Nilodux 20 mg harde maagsapresistente capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DULOXETINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; DULOXETINE

Beschikbaar vanaf:

PharmaSwiss Ceská republika s.r.o.

ATC-code:

N06AX21

INN (Algemene Internationale Benaming):

DULOXETINEHYDROCHLORIDE COMPOSITION corresponding to ; DULOXETINE

farmaceutische vorm:

Maagsapresistente capsule, hard

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Duloxetine

Product samenvatting:

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

Autorisatie datum:

2015-10-29

Bijsluiter

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
NILODUX 20 MG HARDE MAAGSAPRESISTENTE CAPSULES
NILODUX 40 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.
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 a medicine to be taken by mouth to treat Stress Urinary
Incontinence (SUI) in
women.
Stress urinary incontinence is a medical condition in which patients
have accidental loss or
leakage of urine during physical exertion or activities such as
laughing, coughing, sneezing,
lifting, or exercise.
Nilodux is believed to work by increasing the strength of the muscle
that holds back urine when
you laugh, sneeze, or perform physical activities.
The efficacy of Nilodux is reinforced when combined with a training
program called Pelvic
Floor Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NILODUX
DO NOT TAKE NILODUX IF YOU:
-
are allergic to duloxetine or any of the other ingredients of this
medicine (listed in
section 6)
-
have liver disease
-
have severe kidney disease
-
are taking or have taken within the last 14 days, another medicine
known as a
monoamine oxidase inhibitor (MAOI) (see ‘Other medicines

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NILODUX 20 MG HARDE MAAGSAPRESISTENTE CAPSULES
NILODUX 40 MG HARDE MAAGSAPRESISTENTE CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Excipient with known effect:
Each 20 mg capsule contains 64.16 mg sucrose.
Each 40 mg capsule contains 128.33 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
20 mg: Opaque green cap and opaque green body size ‘4’ (14.40 ±
0.40 mm) hard gelatin
capsules, imprinted with ‘H’ on cap and ‘190’ on body, filled
with white to off white colored
pellets.
40 mg: Opaque blue cap and opaque orange body size ‘2’ (17.80 ±
0.40 mm) hard gelatin
capsule imprinted with ‘H’ on cap and ‘D3’ on body with black
ink, filled with white to off
white colored pellets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Nilodux is indicated for women for the treatment of moderate to severe
Stress Urinary
Incontinence (SUI).
Nilodux is indicated in adults.
For further information see section 5.1.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Nilodux is 40 mg twice daily without regard to
meals. After 2-4
weeks of treatment, patients should be re-assessed in order to
evaluate the benefit and
tolerability of the therapy. Some patients may benefit from starting
treatment at a dose of 20 mg
twice daily for two weeks before increasing to the recommended dose of
40 mg twice daily.
Dose escalation may decrease, though not eliminate, the risk of nausea
and dizziness.
A 20 mg capsule is also available. However, limited data are available
to support the efficacy of
Nilodux 20 mg twice daily.
The efficacy of Nilodux has not been evaluated for longer than 3
months in placebo-controlled
studies. The benefit of treatment should be re-assessed at regular
intervals.
Combining Nilodux with a pelvic floor muscle