LIORESAL LIQUID

Dosage Lioresal is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suitable for children or those adults who are unable to take tablets. Dosage titration can be more precisely managed with the liquid.

The lowest dose compatible with an optimal response is recommended. Before starting treatment with Lioresal it is prudent to realistically assess the overall extent of clinical improvement that the patient may be expected to achieve.

Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If too high a dose is initiated or if the dosage is increased too rapidly side effects may occur. This is particularly relevant if the patient is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.

Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks a decision whether to continue with Lioresal should be taken. 4).

Adults:

Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements. 5mg three times a day for three days 10mg three times a day for three days 15mg three times a day for three days 20mg three times a day for three days Satisfactory control of symptoms is usually obtained with doses of up to 60mg daily, but a careful adjustment is often necessary to meet the requirements of each individual patient.

The dose may be increased slowly if required, but a maximum daily dose should not exceed 100mg. Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Lioresal only at night to counteract painful flexor spasm.

Similarly a single dose given approximately 1 hour prior to performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.

Special populations Elderly patients (aged 65 years or above):

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.

g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.

Should nausea persist following a reduction in dosage, it is recommended that Lioresal be ingested with food or a milk beverage. g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

Certain patients have shown increased spasticity as a paradoxical reaction to the medication. e. by reducing the doses given during the day and possibly increasing the evening dose). 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) and not known (cannot be estimated from the available data).

Table 1 Tabulated summary of adverse drug reactions Immune System disorders Not known: Hypersensitivity Nervous system disorders Very common: Sedation, somnolence Common: Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare, myalgia, headache, nystagmus, dry mouth.

Rare:

Paraesthesia, dysarthria, dysgeusia. 4), swelling face and peripheral oedema Investigations Not known: Blood glucose increased *Drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral Lioresal.

* Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100 mg) in patients who are alcohol dependent. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.

Psychiatric and nervous system disorders Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson's disease may be exacerbated by treatment with Lioresal. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.

Suicide and suicide-related events have been reported in patients treated with baclofen. In most cases, the patients had additional risk factors associated with an increased risk of suicide including alcohol use disorder, depression and/or a history of previous suicide attempts.

Close supervision of patients with additional risk factors for suicide should accompany drug therapy. Patients (and caregivers of patients) should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Cases of misuse, abuse and dependence have been reported with baclofen. g. dose escalation, drug-seeking behaviour, development of tolerance. Epilepsy Lioresal may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.

Encephalopathy Cases of encephalopathy have been reported in patients receiving baclofen at therapeutic doses, which were reversible after treatment discontinuation. Symptoms included somnolence, depressed level of consciousness, confusion, myoclonus and coma.

9) If signs of encephalopathy are observed, baclofen should be discontinued. 5). Lioresal should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment. 2). 2 Posology and method of administration).

g. confusion, disorientation, somnolence and depressed level of consciousness) have been observed in patients with renal impairment taking oral baclofen at doses of more than 5mg per day and at doses of 5mg per day in patients with end stage renal failure being treated with chronic hemodialysis.

• Hypersensitivity to baclofen or to any of the excipients • Peptic ulceration