Sertraline 50 mg Film-coated Tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Sertraline hydrochloride

Հասանելի է:

Accord Healthcare Ireland Ltd.

ATC կոդը:

N06AB; N06AB06

INN (Միջազգային անվանումը):

Sertraline hydrochloride

Դոզան:

50 milligram(s)

Դեղագործական ձեւ:

Film-coated tablet

Թերապեւտիկ տարածք:

Selective serotonin reuptake inhibitors; sertraline

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2017-10-13

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50 MG FILM-COATED TABLETS
SERTRALINE 100 MG FILM-COATED TABLETS
Sertraline
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 SERTRALINE IS AND WHAT IT IS USED FOR
.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERTRALINE
.
3
HOW TO TAKE SERTRALINE
.
4
POSSIBLE SIDE EFFECTS.
5
HOW TO STORE SERTRALINE.
6
CONTENTS OF THE PACK AND OTHER INFORMATION.
1
WHAT SERTRALINE IS AND WHAT IT IS USED FOR
Sertraline contains the active substance sertraline. Sertraline is one
of a group of medicines
called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat
depression and/or anxiety disorders.
SERTRALINE CAN BE USED TO TREAT:

Depression and prevention of recurrence of depression (in adults).

Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17
years old).
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to
enjoy life as you used to.
OCD is an illness linked to anxiety with symptoms like being
constantly troubled by
persistent ideas (obsessions) that make you carry out repetitive
rituals (compulsions).
Your doctor has decided that this medicine is suitable for treating
your illness.
You should ask your doctor if you are unsure why you have been given
Sertraline.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERTRALINE
DO NOT TAKE SERTRALINE:

If you are allergic to sertraline or any of the other ingredients of
this medicine (listed in
section 6).
�

Ապրանքի հատկությունները

Health Products Regulatory Authority
14 October 2021
CRN00CJH2
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg Sertraline (as hydrochloride)
Excipients with known effect: Each tablet contains 79.65mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, scored, oval biconvex, embossed with `L` on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major
depressive episodes.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Initial treatment_
_Depression and OCD_
Sertraline treatment should be started at a dose of 50 mg/day.
_Titration_
_Depression and OCD_
Patients not responding to a 50 mg dose may benefit from dose
increases. Dose changes should be made in steps of 50 mg at
intervals of at least one week, up to a maximum of 200 mg/day. Changes
in dose should not be made more frequently than
once per week given the 24-hour elimination half life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However,
longer periods are usually necessary to demonstrate
therapeutic response, especially in OCD.
_Maintenance_
Dosage during long-term therapy should be kept at the lowest effective
level, with subsequent adjustment depending on
therapeutic response.
Health Products Regulatory Authority
14 October 2021
CRN00CJH2
Page 2 of 16
_Depression_
Longer-term treatment may also be appropriate for prevention of
recurrence of major depressive episodes (MDE). In most of
the cases, the recommended dose in prevention of recurrence of MDE is
the same as the one used during current episode.
Patients with depress