Ciprager 20 mg Film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Citalopram

Disponibil de la:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codul ATC:

N06AB; N06AB04

INN (nume internaţional):

Citalopram

Dozare:

20 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Selective serotonin reuptake inhibitors; citalopram

Statutul autorizaţiei:

Marketed

Data de autorizare:

2003-06-03

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPRAGER 10 MG FILM-COATED TABLETS
CIPRAGER 20 MG FILM-COATED TABLETS
citalopram
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 Ciprager is and what it is used for
2.
What you need to know before you take Ciprager
3.
How to take Ciprager
4.
Possible side effects
5.
How to store Ciprager
6.
Contents of the pack and other information
1.
WHAT CIPRAGER IS AND WHAT IT IS USED FOR
Ciprager belongs to a group of medicines called selective serotonin
reuptake inhibitors (SSRIs), also known
as antidepressants. These medicines act on the serotonin-system in the
brain by increasing the levels of a
substance called serotonin. Disturbances in the serotonin-system are
considered an important factor in the
development of depression and related diseases.
Ciprager is used to treat:
•
depression (major depressive episodes)
•
panic disorder (panic attacks), including those caused by agoraphobia,
which is a fear of leaving the
house, entering shops or of public places
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRAGER
DO NOT TAKE CIPRAGER
▪
if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in section 6)
▪
if you are taking MAO (monoamine oxidase) inhibitors e.g.:
-
moclobemide (an antidepressant),
-
linezolid (an antibiotic medicine), unless you are under close
observation with monitoring of
blood pressure.
-
irreversible MAO-inhibitors (other antidepressants) within the last
two weeks or if you have
taken a reversibl

Caracteristicilor produsului

Health Products Regulatory Authority
04 March 2024
CRN00F26X
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprager 20 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains citalopram hydrobromide equivalent to 20mg of
citalopram.
Excipient with known effect: Each tablet contains 53.28 mg of lactose
monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
A white, oval, normal convex film-coated tablets debossed with
“CM” scoreline “20” on one side and “G” on the other. The
tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive episodes_
Adults:
Citalopram should be administered as a single oral dose of 20 mg
daily.
Dependent on individual patient response, the dose may be increased to
a maximum of 40 mg daily. In general, improvement
in patients starts after 2-4 weeks.
As with all antidepressant medicinal products, dosage should be
reviewed and adjusted, if necessary, within 3 to 4 weeks of
initiation of therapy and thereafter as judged clinically appropriate.
Although there may be an increased potential for
undesirable effects at higher doses, if after some weeks on the
recommended dose insufficient response is seen, some patients
may benefit from having their dose increased up to a maximum of 40 mg
a day (see section 5.1). Dosage adjustments should
be made carefully on an individual patient basis, to maintain the
patient at the lowest effective dose.
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 to
give adequate protection against the possibility of a
relapse.
_Panic disorder_
Adults:
A single oral dose of 10 mg is recommended for the first week bef