SIRANALEN CAPSULES 75MG

4.1 Therapeutic indications

Neuropathic pain

Siranalen is indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia in adults.

Epilepsy

Siranalen is indicated as adjunctive therapy of partial seizures, with or without secondary generalization, in adults.

Generalised Anxiety Disorder

Siranalen is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Fibromyalgia

Pregabalin is indicated for the management of fibromyalgia.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Neuropathic pain

Pregabalin treatment can be started at a dose of 150 mg per day.

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.

Epilepsy

Pregabalin treatment can be started with a dose of 150 mg per day.

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.

Generalised Anxiety Disorder

The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dosage of 600 mg per day may be achieved after an additional week.

Fibromyalgia

The recommended dose of pregabalin is 300 to 450 mg per day. Dosing should begin at 75 mg two times a day (150 mg per day) and may be increased to 150 mg two times a day (300 mg per day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg per day may be further increased to 225 mg two times a day (450 mg per day). Although pregabalin was also studied at 600 mg per day, there is no evidence that this dose confers additional benefit and that this dose was less tolerated.

In view of the dose-dependent adverse reactions, treatment with doses above 450 mg per day is not recommended.

Discontinuation of pregabalin

If pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.

Patients with renal impairment

Dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), as indicated in Table 1 determined using the following formula:

For patients receiving hemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour hemodialysis treatment (see Table 1).

Patients with hepatic impairment

No dose adjustment is required for patients with hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in children and adolescents (12 to 17 years of age)

The safety and effectiveness of pregabalin in pediatric patients below the age of 12 years and adolescents have not been established. The use in children and adolescents is not recommended (see section 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly (over 65 years of age)

Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Siranalen may be taken with or without food.

Siranalen is for oral use only.