Novartis Pharmaceuticals UK Ltd

Section 4.4

The following has been added as the second paragraph under the section on Abrupt withdrawal:

Neonatal convulsions have been reported after intrauterine exposure to oral Lioresal (see Section 4.6).

Section 4.6

The following has been added as the second paragraph:

One case of suspected withdrawal reaction (generalised convulsions) has been reported in a week-old infant whose mother had taken oral baclofen 80 mg daily throughout her pregnancy. The convulsions, which were refractory to standard anticonvulsant treatment, ceased within 30 minutes of giving baclofen to the infant.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000), including isolated reportsand Not known (cannot be estimated from the available data).

Not known    Urticaria has been added as below in Table 1.

Patient selection is important when initiating Lioresal therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy.  Treatment should not be commenced until the spastic state has become stabilised.

Paediatric population

Lioresal is indicated in patients 0 to <18 years 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.

Section 4.2

Elderly:  Elderly patients may be more susceptible to side effects, particularly in the early stages of introducing Lioresal.  Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response, under careful supervision.  There is no evidence that the eventual average maximum dose differs from that in younger patients.

ChildrenPaediatric population (0 to < 18 years):  Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses, preferably in 4 divided doses.  Therefore tablets are not suitable for use in children below 33 kg body weight. The dosage should be cautiously raised at about 1 week3 day intervals, until it becomes sufficient for the child’s individual requirements. The usual dailyA dosage for maintenance therapy ranges betweenof 0.75- and 2mg/kg body weight. should be used for maintenance therapy. The total daily dose should not exceed a maximum of 40mg/day in children below 8 years of age.  In children over 8 years of age, a maximum daily dosage of 60mg/day may be given.  The recommended daily dosages for maintenance therapy are as follows:

Children aged:    6 years  - 8 years : 30-40mg

                           Over 8 years: up to 60mg.

Lioresal tablets are not suitable for use in children below 33 kg body weight.

Patients with impaired renal function:  In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of Lioresal should be selected i.e. approx. 5mg daily.

Section 4.4

Abrupt withdrawal:

Anxiety and confusional states, hallucinations, psychotic, manic or paranoid states, convulsions (status epilepticus), dyskinesia, tachycardia, hyperthermia and as rebound phenomenon temporary aggravation of spasticity have been reported with abrupt withdrawal of Lioresal, especially after long term medication.  Treatment should always, (unless serious adverse effects occur), therefore be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.

There is very limited clinical data on the use of Lioresal in children under the age of one year. Use in this patient population should be based on the physician’s consideration of individual benefit and risk of therapy.

In patients with Parkinson's disease receiving treatment with Lioresal and levodopa plus carbidopa, there have been reports of mental confusion, hallucinations, nausea and agitation. 

Drugs or medicinal products that can significantly affect renal function may reduce baclofen excretion leading to toxic effects (see Section 4.4).

• Hypersensitivity to any of the excipients added

• Paragraph reading "Lioresal tablets contain wheat starch...." added
• Abrupt withdrawal: SGOT changed to AST

• Reworded

• Incidences redefined
• Sedation, somnolence and nausea added as examples of unwanted effects that occur mainly at the start of treatment
• Undesirable effects tabulated and categorised in accordance to body area
• Hypothermia added

• SGOT and AP changed to AST and ALP
• Treatment: reworded

• Pharmacotherapeutic group and ATC code added

• Date of revision updated