Lyflex Oral Solution (Baclofen) Abbreviated Prescribing Information

Abbreviated Prescribing Information: Lyflex 5mg/5ml Oral Solution (Baclofen 5mg/5ml Sugar Free Oral Solution). Consult Summary of Product Characteristics before prescribing. Presentation: Each 5ml of oral solution contains 5 mg baclofen. Clear yellowish liquid with an odour and flavour of raspberry. Therapeutic Indications: Baclofen is indicated for the relief of voluntary muscle spasticity resulting from disorders such as multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. Baclofen Oral Solution is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury. Baclofen 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. Baclofen 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. Posology and Method of Administration: Baclofen oral solution can be taken with food or a milk drink to help prevent nausea. Adults: Treatment with Baclofen should be initiated at a low dose and increased gradually to achieve optimal response. In adults, the recommended starting dose is 5 mg three times daily, increasing by 5 mg per dose every three days as tolerated. The usual maintenance dose ranges from 30 mg to 80 mg daily, divided into three to four doses, and should not exceed 100 mg per day. Elderly: Older patients may be more sensitive to adverse effects, particularly at the start of treatment. Therapy should begin with small doses, titrated gradually under close supervision. The eventual maximum dose is generally similar to that used in younger adults. Paediatric population: In children aged one year and above, the initial dose is 0.3 mg/kg/day divided into 2-4 doses, with gradual increases at about 1-week intervals based on clinical response and tolerance. The usual range is 0.75–2 mg/kg/day, not exceeding 40 mg daily in children under eight years and 60 mg daily in older children. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Peptic ulceration. Special Warnings and Precautions for use: Baclofen should be used with caution in patients with psychiatric or neurological conditions such as psychosis, schizophrenia, mood disorders, confusional states, Parkinson’s disease or epilepsy, as symptoms may worsen; close monitoring is essential. Suicidal thoughts and behaviour have been reported, particularly in patients with additional risk factors such as depression, alcohol misuse or previous suicide attempts, and both patients and caregivers should be advised to seek immediate medical attention if behavioural changes occur. Misuse, abuse and dependence have been observed; monitor for signs such as dose escalation, development of tolerance or drug-seeking behaviour. Rare cases of encephalopathy have occurred at therapeutic doses and require discontinuation if symptoms such as confusion or somnolence develop. Baclofen should be used with extreme care in patients receiving antihypertensive therapy, those with cerebrovascular accidents, epileptic patients, respiratory or hepatic impairment, and in elderly patients or those with spasticity of cerebral origin, where cautious dosing is recommended. In renal impairment, particularly end-stage renal failure, use only if benefits outweigh risks and monitor closely for toxicity; dose adjustment and haemodialysis may be required in severe cases. Acute urinary retention may occur in patients with sphincter hypertonia and hence should be used caution. Liver function and blood glucose should be monitored in patients with hepatic disease or diabetes. This medicine contains sorbitol, methyl and propyl parahydroxybenzoate, propylene glycol and sodium; caution is advised in patients with hereditary fructose intolerance, allergies, neonates exposed to ethanol, and those on controlled sodium diets. Abrupt withdrawal should be avoided; taper gradually over 1–2 weeks to prevent severe reactions such as hallucinations, seizures, psychosis or rhabdomyolysis, and note that neonatal withdrawal has been reported after intrauterine exposure. Limited data exist for children under one year; use only if benefit outweighs risk. Finally, exercise caution when spasticity is required to maintain posture and balance during locomotion. Any warning from the MC, CHM CSM or MHRA: Not applicable. Black Triangle notice: Not applicable. A list of common and serious adverse reactions: Very common adverse reactions: Sedation, somnolence, nausea Common adverse reactions: Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare, myalgia, headache, nystagmus, dry mouth, visual impairment, accommodation disorders, cardiac output decreased, hypotension, gastrointestinal disorder, constipation, diarrhoea, retching and vomiting, rash, hyperhidrosis, pollakiuria, enuresis, dysuria. Serious adverse reaction: Encephalopathy, sleep apnoea syndrome, bradycardia, hepatic function abnormal, hypothermia, urinary retention, erectile dysfunction, sexual dysfunction, drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral baclofen, blood glucose increased. Consult the SmPC for full details of other adverse reactions. Pack Size and NHS Price: 300 ml – £7.95. Marketing Authorisation Number: PL 00427/0285. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Legal Category: POM. Date of Preparation: Nov-2025