EDRONAX

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

REBOXETINE METHAN SULFONATE

Διαθέσιμο από:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

N06AX18

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

REBOXETINE METHAN SULFONATE 4 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PFIZER ITALIA S.R.L, ITALY

Θεραπευτική ομάδα:

REBOXETINE

Θεραπευτική περιοχή:

REBOXETINE

Θεραπευτικές ενδείξεις:

Reboxetine is indicated for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.

Ημερομηνία της άδειας:

2014-04-30

Αρχείο Π.Χ.Π.

Edromax LPD CC 160124
2021-0069012 , 2022-0080734
Page: 1 of 9
EDRONAX
®
1.
NAME OF THE MEDICINAL PRODUCT
Edronax
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 4 mg of reboxetine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, convex tablet with a breakline on one side. A ‘P’ is
marked on the left side of the
breakline. A ‘U’ is marked on the right side of the breakline. The
side opposite the breakline is
marked ‘7671’. The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Reboxetine is indicated for the acute treatment of depressive
illness/major depression and for
maintaining the clinical improvement in patients initially responding
to treatment.
4.2.
Posology and method of administration
Reboxetine is for oral use.
The onset of the clinical effect is generally seen after 14 days from
treatment start.
Adults
The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e.8
mg/day administered orally.
The full therapeutic dose can be given upon starting treatment. After
3-4 weeks, this dose can be
increased to 10 mg/day in case of incomplete clinical response. The
maximum daily dose should
not exceed 12 mg/day. The minimum effective dose has not yet been
established.
Elderly
Elderly patients have been studied in clinical trials at doses of 2 mg
b.i.d. However, safety and
efficacy have not been evaluated in placebo-controlled conditions.
Therefore, as for other
antidepressants that have not been studied in placebo-controlled
conditions, reboxetine cannot be
recommended.
Paediatric population
Reboxetine should not be used in the treatment of children and
adolescents under the age of 18
years (see section 4.4).
Renal or hepatic impairment
The starting dose in patients with renal or hepaticimpairment should
be 2 mg b.i.d which can be
increased based on patient tolerance.
Method of administration
Reboxetine is for oral use.
4.3.
Contraindications
Edromax LPD CC 160124
2021-0069012 , 2022-0080734