Sirdalud BSS

SIRDALUD® / SIRDALUD® MR

Important note: Before prescribing, please consult full prescribing information.

Presentation: Tablets containing 2 mg, 4 mg or 6 mg tizanidine hydrochloride; MR (modified release) capsules containing 6 mg or 12 mg tizanidine hydrochloride.

Indications: Treatment of painful muscle spasms associated with static and functional disorders of the spine (cervical and lumbar syndromes) or following surgery, e.g. for herniated intervertebral disc or osteoarthritis of the hip. Treatment of spasticity due to neurological disorders such as multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, cerebrovascular accidents, and cerebral palsy.

Dosage: Painful muscle spasms: 2 to 4 mg three times daily in tablet form; extra dose of 2 or 4 mg in severe cases. Spasticity due to neurological disorders: Tablets: maximum initial dose 6 mg/day in 3 divided doses, then increase stepwise to achieve optimum therapeutic response (generally between 12 to 24 mg/day). The daily dose of 36 mg should not be exceeded. MR capsules: initial dose 6 mg once a day which may be increased stepwise from 6 to 24 mg/day, as necessary.

Contraindications: Known hypersensitivity to tizanidine or to any of the excipients. Severely impaired hepatic function. Concomitant use with strong CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin.

Precautions/Warnings: Co-administration with inhibitors of CYP1A2 such as some anti-arrhythmics (amiodarone, mexiletine, propafenone), cimetidine, some fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives and ticlopidine is not recommended (see also Contraindications). Caution should be exercised when Sirdalud is given with drugs known to increase the QT interval Hypotension may occur with potential severe symptoms such as loss of consciousness and circulatory collapse. Gradual reduction in dosage is recommended to avoid withdrawal syndrome. Liver function tests are recommended in patients receiving doses of 12 mg or above and in case of clinical symptoms suggestive of hepatic dysfunction; discontinue treatment if serum levels of SGPT or SGOT are persistently above three times the upper limit of the normal range. Caution is required in patients with impaired renal function.  Hypersensitivity reactions including anaphylaxis, angioedema, dermatitis, rash, urticarial, pruritis and erythema have been reported in association with tizanidine. Careful patient observation is recommended. If anaphylaxis or angioedema with anaphylactic shock or difficulty of breathing is observed treatment with Sirdalud should be discontinued immediately and appropriate medical treatment should be instituted. Refrain from driving a vehicle or using machines if dizziness or hypotension occurs. Use during pregnancy only if benefit clearly outweighs the risk. Avoid breast-feeding.  Use is not recommended in children and caution is required in elderly patients.

Interactions: Contraindication: CYP1A2 strong inhibitors. Not recommended: other CYP1A2 inhibitors (such as anti-arrhythmics, cimetidine, some fluoquinolones, rofecoxib, oral contraceptives, ticlopidine). To be considered: drugs known to prolong the QT Novartis Confidential Page 3 BSS 02-May-2016 Sirdalud/Sirdalud MR

interval, antihypertensives including diuretics, sedatives, hynoptics and antihistaminics, rifampicin, cigarette smoke, alcohol, other alpha-2 adrenergic agonists.

Adverse reactions: With low doses, such as those recommended for the relief of painful muscle spasms: somnolence, fatigue, dizziness, dry mouth, nausea, gastrointestinal disorder, transaminase increase, blood pressure decrease. With the higher doses, as recommended for the treatment of spasticity, in addition: muscular weakness, insomnia, sleep disorder, hallucinations, hypotension, bradycardia, hepatitis and hepatic failure. Post-marketing adverse drug reactions: Hypersensitivity reactions including anaphylaxis, angioedema and urticaria, hallucination, confusional state, vertigo, syncope, vision blurred, hepatitis, hepatic failure, rash, erythema, pruritus, dermatitis, asthenia. Withdrawal syndrome: rebound hypertension and tachycardia, possibly leading to cerebrovascular accident.