SERTRALINE AUROBINDO 50 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SERTRALINE HYDROCHLORIDE

Available from:

Aurobindo Pharma Limited

ATC code:

N06AB06

INN (International Name):

SERTRALINE HYDROCHLORIDE

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors

Authorization status:

Authorised

Authorization date:

2008-04-18

Patient Information leaflet

at 25 mg/day, and increased to 50 
mg/day after one week. The daily dose 
then may be increased in 50 mg 
increments over a period of weeks. 
The maximum recommended dose is 
200 mg/day. 
CHILDREN AND ADOLESCENTS: 
Sertraline Aurobindo must only be used 
to treat children and adolescents 
suffering from OCD aged 6-17 years old. 
OBSESSIVE COMPULSIVE DISORDER: 
CHILDREN AGED 6 TO 12: the recommended starting dose is 
25 mg daily. After one week, your doctor may increase this 
to 50 mg daily. The maximum dose is 200 mg daily. 
ADOLESCENTS AGED 13 TO 17: the recommended starting 
dose is 50 mg daily. The maximum dose is 200 mg daily. 
If you have liver or kidney problems, please tell your doctor 
and follow the doctor’s instructions. 
Method of administration:
Sertraline Aurobindo tablets may be taken with or without 
food.
Take your medication once daily either in the morning or 
evening.
Your doctor will advise you on how long to take this 
medication for. This will depend on the nature of your 
illness and how well you are responding to the treatment. It 
may take several weeks before your symptoms begin to 
improve Treatment of depression should usually continue 
for 6 months after improvement. 
IF YOU TAKE MORE SERTRALINE AUROBINDO THAN YOU SHOULD: 
If you accidentally take too much Sertraline Aurobindo 
contact your doctor at once or go to the nearest hospital 
casualty department. Always take the labelled medicine 
package with you, whether there is any medication left or 
not. 
Symptoms of overdose may include drowsiness, nausea 
and vomiting, rapid heartrate, shaking, agitation, dizziness 
and in rare cases unconsciousness. 
IF YOU FORGET TO TAKE SERTRALINE AUROBINDO: 
If you forget to take a dose, do not take the missed dose. 
Just take the next dose at the right time. 
Do not take a double dose to make up for a forgotten dose. 
IF YOU STOP TAKING SERTRALINE AUROBINDO: 
Do not stop taking Sertraline Aurobindo unless your doctor 
tells you to. Your doctor will want

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sertraline Aurobindo 50mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg sertraline (as sertraline hydrochloride).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White capsule shaped, film coated tablets debossed with ‘A’ on one side and score line in between ‘8’ and ‘1’ on the
other side.
The tablet can be divided 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.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD)
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.
_Panic Disorder, PTSD, and Social Anxiety Disorder_
Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This
dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic
disorder.
_Titration_
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD_
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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