Majoven XL 75 mg prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine

Available from:

Brillpharma (Ireland) Limited

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine

Dosage:

75 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Therapeutic area:

Other antidepressants; venlafaxine

Authorization status:

Not marketed

Authorization date:

2017-01-27

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
06 September 2021
CRN00CFXX
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Majoven XL 75mg Prolonged Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains 84.90 mg of venlafaxine
hydrochloride, equivalent to 75 mg of venlafaxine free base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Size '1' hard gelatin capsule with peach opaque cap and peach opaque
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 current episode.
Antidepressive medicinal products should continue for at least six
months following remission.
Gener