Lyrica 300mg capsules hard

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pregabalin

Available from:

Pfizer Manufacturing Deutschland GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Dosage:

300mg

Pharmaceutical form:

capsules hard

Units in package:

(14/1x14/) blister, (56/4x14/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-07-03

Summary of Product characteristics

89
1.
NAME OF THE MEDICINAL PRODUCT
Lyrica 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 300 mg of pregabalin.
_Excipients with brown effect:_
Each hard capsule also contains 33 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
White and orange, marked “Pfizer” on the cap and “PGN 300” on
the body with black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Neuropathic vain_
Lyrica is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_ _
_Epilepsy_
Lyrica is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Lyrica is indicated for the treatment of Generalised Anxiety Disorder
(GAD) in adults.
[Stamp\Seal: Illegible]
10.06.15
[Signature: Illegible]
16.06.2015
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 vain_
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 dayafter an interval of 3 to 7
days, and if needed, to a maximum dose of 600 mg per day after
anadditional 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.
90
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. Followin