CITALOPRAM ACTAVIS 20 Milligram Film Coated Tablet
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Selebaran informasi
(PIL)
18-06-2016
Karakteristik produk
(SPC)
16-02-2017
Bahan aktif:
CITALOPRAM HYDROBROMIDE
Tersedia dari:
Actavis Group PTC ehf
Kode ATC:
N06AB04
INN (Nama Internasional):
CITALOPRAM HYDROBROMIDE
Dosis:
20 Milligram
Bentuk farmasi:
Film Coated Tablet
Jenis Resep:
Product subject to prescription which may not be renewed (A)
Area terapi:
Selective serotonin reuptake inhibitors
Status otorisasi:
Authorised
Tanggal Otorisasi:
2007-12-14
Selebaran informasi
PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM ACTAVIS 10 MG FILM-COATED TABLETS
CITALOPRAM ACTAVIS 20 MG FILM-COATED TABLETS
Citalopram
(as
hydrobromide)
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 CITALOPRAM ACTAVIS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM ACTAVIS
3.
HOW TO TAKE CITALOPRAM ACTAVIS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CITALOPRAM ACTAVIS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CITALOPRAM ACTAVIS IS AND WHAT IT IS USED FOR
Citalopram
Actavis
is
a
Selective
Serotonin
Reuptake
Inhibitor
(SSRI)
and
belongs
to
a
group
of
medicines
known
as
antidepressants.
These
medicines
help
to
normalise
the
levels
of
serotonin
in
the
brain.
Disturbances
in
the
serotonin
system
of
the
brain
are
key
factors
in
the
development
of
depression
and
related
disorders.
Citalopram
Actavis
is
used
for
the
treatment
of
depression
(including
the
prevention
of
the
recurrence
of
symptoms)
and
panic
disorders in adults.
_ _
_Depression _is
characterised
by
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Karakteristik produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram Actavis 20 mg Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of Citalopram (as hydrobromide).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, coated, biconvex, scored on both sides with side
scores.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of depressive illness in the initial phase and as
maintenance against potential relapse/recurrence in adults.
Citalopram Actavis is also indicated in the treatment of panic
disorder with or without agoraphobia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treating depression_
_Adults_
The recommended starting dose is a single oral dose of 20 mg per day.
Depending on individual patient response, the
dose may be increased to a maximum of 40 mg daily.
Following treatment initiation, an antidepressant effect should not be
expected for at least two weeks. Treatment should
continue until
the patient
has been free of symptoms for 4-6 months.
Citalopram should be withdrawn slowly;
it
is
advised that the dose is gradually reduced over 1-2 week periods.
_Treating Panic Disorder_
_Adults_
In common with other pharmacotherapy used in this patient group, a low
starting dose is advised to reduce the
likelihood of a paradoxical initial anxiogenic effect.
A single oral dose of 10 mg daily is recommended for the first week
before increasing the dose to 20 mg daily.
Dependent on individual patient response, the dose may be increased to
a maximum of 40 mg daily; however an
optimum dose of 20-30 mg daily was indicated in a clinical study.
Maximum effectiveness of Citalopram Actavis in treating panic disorder
is reached after about 3 months and the
response is maintained during continued treatment. Dependent on
individual patient response it may be necessary to
continue treatment for several months.
_Elderly patients (>65 years of age)_
For
e
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