Durogesic DTrans 50micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Janssen-Cilag Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

50microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012674901113

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUROGESIC
® _DTRANS_
® 12 MICROGRAMS/HOUR TRANSDERMAL PATCH
DUROGESIC
® _DTRANS_
® 25 MICROGRAMS/HOUR TRANSDERMAL PATCH
DUROGESIC
® _DTRANS_
® 50 MICROGRAMS/HOUR TRANSDERMAL PATCH
DUROGESIC
® _DTRANS_
® 75 MICROGRAMS/HOUR TRANSDERMAL PATCH
DUROGESIC
® _DTRANS_
® 100 MICROGRAMS/HOUR TRANSDERMAL PATCH
Fentanyl
Durogesic and DTrans are registered trademarks
IMPORTANT THINGS YOU NEED TO KNOW ABOUT DUROGESIC DTRANS TRANSDERMAL
PATCHES

These patches contain a strong pain killer

Ensure that old patches are removed before applying a new one

Patches must not be cut

Do not expose the patches to a heat source (such as a hot water
bottle)

If you develop a fever tell your doctor immediately

Follow the dosage instructions carefully and only change your patch
every
3 DAYS (72
HOURS)

If your breathing becomes shallow and weak take the patch off and seek
medical help
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 alrea

Summary of Product characteristics

OBJECT 1
DUROGESIC DTRANS 50 MCG/HR TRANSDERMAL PATCH
Summary of Product Characteristics Updated 08-Jun-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Durogesic
®
DTrans
®
50 mcg/hr Transdermal Patch
2. Qualitative and quantitative composition
Each Durogesic DTrans 50 patch contains fentanyl 8.4 mg.
Release rate approximately 50 µg/h; active surface area 21.0 cm
2
.
For excipients, see 6.1
3. Pharmaceutical form
Transdermal patch.
Durogesic is a translucent, rectangular transdermal patch with rounded
corners, marked with the product
name, strength and a border in coloured ink.
Each patch is marked:
Durogesic
50 µg fentanyl/h
Green 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 DTrans 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 DTrans should be based on
the patient's current opioid use. It
is recommended that Durogesic DTrans 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 DTrans refer to
Equianalgesic potency conversion below. The dosage may subsequently be
titrated upwards o