DOXURAL 37.5MG PROLONGED RELEASE CAPSULES

Pays: Chypre

Langue: grec

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingrédients actifs:

VENLAFAXINE HYDROCHLORIDE

Disponible depuis:

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

Code ATC:

N06AX16

DCI (Dénomination commune internationale):

VENLAFAXINE

Dosage:

37.5MG

forme pharmaceutique:

PROLONGED RELEASE CAPSULES

Composition:

VENLAFAXINE HYDROCHLORIDE (8000001467) 42.435MG

Mode d'administration:

ORAL USE

Type d'ordonnance:

Εθνική Διαδικασία

Domaine thérapeutique:

VENLAFAXINE

Descriptif du produit:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 7 CAPS IN BLISTER(S) (310000801) 7 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 10 CAPS IN BLISTER(S) (310000802) 10 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 14 CAPS IN BLISTER(S) (310000803) 14 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 20 CAPS IN BLISTER(S) (310000804) 20 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 28 CAPS IN BLISTER(S) (310000805) 28 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 30 CAPS IN BLISTER(S) (310000806) 30 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 50 CAPS IN BLISTER(S) (310000807) 50 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 98 CAPS IN BLISTER(S) (310000808) 98 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 100 CAPS IN BLISTER(S) (310000809) 100 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή; BOTTLE WITH 50 CAPS (310000810) 50 CAPSULE - Αποσυρθέν - Με Ιατρική Συνταγή; BOTTLE WITH 100 CAPS (310000811) 100 CAPSULE - Αποσυρθέν - Με Ιατρική Συνταγή

Résumé des caractéristiques du produit

1.
NAME OF THE MEDICINAL PRODUCT
Doxural 37,5
Venlafaxine 37,5 mg Prolonged-release capsules.
Doxural 75
Venlafaxine 75 mg Prolonged-release capsules.
Doxural 150
Venlafaxine 150 mg Prolonged-release capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 37,5 mg strength:
Each prolonged-release capsule contains venlafaxine hydrochloride
equivalent to 37,5 mg
venlafaxine.
For 75 mg strength:
Each prolonged-release capsule contains venlafaxine hydrochloride
equivalent to 75 mg venlafaxine.
For 150 mg strength:
Each prolonged-release capsule contains venlafaxine hydrochloride
equivalent to 150 mg venlafaxine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Doxural 37,5 _
_ _
_ mg prolonged-release capsules _
_ _
_ _
White to off-white pellets filled in hard gelatin capsule shells size
“3” with orange cap and clear
transparent body.
_Doxural 75 _
_ _
_ mg prolonged-release capsules_
_ _
_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
White to off-white pellets filled in hard gelatin capsule shells size
“1” with yellow cap and clear
transparent body.
_Doxural 150 _
_ _
_ mg prolonged-release capsules _
_ _
_ _
White to off-white pellets filled in hard gelatin capsule shells size
“0” with buff cap and clear
transparent body.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of social anxiety disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients
not responding to the initial 75 mg/day dose may benefit from dose
increases up to a maximum dose
of 375 mg/day. Dosage increases can be made at intervals of 2 weeks or
more. If clinically warranted
due to symptom severity, dose increases can be made at more frequent
intervals, but not less than 4
days.
Because of the risk of dose-related adverse effects, dose increments
should be made only after a
clinical evaluatio