Duloxetine 40 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:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

oral use

Units in package:

7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 and 500 capsules

Prescription type:

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

Therapeutic group:

Other antidepressants

Therapeutic area:

Other antidepressants

Therapeutic indications:

Duloxetine is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI)

Authorization status:

Not marketed

Authorization date:

2015-10-02

Patient Information leaflet

are taking, have recently taken or might take
any other medicines.
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) an 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
sedative antihistamines.
_MEDICINES THAT INCREASE THE LEVEL OF _
_SEROTONIN:_ Triptans, tramadol, tryptophan,
SSRIs (such as paroxetine and fluoxetine),
SNRIs (such as venlafaxine), tricyclic
antidepressants (such as clomipramine,
amitriptyline), pethidine, St John’s Wort and
MAOIs (such as moclobemide and linezolid).
These medicines increase the risk of side
effects; if you get any unusual symptom
taking any of these medicines together with
duloxetine, you should see your doctor.
_ORAL ANTICOAGULAN

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN00C10Y
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine 40 mg Gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Excipient with known effect:
Each 40 mg capsule contains 128.33 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque blue cap and opaque orange body size ‘2’ (17.80 ± 0.40 mm)
hard gelatin capsule imprinted with ‘H’ on cap and ‘D3’
on body with black ink, filled with white to off white colored
pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Duloxetine is indicated for women for the treatment of moderate to
severe Stress Urinary Incontinence (SUI).
Duloxetine is indicated in adults.
For further information see section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Duloxetine is 40 mg twice daily without regard
to meals. After 2-4 weeks of treatment, patients
should be re-assessed in order to evaluate the benefit and
tolerability of the therapy. Some patients may benefit from starting
treatment at a dose of 20 mg twice daily for two weeks before
increasing to the recommended dose of 40 mg twice daily. Dose
escalation may decrease, though not eliminate, the risk of nausea and
dizziness.
A 20 mg capsule is also available. However, limited data are available
to support the efficacy of Duloxetine 20 mg twice daily.
The efficacy of Duloxetine has not been evaluated for longer than 3
months in placebo-controlled studies. The benefit of
treatment should be re-assessed at regular intervals.
Combining Duloxetine with a pelvic floor muscle training (PFMT)
programme may be more effective than either treatment
alone. It is recommended that consideration be given to concomitant
PFMT.
_Hepatic impairment _
Duloxetine must not be used in women with liver disease resulting in
hepatic impairment (see sections 4.3 a