Citalopram Bluefish 20 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-03-2024
Summary of Product characteristics
(SPC)
08-03-2024
Active ingredient:
Citalopram hydrobromide
Available from:
Bluefish Pharmaceuticals AB
ATC code:
N06AB; N06AB04
INN (International Name):
Citalopram hydrobromide
Dosage:
20 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Selective serotonin reuptake inhibitors; citalopram
Authorization status:
Marketed
Authorization date:
2010-04-09
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM BLUEFISH 10 MG FILM-COATED TABLETS
CITALOPRAM BLUEFISH 20 MG FILM-COATED TABLETS
CITALOPRAM BLUEFISH 40 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 Citalopram Bluefish is and what it is used for
2.
What you need to know before you take Citalopram Bluefish
3.
How to take Citalopram Bluefish
4.
Possible side effects.
5.
How to store Citalopram Bluefish
6.
Contents of the pack and other information
1.
WHAT CITALOPRAM BLUEFISH IS AND WHAT IT IS USED FOR .
Citalopram belongs to a group of antidepressants called selective
serotonin re-uptake inhibitors
(SSRIs). Everyone has a substance called serotonin in their brain. It
is not fully understood how
citalopram works, but it may help by acting on the serotonin system in
the brain.
Citalopram Bluefish is used in the treatment of depression.(major
depressive episodes).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM BLUEFISH
DO NOT TAKE CITALOPRAM BLUEFISH:
-
if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in
section 6) .
-
if you are taking or have recently taken medicines called monoamine
oxidase inhibitors
(MAOIs; amongst others used to treat depression). Before starting with
Citalopram
Bluefish, you must talk to your doctor, because you may have to wait
for up to 14 days
after quitting the use of a MAOI. The MAOI selegiline (used to treat
Parkinson’s disease)
may be used, but not in doses exceeding 10 mg per day
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
08 March 2024
CRN00F2F6
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram Bluefish 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 24.98 mg citalopram hydrobromide, equivalent to
20 mg citalopram.
Excipients with known effects: Lactose monohydrate
Each tablet Citalopram Bluefish 20 mg contains 25.330 mg lactose
(anhydrous).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Citalopram Bluefish 20 mg film-coated tablets are oval, white tablets
scored and with a diameter of 8 mm.
The 20mg tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_Paediatric population_
Citalopram should not be used in the treatment of children and
adolescents under the age of 18 years (see section 4.4).
_Depression_
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.
_Elderly patients (>65 years):_
For elderly patients the dose should be decreased to half of the
recommended dose, e.g. 10-20 mg daily. The recommended
maximum dose for the elderly is 20 mg daily.
_Renal impairment:_
Dosage adjustment is not required if the patient has mild to moderate
renal impairment. Caution is advised in patients with
severe renal impairment since there are no clinical data in this
population (creatinine clearance less than 30mL/min, see section
5.2).
_Reduced hepatic function:_
An initial dose of 10 mg daily for the first two weeks of treatment is
recommended in patients with mild or moderate hepatic
impairment. Depending on individual patient response, the do
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