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LIORESAL (BACLOFEN) TABLETS ADVERSE REACTIONS / SIDE EFFECTS

Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence), if the dosage is increased too rapidly, if large doses are employed or if the patient is elderly. They are often transitory and can be attenuated or eliminated by reducing the dosage. They may necessitate withdrawal of the medication. In patients with a history of psychiatric illness, cortical or organic brain disorders or with cerebrovascular disorders (eg. stroke), as well as inelderly patients, adverse reactions may be more serious.

It is often difficult to distinguish whether some of these are drug effects or manifestations of the diseases under treatment. Psychiatric manifestations can occur in acute or chronic toxicity due to baclofen.

Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

Certain patients have shown increased muscle spasticity as a paradoxical reaction to the medication.

Adverse reactions 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), not known (cannot be estimated from the available data).

Nervous system disorders

Very common: Sedation, somnolence
Common: Respiratory depression, fatigue, confusional state, dizziness, personality changes, vertigo, headache, insomnia, euphoric mood, depression, muscular weakness, ataxia, tremor, hallucination, nightmare, myalgia, nystagmus, dry mouth, tinnitus
Rare: Paraesthesia, dysarthria, dysgeusia, syncope, dyskinesia, coma, taste disturbances
Very rare: Hypothermia

Eye disorders

Common: Accommodation disorder, visual impairment

Cardiac disorders

Common: Cardiac output decreased
Rare: Arrhythmias, palpitations, chest pain
Not known: Bradycardia

Vascular disorders

Common: Hypotension
Rare: Dyspnoea, ankle oedema

Gastrointestinal disorders

Very common: Nausea (particularly at the start of treatment)
Common: Gastrointestinal disorder, retching, vomiting, constipation, diarrhoea
Rare: Colicky abdominal pain, anorexia

Hepatobiliary disorders

Rare: Hepatic function abnormal

Skin and subcutaneous tissue disorders

Common: Hyperhidrosis, rash, pruritus
Not known: Urticaria

Renal and urinary disorders

Common: Pollakiuria, enuresis, dysuria
Rare: Urinary retention, nocturia, haematuria

Reproductive system and breast disorders

Rare: Erectile dysfunction, inability to ejaculate

General disorders and administration site conditions

Very rare: Hypothermia
Not known: Drug withdrawal syndrome

Investigations

Not known: Blood glucose increase

Miscellaneous

Rare: nasal congestion, weight gain



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