Fental Matrix 50 micrograms/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:

50 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:

Marketed

Authorization date:

2007-04-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENTAL MATRIX 25 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENTAL MATRIX 50 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENTAL MATRIX 75 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENTAL MATRIX 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. 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 Fental Matrix is and what it is used for
2. What you need to know before you use Fental Matrix
3. How to use Fental Matrix
4. Possible side effects
5.
How to store Fental Matrix
6. Contents of the pack and other information
1.
WHAT FENTAL MATRIX IS AND WHAT IT IS USED FOR
The name of your medicine is Fental Matrix.
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.
Fental Matrix 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 FENTAL MATRIX
DO NOT USE FENTAL MATRIX IF:
•
You are allergic to fentanyl, colophonium resin (hydrogenated), soya,
peanuts 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 doct

Summary of Product characteristics

Health Products Regulatory Authority
01 September 2023
CRN00DHMY
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fental Matrix 50 micrograms/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch (21 cm
2
absorption surface area) contains 11.56 mg fentanyl equivalent to a
release rate of the active
substance of 50 microgram/hour.
Excipient with known effect:
Each transdermal patch contains 11.56 mg of refined Soya-bean oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Transparent rounded oblong transdermal patch, consisting of a
protective film (to be removed prior to application of the
patch) and two functional layers: one self-adhesive matrix layer
containing fentanyl and a carrier film impermeable to water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Fental Matrix 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, 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 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