Victanyl 100micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Accord-UK 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: 5012617018021

Patient Information leaflet

IMPORTANT THINGS YOU NEED TO KNOW ABOUT VICTANYL TRANSDERMAL PATCHES
•
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).
•
Do not soak in a hot bath or take a hot shower whilst wearing a patch.
•
If you develop a fever tell your doctor immediately.
•
Follow the dosage instructions carefully and only change your patch at
the SAME TIME of day
every 3 DAYS (72 HOURS).
•
If your breathing becomes shallow and weak take the patch off and seek
medical help.
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 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 VICTANYL_ _IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU USE VICTANYL
3 HOW TO USE VICTANYL
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE VICTANYL
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT VICTANYL_ _IS AND WHAT IT IS USED FOR
The name of your medicine is Victanyl.
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
Victanyl contains a medicine called fentanyl. It belongs to a group of
strong painkillers called opioids.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE VICTANYL
DO NOT USE VICTANYL IF:
•
You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6).
•
Y

Summary of Product characteristics

OBJECT 1
VICTANYL 100 MICROGRAMS/HOUR TRANSDERMAL
PATCH
Summary of Product Characteristics Updated 08-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
Victanyl 100 micrograms/hour Transdermal Patch
Fentanyl
2. Qualitative and quantitative composition
Each patch releases 100 micrograms fentanyl per hour. Each patch of 30
cm2 contains 16.5 mg fentanyl.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Each patch: Transparent and colourless patch with blue imprint on the
backing foil “fentanyl 100 µg/h“.
4. Clinical particulars
4.1 Therapeutic indications
Adults:
Victanyl 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
Victanyl 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 25, 50, 75, and 100 mcg/h fentanyl to the
systemic circulation, which represent
about 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
_Initial dosage selection _
The appropriate initiating dose of Victanyl should be based on the
patient's current opioid use. It is
recommended that Victanyl 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
Victanyl 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 achieve the lowest
appropriate dosage of Victanyl depending on
the response and