Gabapentin Abbreviated Prescribing Information
Abbreviated Prescribing Information: Gabapentin Rosemont 50mg/mL Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: A clear, colourless oral solution. Each 1 mL containing 50 mg Gabapentin. Therapeutic Indications: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above. Gabapentin is also indicated for treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults. Posology and Method of Administration: For epilepsy: Adults and young people over 12 years old the usual starting dose is between 300mg and 900mg a day (6 to 18mL). Based on individual patient response and tolerability the dose can be further increased. The maximum dose is 3,600mg a day (72 mL). The medicine can be taken in three separate doses and the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions. For children aged 6 years old and above, the effective dose of gabapentin is 25 to 35 mg/kg/day. It is usually given in three separate doses and the maximum time interval between doses should not exceed 12 hours. Gabapentin is not recommended for use in children under 6 years old. For peripheral neuropathic pain in adults, the usual starting dose is between 300mg and 900mg a day (6 to 18 mL) and the maximum recommended dose in a day is 3,600 mg (72 mL). The medicine is taken in three separate doses: once in the morning, once in the afternoon and once in the evening. A different dosing schedule and/or dose may be prescribed by doctor for elderly patients and patients with kidney related problems or patients undergoing haemodialysis. Paediatric population: Gabapentin is not recommended for use in children under 6 years old. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Special Warnings and Precautions for use: Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking antiepileptic drugs including gabapentin. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Anaphylaxis: Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis. Suicidal ideation and behaviour: Cases of suicidal ideation and behaviour have been observed in patients treated with gabapentin in the post-marketing experience. Discontinuation of gabapentin treatment should be considered in case of suicidal ideation and behaviour. Acute pancreatitis: If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered. Seizures: Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsant agents in epileptic patients may precipitate status epilepticus. Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). Concomitant use with opioids: Caution is advised when prescribing gabapentin concomitantly with opioids due to risk of CNS depression. Respiratory depression: Gabapentin has been associated with severe respiratory depression. Caution should be exercised when gabapentin is used in elderly patients, as somnolence, peripheral oedema, and asthenia occurred in higher percentage in patients aged 65 years or above with neuropathic pain, than in younger patients. Abuse and Dependence: Cases of abuse and dependence have been reported in the post-marketing database. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. Undesirable Effects: Very common and Common reactions are presented below and refer the SmPC for details of other adverse reactions : Viral infection, Pneumonia, respiratory infection, urinary tract infection, infection, otitis media, leucopenia, anorexia, increased appetite, hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal, somnolence, dizziness, ataxia, convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes, Visual disturbances such as amblyopia, diplopia, vertigo, hypertension, vasodilatation, dyspnoea, bronchitis, pharyngitis, cough, rhinitis, vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence, facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne, arthralgia, myalgia, back pain, twitching, impotence, fatigue, fever, peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome, WBC (white blood cell count) decreased, weight gain, accidental injury, fracture and abrasion. Pack Size and NHS Price: 150 mL – £67.29. Marketing Authorisation Number: UK: PL 00427/0155 and Ireland: PA23081/010/001. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd. (UK) and TAW PHARMA (IRELAND) LTD. Date of Preparation: November 2023.
Adverse Drug Events
Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400