Depalta Gastro-Resistant Hard Capsules 60mg

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

DULOXETINE

थमां उपलब्ध:

Wave Pharma Limited 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, Middlesex, HA8 5AW, United Kingdom

ए.टी.सी कोड:

N06AX21

INN (इंटरनेशनल नाम):

DULOXETINE 60 mg

फार्मास्यूटिकल फॉर्म:

GASTRO-RESISTANT HARD CAPSULE

रचना:

DULOXETINE 60 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

PSYCHOANALEPTICS

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2015-09-23

सूचना पत्रक

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEPALTA 30MG GASTRO-RESISTANT CAPSULES, HARD
DEPALTA 60MG GASTRO-RESISTANT CAPSULES, HARD
Duloxetine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
-
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Depalta Gastro-resistant Capsules are and what they are used for
2.
What you need to know before you take Depalta Gastro-resistant
Capsules
3.
How to take Depalta Gastro-resistant Capsules
4.
Possible side effects
5.
How to store Depalta Gastro-resistant Capsules
6.
Contents of the pack and other information
1.
WHAT DEPALTA GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR
Depalta Gastro-resistant Capsules contain the active substance
duloxetine. Duloxetine increases the levels of
serotonin and noradrenaline in the nervous system.
Depalta is used to treat the following conditions in adults:
•
depression
•
diabetic neuropathic pain (often described as burning, stabbing,
stinging, shooting or aching or like an
electric shock.There may be loss of feeling in the affected area,or
sensations such as touch, heat, cold
or pressure may cause pain)
•
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
Depalta Gastro-resistant Capsule starts to work in most people with
depression or anxiety within two weeks
of starting treatment,but it may take 2-4 weeks before you feel
better. Tell your doctor if you do not start to
feel better after this time. Your doctor may continue to give you
Depalta Gastro-resistant Capsule when you
are feeling better to prevent your depression or anxi

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Depalta 60mg gastro-resistant capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipients with known effect:
Each capsule contains 167 mg sucrose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
White to off white spherical to oval pellets filled in hard gelatin
capsule shells of size "3" with “
” imprinted
in grey ink on opaque white coloured cap and "086" imprinted in black
ink on clear transparent body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive disorder _
The starting and recommended maintenance dose is 60 mg once daily with
or without food. Dosages above
60 mg once daily, up to a maximum dose of 120 mg per day have been
evaluated from a safety perspective in
clinical trials. However, there is no clinical evidence suggesting
that patients not responding to the initial
recommended dose may benefit from dose up-titrations.
Therapeutic response is usually seen after 2-4 weeks of treatment.
After consolidation of the antidepressive response, it is recommended
to continue treatment for several
months, in order to avoid relapse. In patients responding to
duloxetine, and with a history of repeated
episodes of major depression, further long-term treatment at a dose of
60 to 120 mg/day could be considered.
_Generalised anxiety disorder _
The recommended starting dose in patients with generalised anxiety
disorder is 30 mg once daily with or
without food. In patients with insufficient response the dose should
be increased to 60 mg, which is the usual
maintenance dose in most patients.
In patients with co-morbid major depressive disorder, the