País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
BACLOFEN
NOVARTIS (SINGAPORE) PTE LTD
M03BX01
10 mg
TABLET
BACLOFEN 10 mg
ORAL
Prescription Only
NOVARTIS FARMA S P A
ACTIVE
1991-01-07
LIORESAL Antispastic with spinal site of action DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Lioresal scored tablets: 10 mg of baclofen. ACTIVE SUBSTANCE Baclofen ACTIVE MOIETY Baclofen EXCIPIENTS TABLETS : silica aerogel; cellulose, microcrystalline; magnesium stearate; polyvidone; wheat starch. Pharmaceutical formulations may vary between countries. INDICATIONS ADULT AND PAEDIATRIC POPULATION (6-<18 YEARS) Lioresal is indicated for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. Lioresal is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord. DOSAGE AND ADMINISTRATION DOSAGE Treatment should always be initiated with small, gradually increasing doses of Lioresal. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be individualized in such a way that clonus, flexor and extensor spasms and spasticity are reduced, but adverse effects are avoided as far as possible. If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be taken whether to continue with Lioresal. Novartis Page 2 Country Specific Package Leaflet (Singapore)30 Jul 2012 Lioresal Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serio Llegiu el document complet
Lioresal Oct 2023.SIN Page 1 of 11 LIORESAL Antispastic with spinal site of action DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Lioresal scored tablets: 10 mg of baclofen. White to faintly yellowish, round, flat tablets with a slightly bevelled edge. Debossed with “CG” on one side and the other the debossment “K”, score “J”. The score line on one side is to divide the tablet into equal doses. ACTIVE SUBSTANCE Baclofen EXCIPIENTS TABLETS : wheat starch; cellulose microcrystalline; povidone; silica colloidal anhydrous; magnesium stearate. Pharmaceutical formulations may vary between countries. INDICATIONS ADULT AND PAEDIATRIC POPULATION (6-<18 YEARS) Lioresal is indicated for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. Lioresal is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord. DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN Treatment should always be initiated with small, gradually increasing doses of Lioresal. The lowest dose compatible with an optimal response is recommended. The optimum daily dosage should be adapted to each individual in such a way that clonus, flexor and extensor spasms and spasticity are reduced, but adverse effects are avoided as far as possible. If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be made whether to continue using Lioresal. Lioresal Oct 2023.SIN Page 2 of 11 Discontinuation of treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, Llegiu el document complet