Vortioxetine Clonmel 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Vortioxetine hydrobromide

Available from:

Clonmel Healthcare Ltd

ATC code:

N06AX26

INN (International Name):

Vortioxetine hydrobromide

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

vortioxetine

Authorization status:

Not marketed

Authorization date:

2024-02-09

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORTIOXETINE CLONMEL 5 MG FILM-COATED TABLETS
VORTIOXETINE CLONMEL 10 MG FILM-COATED TABLETS
VORTIOXETINE CLONMEL 15 MG FILM-COATED TABLETS
VORTIOXETINE CLONMEL 20 MG FILM-COATED TABLETS
vortioxetine
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 Vortioxetine Clonmel is and what it is used for
2.
What you need to know before you take Vortioxetine Clonmel
3.
How to take Vortioxetine Clonmel
4.
Possible side effects
5.
How to store Vortioxetine Clonmel
6.
Contents of the pack and other information
1.
WHAT VORTIOXETINE CLONMEL IS AND WHAT IT IS USED FOR
Vortioxetine Clonmel contains the active substance vortioxetine. It
belongs to a group of medicines
called antidepressants.
This medicine is used to treat major depressive episodes in adults.
Vortioxetine has been shown to reduce the broad range of depressive
symptoms, including sadness,
inner tension (feeling anxious), sleep disturbances (reduced sleep),
reduced appetite, difficulty in
concentrating, feelings of worthlessness, loss of interest in
favourite activities, feeling of being slowed
down.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORTIOXETINE CLONMEL
DO NOT TAKE VORTIOXETINE CLONMEL:
-
if you are allergic to vortioxetine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are taking other medicines for depression known as
non-selective monoamine oxidase
inhibitors or selective MAO-A inhibitors. Ask your doctor if you are
uncertain.
WARNINGS AND PRECAUTIONS
T

Summary of Product characteristics

Health Products Regulatory Authority
09 February 2024
CRN00D0QQ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vortioxetine Clonmel 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 20 mg vortioxetine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablets debossed
with '20' on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vortioxetine Clonmel is indicated for the treatment of major
depressive episodes in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting and recommended dose of Vortioxetine Clonmel is 10 mg
vortioxetine once daily in adults less than 65 years of
age.
Depending on individual patient response, the dose may be increased to
a maximum of 20 mg vortioxetine once daily or
decreased to a minimum of 5 mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months
is recommended for consolidation of the
antidepressive response.
Treatment discontinuation
A gradual reduction in dosage may be considered to avoid the
occurrence of discontinuation symptoms (see section 4.8).
However, there is insufficient data to provide specific
recommendations for a tapering schedule for patients treated with this
medicinal product.
Special populations
_Elderly patients_
The lowest effective dose of 5 mg vortioxetine once daily should
always be used as the starting dose in patients ≥ 65 years of
age. Caution is advised when treating patients ≥ 65 years of age
with doses higher than 10 mg vortioxetine once daily for
which data are limited (see section 4.4).
_Cytochrome P450 inhibitors_
Depending on individual patient response, a lower dose of vortioxetine
may be considered if a strong CYP2D6 inhibitor (e.g.
bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine
treatment (see section 4.5).
_Cytochrome P450 ind