Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Fingolimod hydrochloride eqv. Fingolimod
ACCORD HEALTHCARE PRIVATE LIMITED
L04AA27
CAPSULE, GELATIN COATED
Fingolimod hydrochloride eqv. Fingolimod 0.5 MG
ORAL
Prescription Only
Intas Pharmaceuticals Limited
ACTIVE
2022-06-29
PRESCRIBING INFORMATION For the use of a registered medical practitioner or a hospital or a laboratory only FINCORD FINGOLIMOD CAPSULES 0.5MG 1. NAME OF THE MEDICINAL PRODUCT FINCORD [Fingolimod Capsules 0.5mg] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains: Fingolimod hydrochloride USP 0.56mg eq.to Fingolimod 0.5mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gelatin capsule Bright yellow opaque/white opaque size “3” hard gelatin capsule imprinted with “FO 0.5 mg” on the cap and two radial bands on the capsule body with yellow ink containing white to off white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fincord is indicated as monotherapy for the treatment of adult patients and paediatric patients of 10 years of age and above with the relapsing-remitting form of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the progression of physical disability. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. Posology In adults, the recommended dose of Fincord is one 0.5 mg capsule taken orally once daily. In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: - Paediatric patients with body weight ≤ 40 kg: one 0.25 mg capsule daily taken orally. - Paediatric patients with body weight > 40 kg: one 0.5 mg capsule daily taken orally. Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules. Fincord can be taken with or without food. If a dose is missed treatment should be continued with the next dose as planned. When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the observation after first dose. For recommendations related to switching patients from other disease modifying therapies to Fingolimod (see section 4.4). Special populations _Elderly populati Read the complete document