Duloxetine Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

duloxetine

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N06AX21

INN (International Name):

duloxetine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders

Therapeutic indications:

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

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2015-06-19

Patient Information leaflet

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE MYLAN 30 MG HARD GASTRO-RESISTANT CAPSULES
DULOXETINE MYLAN 60 MG HARD GASTRO-RESISTANT CAPSULES
duloxetine
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.
WHAT IS IN THIS LEAFLET
1.
What Duloxetine Mylan is and what it is used for
2.
What you need to know before you take Duloxetine Mylan
3.
How to take Duloxetine Mylan
4.
Possible side effects
5.
How to store Duloxetine Mylan
6.
Contents of the pack and other information
1.
WHAT DULOXETINE MYLAN IS AND WHAT IT IS USED FOR
Duloxetine Mylan contains the active substance duloxetine. Duloxetine
Mylan increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine Mylan 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 in the affected area,
or sensations such as touch,
heat, cold or pressure may cause pain)
Duloxetine Mylan 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 Mylan 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Mylan 30 mg hard gastro-resistant capsules
Duloxetine Mylan 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
30 mg capsules
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule contains 62.1 mg sucrose.
For the full list of excipients, see section 6.1.
60 mg capsules
Each capsule contains 60 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect _
Each capsule contains 124.2 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule
30 mg capsules
Opaque blue cap and opaque white body approximately 15.9 mm, imprinted
in gold ink with ‘MYLAN’
over ‘DL 30’ on both the cap and the body.
60 mg capsules
Opaque blue cap and opaque yellow body approximately 21.7 mm,
imprinted in white ink with ‘MYLAN’
over ‘DL 60’ on both the cap and the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Mylan is indicated in adults.
3
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 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