Venlafaxine retard CF 75 mg, capsule met verlengde afgifte, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VENLAFAXINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VENLAFAXINE

Beschikbaar vanaf:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINEHYDROCHLORIDE COMPOSITION corresponding to ; VENLAFAXINE

farmaceutische vorm:

Capsule met verlengde afgifte, hard

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Venlafaxine

Product samenvatting:

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

Autorisatie datum:

2008-01-09

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFAXINE RETARD CF 37,5 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLAFAXINE RETARD CF 75 MG, CAPSULES MET VERLENGDE AFGIFTE, HARD
VENLAFAXINE RETARD CF 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 [XXX] is and what it is used for
2. What you need to know before you take [XXX]
3. How to take [XXX]
4. Possible side effects
5. How to store [XXX]
6. Contents of the pack and other information
1. WHAT [XXX] IS AND WHAT IT IS USED FOR
[XXX] contains the active substance venlafaxine.
[XXX] 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.
[XXX] 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
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 and more difficult to

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Venlafaxine retard CF 37,5 mg, capsules met verlengde afgifte, hard
Venlafaxine retard CF 75 mg, capsules met verlengde afgifte, hard
Venlafaxine retard CF 150 mg, capsules met verlengde afgifte, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[For 37.5 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg
of venlafaxine.
Excipients with known effect
Sucrose max. 46.35 mg
Ponceau 4R red (E124) 0.0267 mg
[For 75 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 75 mg of
venlafaxine.
Excipients with known effect
Sucrose max. 92.69 mg
Sunset yellow FCF (E110) 0.0006 mg
[For 150 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 150 mg
of venlafaxine.
Excipients with known effect
Sucrose max. 185.38 mg
Sunset yellow FCF (E110) 0.0183 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
[XXX] 37.5 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “3” with an orange
cap and transparent body.
[XXX] 75 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “1” with a yellow
cap and transparent body.
[XXX] 150 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “0” with a buff cap
and transparent body.
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 of 375 mg/day. Dosage increases can be mad