País: Chipre
Língua: grego
Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
VENLAFAXINE HYDROCHLORIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N06AX16
VENLAFAXINE
37.5MG
PROLONGED RELEASE CAPSULES
VENLAFAXINE HYDROCHLORIDE (8000001467) 42.435MG
ORAL USE
Εθνική Διαδικασία
VENLAFAXINE
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
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 Leia o documento completo