Duloxetine 20mg Gastro-resistant Capsules, hard

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Duloxetine

Available from:

Caduceus Pharma Ltd

ATC code:

N06AX21

INN (International Name):

Duloxetine

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant capsule, hard

Administration route:

Oral use

Units in package:

Pack sizes: 28 and 56 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Balkanpharma-Dupnitsa AD

Therapeutic group:

Other antidepressants

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-03-13

Patient Information leaflet

Duloxetine 20mg & 40mg Capsules PIL - UK
item no: AAAH5163 
print proof no: 1
origination date: 17.12.14 
originated by: S.Anson
revision date:  
revised by: 
dimensions: 145 x 400 
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2. 
3. 
4.
5.
6.
1. 
2.
3.
date sent: 17.12.14
supplier: Actavis Bulgaria Dupnitsa
technically app. date: 17.12.14
min pt size: 8
TECHNICAL APPROVAL
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 increases the levels of 
serotonin and noradrenaline in the nervous system.
Duloxetine capsules 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 exerci

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Duloxetine 20mg Gastro-resistant Capsules, hard 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 20 mg of duloxetine (as hydrochloride). 

Excipient with known effect: Each capsule contains 67.1
mg sucrose. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Gastro-resistant capsule, hard. 

Opaque blue body imprinted with ‘DLX 20’ and an opaque
blue cap, imprinted with 
‘DLX 20’. 

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 safet