Alventa capsules prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

venlafaxine (venlafaxine hydrochloride)

Available from:

KRKA d.d.

ATC code:

N06AX16

INN (International Name):

venlafaxine (venlafaxine hydrochloride)

Dosage:

75mg

Pharmaceutical form:

capsules prolonged-release

Units in package:

(28/2x14/) in blister, (56/4x14/) in bliser

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-30

Patient Information leaflet

Package leaflet
CONFIDENTIAL
Alventa prolonged-release capsules 37.5 mg, 75 mg, 150
mg
MODULE 1
VOL: 1; P: 54 / 274
1.3.1
Venlafaxine hydrochloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL132844_1
23.07.2019 – Updated: 23.07.2019
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALVENTA 37.5 MG PROLONGED-RELEASE CAPSULES
ALVENTA 75 MG PROLONGED-RELEASE CAPSULES
ALVENTA 150 MG PROLONGED-RELEASE CAPSULES
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 Alventa is and what it is used for
2.
What you need to know before you take Alventa
3.
How to take Alventa
4.
Possible side effects
5.
How to store Alventa
6.
Contents of the pack and other information
1.
WHAT ALVENTA IS AND WHAT IT IS USED FOR
Alventa contains the active substance venlafaxine.
Alventa 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.
Alventa is a treatment for adults with depression. Alventa 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 at

Summary of Product characteristics

1.3.1
Venlafaxine hydrochloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL132842_1
23.07.2019 – Updated: 23.07.2019
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Alventa 37.5 mg Prolonged-release capsules
Alventa 75 mg Prolonged-release capsules
Alventa 150 mg Prolonged-release capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alventa 37.5 mg Prolonged-release capsules
Each Prolonged-release capsule, contains 37.5 mg venlafaxine (as 42.43
mg venlafaxine
hydrochloride).
Alventa 75 mg Prolonged-release capsules
Each Prolonged-release capsule, contains 75 mg venlafaxine (as 84.85
mg venlafaxine hydrochloride).
Alventa 150 mg Prolonged-release capsules
Each Prolonged-release capsule, contains 150 mg venlafaxine (as 169.70
mg venlafaxine
hydrochloride).
Excipient with known effect:
37.5 mg capsule
75 mg capsule
150 mg capsule
sucrose
32.5 mg
65 mg
130 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule.
Alventa 37.5 mg Prolonged-release capsules
Hard gelatine capsules, the body of the capsule is white and the cap
of the capsule is brownish-pink
coloured. The capsules are filled with white to almost white pellets.
Alventa 75 mg Prolonged-release capsules
Hard gelatine capsules, the body and the cap of the capsule are light
pink coloured. The capsules are
filled with white to almost white pellets.
Alventa 150 mg Prolonged-release capsules
Hard gelatine capsules, the body and the cap of the capsule are
orange-brownish coloured. The
capsules are filled with white to almost white pellets.
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 (SAD).
Treatment of panic disorder, with or without agoraphobia.
CONFIDENTIAL
Alventa prolonged-release capsules 37.5 mg, 75 mg, 150
mg
MODULE 1
VOL: 1; P: 35 / 274
1.3.1
Venlafaxine hydrochloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL132842_1
23.07.