Duloxetine Milpharm 30mg gastro-resistant capsules, hard

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Duloxetine (as duloxetine hydrochloride)

Available from:

Milpharm Limited

ATC code:

N06AX21

INN (International Name):

Duloxetine (as duloxetine hydrochloride)

Dosage:

30mg

Pharmaceutical form:

Gastro-resistant capsules

Units in package:

Blister packs: 7, 14, 28, 30 and 98 capsules; bottle pack: 30, 98, 250 and 1000 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

APL Swift Services (Malta) Limited

Therapeutic group:

Other antidepressants

Therapeutic indications:

Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.

Authorization status:

Authorised

Authorization date:

2015-07-29

Patient Information leaflet

DULOXETINE 30 MG GASTRO-RESISTANT CAPSULES, HARD
DULOXETINE 60 MG GASTRO-RESISTANT CAPSULES, HARD
Duloxetine (as hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any get any side effects, talk to your doctor or pharmacist. 
This includes any possible side effects not listed in this leaflet. 
See section 4.  
WHAT IS IN THIS LEAFLET:
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 
Duloxetine contains the active substance duloxetine. Duloxetine 
increases the levels of serotonin and noradrenaline in the nervous 
system. 
Duloxetine is used 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 in the affected area, or sensations such as 
touch, heat, cold or pressure may cause pain)
Duloxetine starts to work in most people with depression or anxiety 
within two weeks of starting treatment, but it may take 2-4 weeks 
before you feel better. Tell your doctor if you do not start to
feel 
better after this time. Your doctor may continue to give you 
Duloxetine when you are feeling better to prevent your depression 
or anxiety from returning. 
In people with diabetic neuropathic pain it can take some weeks 
before you feel better. Talk to your doctor if you do not feel
better 
after 2

Summary of Product characteristics

Duloxetine Milpharm 30mg gastro­resistant capsules
Summary of Product Characteristics Updated 10­Aug­2015 | Aurobindo Pharma ­ Milpharm Ltd.
1. Name of the medicinal product
Duloxetine Milpharm 30 mg gastro­resistant capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: Each capsule contains 71.76 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro­resistant capsule, hard
Blue opaque /white opaque, size “3” hard gelatin capsule filled with white to off white pellets and imprinted with "X" on
blue opaque cap and "02" on white opaque body with black ink
4. Clinical particulars
4.1 Therapeutic indications
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Milpharm 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 up­titrations.
Therapeutic response is usually seen after 2­4 weeks of treatment.
After consolidation of the antidepressive 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 long­term treatment at a dose of 60 to 120 mg/day could be�