Duloxetine 40mg gastro-resistant capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Duloxetine hydrochloride

Commercializzato da:

Actavis UK Ltd

Codice ATC:

N06AX21

INN (Nome Internazionale):

Duloxetine hydrochloride

Dosaggio:

40mg

Forma farmaceutica:

Gastro-resistant capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 07040200; GTIN: 5012617025340

Foglio illustrativo

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.
•
The full name of this medicine is Duloxetine 20mg
and 40mg Gastro-resistant Capsules, hard, but
within the leaflet it will be referred to as Duloxetine
capsules.
WHAT IS IN THIS LEAFLET
1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY
ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DULOXETINE CAPSULES
3.
HOW TO TAKE DULOXETINE CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DULOXETINE CAPSULES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY
ARE USED FOR
Duloxetine capsules contain the active substance
duloxetine. Duloxetine capsules increase the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine capsules are 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 capsules are 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 capsules is reinforced
when combined with a training program called Pelvic
Floor Muscle Training (PFMT).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DULOXETINE CAPSULES
DO NOT TAKE DULOXETINE CAPSULES IF YOU:
•
are allergic to duloxetine or any of the other
ingredients of this medicine (listed in section 6)
•
have liver dise

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Duloxetine 40mg Gastro-resistant Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Excipient with known effect: Each capsule contains 134.2 mg sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque yellow body imprinted with ‘DLX 40’ and an opaque yellow
cap, imprinted
with ‘DLX 40’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duloxetine is indicated for women for the treatment of moderate to
severe Stress
Urinary Incontinence (SUI).
Duloxetine is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Duloxetine 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 20mg capsule is also available. However, limited data are available
to support the
efficacy of Duloxetine 20 mg twice daily.
The efficacy of Duloxetine 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 Duloxetine with a pelvic floor muscle training (PFMT)
programme may
be more effective than either treatment alone. It is recommended that
consideration be
given to concomitant PFMT.
Special populations
_Paediatric population _
The safety and efficacy of Duloxetine for the treatment of stress
urinary incontinence
has not been studied. No data are available.
_Elderly _
Caution should be exercised when treating the elderly.
_Hepatic impairment _
Duloxetine must not be used in women with liver diseas