Pregamid 100 mg harde capsules

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

PREGABALINE 100 mg/stuk

Tersedia dari:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

Kode ATC:

N03AX16

INN (Nama Internasional):

PREGABALINE 100 mg/stuk

Bentuk farmasi:

Capsule, hard

Komposisi:

AMMONIA (E 527) ; GELATINE (E 441) ; 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,

Rute administrasi :

Oraal gebruik

Area terapi:

Pregabalin

Ringkasan produk:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); 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;

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGAMID 25 MG HARDE CAPSULES
PREGAMID 50 MG HARDE CAPSULES
PREGAMID 75 MG HARDE CAPSULES
PREGAMID 100 MG HARDE CAPSULES
PREGAMID 150 MG HARDE CAPSULES
PREGAMID 200 MG HARDE CAPSULES
PREGAMID 225 MG HARDE CAPSULES
PREGAMID 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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] belongs to a group of medicines used to treat
epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: [Invented name] 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: [Invented name] is used to treat a certain form of epilepsy
(partial seizures with or without
secondary generalisation) in adults. Your doctor will prescribe
[Invented nam

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Pregamid 25 mg harde capsules
Pregamid 50 mg harde capsules
Pregamid 75 mg harde capsules
Pregamid 100 mg harde capsules
Pregamid 150 mg harde capsules
Pregamid 200 mg harde capsules
Pregamid 225 mg harde capsules
Pregamid 300 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Invented name] 25 mg hard capsules:
Each hard capsule contains 25 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 35 mg lactose monohydrate.
[Invented name] 50 mg hard capsules:
Each hard capsule contains 50 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 70 mg lactose monohydrate.
[Invented name] 75 mg hard capsules:
Each hard capsule contains 75 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 8.25 mg lactose monohydrate.
[Invented name] 100 mg hard capsules:
Each hard capsule contains 100 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 11 mg lactose monohydrate.
[Invented name] 150 mg hard capsules:
Each hard capsule contains 150 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 16.50 mg lactose monohydrate.
[Invented name] 200 mg hard capsules:
Each hard capsule contains 200 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 22.00 mg lactose monohydrate.
[Invented name] 225 mg hard capsules:
Each hard capsule contains 225 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 24.75 mg lactose monohydrate.
[Invented name] 300 mg hard capsules:
Each hard capsule contains 300 mg of pregabalin.
_Excipients with known effect: _
Each hard capsule contains 33.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
_ _
[Invented name] 25 mg hard capsules:
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.
[Invented n