Venlafaxine STADA 150 mg, harde capsules met verlengde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE

farmaceutische vorm:

Capsule met verlengde afgifte, hard

Samenstelling:

ALLURAROOD AC (E129) ; BRILJANTBLAUW FCF (E 133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMHYDROXIDE (E 524) ; POVIDON (E 1201) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WITTE INKT ; ZONNEGEEL FCF (E 110), ALLURAROOD AC (E129) ; BRILJANTBLAUW FCF (E 133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMHYDROXIDE (E 524) ; POVIDON (E 1201) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WITTE INKT ; ZONNEGEEL FCF (E 110),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Venlafaxine

Product samenvatting:

Hulpstoffen: ALLURAROOD AC (E129); BRILJANTBLAUW FCF (E 133); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; ETHYLCELLULOSE (E 462); GELATINE (E 441); MAGNESIUMSTEARAAT (E 470b); NATRIUMHYDROXIDE (E 524); POVIDON (E 1201); POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); WITTE INKT; ZONNEGEEL FCF (E 110);

Autorisatie datum:

2017-10-26

Bijsluiter

PL Venlafaxine NL3669 - PRAC recommendations on signals Adopted at the
28 September-1 October 2020 PRAC meeting
(published 26-Oct-2020); EMA publication letter EMA/PRAC/513083/2020:
EPITT No 19552-Signal on postpartum hemorrhage
2020-11-06/PH
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFAXINE STADA 37,5 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE STADA 75 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE STADA 150 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE STADA 225 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
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 [product name] is and what is used for
2. What you need to know before you take [product name]
3. How to take [product name]
4. Possible side effects
5. How to store [product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product name] contains the active substance venlafaxine.
[product name] 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.
[product name] is a treatment for adults with depression. It is also a
treatmen

Productkenmerken

SmPC Venlafaxine NL3669 - PRAC recommendations on signals Adopted at
the 28 September-1 October 2020 PRAC meeting
(published 26-Oct-2020); EMA publication letter EMA/PRAC/513083/2020:
EPITT No 19552-Signal on postpartum hemorrhage
2020-11-06/PH
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Venlafaxine STADA 37,5 mg, harde capsules met verlengde afgifte
Venlafaxine STADA 75 mg, harde capsules met verlengde afgifte
Venlafaxine STADA 150 mg, harde capsules met verlengde afgifte
Venlafaxine STADA 225 mg, harde capsules met verlengde afgifte
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 37.5 mg prolonged-release capsules, hard:
Each capsule contains 42.45 mg venlafaxine hydrochloride equivalent to
37.5 mg venlafaxine.
[Product name] 75 mg prolonged-release capsules, hard:
Each capsule contains 84.9 mg venlafaxine hydrochloride equivalent to
75 mg venlafaxine.
[Product name] 150 mg prolonged-release capsules, hard:
Each capsule contains 169.8 mg venlafaxine hydrochloride equivalent to
150 mg venlafaxine.
Excipients with known effect
Contains 0.2 mg allura red AC (E129) and 0.4 mg sunset yellow FCF
(E110).
[Product name] 225 mg prolonged-release capsules, hard:
Each capsule contains 254.7 mg venlafaxine hydrochloride equivalent to
225 mg venlafaxine.
Excipients with known effect
Contains 0.02 mg carmoisine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release capsule, hard
[Product name] 37.5 mg prolonged-release capsules, hard:
Light grey opaque / peach opaque, size ‘3’ hard gelatin capsules
of approximately 15.40 mm
to 16.20 mm 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 12.5 mg each.
[Product name] 75 mg prolonged-release capsules, hard:
Peach opaque / peach opaque, size ‘1’ hard gelatin capsules of
approximately 18.90 mm to
19.70 mm having thick and thin radial