Duloxetine 40mg Gastro-resistant Capsules, Hard

Země: Velká Británie

Jazyk: angličtina

Zdroj: myHealthbox

Aktivní složka:

Duloxetine

Dostupné s:

TEVA UK Limited

ATC kód:

N06AX21

INN (Mezinárodní Name):

Duloxetine

Dávkování:

40mg

Léková forma:

Gastro-resistant capsule, hard

Podání:

Oral use

Jednotky v balení:

14, 28, 56, 84, 98, 140 or 196 (2x98) capsules

Druh předpisu:

POM - Prescription Only Medicine

Výrobce:

Merckle GmbH

Terapeutické skupiny:

Psychoanaleptics; Other antidepressants

Terapeutické indikace:

It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI)

Stav Autorizace:

Authorised

Datum autorizace:

2015-04-28

Informace pro uživatele

322K888571214
DULOXETINE 20 MG AND 40 MG 
GASTRO-RESISTANT 
CAPSULES, HARD
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.
1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE
3. HOW TO TAKE DULOXETINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DULOXETINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT DULOXETINE IS AND WHAT IT IS 
USED FOR
Duloxetine contains the active substance duloxetine. 
Duloxetine increases the levels of serotonin and 
noradrenaline in the nervous system. 
Duloxetine is a medicine 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 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 is reinforced when combined 
with a training program called Pelvic Floor Muscle 
Training (PFMT).
WHAT YOU  NEED TO  KNOW  BEFORE YOU 
TAKE DULOXETINE
DO NOT TAKE DULOXETINE 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

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Duloxetine 40 mg Gastro-resistant Capsules, Hard  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each gastro-resistant capsule, hard contains 40 mg of duloxetine
(as hydrochloride).  
Excipient(s) with known effect: Each gastro-resistant capsule, hard
contains 54.73 mg 
of sucrose. For the full list of excipients, see section 6.1.  

3 PHARMACEUTICAL 
FORM 
Gastro-resistant capsule, hard  
A hard gelatin size 2 capsule with blue opaque cap and gold
opaque body, filled with 
off white to yellow coated pellets. Imprinting on body: 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 20 mg 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 PFM