Venlafaxine HCl Sandoz 225 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:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE

farmaceutische vorm:

Capsule met verlengde afgifte, hard

Samenstelling:

AMMONIA (E 527) ; AZORUBINE (E 122) ; BLAUWE INKT ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AMMONIA (E 527) ; AZORUBINE (E 122) ; BLAUWE INKT ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; 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); AZORUBINE (E 122); BLAUWE INKT; CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; ETHYLCELLULOSE (E 462); GELATINE (E 441); INDIGOKARMIJN ALUMINIUMLAK (E 132); MAGNESIUMSTEARAAT (E 470b); POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-01-22

Bijsluiter

Sandoz B.V.
Page 1/11
Venlafaxine HCl Sandoz
®
37,5/75/150 mg, harde capsule met verlengde afgifte
RVG 120505-120506-120507-120508
1313-V4
1.3.1.3 Bijsluiter
Augustus 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENLAFAXINE HCL SANDOZ
® 37,5 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE HCL SANDOZ
® 75 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE HCL SANDOZ
® 150 MG, HARDE CAPSULES MET VERLENGDE AFGIFTE
VENLAFAXINE HCL SANDOZ
® 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance venlafaxine.
[Nationally completed 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.
[Nationally complete

Productkenmerken

Sandoz B.V.
Page 1/23
Venlafaxine HCl Sandoz 37,5/75/150 mg, harde capsules met verlengde
afgifte
RVG 120505-120506-120507-120508
1311-V5
1.3.1.1 Summary of the Product Characteristics
Augustus 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Venlafaxine HCl Sandoz 37,5 mg, harde capsules met verlengde afgifte
Venlafaxine HCl Sandoz 75 mg, harde capsules met verlengde afgifte
Venlafaxine HCl Sandoz 150 mg, harde capsules met verlengde afgifte
Venlafaxine HCl Sandoz 225 mg, harde capsules met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule, hard contains 42.45 mg venlafaxine
hydrochloride equivalent to 37.5 mg
of venlafaxine.
Each prolonged-release capsule, hard contains 84.9 mg venlafaxine
hydrochloride equivalent to 75 mg of
venlafaxine.
Each prolonged-release capsule, hard contains of 169.8 mg venlafaxine
hydrochloride equivalent to 150
mg of venlafaxine.
Excipients with known effect
Each capsule contains 0.4 mg of Sunset Yellow FCF (E 110) and 0.2 mg
of Allura Red AC (E 129).
Each prolonged-release capsule, hard contains of 254.7 mg venlafaxine
hydrochloride equivalent to 225
mg of venlafaxine.
Excipient with known effect
Each capsule contains 0.02 mg of Carmoisine (E 122).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Light grey opaque/peach opaque, hard gelatin capsules of approximately
16 mm having thick and thin
radial circular band in red ink on the body and the cap.
The capsule is filled with 3 white to off-white, round, biconvex,
film-coated mini tablets of 12.5 mg each.
Peach opaque/peach opaque hard gelatin capsules of approximately 19 mm
having thick and thin radial
circular band in red ink on the body and the cap.
The capsule is filled with 6 white to off white, round, biconvex, film
coated mini tablets of 12.5 mg each.
Dark orange/dark orange opaque hard gelatin capsules of approximately
21 mm having thick and thin
radial circular band in white ink on the body and the cap