Duloxetine 30mg 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:

30mg

Pharmaceutical form:

Gastro-resistant capsule, hard

Administration route:

Oral use

Units in package:

Pack sizes: 28 capsules.

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Balkanpharma-Dupnitsa AD

Therapeutic group:

Other antidepressants

Therapeutic indications:

Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine is indicated in adults.

Authorization status:

Authorised

Authorization date:

2015-03-13

Patient Information leaflet

Duloxetine 30mg & 60mg Capsules PIL - UK
item no: AAAH5164 
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 30mg and 
60mg 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 used in adults to treat:
•   depression
•   generalised anxiety disorder (chronic feeling of anxiety 
or nervousness)
•   diabetic neuropathic pain (often described as burning, 
stabbing, stinging, shooting or aching or like an electric 
shock. There may be loss of feeling

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Duloxetine 30mg Gastro-resistant Capsules, hard 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 30 mg of duloxetine (as hydrochloride). 
Excipient with known effect: Each capsule contains 100.6
mg sucrose. 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Gastro-resistant capsule, hard. 
Opaque grey body imprinted with ‘DLX 30’ and an opaque
blue cap, imprinted with 
‘DLX 30’. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Treatment of major depressive disorder. 

Treatment of diabetic peripheral neuropathic pain. 

Treatment of generalised anxiety disorder. 

Duloxetine is indicated in adults. 

For further information see section 5.1. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

_Major depressive disorder _
The starting and recommended maintenance dose is 60 mg once
daily with or without 
food. Dosages above 60 mg once daily, up to a maximum dose of 120
mg per day 
have been evaluated from a safety perspective in clinical trials.
However, there is no 
clinical evidence suggesting that patients not responding to
the initial recommended 
dose may benefit from dose up-titrations. 

Therapeutic response is usually seen after 2-4 weeks of
treatment. 

After consolidation of the
anti-depressive response, it is recommended to continue 
treatment for several months, in order
to avoid relapse. In patients responding to 
duloxetine, and with a history of repeated episodes of major
depression, further long-
term treatment at a dose of 60 to 120 mg/day could
be considered. 
_ _
_Generalised anxiety disorder _
The recommended starting dose in patients with generalised
anxiety disorder is 30 mg 
once daily with or without food. In patients
with insufficient response the