Duloxetine Clonmel 60 mg gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Duloxetine

Available from:

Clonmel Healthcare Ltd

ATC code:

N06A

INN (International Name):

Duloxetine

Dosage:

60 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Administration route:

oral use

Units in package:

Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 140 capsules

Prescription type:

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

Manufactured by:

STADA Arzneimittel AG

Therapeutic group:

Psychoanaleptics; Other antidepressants

Therapeutic area:

ANTIDEPRESSANTS

Therapeutic indications:

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

Authorization status:

Marketed

Authorization date:

2015-09-25

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE CLONMEL 30MG GASTRO-RESISTANT CAPSULES, HARD
DULOXETINE CLONMEL 60MG GASTRO-RESISTANT CAPSULES, HARD
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 Duloxetine Clonmel is and what it is used for
2.
What you need to know before you take Duloxetine Clonmel
3.
How to take Duloxetine Clonmel
4.
Possible side effects
5.
How to store Duloxetine Clonmel
6.
Contents of the pack and other information
1.
WHAT DULOXETINE CLONMEL IS AND WHAT IT IS USED FOR
Duloxetine Clonmel contains the active substance duloxetine.
Duloxetine Clonmel increases the levels
of serotonin and noradrenaline in the nervous system.
Duloxetine Clonmel 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 Clonmel 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 Clonmel when you are
feeling better to prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain it can take some weeks

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2021
CRN00CMFC
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Clonmel 60 mg gastro resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule, hard contains 60 mg of duloxetine (as
hydrochloride).
Excipient(s) with known effect
Each gastro-resistant capsule, hard contains 132 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Duloxetine Clonmel 60 mg capsules are body-green, cap-dark blue,
filled with off white gastro-resistant pellets with a length of
19.4 ±1 mm and a width of 6.91 ±1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Clonmel 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 should be increased to 60
mg, which is the usual main