Pregabaline AET 50 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PREGABALINE

Beschikbaar vanaf:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

ATC-code:

N03AX16

INN (Algemene Internationale Benaming):

PREGABALIN

farmaceutische vorm:

Capsule, hard

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Pregabalin

Product samenvatting:

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

Autorisatie datum:

2015-07-21

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREGABALINE AET 25 MG HARDE CAPSULES
PREGABALINE AET 50 MG HARDE CAPSULES
PREGABALINE AET
75 MG HARDE CAPSULES
PREGABALINE AET 100 MG HARDE CAPSULES
PREGABALINE AET 150 MG HARDE CAPSULES
PREGABALINE AET 200 MG HARDE CAPSULES
PREGABALINE AET 225 MG HARDE CAPSULES
PREGABALINE AET 300 MG HARDE CAPSULES
Pregabalin
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 AET is and what it is used for
2.
What you need to know before you take Pregabaline AET
3.
How to take Pregabaline AET
4.
Possible side effects
5.
How to store Pregabaline AET
6.
Contents of the pack and other information
1.
WHAT PREGABALINE AET IS AND WHAT IT IS USED FOR
Pregabaline AET belongs to a group of medicines used to treat
epilepsy, neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Pregabaline AET 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:
Pregabaline AET is used to treat a certain form of epilepsy (partial
seizures with or without
secondary gener

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabaline AET 25 mg harde capsules
Pregabaline AET 50 mg harde capsules
Pregabaline AET 75 mg harde capsules
Pregabaline AET 100 mg harde capsules
Pregabaline AET 150 mg harde capsules
Pregabaline AET 200 mg harde capsules
Pregabaline AET 225 mg harde capsules
Pregabaline AET 300 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[For 25 mg:]_
Each hard capsule contains 25 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 35 mg lactose monohydrate.
_[For 50 mg:] _
Each hard capsule contains 50 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 70 mg lactose monohydrate.
_[For 75 mg:] _
Each hard capsule contains 75 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 8.25 mg lactose monohydrate.
_[For 100 mg:] _
Each hard capsule contains 100 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 11 mg lactose monohydrate.
_[For 150 mg:] _
Each hard capsule contains 150 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 16.50 mg lactose monohydrate.
_[For 200 mg:] _
Each hard capsule contains 200 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 22.00 mg lactose monohydrate.
_[For 225 mg:] _
Each hard capsule contains 225 mg of pregabalin.
_Excipients with known effect: _
2
Each hard capsule also contains 24.75 mg lactose monohydrate.
_[For 300 mg:]_
Each hard capsule contains 300 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule also contains 33.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
_ _
_[For 25 mg:]_
Hard capsules, size 4, with a white cap and a white body, with
“25” printed in black ink on the body.
The capsules contain a white to off-white powder.
_[For 50 mg:]_
Hard capsules, size 3, with a white cap and a pinkish-orange body,
with “50” pr