Opiodur 12micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Pfizer Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

12microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5013457011012

Patient Information leaflet

Page 1 of 16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPIODUR
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
•
These patches contain a strong painkiller.
•
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 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 or pharmacist.
-
This medicine has been prescribed for you. 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.
WHAT IS IN THIS LEAFLET
1.
What Opiodur is and what it is used for
2.
What you need to know before you use Opiodur
3.
How to use Opiodur
4.
Possible side effects
5.
How to store Opiodur
6.
Contents of the pack and other information
1.
WHAT OPIODUR IS AND WHAT IT IS USED FOR
Fentanyl is one of a group of strong painkillers called opioids.
The painkiller, fentanyl, slowly passes from the patch, through the
skin and into the body.
ADULTS
Opiodur is used for treatment of severe and long-lasting pain that can
only adequately be managed
with strong pain relievers (opioids).
CHILDREN
Long term management of severe chronic pain in children receiving
opioid therapy from 2 years of
age.
Page 2 of 16
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPIODUR
DO NOT USE OPIODUR:
-
if you are allergic to fentanyl or any of

Summary of Product characteristics

OPIODUR 12 MICROGRAMS/HOUR TRANSDERMAL PATCH
Summary of Product Characteristics Updated 02-Aug-2016 | Pfizer
Limited
1. Name of the medicinal product
Opiodur 12 micrograms/hour transdermal patch
2. Qualitative and quantitative composition
Each Opiodur 12 micrograms/ hour transdermal patch contains 1.375 mg
of fentanyl in a patch size of
5cm
2
, releasing 12 micrograms of fentanyl per hour.
Excipients(s) with known effect:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal Patch
Opiodur transdermal patch is a rectangular, tan coloured patch placed
between two oversized, transparent
protective layers which must be removed prior to the patch
application.
The patches will be imprinted:
“Fentanyl 12 μg/h“ in red ink
4. Clinical particulars
4.1 Therapeutic indications
ADULTS
This product is indicated in severe chronic pain which can be
adequately managed only with opioid
analgesics.
CHILDREN
Long term management of severe chronic pain in children receiving
opioid therapy from 2 years of age.
4.2 Posology and method of administration
It is not possible to ensure the interchangeability of different
fentanyl containing transdermal patch
product in individual patients. Therefore, it should be emphasised
that patients should not be changed
from one fentanyl containing product to another without specific
counselling on the change from their
healthcare professionals.
Initial dose selection
The appropriate initiating dose of fentanyl should be based on the
patient's current opioid use. It is
recommended that fentanyl 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
fentanyl refer to _Equianalgesic _
_potency conversion_ below. The dosage may subsequently be titrated
upwards or downwards, if