Durogesic DTrans 75 micrograms/hour transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fentanyl

Available from:

Imbat Limited

ATC code:

N02AB; N02AB03

INN (International Name):

Fentanyl

Dosage:

75 micrograms/hour

Pharmaceutical form:

Transdermal patch

Prescription type:

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

Therapeutic area:

Phenylpiperidine derivatives; fentanyl

Authorization status:

Authorised

Authorization date:

2015-11-13

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUROGESIC
® DTRANS
® 75 MICROGRAMS/HOUR TRANSDERMAL PATCH
(fentanyl)
Your medicine is available using the above name but will be referred
to as Durogesic DTrans
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.

This medicine has been prescribed for you (or your child) 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 side effects talk to your doctor, pharmacist or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS
3.
HOW TO USE DUROGESIC DTRANS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DUROGESIC DTRANS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR
The name of your medicine is Durogesic DTrans.
The patches help relieve pain that is very bad and long-lasting:

in adults who need continuous pain treatment

in children above 2 years of age who are already using opioid
medication and who need
continuous pain treatment.
Durogesic DTrans contains a medicine called fentanyl. It belongs to a
group of strong painkillers
called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS
DO NOT USE DUROGESIC DTRANS IF:

You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in
section 6)

You have pain which lasts only for a short period, such as sudden pain
or pain after having
an operation

You have breathing difficulties, with slow or shallow breathing
Do not use this medicine if any of the above apply to you or your
child. If you are not sure, talk
to your doctor or pharmacist before using Durogesic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Durogesic DTrans 75 micrograms/hour Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Durogesic DTrans 75 patch contains fentanyl 12.6 mg.
Release rate of approximately 75 micrograms per hour; active surface
area 31.5 cm².
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
_Product imported from Poland_
Translucent rectangular patch with rounded corners, marked with
product name, strength and a border in blue coloured
ink.
The patch has a sticky back so that it can be stuck onto the skin.
Each patch is marked
Durogesic
®
75 µg fentanyl/h
4 CLINICAL PARTICULARS
As per PA0748/002/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/002/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polyacrylate adhesive
Polyethylene terephthalate/ethyl vinyl acetate film
blue printing ink
Siliconised polyester film
6.2 INCOMPATIBILITIES
To prevent interference with the adhesive properties of Durogesic
DTrans, no creams, oils, lotions or powder should be
applied to the skin area when the Durogesic DTrans transdermal patch
is applied.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
patch pouch and outer carton of the product as
marked in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any other special storage
conditions.
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