Fencino 25micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Luye Pharma Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

25microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5060078671583

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENCINO 12 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENCINO 25 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENCINO 50 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENCINO 75 MICROGRAMS/HOUR TRANSDERMAL PATCH
FENCINO 100 MICROGRAMS/HOUR TRANSDERMAL PATCH
fentanyl
_ _

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 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 Fencino is and what it is used for
2.
What you need to know before you use Fencino
3.
How to use Fencino
4.
Possible side effects
5.
How to store Fencino
6.
Contents of the pack and other information
1.
WHAT FENCINO IS AND WHAT IT IS USED FOR
The name of your medicine is Fencino.
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
Fencino contains a medicine called fentanyl. It belongs to a group of
strong painkillers cal

Summary of Product characteristics

OBJECT 1
FENCINO 12 MICROGRAMS/HOUR TRANSDERMAL
PATCH
Summary of Product Characteristics Updated 08-Mar-2017 | Ethypharm UK
Ltd
1. Name of the medicinal product
Fencino 12 micrograms/hour transdermal patch
Fencino 25 micrograms/hour transdermal patch
Fencino 50 micrograms/hour transdermal patch
Fencino 75 micrograms/hour transdermal patch
Fencino 100 micrograms/hour transdermal patch
2. Qualitative and quantitative composition
Fencino 12 micrograms/hour: 1 transdermal patch contains 2.55 mg
fentanyl in a patch size of 4.25 cm
2
and releases 12.5 micrograms fentanyl per hour.
Fencino 25 micrograms/hour: 1 transdermal patch contains 5.1 mg
fentanyl in a patch size of 8.5 cm
2
and
releases 25 micrograms fentanyl per hour.
Fencino 50 micrograms/hour: 1 transdermal patch contains 10.2 mg
fentanyl in a patch size of 17 cm
2
and
releases 50 micrograms fentanyl per hour.
Fencino 75 micrograms/hour: 1 transdermal patch contains 15.3 mg
fentanyl in a patch size of 25.5 cm
2
and releases 75 micrograms fentanyl per hour.
Fencino 100 micrograms/hour: 1 transdermal patch contains 20.4 mg
fentanyl in a patch size of 34 cm
2
and releases 100 micrograms fentanyl per hour.
Excipient with known effect: soya oil
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Fencino is an opaque, colourless, rectangular shaped patch with round
corners and imprint on the backing
foil:
“Fentanyl 12µg/h” for Fencino 12 micrograms/hour
“Fentanyl 25µg/h” for Fencino 25 micrograms/hour
“Fentanyl 50µg/h” for Fencino 50 micrograms/hour
“Fentanyl 75µg/h” for Fencino 75 micrograms/hour
“Fentanyl 100µg/h” for Fencino 100 micrograms/hour
4. Clinical particulars
4.1 Therapeutic indications
ADULTS
Fencino 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
Fencino doses sh