Duloxetine Pinewood 30 mg hard gastro-resistant capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Duloxetine hydrochloride

Available from:

Pinewood Laboratories Ltd

ATC code:

N06AX21

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Gastro-resistant capsule, hard

Therapeutic area:

duloxetine

Authorization status:

Not marketed

Authorization date:

2023-09-15

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
15 September 2023
CRN00DHF8
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duloxetine Pinewood 30 mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains from 52.38 to 70.92 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Hard gelatin capsule #3, opaque blue cap and opaque white 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 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.
In patients with co-morbid major depressive disorder, the starting and
maintenance dose is 60 mg once d