PREGAREDI CAPSULE 150 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Pregabalin

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

N03AX16

Pharmaceutical form:

CAPSULE

Composition:

Pregabalin 150mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Dr Reddy’s Laboratories Ltd

Authorization status:

ACTIVE

Authorization date:

2023-04-18

Summary of Product characteristics

PREGAREDI®
(Pregabalin 75 mg
and
150 mg Capsule)
NAME OF THE MEDICINAL PRODUCT
Pregaredi®
COMPOSITION
Each Hard capsule contains 75 mg
and
150 mg of Pregabalin.
_List of Excipients: _
_Capsule contents:_
Lactose monohydrate, Maize starch, Talc
_Capsule shell:_
Gelatin, Sodium laurilsulfate, Purified water, Titanium dioxide
(E171),
Iron Oxide (E172) only for 75 mg shell only
_Printing Ink_
: Shellac (E904), Dehydrated Alcohol (E1510), Isopropyl Alcohol, Butyl
Alcohol,
Propylene glycol (E1520), Strong Ammonia Solution (E527), Black Iron
oxide (E172),
Potassium hydroxide (E525), Purified Water
PHARMACEUTICAL FORM
75 mg:
White to off white powder filled in Size '4' hard gelatin capsules
with opaque red coloured cap
and opaque white coloured body imprinted 'RDY' on cap and '293' on
body with black
imprinting ink.
150 mg:
White to off white powder filled in size '2' hard gelatin capsules
with opaque white coloured
cap and opaque white coloured body imprinted 'RDY' on cap and '295' on
body with black
imprinting ink.
CLINICAL INFORMATION
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.
Generalized anxiety disorder
Pregabalin is indicated for the treatment of Generalized Anxiety
Disorder (GAD) in adults.
Fibromyalgia
Pregabalin is indicated for the management of fibromyalgia.
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 mg per day after an
additional 7-day
interval.
Epilepsy
Pregabalin treatment