Majoven XL 150mg Prolonged Release Capsules, Hard

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Venlafaxine

Dostupné z:

Brillpharma (Ireland) Limited

ATC kód:

N06AX; N06AX16

INN (Medzinárodný Name):

Venlafaxine

Dávkovanie:

150 milligram(s)

Forma lieku:

Prolonged-release capsule, hard

Terapeutické oblasti:

Other antidepressants; venlafaxine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2017-01-27

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MAJOVEN® XL 37.5 MG PROLONGED RELEASE CAPSULES, HARD
MAJOVEN® XL 75 MG PROLONGED RELEASE CAPSULES, HARD
MAJOVEN® XL 150 MG PROLONGED RELEASE CAPSULES, HARD
VENLAFAXINE (AS HYDROCHLORIDE)
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The active substance in this medicine is Venlafaxine. Venlafaxine 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
norepinephrine
in
the
brain.
It
is
not
fully
understood
how
antidepressants
work,
but
they
may
help
by
increasing
the
levels
of
serotonin
and
norepinephrine in the brain.
Venlafaxine 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 a

Súhrn charakteristických

Health Products Regulatory Authority
06 September 2021
CRN00CFXX
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Majoven XL 150mg Prolonged Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains 169.80 mg of venlafaxine
hydrochloride, equivalent to 150 mg of venlafaxine free
base.
Excipients with known effect: Also contains 0.39 mg of Sunset yellow
(E110) and 0.19 mg of Allura red (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Size '0' hard gelatin capsule with dark orange cap and dark orange
body filled with white to off 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.
Treatment of panic disorder, with or without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Major depressive episodes
The recommended starting dose for Majoven XL prolonged-release
capsules 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 of the risk of dose-related adverse effects, dose increments
should be made only after a clinical evaluation (see section
4.4). The lowest effective dose should be maintained.
Patients should be treated for a sufficient period of time, usually
several months or longer. Treatment should be reassessed
regularly on a case-by-case basis. Longer-term treatment may also be
appropriate for prevention of recurrence of major
depressive episodes (MDE). In most of the cases, the recommended dose
in prevention of recurrence of MDE is the same as the
one used during the curren