REWISCA HARD CAPSULES 75MG

KRKA, D.D., NOVO MESTO (SLOVENIA)🇸🇬 Health Sciences Authority

Approval Date: Apr 2, 2019
Approval ID: 5b9f391e18bcde62
Company: KRKA, D.D., NOVO MESTO (SLOVENIA)
Type: Therapeutic

Approval Details

Approval Id: 5b9f391e18bcde62
Drug Name: REWISCA HARD CAPSULES 75MG
Product Name: REWISCA HARD CAPSULES 75MG
Approval Number: SIN15656P
Approval Date: 2019-04-02
Registrant: SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
Licence Holder: SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: 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 given as two or three divided doses. 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 given as two or three divided doses. 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 dose 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 In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with renal impairment Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula: <img src="/TGIF/Rewisca-Formula1.png" alt="Rewisca Dosage Formula 1" /> Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, 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 haemodialysis treatment (see Table 1). <img src="/TGIF/Rewisca-Table1.png" alt="Rewisca Dosage 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). Paediatric population The safety and efficacy of Rewisca in children below the age of 12 years and in adolescents (12–17 years of age) have not been established. No data are available. The use in children and adolescents is not recommended. Older people (over 65 years of age) Older people may require a dose reduction of pregabalin due to a decreased renal function (see Patients with renal impairment). Method of administration Rewisca may be taken with or without food. Rewisca is for oral use only.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Neuropathic pain Rewisca is indicated for the treatment of neuropathic pain which includes diabetic peripheral neuropathy and post-herpetic neuralgia in adults. Epilepsy Rewisca is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Rewisca is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Rewisca is indicated for the management of fibromyalgia.
Contraindications: 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.
Atc Code: N03AX16
Atc Item Name: xn 03 ax 16
Pharma Manufacturer Name: SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Active Ingredients

Pregabalin

75.00mg

PREGABALIN

75 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 2, 2019

Approval ID

5b9f391e18bcde62

Type

Therapeutic

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