Duloxetine Sandoz 20 mg, maagsapresistente harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DULOXETINEHYDROCHLORIDE 22,4 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 20 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N06AX21

INN (Algemene Internationale Benaming):

DULOXETINEHYDROCHLORIDE 22,4 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 20 mg/stuk

farmaceutische vorm:

Maagsapresistente capsule, hard

Samenstelling:

AMMONIA (E 527) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; HYPROMELLOSEFTALAAT ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; HYPROMELLOSEFTALAAT ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; HYPROMELLOSEFTALAAT ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Duloxetine

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); HYPROMELLOSEFTALAAT; IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); ZWARTE INKT;

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
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Duloxetine Sandoz 20 mg / 40 mg, maagsapresistente harde capsules
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1.3.1.3 Bijsluiter
Februari 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[DULOXETINE SANDOZ 20 MG, MAAGSAPRESISTENTE HARDE CAPSULES
DULOXETINE SANDOZ 40 MG, MAAGSAPRESISTENTE HARDE 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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance duloxetine.
[Nationally completed name]
increases the levels of serotonin and noradrenaline in the nervous
system.
[Nationally completed name] 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.
[Nationally completed name] 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 [Nationally completed name] is reinforced when
combined with a training program
called Pelvic Floor Muscle Training (PFMT).
2.

Productkenmerken

Sandoz B.V.
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Duloxetine Sandoz 20 mg/40 mg, maagsapresistente harde capsules
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1.3.1.1 Samenvatting van de Productkenmerken
Februari 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Sandoz 20 mg, maagsapresistente harde capsules
Duloxetine Sandoz 40 mg, maagsapresistente harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 20 mg of duloxetine (as
hydrochloride).
Excipient with known effect
Each hard gastro-resistant capsule contains 34.37 mg of sucrose.
Each hard gastro-resistant capsule contains 40 mg of duloxetine (as
hydrochloride).
Excipient with known effect
Each hard gastro-resistant capsule contains 68.74 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
_20 mg hard gastro-resistant capsule _
Opaque blue body, imprinted with ‘163’ and an opaque blue cap,
imprinted with ‘A’.
Size “4” hard gastro-resistant capsules filled with white to off
white colored pellets.
_40 mg hard gastro-resistant capsule _
Opaque orange body, imprinted with ‘162’ and an opaque blue cap,
imprinted with ‘A’.
Size “2” hard gastro-resistant capsules filled with white to off
white colored pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for women for the treatment
of moderate to severe Stress
Urinary Incontinence (SUI).
[Nationally completed name] is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sandoz B.V.
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1.3.1.1 Samenvatting van de Productkenmerken
Februari 2021
Posology
The recommended dose of [Nationally completed name] 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 st