Fetanex 37.5 microgram/hour Transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fentanyl

Available from:

Rowex Ltd

ATC code:

N02AB; N02AB03

INN (International Name):

Fentanyl

Dosage:

37.5 Microgram per hour

Pharmaceutical form:

Transdermal patch

Prescription type:

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

Therapeutic area:

Phenylpiperidine derivatives; fentanyl

Authorization status:

Not marketed

Authorization date:

2008-11-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FETANEX 12.5 MICROGRAM/HOUR TRANSDERMAL PATCH
FETANEX 37.5 MICROGRAM/HOUR TRANSDERMAL PATCH
fentanyl
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 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fetanex is and what it is used for
2.
What you need to know before you use Fetanex
3.
How to use Fetanex
4.
Possible side effects
5.
How to store Fetanex
6.
Contents of the pack and other information
1.
WHAT FETANEX IS AND WHAT IT IS USED FOR
The name of your medicine is Fetanex.
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
medicines and who need continuous pain
treatment.
Fetanex contains an active substance called fentanyl. It belongs to a
group of strong painkillers called
opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FETANEX
DO NOT USE FETANEX 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 Fetanex.
WARNINGS AND PRECAUTIONS
•
Fetanex can have life-threatening side effects in people who are not
already regularly using prescribed
opioid medicines.
•
Fetanex is a medicine t

Summary of Product characteristics

Health Products Regulatory Authority
12 June 2019
CRN0093F5
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fetanex 37.5 microgram/hour Transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patch releases 37.5 micrograms fentanyl per hour. Each patch of
15.75 cm² contains 6.3 mg fentanyl.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Transparent rounded oblong transdermal patch with imprint on the
backing film:
"fentanyl 37.5 µg/h"
The patch consists of a release liner (to be removed prior to
application of the patch) and two functional layers: one
self-adhesive matrix layer containing fentanyl and a backing film
impermeable to water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Fetanex 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
Doses of fentanyl transdermal patches 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
12.5, 25, 37.5, 50, 75 and 100 mcg/h fentanyl to the systemic
circulation, which represent about 0.3, 0.6, 0.9, 1.2, 1.8 and 2.4 mg
per day, respectively.
_Initial dose selection_
The appropriate initiating dose of fentanyl patches should be based on
the patient's current opioid use. It is recommended that
fentanyl patches 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
Fetanex refer to equianalgesic po