LYRIJUB CAPSULE 75MG

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Compra

Scarica Scheda tecnica (SPC)
30-05-2023

Principio attivo:

Pregabalin

Commercializzato da:

GOLDPLUS UNIVERSAL PTE LTD

Codice ATC:

N02BF02

Forma farmaceutica:

CAPSULE

Composizione:

Pregabalin 75 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Jubilant Generics Limited

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2023-05-30

Scheda tecnica

                                LYRIJUB
PREGABALIN CAPSULES 25 MG, 75 MG AND 150 MG
NAME OF THE MEDICINAL PRODUCT
Lyrijub Capsule 25 mg
Lyrijub Capsule 75 mg
Lyrijub Capsule 150 mg
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin
2.
PHARMACEUTICAL FORM
Pregabalin 25 mg hard capsules:
White to off-white colored cap and body, size ’4’ hard gelatin
capsule printed in black ink with “25” on the cap and
“608” on the body containing white to off-white powder.
Pregabalin 75 mg hard capsules:
Reddish brown colored cap and white to off-white colored body, size
“4” hard gelatin capsule printed in black ink with
“610” on the body containing white to off-white powder.
Pregabalin 150 mg hard capsules:
White to off white colored cap and body, size ‘2’ hard gelatin
capsule printed in black ink with “612” on the body
containing white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neuropathic pain
Pregabalin is indicated for the treatment of neuropathic pain, which
includes diabetic peripheral neuropathy and
post-herpetic neuralgia, in adults.
Epilepsy
Pregabalin is indicated as adjunctive therapy of partial seizures,
with or without secondary generalisation, in adults.
Generalised anxiety disorder
Pregabalin is indicated for the treatment of Generalised Anxiety
Disorder (GAD) in adults.
Fibromyalgia
Pregabalin is indicated for the management of fibromyalgia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dose range is 150 to 600 mg per day given in either two or three
divided doses.
Pregabalin may be taken with or without food.
Neuropathic pain
Pregabalin treatment can be started at a dose of 150 mg per day. Based
on individual patient response and tolerability,
the dosage 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
                                
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