Agomelatine Rowex 25mg Film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Agomelatine

Dostupné z:

Rowex Ltd

ATC kód:

N06AX; N06AX22

INN (Medzinárodný Name):

Agomelatine

Dávkovanie:

25 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Other antidepressants; agomelatine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2018-06-14

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOMELATINE ROWEX 25 MG FILM-COATED TABLETS
Agomelatine
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 Agomelatine Rowex is and what it is used for
2.
What you need to know before you take Agomelatine Rowex
3.
How to take Agomelatine Rowex
4.
Possible side effects
5.
How to store Agomelatine Rowex
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE ROWEX IS AND WHAT IT IS USED FOR
Agomelatine Rowex contains the active substance agomelatine. It
belongs to a group of
medicines called antidepressants and you have been given Agomelatine
Rowex to treat your
depression.
Agomelatine Rowex is used in adults.
Depression is a continuing disturbance of mood that interferes with
everyday life. The
symptoms of depression vary from one person to another, but often
include deep sadness,
feelings of worthlessness, loss of interest in favourite activities,
sleep disturbances, feeling of
being slowed down, feelings of anxiety, changes in weight.
The expected benefits of Agomelatine Rowex are to reduce and gradually
remove the
symptoms related to your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE ROWEX
DO NOT TAKE AGOMELATINE ROWEX

if you are allergic to agomelatine or any of the other ingredients of
this medicine (listed in
section 6)

if your liver does not work properly (hepatic impairment)

if you are taking fluvoxamine (another medicine used in the treatment
of depression) or
ciprofloxacin (an antibiotic).
WARNING

Súhrn charakteristických

Health Products Regulatory Authority
03 November 2019
CRN0094JF
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agomelatine Rowex 25mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of agomelatine (as agomelatine
urea).
Excipient with known effect: each tablet contains 53 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dark yellow, oval, biconvex film-coated tablets, debossed with 25 on
one side.
Dimensions: approximately 8.5 mm x 4.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Agomelatine Rowex is indicated for the treatment of major depressive
episodes in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms,
the dose may be increased to 50 mg once daily, i.e. two
25 mg tablets, taken together at bedtime.
Decision of dose increase has to be balanced with a higher risk of
transaminases elevation. Any dose increase to 50 mg should
be made on an individual patient benefit/risk basis and with strict
respect of Liver Function Test (LFT) monitoring.
Liver function tests should be performed in all patients before
starting treatment. Treatment should not be initiated if
transaminases exceed 3 X upper limit of normal (see sections 4.3 and
4.4).
During treatment transaminases should be monitored periodically after
around three weeks, six weeks (end of acute phase),
twelve weeks and twenty four weeks (end of maintenance phase) and
thereafter when clinically indicated (see also section 4.4).
Treatment should be discontinued if transaminases exceed 3 X upper
limit of normal (see sections 4.3 and 4.4).
When increasing the dose, liver function tests should again be
performed at the same frequency as when initiating treatment.
Treatment duration
Patients with depression should be treated for a sufficient period o