Topiramate Abbreviated Prescribing Information

Abbreviated Prescribing Information: Topiramate Rosemont 10mg/ml and 20mg/ml Oral Suspension Consult Summary of Product Characteristics before prescribing. Presentation: Colourless or off-white suspension. Each 1ml contains 10mg of topiramate for the 10mg/ml strength and 20 mg for the 20mg/ml strength. Therapeutic Indications: Topiramate is indicated to treat seizures in adults and children over age 6 and to prevent migraine headaches in adults. Topiramate can also be used with other medicines to treat seizures in adults and children aged 2 years and above. Posology and Method of Administration: It is recommended that therapy be initiated at a low dose followed by titration to an effective dose. Dose and titration rate should be guided by clinical response. If low doses are required, the 10mg/ml strength product is the most suitable presentation. If high doses are required, the 20mg/ml strength product is the most suitable presentation. For Adults: Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used. Paediatric population: Dose and titration rate in children should be guided by clinical outcome. Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used. For children aged 2 years and above: The recommended total daily dose of topiramate as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed. Migraine prophylaxis in pregnancy and in women of childbearing potential if not using a highly effective method of contraception. Special Warnings and Precautions for use: Topiramate may cause fetal harm and fetal growth restriction (small for gestational age and low birth weight) when administered to a pregnant woman. Before the initiation of treatment with topiramate in a woman of childbearing potential, pregnancy testing should be performed, and a highly effective contraceptive method advised and the patient should be fully informed of the risks related to the use of topiramate during pregnancy. Decreased sweating and hyperthermia (rise in body temperature) may occur especially in young children exposed to high ambient temperature. An increased incidence of mood disturbances and depression has been observed during topiramate treatment. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. Patients therefore should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Serious skin reactions (Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)) have been reported in patients receiving topiramate. It is recommended that patients be informed about the signs of serious skin reactions and use of topiramate should be discontinued. In patients with impaired renal function (CLCR ≤70mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased. In hepatically impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure. Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure. If visual field defects occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.Hyperchloremic, non-anion gap, metabolic acidosis is associated with topiramate treatment. Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia. Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis. There have been reports in the literature of impairment of cognitive function in adults on topiramate therapy which required reduction in dosage or discontinuation of treatment. Hyperammonemia with or without encephalopathy has been reported with topiramate treatment. The risk for hyperammonemia with topiramate appears dose related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Some patients may experience weight loss whilst on treatment with topiramate. It is recommended that patients on topiramate treatment should be monitored for weight loss. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable effects: Very common and common reactions are presented below and refer the SmPC for details of other adverse reactions: Nasopharyngitis, Depression, Paraesthesia, Somnolence, Dizziness, Nausea, Diarrhoea, Fatigue, Weight decreased, Anaemia, Hypersensitivity, Anorexia, decreased appetite, Bradyphrenia, Insomnia, Expressive language disorder, Anxiety, Confusional state, Disorientation, Aggression, Mood altered, Agitation, Mood swings, Depressed mood, Anger, Abnormal behaviour, Disturbance in attention, Memory impairment, Amnesia, Cognitive disorder, Mental impairment, Psychomotor skills impaired, Convulsion, Coordination abnormal, Tremor, lethargy, Hypoaesthesia, Nystagmus, Dysgeusia, Balance disorder, Dysarthria, Intention tremor, SLedation, Vision blurred, Diplopia, Visual disturbance, Vertigo, Tinnitus, Ear pain, Dyspnoea, Epistaxis, Nasal congestion, Rhinorrhoea, Cough*, Vomiting, Constipation, Abdominal pain upper, Dyspepsia, Abdominal pain, Dry mouth, Stomach discomfort, Paraesthesia oral, Gastritis, Abdominal discomfort, Alopecia, Rash, Pruritus, Arthralgia, Muscle spasms, Myalgia, Muscle twitching, Muscular weakness, Musculoskeletal chest pain, Nephrolithiasis, Pollakiuria, Dysuria, Nephrocalcinosis, Pyrexia, Asthenia, Irritability, Gait disturbance, Feeling abnormal, Malaise, and Weight increased. Pack Size and NHS Price: 10mg/ml 150ml £228.96 or 20mg/ml 280ml – £330.72 Marketing Authorisation Number: PL 00427/0245 and PL 00427/0246. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Jan-2023]