OSPOLOT

Posology The dose must be established and monitored by the doctor on an individual basis. The maintenance dose is about 5 to 10 mg per kg body weight per day. It should be built up step-wise (tapered in) over a one-week period. Due to the short half-life of sulthiame, the daily dose should as far as possible be spread over three single doses (see tables 1 and 2 with dosing examples).

If the daily dose is spread over the day in this way, constant plasma levels are to be expected after five to six days. Therapeutic plasma concentrations of sulthiame have not yet been determined. A switch from another medicinal product or from combination treatment should be done gradually.

Paediatric population Ospolot is suitable for use in children and adolescents weighing 12 kg or more. For dosing examples, refer to tables 1 and 2. However, dose titration must be carried out on an individual basis. 25 ml = 5 mg sulthiame Duration of treatment Ospolot should not be discontinued abruptly.

A paediatric neurologist experienced in treating epilepsy should decide on the duration of treatment and discontinuation on an individual basis. If therapy is not successful, treatment with sulthiame should be discontinued after about one to two months.

Method of administration Ospolot is for oral use. A graduated 10 ml oral syringe with a corresponding adapter, and instructions for use within the package leaflet, are provided. Before taking Ospolot, the bottle should be shaken very well (at least once for 30 seconds) and the dose drawn-up immediately afterwards (to avoid sedimentation).

The oral suspension may be swallowed directly from the oral syringe, or taken straight after mixing it, preferably with a small volume of water or alternatively with orange juice, milk, yoghurt or wheat porridge. When taking the oral suspension directly from the oral syringe, the patient should drink some water, juice or milk immediately afterwards due to the bitter taste of sulthiame.

Ospolot may be taken with or without food but carbonated beverages or hot food should be avoided as these can cause eructation or slowed swallowing. It is preferable that the way Ospolot is taken remains constant during therapy. The oral suspension may also be administered via a feeding tube that should be flushed with a minimum of 15 ml of water immediately after administration.

g. g. nausea, vomiting (in about 10% of patients) Not known: diarrhoea Hepatobiliary disorders Not known: hepatotoxic reactions, increase in liver enzymes Skin and subcutaneous disorders Not known: Stevens-Johnson syndrome, TEN (toxic epidermal necrolysis) Musculoskeletal and connective tissue disorders Uncommon: joint pain Renal and urinary disorders Not known: acute renal failure *Dose-dependent, if necessary the dose should be adjusted.

One patient with long-standing refractory epilepsy experienced progressive weakness of the limbs, hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated within hours of sulthiame being discontinued. Sulthiame is a carbonic anhydrase inhibitor.

g. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sulthiame should not be administered, or only administered with special caution - in patients with impaired renal function - in patients with a history of psychiatric disorders. Laboratory monitoring It is recommended that blood count, liver enzymes and renal function are measured before starting treatment with Ospolot.

They should then be monitored weekly for the first month then at monthly intervals during the first six months. After six months of treatment, two to four checks per year are sufficient.

Note:

Treatment should be discontinued if a persistent increase in creatinine occurs.

Hypersensitivity reactions:

Instructions should be given to seek urgent medical advice if fever, sore throat, allergic skin reactions with lymph node swelling and/or flu-like symptoms occur during treatment with Ospolot. In cases of severe allergic reactions Ospolot must be discontinued immediately.

Progressive thrombocytopenia or leukopenia accompanied by clinical symptoms require discontinuation of Ospolot.

LHON:

In two patients with the inherited Leber hereditary optic neuropathy (LHON), sulthiame was considered a trigger for visual loss. Suicidal ideation and suicidal behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.

A meta-analysis of randomised placebo controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for sulthiame.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

1, - Hyperthyroidism, - Hypertension, - Known acute porphyria.