Fentadur 12 micrograms/hour transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fentanyl

Available from:

Lavipharm S.A.

ATC code:

N02AB; N02AB03

INN (International Name):

Fentanyl

Dosage:

12 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:

2012-05-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTADUR
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
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 Fentadur is and what it is used for
2.
What you need to know before you use Fentadur
3.
How to use Fentadur
4.
Possible side effects
5.
How to store Fentadur
6.
Contents of the pack and other information
1.
WHAT
FENTADUR IS AND WHAT IT IS USED FOR
The name of your medicine is Fentadur.
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.
Fentadur contains a medicine called fentanyl. It belongs to a group of
strong painkillers called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FENTADUR
DO NOT USE FENTADUR IF:
-
You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6).
-
You suffer from 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 Fentadur.
WARNINGS AND PRECAUTIONS
PATCH STICKING TO ANOTHER PERSON
The patch sho

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2024
CRN00DJRR
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentadur 12 micrograms/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fentadur 12 micrograms/ hour transdermal patch contains 1.375 mg
of fentanyl in a patch size of 5 cm
2
, releasing 12
micrograms of fentanyl per hour.
Excipients with known effect:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
Fentadur transdermal patch is rectangular with rounded corners and a
two-colour printing on its backing. It is placed between
two oversized, transparent protective layers which must be removed
prior to the patch application.
The patches are printed as follows:
Beige diagonal stripes with repetitive "Fentanyl" in orange font
alternating with orange diagonal stripes with repetitive "12
microg/h" in beige font.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
The product 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 receiving
opioid therapy from 2 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fentadurdoses 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 dose selection
The appropriate initiating dose of Fentadur should be based on the
patient's current opioid use. It is recommended that
Fentadur 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
Opi