PecFent

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

fentanyl

Available from:

Kyowa Kirin Holdings B.V.

ATC code:

N02AB03

INN (International Name):

fentanyl

Therapeutic group:

Analgesics

Therapeutic area:

Pain; Cancer

Therapeutic indications:

PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2010-08-31

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
PECFENT 100 MICROGRAMS/SPRAY NASAL SPRAY, SOLUTION
PECFENT 400 MICROGRAMS/SPRAY NASAL SPRAY, SOLUTION
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 doctoror 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.
WHAT IS IN THIS LEAFLET
1.
What PecFent is and what it is used for
2.
What you need to know before you use PecFent
3.
How to use PecFent
4.
Possible side effects
5.
How to store PecFent
6.
Contents of the pack and other information
1.
WHAT PECFENT IS AND WHAT IT IS USED FOR
WHAT PECFENT IS
PecFent contains fentanyl, which is a strong pain-relieving medicine
known as an opioid pain killer.
WHAT PECFENT IS USED FOR
PecFent is used in adults with cancer for a type of pain called
‘breakthrough’ pain.
•
Breakthrough pain comes on suddenly.
•
It comes on even though you have taken your usual opioid pain killer
(such as morphine,
fentanyl, oxycodone or hydromorphone) to control your constant
background pain.
PecFent is only to be used by adults who are already taking other
opioid medicines daily for their
constant cancer pain.
HOW PECFENT WORKS
PecFent is a nasal spray, solution
•
When you spray PecFent into your nose the very small spray droplets
form a thin gel.
•
Fentanyl is absorbed quickly through the lining of your nose and into
the blood stream.
•
This means the medicine gets into your system quickly to relieve your
breakthrough pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PECFENT
DO NOT USE PECFENT IF:
•
you are allergic to fentanyl or any of the other ingredients of this
medicine (

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
PecFent 100 micrograms/spray nasal spray, solution
PecFent 400 micrograms/spray nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PecFent 100 micrograms/spray nasal spray, solution
Each ml of solution contains 1,000 micrograms fentanyl (as citrate)
1 spray (100 microlitres) contains 100 micrograms fentanyl (as
citrate)
Bottles contain:
0.95 ml (950 micrograms fentanyl) -
2 spray bottle
or
1.55 ml (1,550 micrograms fentanyl) - 8 spray bottle
PecFent 400 micrograms/spray nasal spray, solution
Each ml of solution contains 4,000 micrograms fentanyl (as citrate)
1 spray (100 microlitres) contains 400 micrograms fentanyl (as
citrate)
Each bottle contains 1.55 ml (6,200 micrograms fentanyl)
Excipients with known effect:
_ _
Each spray contains 0.02 mg propylparahydroxybenzoate (E216).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray).
A clear to practically clear colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PecFent is indicated for the management of breakthrough pain (BTP) in
adults who are already
receiving maintenance opioid therapy for chronic cancer pain.
Breakthrough pain is a transitory
exacerbation of pain that occurs on a background of otherwise
controlled persistent pain.
Patients receiving maintenance opioid therapy are those who are taking
at least 60 mg of oral
morphine daily, at least 25 micrograms of transdermal fentanyl per
hour, at least 30 mg of oxycodone
daily, at least 8 mg of oral hydromorphone daily or an equianalgesic
dose of another opioid for a week
or longer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the supervision of a
physician experienced in the
management of opioid therapy in cancer patients. Physicians should
keep in mind the potential for
abuse of fentanyl.
3
Posology
PecFent should be titrated to an “effective” dose that provides
adequate anal