CIPRAMIL 40 MG TABLETS

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

CITALOPRAM AS HYDROBROMIDE

Dostopno od:

LUNDBECK ISRAEL LTD.

Koda artikla:

N06AB04

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

CITALOPRAM AS HYDROBROMIDE 40 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

H. LUNDBECK A/S, DENMARK

Terapevtska skupina:

CITALOPRAM

Terapevtsko območje:

CITALOPRAM

Terapevtske indikacije:

For the treatment of states of depresion and panic disorder.

Datum dovoljenje:

2014-12-31

Navodilo za uporabo

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed by a doctor’s prescription only
CIPRAMIL® 20 MG Tablets
CIPRAMIL® 40 MG Tablets
COMPOSITION:
EACH FILM-COATED TABLET OF CIPRAMIL 20 MG CONTAINS:
The active ingredient Citalopram Hydrobromide, equivalent to 20 mg
Citalopram
EACH FILM-COATED TABLET OF CIPRAMIL 40 MG CONTAINS:
The active ingredient Citalopram Hydrobromide, equivalent to 40 mg
Citalopram
INACTIVE INGREDIENTS: see section 6 and section "Important information
about some
of the ingredients of Cipramil".
-
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about the medicine. If you have further
questions,
refer to the doctor or the pharmacist.
-
IT IS RECOMMENDED TO LET A FAMILY MEMBER OR ANOTHER PERSON WHO IS
CLOSE TO
YOU TO READ THIS LEAFLET.
-
This medicine was prescribed for you. Do not pass it on to others. It
can harm
them even if it seems to you that their medical state is similar.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants and anti-anxiety medications increase the risk of
suicidal thoughts
and behaviour in children, adolescents, and young adults up to 25
years old.
In patients of all ages who start taking this medicine, the patients
and their relatives
should monitor behavioural changes such as worsening of depression,
suicidal
thoughts, aggression and other similar changes. In case such changes
occur, contact
your doctor immediately.
1.
WHAT IS THE MEDICINE INTENDED FOR?
THERAPEUTIC ACTIVITY: for the treatment of depression and panic
disorder.
Cipramil belongs to a group of antidepressants called Selective
Serotonin Reuptake
Inhibitors (SSRIs). These medicines increase the serotonin level in
the brain.
Disturbances in the serotonin-system in the brain are considered an
important factor
in the development of depression and related diseases.
PHARMACOTHERAPEUTIC GROUP: Selective Serotonin Reuptake Inhibitors
(SSRI).
2.
BEFORE USING THE MEDICINE
SPECIAL WARNING

Lastnosti izdelka

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAMES OF THE MEDICINAL PRODUCTS
Cipramil
20 mg tablets , film coated
Cipramil 40 mg tablets, film coated
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipramil 20 mg tablet: Each tablet contains 20 mg citalopram (as 24.98
mg
citalopram hydrobromide).
Cipramil 40 mg: Each tablet contains 40 mg citalopram (as 49.96 mg
citalopram
hydrobromide).
Excipients with known effect:
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Cipramil 20 mg tablet: White, oval, scored, film-c
oated tablet marked “C” and “N”
symmetrically around the score. The tablet can be divided into equal
doses.
Cipramil 40 mg: White, oval, scored, film-coated tablets marked
“C” and “R”
symmetrically around the score. The tablet can be divided into equal
doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of states of depression and panic disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show an
increase in the risk of suicidal thoughts and behavior with
antidepressant use in patients
over age 25; there was a reduction in risk with antidepressant use in
patients aged 65 and
older [see Warnings and Precautions (4.4)].
In patients of all ages who are started on antidepressant therapy
monitor closely for
clinical worsening and emergence of suicidal thoughts and behaviors.
Advise families and
caregivers of the need for close observation and communication with
the prescriber [see
Warnings and Precautions (4.4)].
Page 2 of 18
POSOLOGY
DEPRESSION
Citalopram should be administered as a single oral dose of 20 mg
daily. Dependent on
individual patient response this may be increased to a maximum of 40
mg daily.
Duration of treatment
The antidepressant effect usually sets in after 2 to 4 weeks.
Treatment with antidepressants is
sym