CITALOPRAM

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

CITALOPRAM HYDROCHLORIDE

Beschikbaar vanaf:

Focus Pharmaceuticals Ltd

ATC-code:

N06AB04

INN (Algemene Internationale Benaming):

CITALOPRAM HYDROCHLORIDE

Dosering:

40 Mg/Ml

farmaceutische vorm:

Oral Drops Solution

Prescription-type:

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

Therapeutisch gebied:

citalopram

Autorisatie-status:

Not Marketed

Autorisatie datum:

2009-04-03

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM 40MG/ML ORAL DROPS
Citalopram Hydrochloride
_ _
Nine important things you need to know about Citalopram Oral Drops.
You should read all of this leaflet carefully before taking your
medicine. It includes a lot
of additional important information.

CITALOPRAM ORAL DROPS TREAT DEPRESSION AND PANIC ATTACKS. Like all
medicines it can
cause side effects. Before you start taking your medicine it is
important that you and your
doctor discuss the benefits of treatment against the possible side
effects (See section 4,
Possible side effects)

CITALOPRAM ORAL DROPS SHOULD NOT BE USED BY CHILDREN AND ADOLESCENTS
UNDER 18
YEARS OF AGE (See section 3, Children and adolescents under 18 years
of age)

SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES. If
you start to feel worse, or think of harming or killing yourself, see
your doctor or go to a
hospital straight away (See section 4, Possible side effects)

IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL, OR
YOU WANT TO KEEP MOVING
AROUND, TELL YOUR DOCTOR. If your dose of Citalopram Oral Drops is
increased it may make
these feelings worse (See section 4, Possible side effects)

CITALOPRAM ORAL DROPS DO NOT WORK STRAIGHT AWAY. Some people taking
antidepressants
feel worse before feeling better. Your doctor should ask to see you
again a couple of weeks
after you first start treatment. Tell your doctor if you haven’t
started feeling better (See
section 3, How to take Citalopram Oral Drops)

DON’T STOP TAKING CITALOPRAM ORAL DROPS WITHOUT TALKING TO YOUR
DOCTOR. If you stop
taking your medicine suddenly or miss a dose, you may get withdrawal
effects (See section
3, If you stop taking Citalopram Oral Drops)

TAKING SOME OTHER MEDICINES WITH CITALOPRAM CAN CAUSE PROBLEMS. You
may need to
talk to your doctor (See section 2, What you need to know before you
take Citalopram
Oral Drops)

If any of the side effects get serious, or if you notice any side
effects n

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram 40mg/ml Oral Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of Citalopram Oral Drops contains 40mg of citalopram (as
hydrochloride).
Each 1ml of Citalopram Oral
Drops, solution contains 20 drops.
Each drop contains 2mg citalopram (as hydrochloride).
Excipients with known effect:
76mg/ml ethanol, 1mg/ml methyl hydroxybenzoate (E218) and 0.1mg/ml
propyl hydroxybenzoate (E216).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral Drops, Solution.
A colourless to yellowish clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of depressive illness in the initial phase and as
maintenance against potential relapse/recurrence.
Citalopram 40mg/ml Oral Drops is also indicated in the treatment of
panic disorder with or without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Depression_
Adults:
Citalopram should be administered as a single oral
dose of 16mg (8 drops) daily.
Dependent
on individual
patient
response, the dose may be increased to a maximum of 32mg (16 drops)
daily.
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. Dosage adjustments should be made carefully on
an individual patient basis, to maintain the patient at the lowest
effective dose.
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that they are free from
symptoms.
_Panic disorder_
Adults:
A single oral dose of 8mg (4 drops) is recommended for the first week
before increasing the dose to 16mg (8 drops)
daily. Dependent on individual patient response, the dose may be
increased to a maximum of 32mg (16 drops) daily.
A low initial starting dose is recommended to minimise the potential
worsening of panic symptoms, which is generally
recognised to occur
early in the treatment
of
this
disorder.
Although there m