Duloxetine Belupo 60 mg, harde maagsapresistente capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DULOXETINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; DULOXETINE

Beschikbaar vanaf:

BELUPO Pharmaceuticals and Cosmetics, Inc.

ATC-code:

N06AX21

INN (Algemene Internationale Benaming):

DULOXETINEHYDROCHLORIDE COMPOSITION corresponding to ; DULOXETINE

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CARBOXYMETHYLETHYLCELLULOSE ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 400 ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WITTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Duloxetine

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); CARBOXYMETHYLETHYLCELLULOSE; CROSPOVIDON (E 1202); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MACROGOL 400; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); WITTE INKT;

Autorisatie datum:

2018-04-09

Bijsluiter

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE BELUPO 30 MG Duloxetine Belupo 30 mg, harde
maagsapresistente capsules
DULOXETINE BELUPO 60 MG Duloxetine Belupo 60 mg, harde
maagsapresistente capsules
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 of the 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 Duloxetine Belupo is and what it is used for
2.
What you need to know before you take Duloxetine Belupo
3.
How to take Duloxetine Belupo
4.
Possible side effects
5.
How to store Duloxetine Belupo
6.
Contents of the pack and other information
1.
WHAT DULOXETINE BELUPO IS AND WHAT IT IS USED FOR
Duloxetine Belupo contains the active substance duloxetine. Duloxetine
Belupo increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine Belupo is used in adults to treat:
•
depression
•
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
•
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)
Duloxetine Belupo 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
Duloxetine Belupo when you are feeling
better to prevent your depression or anxiety from returning.
In people with diabetic neuropa

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Belupo 30 mg harde maagsapresistente capsules
Duloxetine Belupo 60 mg harde maagsapresistente capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient with known effect:
Each 30 mg capsule contains 96.25 mg sucrose.
Each 60 mg capsule contains 192.49 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
30 mg: Opaque blue cap and opaque white body size ‘3’ (15.80 ±
0.40 mm) hard gelatin capsules
imprinted with ‘H’ on cap and ‘191’ on body, filled with white
to off white colored pellets.
60 mg: Opaque blue cap and opaque green body size ‘1’ (19.30 ±
0.40 mm) hard gelatin capsules
imprinted with ‘H’ on cap and ‘192’ on body, filled with white
to off white colored pellets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Belupo 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.