Nilodux 30 mg harde maagsapresistente capsules

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

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

Δραστική ουσία:

DULOXETINEHYDROCHLORIDE

Διαθέσιμο από:

PharmaSwiss Ceská republika s.r.o.

Φαρμακολογική κατηγορία (ATC):

N06AX21

INN (Διεθνής Όνομα):

DULOXETINEHYDROCHLORIDE

Φαρμακοτεχνική μορφή:

Maagsapresistente capsule, hard

Σύνθεση:

AMMONIA (E 527) ; CARMELLOSE (E 466) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; GOUDKLEURIGE INKT ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; 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),

Οδός χορήγησης:

Oraal gebruik

Θεραπευτική περιοχή:

Duloxetine

Περίληψη προϊόντος:

Hulpstoffen: AMMONIA (E 527); CARMELLOSE (E 466); CROSPOVIDON (E 1202); GELATINE (E 441); GOUDKLEURIGE INKT; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN (E 132); 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);

Ημερομηνία της άδειας:

2015-10-29

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
NILODUX 30 MG HARDE MAAGSAPRESISTENTE CAPSULES
NILODUX 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 Nilodux is and what it is used for
2.
What you need to know before you take Nilodux
3.
How to take Nilodux
4.
Possible side effects
5.
How to store Nilodux
6.
Contents of the pack and other information
1.
WHAT NILODUX
IS AND WHAT IT IS USED FOR
Nilodux contains the active substance duloxetine. Nilodux increases
the levels of serotonin and
noradrenaline in the nervous system.
Nilodux 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)
Nilodux 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
Nilodux 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 YOU TAKE NILODUX
D

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NILODUX 30 MG HARDE MAAGSAPRESISTENTE CAPSULES
NILODUX 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.
Nilodux 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 consid