Durogesic DTrans 25 micrograms/hour transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fentanyl

Available from:

Janssen Sciences Ireland UC

ATC code:

N02AB; N02AB03

INN (International Name):

Fentanyl

Dosage:

25 micrograms/hour

Pharmaceutical form:

Transdermal patch

Therapeutic area:

Phenylpiperidine derivatives; fentanyl

Authorization status:

Marketed

Authorization date:

1995-10-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DUROGESIC
® _DTRANS_
®
12 MICROGRAMS /HOUR TRANSDERMAL PATCH
25 MICROGRAMS /HOUR TRANSDERMAL PATCH
50 MICROGRAMS /HOUR TRANSDERMAL PATCH
75 MICROGRAMS /HOUR TRANSDERMAL PATCH
100 MICROGRAMS /HOUR TRANSDERMAL PATCH
fentanyl
Durogesic is a registered trademark and DTrans is a trademark
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.

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2023
CRN00DHMV
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Durogesic DTrans 25 micrograms/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DUROGESIC DOSE (MICROGRAMS/HOUR)
PATCH SIZE (CM
2
)
QUANTITY OF FENTANYL PER PATCH (MG)
DUROGESIC 25 micrograms/hour
25
10.5
4.2
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Durogesic DTrans is a translucent, rectangular transdermal patch with
rounded corners. Each patch is marked in coloured
printing ink as follows:
Each patch is 10.5 cm
2
, and is marked with a border and "DUROGESIC 25 µg fentanyl/h" in red
printing ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Durogesic DTrans is indicated for management of severe chronic pain
that requires continuous long- term opioid
administration.
Children
Long-term management of severe chronic pain in children from 2 years
of age who are receiving opioid therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
DUROGESIC doses should be individualised based upon the status of the
patient and should be assessed at regular intervals
after application. The lowest effective dose should be used. The
patches are designed to deliver approximately 12, 25, 50, 75,
and 100 mcg/h fentanyl to the systemic circulation, which represent
about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
_Initial dosage selection_
The appropriate initiating dose of DUROGESIC should be based on the
patient's current opioid use. It is recommended that
DUROGESIC be used in patients who have demonstrated opioid tolerance.
Other factors to be considered are the current
general condition and medical status of the patient, including body
size, age, and extent of debilitation as well as degree of
opioid tolerance.
Adults
_Opioid-tolerant patients_
To convert opioid-tolerant patients from oral or parenteral opioids to
DUROGESIC refer to Equianalgesic potency conversion
below. The dosage may subsequently