Venlafaxine Mylan 37,5 mg, capsules met verlengde afgifte, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE

Beschikbaar vanaf:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE

farmaceutische vorm:

Capsule met verlengde afgifte, hard

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 400 ; MACROGOL 8000 ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Venlafaxine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); ETHYLCELLULOSE (E 462); GELATINE (E 441); HYPROLOSE (E 463); HYPROMELLOSE (E 464); HYPROMELLOSE (Release controlling polymer)(E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MACROGOL 400; MACROGOL 8000; PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2012-06-12

Bijsluiter

PRODUCT INFORMATIE
Venlafaxine Mylan 37,5 mg / 75 mg en 150 mg, capsules met verlengde
afgifte, hard RVG 109838, 109840/41
Versie: september 2021
PAGE 32 OF 41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENLAFAXINE MYLAN 37,5 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLAFAXINE MYLAN 75 MG, CAPSULES MET VERLENGDE AFGIFTE , HARD
VENLAFAXINE MYLAN 150 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD
venlafaxine
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 Venlafaxine Mylan is and what it is used for
2.
What you need to know before you take Venlafaxine Mylan
3.
How to take Venlafaxine Mylan
4.
Possible side effects
5.
How to store Venlafaxine Mylan
6.
Contents of the pack and other information
1.
WHAT VENLAFAXINE MYLAN IS AND WHAT IT IS USED FOR
_ _
Venlafaxine Mylan contains the active substance venlafaxine.
Venlafaxine Mylan is an antidepressant that belongs to a group of
medicines called serotonin and
norepinephrine reuptake inhibitors (SNRIs). This group of medicines is
used to treat depression and
other conditions such as anxiety disorders. It is thought that people
who are depressed and/or anxious
have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how
antidepressants work, but they may help by increasing the levels of
serotonin and noradrenaline in the
brain.
Venlafaxine Mylan is a treatment for adults with depression.
Venlafaxine Mylan is also a treatment for
adults with the following anxiety disorders: generalised anxiety
disorder, social anxiety disorder

Productkenmerken

PRODUCT INFORMATIE
Venlafaxine Mylan 37,5 mg / 75 mg en 150 mg, capsules met verlengde
afgifte, hard RVG 109838, 109840/41
Versie: december 2020
PAGE 3 OF 41
1.
NAME OF THE MEDICINAL PRODUCT
Venlafaxine Mylan 37,5 mg, capsules met verlengde afgifte, hard
Venlafaxine Mylan 75 mg, capsules met verlengde afgifte , hard
Venlafaxine Mylan 150 mg, capsules met verlengde afgifte, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule, hard contains 37.5 mg of venlafaxine
(as hydrochloride).
Each prolonged release capsule, hard contains 75 mg of venlafaxine (as
hydrochloride).
Each prolonged release capsule, hard contains 150 mg of venlafaxine
(as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard
[For 37.5 mg] Size 3, hard, gelatine capsule with an opaque iron grey
cap and opaque flesh (pink)
body, axially printed with “MYLAN” over “VE37.5” in black ink.
[For 75 mg] Size 1, hard, gelatine capsule with opaque flesh (pink)
cap and body, axially printed with
“MYLAN” over “VE75” in black ink.
[For 150 mg] Size 0, hard, gelatine capsule with opaque dark orange
cap and body, axially printed
with “MYLAN” over “VE150” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of generalised anxiety disorder.
Treatment of social anxiety disorder.
Treatment of panic disorder, with or without agoraphobia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive episodes _
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients
not responding to the initial 75 mg/day dose may benefit from dose
increases up to a maximum dose
PRODUCT INFORMATIE
Venlafaxine Mylan 37,5 mg / 75 mg en 150 mg, capsules met verlengde
afgifte, hard RVG 109838, 109840/41
Versie: december 2020
PAGE 4 OF 41
of 375 mg/day. Dosage increases can be made at intervals of 2 weeks