction has been reported in association with tizanidine, but rarely at daily doses up to 12 mg, it is recommended that liver function tests should be monitored monthly for the first four months in patients receiving doses of 12 mg and higher and in patients who develop clinical symptoms suggestive of hepatic dysfunction, such as unexplained nausea, anorexia or tiredness.
Treatment with tizanidine should be discontinued if serum levels of SGPT (serum glutamic-pyruvic transaminase) and/or SGOT (serum glutamic-oxaloacetic transaminase) are persistently above three times the upper limit of the normal range.
Tizanidine should be discontinued in patients with symptoms compatible with hepatitis or where jaundice occurs. Cardiovascular, hepatic or renal disorders Caution is required in patients with cardiovascular disorders, coronary artery disease, or renal or hepatic disorders.
Regular clinical laboratory and ECG monitoring is recommended during treatment with tizanidine. Renal impairment Tizanidine should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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c. g. antidepressants. Withdrawal syndrome Rebound hypertension and tachycardia have been observed after sudden withdrawal of tizanidine, when it had been used chronically, and/or in high daily dosages, and/or concomitantly with antihypertensive drugs.
5). d. Paediatric population Spontaneous adverse event reports were compared in a clinical adverse event database for children (≤ 16 years; n = 99) and adults (> 16 years; n = 1,153). The overall safety of tizanidine in the paediatric group appeared good; however, the adverse event profile differed from that in adults.
3%). 9%). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. 2). Sedation Tizanidine can cause sedation, which may interfere with everyday activity.
In multiple dose studies, the prevalence of patients with sedation peaked following the first week of titration and then remained stable for the duration of the maintenance phase of the study. Hallucinosis/Psychotic-like symptoms Tizanidine use has been associated with hallucinations.
Formed, visual hallucinations or delusions have been reported in 5 of 170 patients (3%) in two North American controlled clinical studies. Most of the patients were aware that the events were unreal. One patient developed psychosis in association with the hallucinations.
One patient among these 5 continued to have problems for at least 2 weeks following discontinuation of tizanidine. Discontinuing should be considered in patients who develop hallucinations. Hypersensitivity reactions Tizanidine can cause anaphylaxis.
Signs and symptoms including respiratory compromise, urticaria, and angioedema of the throat and tongue have been reported. Patients should be informed of the signs and symptoms of severe allergic reactions and instructed to discontinue tizanidine and seek immediate medical care if they occur.
Tizanidine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Tizanidine contains sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.