Duloxetine Teva 30 mg Gastro resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Duloxetine hydrochloride

Available from:

Teva B.V.

ATC code:

N06A

INN (International Name):

Duloxetine hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

ANTIDEPRESSANTS

Authorization status:

Not marketed

Authorization date:

2015-07-10

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE TEVA 30 MG GASTRO-RESISTANT CAPSULES, HARD
DULOXETINE TEVA 60 MG GASTRO-RESISTANT CAPSULES, HARD
_ _
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 Teva is and what it is used for
2.
What you need to know before you take Duloxetine Teva
3.
How to take Duloxetine Teva
4.
Possible side effects
5.
How to store Duloxetine Teva
6.
Contents of the pack and other information
1.
WHAT DULOXETINE TEVA IS AND WHAT IT IS USED FOR
Duloxetine Teva contains the active substance duloxetine. Duloxetine
Teva increases the levels of serotonin
and noradrenaline in the nervous system.
Duloxetine Teva 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 Teva 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 Teva
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 fe

Summary of Product characteristics

Health Products Regulatory Authority
11 September 2019
CRN00982F
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Teva 30 mg Gastro resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 30 mg of duloxetine (as
hydrochloride).
Excipient with known effect:
Each hard gastro-resistant capsule of Duloxetine Teva 30 mg contains
41.05 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Duloxetine Teva 30 mg are hard gelatin size 3 capsules, approx. 16 mm
x 6 mm, with blue opaque cap and white body, filled
with off white to yellow coated pellets, imprinted with “30” on
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 Teva 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 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
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 dose sho