Duloxetine Hetero 40 mg harde maagsapresistente capsules

Šalis: Nyderlandai

kalba: olandų

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

Veiklioji medžiaga:

DULOXETINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; DULOXETINE

Prieinama:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

ATC kodas:

N06AX21

INN (Tarptautinis Pavadinimas):

DULOXETINEHYDROCHLORIDE COMPOSITION corresponding to ; DULOXETINE

Vaisto forma:

Maagsapresistente capsule, hard

Sudėtis:

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 ROOD (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,

Vartojimo būdas:

Oraal gebruik

Gydymo sritis:

Duloxetine

Produkto santrauka:

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 ROOD (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;

Leidimo data:

2015-10-29

Pakuotės lapelis

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE HETERO 20 MG HARDE MAAGSAPRESISTENTE CAPSULES
DULOXETINE HETERO 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 Duloxetine Hetero is and what it is used for
2.
What you need to know before you take Duloxetine Hetero
3.
How to take Duloxetine Hetero
4.
Possible side effects
5.
How to store Duloxetine Hetero
6.
Contents of the pack and other information
1.
WHAT DULOXETINE HETERO IS AND WHAT IT IS USED FOR
Duloxetine Hetero contains the active substance duloxetine. Duloxetine
Hetero increases the
levels of serotonin and noradrenaline in the nervous system.
Duloxetine Hetero 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.
Duloxetine Hetero 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 Duloxetine Hetero is reinforced when combined with a
training program called
Pelvic Floor Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE HETERO
DO NOT TAKE DULOXETINE HETERO 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

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Hetero 20 mg harde maagsapresistente capsules
Duloxetine Hetero 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
Duloxetine Hetero is indicated for women for the treatment of moderate
to severe Stress Urinary
Incontinence (SUI).
Duloxetine Hetero is indicated in adults.
For further information see section 5.1.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Duloxetine Hetero 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
Duloxetine Hetero 20 mg twice daily.
The efficacy of Duloxetine Hetero has not been evaluated for longer
than 3 months in
placebo-controlled studies. The benefit of treatment should be
re-asses