MATRIFEN 12 Microgram per hour Transdermal Patch

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

FENTANYL

Verfügbar ab:

Takeda UK Limited

ATC-Code:

N02AB03

INN (Internationale Bezeichnung):

FENTANYL

Dosierung:

12 Microgram per hour

Darreichungsform:

Transdermal Patch

Verschreibungstyp:

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

Therapiebereich:

Phenylpiperidine derivatives

Berechtigungsstatus:

Transfer Pending

Berechtigungsdatum:

2013-03-22

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
_Matrifen 12 micrograms/hour transdermal patch _
_Matrifen 25 micrograms/hour transdermal patch _
_Matrifen 50 micrograms/hour transdermal patch _
_Matrifen 75 micrograms/hour transdermal patch _
_Matrifen 100 micrograms/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 (or your child). 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 Matrifen is and what it is used for
2.
What you need to know before you use Matrifen
3.
How to use Matrifen
4.
Possible side effects
5.
How to store Matrifen
6.
Contents of the pack and other information
1.
WHAT MATRIFEN IS AND WHAT IT IS USED FOR
The name of your medicine is Matrifen
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.
Matrifen contains a medicine called fentanyl. It belongs to a group of
strong painkillers called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MATRIFEN
DO NOT USE MATRIFEN 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 Matrifen.
WARNIN

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Matrifen, 12 micrograms/hour Transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Matrifen 12 micrograms/hour:
Each transdermal
patch contains 1.38 mg fentanyl in a patch of 4.2 cm
2
and releases
fentanyl 12 micrograms/hour
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Rectangular, translucent patch on a removable protective film. The
protective film is larger than the patch.
Patches are marked with a coloured imprint stating the trade name and
strength:
Matrifen 12 micrograms/hour patch: brown imprint
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults:
Matrifen 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
Matrifen 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 Matrifen should be based on the
patient’s current opioid use. It is recommended that
Matrifen 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
Matrifen refer to Equianalgesic potency conversion
below. The dosage may subsequently be titrated upwards or downwards,
if required, in increments of either 12 or 25 mcg/h
to achiev