Pregabaline Aurobindo 25 mg, harde capsules

Država: Nizozemska

Jezik: nizozemski

Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivni sastojci:

PREGABALINE

Dostupno od:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC koda:

N03AX16

INN (International ime):

PREGABALIN

Farmaceutski oblik:

Capsule, hard

Sastav:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Administracija rute:

Oraal gebruik

Područje terapije:

Pregabalin

Proizvod sažetak:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Datum autorizacije:

2017-05-22

Uputa o lijeku

PREGABALINE AUROBINDO 25 MG, HARDE CAPSULES RVG 120020
MODULE 1
Administrative information and prescribing information
1.3.1 BIJSLUITER
Rev.nr. 2206a
Pag. 1 van 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREGABALINE AUROBINDO 25 MG, HARDE CAPSULES
PREGABALINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pregabaline Aurobindo is and what it is used for
2.
What you need to know before you take Pregabaline Aurobindo
3.
How to take Pregabaline Aurobindo
4.
Possible side effects
5.
How to store Pregabaline Aurobindo
6.
Contents of the pack and other information
1.
WHAT PREGABALINE AUROBINDO IS AND WHAT IT IS USED FOR
Pregabalin belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Pregabalin Aurobindo is used to treat long lasting pain
caused by damage to the nerves. A variety of diseases can cause
peripheral neuropathic pain, such as
diabetes or shingles. Pain sensations may be described as hot,
burning, throbbing, shooting, stabbing,
sharp, cramping, aching, tingling, numbness, pins and needles.
Peripheral and central neuropathic
pain may also be associated with mood changes, sleep disturbance,
fatigue (tiredness), and can have
an impact on physical and social functioning and overall quality of
life.
EPILEPSY:
Pregabalin Aurobindo is used to treat a certain form of epilepsy
(partial seizures with or
without secondary generalization) in adults. Your doctor will
prescribe Pregabalin Au

Svojstava lijeka

PREGABALINE AUROBINDO 25 MG, HARDE CAPSULES
RVG 120020
MODULE 1
Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 2206a
Pag. 1 van 17
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pregabaline Aurobindo 25 mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabaline Aurobindo 25 mg, harde capsules: Each hard capsule
contains 25mg, of Pregabalin
Excipients with known effect
_: _
25 mg: Each hard capsule also contains 9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard
Pregabaline Aurobindo 25 mg, harde capsules
: Hard gelatin capsules, size no. 4, cap: opaque white colour, body:
opaque white colour, Content
of capsules: White powder.
Imprinted APO P25 in black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
Neuropathic pain
Pregabaline Aurobindo 25 mg, harde capsules is indicated for the
treatment of peripheral and central
neuropathic pain in adults.
_ _
Epilepsy
Pregabaline Aurobindo 25 mg, harde capsules is indicated as adjunctive
therapy in adults with partial
seizures with or without secondary generalisation.
_ _
Generalised 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
PREGABALINE AUROBINDO 25 MG, HARDE CAPSULES
RVG 120020
MODULE 1
Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 2206a
Pag. 2 van 17
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 do