Mylafent 100micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Viatris UK Healthcare Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

100microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5016695001685

Patient Information leaflet

PAGE 1 OF 13
PACKAGE LEAFLET
PAGE 2 OF 13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
M
YLAFENT
® 12
MICROGRAM
/
HOUR
T
RANSDERMAL
P
ATCH
M
YLAFENT
® 25
MICROGRAM
/
HOUR
T
RANSDERMAL
P
ATCH
M
YLAFENT
® 50
MICROGRAM
/
HOUR
T
RANSDERMAL
P
ATCH
M
YLAFENT
® 75
MICROGRAM
/
HOUR
T
RANSDERMAL
P
ATCH
M
YLAFENT
® 100 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
These patches contain a strong pain killer.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Mylafent is and what it is used for
2.
What you need to know before you use Mylafent.
3.
How to use Mylafent.
4.
Possible side effects
5.
How to store Mylafent.
6.
Contents of the pack and other information
1.
WHAT M
YLAFENT
IS AND WHAT IT IS USED FOR
Mylafent contains fentanyl, which belongs to a group of strong
painkillers called opioids.
The painkiller, fentanyl, slowly passes from the patch, through the
skin and into the body.
Adults:
Mylafent is indicated in severe chronic pain which can be adequately
managed only with opioid
analgesics.
Children and adolescents:
Mylafent is used for the long term treatment of severe and long
lasting pain in children and
adole

Summary of Product characteristics

OBJECT 1
MYLAFENT 100 MICROGRAM/HOUR TRANSDERMAL
PATCH
Summary of Product Characteristics Updated 03-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Mylafent 100 microgram/hour Transdermal Patch
2. Qualitative and quantitative composition
Each Mylafent 100 microgram/hour transdermal patch contains 16.8 mg of
fentanyl in a patch size 42.0
cm
2
, releasing 100 micrograms of fentanyl per hour.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
A translucent rectangular patch printed with white ink on a removable
liner.
The following is printed on each patch:
Fentanyl 100 µg/h
4. Clinical particulars
4.1 Therapeutic indications
Adults:
Mylafent is indicated in severe chronic pain which can be adequately
managed only with opioid
analgesics.
Children and adolescents:
Long term management of severe chronic pain in children and
adolescents receiving opioid therapy from
2 years of age.
4.2 Posology and method of administration
Posology
Adults:
_Initial dose selection_
The dosing is individual and based on the patient's opioid history and
takes in to account:
• possible development of tolerance
• the current general condition, the medical status of the patient,
and
• the degree of severity of the disorder
The required fentanyl dosage is adjusted individually and should be
assessed regularly after each
administration.
_Patients receiving opioid treatment for the first time_
Patches with a release rate of 12 micrograms/hour are available and
should be used for initial dosing. In
very elderly or weak patients, it is not recommended to initiate a
treatment with Mylafent, due to their
known susceptibility to opioid treatments. In these cases, it would be
preferable to initiate a treatment
with low doses of immediate release morphine and to prescribe Mylafent
after determination of the
optimal dosage.
_Switching from other opioids_
When changing over from oral or parenteral opioids to fentanyl
treatment, the initial dosage should be
calculated as follows:
1. The qu