Agomelatine Teva 25 mg Film Coated Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

AGOMELATINE UREA

Pieejams no:

Teva B.V.

ATĶ kods:

N06AX; N06AX22

SNN (starptautisko nepatentēto nosaukumu):

AGOMELATINE UREA

Deva:

25 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

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

Ārstniecības joma:

Other antidepressants; agomelatine

Autorizācija statuss:

Authorised

Autorizācija datums:

2018-06-01

Lietošanas instrukcija

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active ingredient agomelatine. It belongs
to a group of medicines called
antidepressants and you have been given to treat your
depression.
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 are to reduce and gradually
remove the symptoms related to
your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

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).
WARNINGS AND PRECAUTIONS
Talk to your do

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agomelatine Teva 25 mg 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 55 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated 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
Treatment of major depressive episodes.
Agomelatine Teva is indicated 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 dosage, 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 of
at least 6 months to ensure that they are free of
symptoms.
_Switching therapy from SSRI