Trevilor 75 mg Depotkapsel, hård

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

venlafaxinhydroklorid

Tilgængelig fra:

Upjohn EESV

ATC-kode:

N06AX16

INN (International Name):

venlafaxine hydrochloride

Dosering:

75 mg

Lægemiddelform:

Depotkapsel, hård

Sammensætning:

venlafaxinhydroklorid 84,85 mg Aktiv substans; propylenglykol Hjälpämne

Klasse:

Apotek

Recept type:

Receptbelagt

Terapeutisk område:

Venlafaxin

Produkt oversigt:

Förpacknings: Blister, 7 kapslar; Blister, 10 kapslar; Blister, 15 kapslar; Blister, 28 kapslar; Blister, 30 kapslar; Blister, 56 kapslar; Blister, 60 kapslar; Blister, 98 kapslar; Blister, 14 x 1 kapslar (endos); Blister, 28 x 1 kapslar (endos); Blister, 84 x 1 kapslar (endos); Blister, 100 x 1 kapslar (endos); Burk, 14 kapslar; Burk, 20 kapslar; Burk, 50 kapslar; Burk, 100 kapslar; Burk, 500 kapslar (sjukhusförpackning); Burk, 1000 kapslar (sjukhusförpackning); Blister, 14 kapslar; Blister, 20 kapslar; Blister, 50 kapslar; Blister, 100 kapslar; Blister, 500 (10 x 50) kapslar (sjukhusförpackning); Blister, 1000 (10 x 100) kapslar (sjukhusförpackning)

Autorisation status:

Godkänd

Autorisation dato:

2009-11-13

Indlægsseddel

PACAKAGE LEAFLET: INFORMATION FOR THE USER
TREVILOR 37.5 MG PROLONGED-RELEASE CAPSULES, HARD
TREVILOR 75 MG PROLONGED-RELEASE CAPSULES, HARD
TREVILOR 150 MG PROLONGED-RELEASE CAPSULES, 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 Trevilor is and what it is used for
2.
What you need to know before you take Trevilor
3.
How to take Trevilor
4.
Possible side effects
5.
How to store Trevilor
6.
Contents of the pack and other information
1.
WHAT TREVILOR IS AND WHAT IT IS USED FOR
Trevilor contains the active substance venlafaxine.
Trevilor 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.
Trevilor 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 treat.
2.
WHAT YOU N

Produktets egenskaber

Produktinformationen för Trevilor 37,5 mg, 75 mg, 150 mg depotkapsel,
hård, MTnr 42825, 42826,
42827, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att uppdateras
eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning
finns inte någon svensk
produktinformation.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror det
på att läkemedlet i Sverige är godkänt under ett annat namn.
2/18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trevilor
®
retard 37.5 mg
Trevilor
®
retard 75 mg
Trevilor
®
retard 150 mg
Prolonged-release capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Venlafaxine
_Trevilor retard 37.5 mg:_
One hard prolonged-release capsule contains 42.43 mg venlafaxine
hydrochloride corresponding to 37.5
mg venlafaxine.
_Trevilor retard 75 mg:_
One hard prolonged-release capsule contains 84.84 mg venlafaxine
hydrochloride corresponding to 75 mg
venlafaxine.
_Trevilor retard 150 mg:_
One hard prolonged-release capsule contains 169.7 mg venlafaxine
hydrochloride corresponding to 150
mg venlafaxine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsules, hard
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
Major depressive episodes
3/18
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 made at intervals of 2 weeks or
more. If clinically warranted due to
symptom severity, dose increases can be made at more frequent
intervals, but not less than 4 days.
Because o