Victanyl 12micrograms/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:

12microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012617025777

Patient Information leaflet

BBBA1117
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VICTANYL 12MICROGRAMS/HOUR
TRANSDERMAL PATCH
Fentanyl
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 or pharmacist.
•
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 or pharmacist. 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 Transdermal Patch. It is called
‘Victanyl patch’ or just ‘patch’ in this
leaflet.
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 patch contains a medicine called fentanyl. It belongs to a
group of strong painkillers called
opioids.
2
_ _WHAT YOU NEED TO K

Summary of Product characteristics

OBJECT 1
VICTANYL 12MICROGRAMS/HOUR TRANSDERMAL PATCH
Summary of Product Characteristics Updated 07-Apr-2017 | Accord-UK Ltd
1. Name of the medicinal product
Victanyl 12micrograms/hour Transdermal Patch
2. Qualitative and quantitative composition
Victanyl 12 micrograms/h transdermal patch
Each patch releases 12.5 micrograms fentanyl per hour. Each patch of
4.25 cm
2
contains 2.55 mg
fentanyl.
Excipient with known effect
Aloe vera leaf extract oil (on the basis of soya oil tocopherol
acetate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Each patch: Opaque and colourless rectangular shaped patch with round
corners and imprint on the
backing foil:
“Fentanyl 12µg/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 patch is designed to
deliver approximately 12 mcg/h fentanyl to the systemic circulation,
which represent about 0.3 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,
i