Dulodet 30 mg harde maagsapresistente capsules

País: Països Baixos

Idioma: neerlandès

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

ingredients actius:

DULOXETINEHYDROCHLORIDE 33,6 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 30 mg/stuk

Disponible des:

Egis Pharmaceuticals Private Limited Company Keresztiiri út 30-38 1106 BUDAPEST (HONGARIJE)

Codi ATC:

N06AX21

Designació comuna internacional (DCI):

DULOXETINEHYDROCHLORIDE 33,6 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 30 mg/stuk

formulario farmacéutico:

Maagsapresistente capsule, hard

Composición:

AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; GLYCEROLMONOSTEARAAT (E 471) ; GROENE INKT ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; GLYCEROLMONOSTEARAAT (E 471) ; GROENE INKT ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Vía de administración:

Oraal gebruik

Área terapéutica:

Duloxetine

Resumen del producto:

Hulpstoffen: AMMONIA (E 527); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); GELATINE (E 441); GLYCEROLMONOSTEARAAT (E 471); GROENE INKT; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MAÏSZETMEEL; POLYSORBAAT 80 (E 433); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Data d'autorització:

2015-09-17

Informació per a l'usuari

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DULODET 30 MG HARDE MAAGSAPRESISTENTE CAPSULES
DULODET 60 MG HARDE MAAGSAPRESISTENTE CAPSULES
Duloxetine (as hydrochloride)
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 Dulodet is and what it is used for
2.
What you need to know before you take Dulodet
3.
How to take Dulodet
4.
Possible side effects
5.
How to store Dulodet
6.
Contents of the pack and other information
1.
WHAT DULODET IS AND WHAT IT IS USED FOR
Dulodet contains the active substance duloxetine. Dulodet increases
the levels of serotonin and noradrenaline
in the nervous system.
Dulodet 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)
Dulodet 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 Dulodet when you are feeling
better to prevent your depression or
anxiety from returning
In people with diabetic neuropathic pain it can take some weeks before
you feel better. Talk to your doctor if
you do not feel better after 2 months.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dulodet 30 mg harde maagsapresistente capsules
Dulodet 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).
Excipientwith known effect
Each capsule contains from 52,38 to 70,92 mg - sucrose.
Each capsule contains from 104,74 to 141,83 mg - sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Hard gelatin capsule #3, ink-printed in yellow with “DLX” on the
opaque blue cap and “30 mg” on the
opaque white body.
Hard gelatin capsule #1, ink-printed in white with “DLX” on the
opaque blue cap and “60 mg” on the
opaque green body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Dulodet 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
2
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