Aritavi 60mg hard gastro-resistant capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DULOXETINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N06AX21

INN (International Name):

DULOXETINE 60 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

DULOXETINE 60 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2015-07-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARITAVI 30 MG HARD GASTRO-RESISTANT CAPSULES
ARITAVI 60 MG HARD GASTRO-RESISTANT CAPSULES
duloxetine (as hydrochloride)
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 Aritavi is and what it is used for
2.
What you need to know before you take Aritavi
3.
How to take Aritavi
4.
Possible side effects
5.
How to store Aritavi
6.
Contents of the pack and other information
1.
WHAT ARITAVI IS AND WHAT IT IS USED FOR
Aritavi contains the active substance duloxetine. Aritavi increases
the levels of serotonin and
noradrenaline in the nervous system.
Aritavi 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)
Aritavi 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
Aritavi 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 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARITAVI
D

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Aritavi 30 mg hard gastro-resistant capsules
Aritavi 60 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient with known effect: Each capsule contains 100.6 mg sucrose.
Excipient with known effect: Each capsule contains 201.3 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Opaque grey body imprinted with ‘DLX 30’ and an opaque blue cap
imprinted with ‘DLX 30’,
length 18.0 mm.
Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap
imprinted with ‘DLX 60’,
length 20.4 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Aritavi 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
2
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 respons