Venlafaxine Fair-Med 75 mg capsules met verlengde afgifte, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VENLAFAXINEHYDROCHLORIDE 84,9 mg/stuk SAMENSTELLING overeenkomend met ; VENLAFAXINE 75 mg/stuk

Beschikbaar vanaf:

Fairmed Healthcare GmbH Dorotheenstrasse 48 22301 HAMBURG (DUITSLAND)

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINEHYDROCHLORIDE 84,9 mg/stuk SAMENSTELLING overeenkomend met ; VENLAFAXINE 75 mg/stuk

farmaceutische vorm:

Capsule met verlengde afgifte, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Venlafaxine

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; ETHYLCELLULOSE (E 462); GELATINE (E 441); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MAGNESIUMSTEARAAT (E 470b); POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); RODE INKT; SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-11-16

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFAXINE FAIR-MED 37,5 MG CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLAFAXINE FAIR-MED 75 MG CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLAFAXINE FAIR-MED 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
is a treatment for adults with depression. is also a treatment
for adults with the following anxiety disorders: generalised anxiety
disorder, social anxiety
disorder (fear or avoidance of social situations) and panic disorder
(panic attacks). Treating
depression or anxiety disorders properly is important to help you get
better. If it is not treated,
your condition may not go away and may become more serious

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Venlafaxine Fair-Med 37,5 mg capsules met verlengde afgifte, hard
Venlafaxine Fair-Med 75 mg capsules met verlengde afgifte, hard
Venlafaxine Fair-Med 150 mg capsules met verlengde afgifte, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
37.5mg capsules contain venlafaxine hydrochloride,
equivalent to 37.5mg
of venlafaxine.
75mg capsules contain venlafaxine hydrochloride,
equivalent to 75mg of
venlafaxine.
150mg capsules contain venlafaxine hydrochloride,
equivalent to 150mg of
venlafaxine.
Excipients with known effect:
Each 150 mg prolonged-release capsule, hard, contains 39.686 mg of
E110 sunset yellow FCF
Each 150 mg prolonged-release capsule, hard, contains 19.872 mg of
E129 allura red AC
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard prolonged-release capsule
37.5mg: light grey opaque / peach opaque, size “3”
hard gelatin capsules
having thick and thin radial circular band on the body in red ink and
thick and thin radial
circular band on the cap in red ink. The capsule is filled with 3
white to off-white, round
biconvex, film-coated mini tablets of 12.5mg each.
75mg: peach opaque / peach opaque, size “1” hard
gelatin capsules having
thick and thin radial circular band on the body in red ink and thick
and thin radial circular
band on the cap in red ink. The capsule is filled with 6 white to
off-white, round biconvex,
film-coated mini tablets of 12.5mg each.
150mg: dark orange / dark orange opaque, size “0”
hard gelatin capsules
having thick and thin radial circular band on the body in white ink
and thick and thin radial
circular band on the cap in white ink. The capsule is filled with 12
white to off-white, round
biconvex, film-coated mini tablets of 12.5mg each.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episode