Cipramil 40 mg/ml Oral drops, solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Citalopram

Commercializzato da:

Lundbeck ( Ireland ) Limited

Codice ATC:

N06AB; N06AB04

INN (Nome Internazionale):

Citalopram

Dosaggio:

40 milligram(s)/millilitre

Forma farmaceutica:

Oral drops, solution

Tipo di ricetta:

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

Area terapeutica:

Selective serotonin reuptake inhibitors; citalopram

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1999-04-16

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL 40 MG/ML ORAL DROPS, SOLUTION
Citalopram (as hydrochloride)
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. 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.
WHAT IS IN THIS LEAFLET
1.
What Cipramil is and what it is used for
2.
What you need to know before you take Cipramil
3.
How to take Cipramil
4.
Possible side effects
5.
How to store Cipramil
6.
Contents of the pack and other information
1.
WHAT CIPRAMIL IS AND WHAT IT IS USED FOR
HOW DOES CIPRAMIL WORK
Cipramil belongs to a group of antidepressants called Selective
Serotonin Reuptake Inhibitors (SSRIs).
These medicines act on the serotonin-system in the brain by increasing
the serotonin level.
WHAT IS CIPRAMIL USED FOR
Cipramil contains citalopram and is used for the treatment of
depression and when you feel better, to
help prevent these symptoms recurring.
Further, Cipramil is used for long-term treatment to prevent the
occurrence of new depressive episodes
in patients who have recurrent depression.
Cipramil is also beneficial in relieving symptoms in patients prone to
panic attacks.
Ask your doctor if you have any questions about why Cipramil has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRAMIL
DO NOT TAKE CIPRAMIL:
•
if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in
section 6).
•
if you take other medicines which belong to a group called monoamine
oxidase inhibitors
(MAOIs). MAOIs include medicines such as phenelzine, iproniazid,
isocarboxazid, nialamide,
tranylcypromine, selegiline (used in the treatmen

Scheda tecnica

Health Products Regulatory Authority
11 October 2023
CRN00DF18
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cipramil 40 mg/ml Oral drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 40 mg citalopram (as 44.48 mg citalopram hydrochloride)
1 ml = 20 drops. 1 drop = 2 mg citalopram
Excipients with known effect :
Methyl parahydroxybenzoate (E218) 1.0 mg/ml
Propyl parahydroxybenzoate (E216) 0.1 mg/ml
Ethanol 96% 76.0 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear, nearly colourless to yellowish solution with a bitter taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Depressive illness in the initial phase and as maintenance against
potential relapse/recurrence.
Cipramil is also indicated in the treatment of panic disorder with or
without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Depression_
_Adults:_
Citalopram drops should be administered as a single oral dose of 16 mg
(8 drops) daily. Depending on individual patient
response, the dose may be increased to a maximum of 32 mg (16 drops)
daily.
_Duration of treatment:_
The antidepressant effect usually sets in after 2 to 4 weeks.
Treatment with antidepressants is symptomatic and must therefore
be continued for an appropriate length of time, usually up to 6 months
after recovery in order to prevent relapse. In patients
with recurrent depression (unipolar) maintenance therapy may need to
be continued for a number of years to prevent new
episodes.
_Panic Disorder_
_Adults:_
A single oral dose of 8 mg (4 drops) daily is recommended for the
first week before increasing the dose to 16 mg (8 drops)
daily. Depending on individual patient response, the dose may be
increased to a maximum of 32 mg (16 drops) daily.
_Duration of treatment:_
Maximum effectiveness of citalopram in treating panic disorder is
reached after about 3 months and the response is
maintained during continued treatment.
Health Products Regulatory Authority
11 Octobe