TRENEL 100MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

SERTRALINE HYDROCHLORIDE

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

N06AB06

INN (Διεθνής Όνομα):

SERTRALINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

SERTRALINE HYDROCHLORIDE (8000002128) 111,8MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

SERTRALINE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) (310025909) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET : INFORMATION FOR THE USER
TRENEL 50 MG FILM-COATED TABLETS
TRENEL 100 MG FILM-COATED TABLETS
Sertraline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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 symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
IN THIS LEAFLET:
1.
What Trenel is and what it is used for
2.
Before you take Trenel
3.
How to take Trenel
4.
Possible side effects
5.
How to store Trenel
6.
Further information
1.
WHAT TRENEL IS AND WHAT IT IS USED FOR
Trenel contains the active ingredient 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.
TRENEL CAN BE USED TO TREAT:

Depression and prevention of recurrence of depression (in adults).

Social anxiety disorder (in adults).

Post traumatic stress disorder (PTSD) (in adults).

Panic disorder (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 and Panic disorders are illnesses linked to anxiety with symptoms
like being constantly
troubled by persistent ideas (obsessions) that make you carry out
repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some
symptoms that are similar to depression and anxiety. Social anxiety
disorder (social phobia) is an
illness linked to anxiety. It is characterised by feelings of intense
anxiety or distress in social
situations (for example: talking to strangers, sp

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Trenel 50 mg Film-coated tablets
Trenel 100 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 50 mg strength:
Each film-coated tablet contains 55.9 mg sertraline hydrochloride
corresponding to 50.0 mg
of sertraline base.
Excipient(s) with known effect: each tablet contains 79.65 mg of
lactose monohydrate.
For 100 mg strength:
Each film-coated tablet contains 111.8 mg sertraline hydrochloride
corresponding to 100.0
mg of sertraline base.
Excipient(s) with known effect: each tablet contains 159.3 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
For 50 mg strength:
White oval biconvex, 10x5 mm, coated tablets, scored on one side, on
other side with “L”
markings.
For 100 mg strength:
White, round biconvex, 10 mm, coated tablets, scored on one side,
other side with “C”
markings.
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
1
Sertraline should be administered once daily, either in the morning or
evening.
Sertraline tablet can be administered with or without food.
_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