BREAKYL 1200 microgram buccal film

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FENTANYL CITRATE

Available from:

Mylan IRE Healthcare Limited

ATC code:

N02AB; N02AB03

INN (International Name):

FENTANYL CITRATE

Dosage:

1200 microgram(s)

Pharmaceutical form:

Buccal film

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Phenylpiperidine derivatives; fentanyl

Authorization status:

Not marketed

Authorization date:

2011-05-03

Patient Information leaflet

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_ _
B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BREAKYL 200 MICROGRAM BUCCAL FILM
BREAKYL 400 MICROGRAM BUCCAL FILM
BREAKYL 600 MICROGRAM BUCCAL FILM
BREAKYL 800 MICROGRAM BUCCAL FILM
BREAKYL 1200 MICROGRAM BUCCAL FILM
Active substance: 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.
WHAT IS IN THIS LEAFLET:
1.
What Breakyl is and what it is used for
2.
What you need to know before you use Breakyl
3.
How to use Breakyl
4.
Possible side effects
5.
How to store Breakyl
6.
Contents on the pack and other information
1.
WHAT BREAKYL IS AND WHAT IT IS USED FOR
Breakyl buccal film contains the active substance fentanyl, a strong
pain-relieving medicine known as an
opioid. Breakyl is indicated for the management of breakthrough cancer
pain in adult patients. Breakthrough
pain is additional sudden pain. This may occur although you have taken
your regular opioid pain relieving
medicine.
Breakyl must only be used, if you are already taking and are used to
regular opioid therapy like morphine,
oxycodone, or transdermal fentanyl for a minimum of one week to treat
your chronic cancer pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BREAKYL
DO NOT USE BREAKYL:

if you are allergic (hypersensitive) to fentanyl, or any of the other
ingredients of this medicine (listed in
section 6).

if you are currently taking monoamine-oxidase (MAO) inhibitors (used
for severe depression) or have
done so in the past 2 weeks.

if you suffer from severe breathing problems or severe obstructive
lung conditions (like severe ast

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2019
CRN008J71
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BREAKYL 1200 microgram buccal film
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One buccal film contains: 1200 micrograms fentanyl (as fentanyl
citrate)
Excipients with known effect:
Breakyl, strength (microgram)
Excipient
1200
propylene glycol (E1520) (mg)
1.04
Sodium benzoate (E211) (mg)
0.69
methyl parahydroxybenzoate (E218) (mg)
0.71
propyl parahydroxybenzoate (E216) (mg)
0.18
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Buccal film
Breakyl is a soluble rectangular, flat, flexible buccal film with a
pink side and a white side designed to deliver fentanyl directly
into the blood circulation. The pink side contains the active
substance fentanyl. The white side minimises fentanyl release into
the saliva to avoid swallowing of the active substance.
The following stencil shows the sizes of the available Breakyl
strengths:
__________________________________________________
microgam microgram microgram microgram microgram
0.78 cm
2
1.56 cm
2
2.34 cm
2
3.11 cm
2
4.67 cm
2
(Dimensions probably incorrect if viewed electronically.)
Each buccal film is individually sealed in a child resistant sachet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BREAKYL IS INDICATED FOR THE TREATMENT OF BREAKTHROUGH PAIN (BTP) IN
ADULTS WITH CANCER WHO ARE ALREADY RECEIVING
MAINTENANCE OPIOID THERAPY FOR CHRONIC CANCER PAIN.
BTP 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.
Health Products Regulatory Authority
29 July 2019
CRN008J71
Page 2 of 12
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment has to be in