Lirra

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

pregabalin

Dostupné s:

Orion Pharma Ltd.

INN (Mezinárodní Name):

pregabalin

Dávkování:

75mg

Léková forma:

capsules

Druh předpisu:

Prescription

Informace pro uživatele

LIRRA
®
Pregabalin 75 mg
_PATIENT INFORMATION LEAFLET _
NAME OF THE MEDICINAL PRODUCT: Lirra
INTERNATIONAL NONPROPRIETARY NAME: Pregabalin
QUALITATIVE AND QUANTITATIVE COMPOSITION:
_ACTIVE SUBSTANCES:_ Pregabalin 75 mg.
_EXCIPIENTS:_ Lactose Monohydrate, Purified Talc, EHG Capsule Shell #
2,
_EMPTY CAPSULES CONTENTS:_
Gelatin, Purified Water, Sodium Lauryl Sulphate, Methyl Paraben,
Propyl Paraben
_COLORS USED: CAP_ (
Sunset Yellow, Erythrosine, Brilliant Blue, Titanium Dioxide
)
_BODY_ (
Titanium Dioxide
)
PHARMACEUTICAL FORM: Capsules (Body-White, Cap- Pink)
PHARMACEUTICAL GROUP: Antiepileptic
ANATOMICAL THERAPEUTIC CHEMICAL CODE (ATC): N03AX16
THERAPEUTIC INDICATIONS:
_NEUROPATHIC PAIN:_ Pregabalin is indicated for the treatment of
peripheral and central neuropathic pain in adults.
_EPILEPSY:_ Pregabalin is indicated as adjunctive therapy in adults
with partial seizures with or without secondary
generalisation.
_GENERALIZED ANXIETY DISORDER: _Pregabalin is indicated for the
treatment of Generalized Anxiety Disorder (GAD)
in adults
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.
GENERALIZED 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.
DISCONTINUATION OF PREGABALIN: In accordance with current cl

Charakteristika produktu

Orion Pharma Limited
PRODUCT REGISTRATION DOSSIER FOR ARMENIA (LIRRA CAPSULES)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT: Lirra
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard capsule contains 75 mg of pregabalin.
3.
PHARMACEUTICAL FORM :
Capsules (Body-White, Cap- Pink)
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NEUROPATHIC PAIN
:
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
EPILEPSY:
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
GENERALIZED ANXIETY DISORDER:
Pregabalin is indicated for the treatment of Generalised Anxiety
Disorder (GAD) in adults
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.
_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).
Special populations
_Patients with renal impairment_
Pregabalin is eliminated from the systemic circulation primarily by
renal excretio