Pregabaline Torrent 300 mg harde capsules

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

PREGABALINE

Tersedia dari:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

Kode ATC:

N03AX16

INN (Nama Internasional):

PREGABALIN

Bentuk farmasi:

Capsule, hard

Komposisi:

GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD,

Rute administrasi :

Oraal gebruik

Area terapi:

Pregabalin

Ringkasan produk:

Hulpstoffen: GELATINE (E 441); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;

Tanggal Otorisasi:

2015-10-31

Selebaran informasi

Pregabaline Torrent 25/50/75/100/150/200/225/300 mg harde capsules –
NL/H/3264/001-008/DC
Page 1
NL pl
NL/p/012/15/3
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALINE TORRENT 25 MG HARDE CAPSULES
PREGABALINE TORRENT 50 MG HARDE CAPSULES
PREGABALINE TORRENT 75 MG HARDE CAPSULES
PREGABALINE TORRENT 100 MG HARDE CAPSULES
PREGABALINE TORRENT 150 MG HARDE CAPSULES
PREGABALINE TORRENT 200 MG HARDE CAPSULES
PREGABALINE TORRENT 225 MG HARDE CAPSULES
PREGABALINE TORRENT 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 Torrent is and what it is used for
2.
What you need to know before you take Pregabaline Torrent
3.
How to take Pregabaline Torrent
4.
Possible side effects
5
How to store Pregabaline Torrent
6.
Contents of the pack and other information
1.
WHAT PREGABALINE TORRENT IS AND WHAT IT IS USED FOR
Pregabaline Torrent 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 Torrent 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 physica

Karakteristik produk

Pregabaline Torrent 25/50/75/100/150/200/225/300 mg harde capsules –
NL/H/3264/001-008/DC
Page 1
NL SmPC
NL/s/009/15/4
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabaline Torrent 25 mg harde capsules
Pregabaline Torrent 50 mg harde capsules
Pregabaline Torrent 75 mg harde capsules
Pregabaline Torrent 100 mg harde capsules
Pregabaline Torrent 150 mg harde capsules
Pregabaline Torrent 200 mg harde capsules
Pregabaline Torrent 225 mg harde capsules
Pregabaline Torrent 300 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Pregabaline Torrent 25 mg capsules, hard _
Each hard capsule contains 25 mg of pregabalin.
_Pregabaline Torrent 50 mg capsules, hard _
Each hard capsule contains 50 mg of pregabalin.
Pregabaline Torrent
_ 75 mg capsules, hard _
Each hard capsule contains 75 mg of pregabalin.
_Pregabaline Torrent 150 mg capsules, hard _
Each hard capsule contains 150 mg of pregabalin.
_Pregabaline Torrent 200 mg capsules, hard _
Each hard capsule contains 200 mg of pregabalin.
_Pregabaline Torrent 225 mg capsules, hard _
Each hard capsule contains 225 mg of pregabalin.
_Pregabaline Torrent 300 mg capsules, hard _
Each hard capsule contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
_Pregabaline Torrent 25 mg _
White opaque capsules, size ‘4’, containing white to off-white
powder, imprinted with black ink, with
‘1358’ on the cap and ‘25’ on the body.
_Pregabaline Torrent 50 mg _
White opaque capsules, size ‘3’, containing white to off-white
powder, imprinted with black ink,
with‘1359’ on the cap and ‘50’ on the body.
_Pregabaline Torrent 75 mg _
Pregabaline Torrent 25/50/75/100/150/200/225/300 mg harde capsules –
NL/H/3264/001-008/DC
Page 2
NL SmPC
NL/s/009/15/4
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Capsules with white opaque body and orange opaque cap, size ‘4’,
containing white to off-white
powder, imprinted with black ink, with ‘1360’ on the cap and
‘75’ on the body.
_Pregabaline Torrent 100 mg _
Orange