Venladoz XR 150 mg capsules met verlengde afgifte, hard

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE

Tillgänglig från:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-kod:

N06AX16

INN (International namn):

VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE

Läkemedelsform:

Capsule met verlengde afgifte, hard

Sammansättning:

CHINOLINEGEEL (E 104) ; DIBUTYLSEBACAAT ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; OLIEZUUR ; PATENTBLAUW V (E131) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110), CHINOLINEGEEL (E 104) ; DIBUTYLSEBACAAT ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; OLIEZUUR ; PATENTBLAUW V (E131) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110),

Administreringssätt:

Oraal gebruik

Terapiområde:

Venlafaxine

Produktsammanfattning:

Hulpstoffen: CHINOLINEGEEL (E 104); DIBUTYLSEBACAAT; ETHYLCELLULOSE (E 462); GELATINE (E 441); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); OLIEZUUR; PATENTBLAUW V (E131); SACCHAROSE; SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF (E 110);

Tillstånd datum:

2006-09-04

Bipacksedel

Sandoz B.V.
Pagina 1 van 11
Venladoz XR 37,5/ 75/ 150 mg capsules met verlengde afgifte, hard
RVG 34343-34344-34345
1313-V18
1.3.1.3 Package Leaflet
April 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENLADOZ XR 37,5 MG CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLADOZ XR 75 MG CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLADOZ XR 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 [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] 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 completed name] is a treatment for adults with depression.
It is also a treatment for adults with
the following anxiety disorders: generalised anxiety disorder, social
anxiety disorder (fear or avoidance of
s

Produktens egenskaper

20201217
Sandoz B.V.
Pagina 1 van 22
Venladoz XR 37,5/75/150 mg capsules met verlengde afgifte, hard
RVG 34343-34344-34345
1311-V14
1.3.1.1 Summary of Product Characteristics
April 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Venladoz XR 37,5 mg capsules met verlengde afgifte, hard
Venladoz XR 75 mg capsules met verlengde afgifte, hard
Venladoz XR 150 mg capsules met verlengde afgifte, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
37.5 mg:
One
prolonged-release
capsule,
hard
contains
venlafaxine
hydrochloride,
equivalent
to
37.5 mg
of
venlafaxine.
Excipients with known effect
One prolonged-release capsule, hard contains up to 46.6 mg of sucrose
and up to 0.0279 mg of azo
colouring agent ponceau 4R.
_75 mg: _
One prolonged-release capsule, hard contains venlafaxine
hydrochloride, equivalent to 75 mg of
venlafaxine.
Excipients with known effect
One prolonged-release capsule, hard contains up to 93.2 mg of sucrose
and 0.0006 mg of azo colouring
agent sunset yellow FCF.
_150 mg: _
One
prolonged-release
capsule,
hard
contains
venlafaxine
hydrochloride,
equivalent
to
150 mg
of
venlafaxine.
Excipients with known effect
One prolonged-release capsule, hard contains up to 186.4 mg of sucrose
and 0.0169 mg of azo colouring
agent sunset yellow FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
[Nationally completed name] 37.5 mg prolonged-release capsules, hard:
White to off-white granules in a hard gelatin capsule ‘size 3’
with orange cap and clear transparent body.
[Nationally completed name] 75 mg prolonged-release capsules, hard:
White to off-white granules in a hard gelatin capsule ‘size 1’
with yellow cap and clear transparent body.
[Nationally completed name] 150 mg prolonged-release capsules, hard:
White to off-white granules in a hard gelatin capsule ‘size 0’
with ochre-coloured cap and clear
transparent body.
20201217
Sandoz B.V.
Pagina 2 van 22
Venladoz XR 37,5/75/150 mg capsules met verlengde afgifte, hard
RVG 3