Duloxetine 30 mg Gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Duloxetine hydrochloride

Available from:

Wockhardt UK Limited

ATC code:

N06AX

INN (International Name):

Duloxetine hydrochloride

Dosage:

30 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

oral use

Units in package:

blister packs of 7, 28 and 56 capsules

Prescription type:

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

Therapeutic group:

: Other antidepressants

Therapeutic area:

Other antidepressants

Therapeutic indications:

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

Authorization status:

Not marketed

Authorization date:

2015-10-02

Patient Information leaflet

go back to your doctor. You should inform
your doctor if any of the symptoms listed
above develop or worsen when patients
under 18 are taking Duloxetine Capsules.
Also, the long-term safety effects concerning
growth, maturation, and cognitive and
behavioural development of duloxetine in this
age group have not yet been demonstrated.
OTHER MEDICINES AND DULOXETINE CAPSULES
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including medicines
obtained without a prescription.
The main ingredient of Duloxetine Capsules,
duloxetine, is used in other medicines for
other conditions:
•
diabetic neuropathic pain, depression,
anxiety and urinary incontinence
Using more than one of these medicines at
the same time should be avoided. Check with
your doctor if you are already taking other
medicines containing duloxetine.
Your doctor should decide whether you can
take Duloxetine Capsules with other
medicines. DO NOT START OR STOP TAKING ANY
MEDICINES, INCLUDING THOSE BOUGHT WITHOUT
A PRESCRIPTION AND HERBAL REMEDIES, BEFORE
CHECKING WITH YOUR DOCTOR.
You should also tell your doctor if you are
taking any of the following:
_MONOAMINE OXIDASE INHIBITORS (MAOIS):_ You
should not take Duloxetine Capsules if you
are taking, or have recently taken (within the
last 14 days) another antidepressant
medicine called a monoamine oxidase
inhibitor (MAOI). Examples of MAOIs include
moclobemide (an antidepressant) and
linezolid (an antibiotic). Taking a MAOI
together with many prescription medicines,
including duloxetine, can cause serious or
even life-threatening side effects. You must
wait at least 14 days after you have stopped
taking an MAOI before you can take
Duloxetine Capsules. Also, you need to wait
at least 5 days after you stop taking
Duloxetine Capsules before you take a MAOI.
_MEDICINES THAT CAUSE SLEEPINESS:_ These
include medicines prescribed by your doctor
including benzodiazepines, strong
painkillers, antipsychotics, phenobarbital and
antihistamines.
_MEDICINES THAT IN

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN00C10Y
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine 30 mg Gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient with known effect:
Each 30 mg capsule contains 96.25 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque blue cap and opaque white body size ‘3’ (15.80 ± 0.40 mm)
hard gelatin capsules imprinted with ‘H’ on cap and ‘191’
on body, filled with white to off white colored pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine 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 maintenance dose in most
patients.
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