BREAKYL 400 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENTANYL AS CITRATE

Available from:

MEGAPHARM LTD

ATC code:

N01AH01

Pharmaceutical form:

BUCCAL FILM

Composition:

FENTANYL AS CITRATE 400 MCG

Administration route:

OROMUCOSAL

Prescription type:

Required

Manufactured by:

MEDA PHARMA GmbH & CO.KG, GERMANY

Therapeutic area:

FENTANYL

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.

Authorization date:

2015-08-19

Patient Information leaflet

Megapharm Ltd.
BREAK PIL 012016 P.3
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
BREAKYL 200, 400, 600, 800, 1200 MCG_ _
BUCCAL FILM
COMPOSITION:
ACTIVE INGREDIENT:
Fentanyl (as citrate) 200, 400, 600, 800, 1200 mcg.
For the full ingredients list see: “Additional information”.
_ _
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential
information about this medicine. If you have any further questions,
refer to the physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it
seems to you that their illness is similar.
The medicine is not intended for use in children and adolescents below
the age of 18 years.
WHAT IS THIS MEDICINE INTENDED FOR?
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.
You may use BREAKYL only if you are taking other opioids such as
morphine, oxycodone or transdermal fentanyl
as maintenance opioid therapy for chronic cancer pain for at least 1
week.
THERAPEUTIC GROUP: BREAKYL belongs to the group of opioid drugs.
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE THE TREATMENT WITH BREAKYL, TELL YOUR PHYSICIAN IF:
•
The other opioids taken by you for chronic cancer pain have not yet
been stabilised in your body (less than
one week)_ _
•
You suffer from respiratory problems
•
You suffer from a head injury and the physician has diagnosed an
increased intracranial pressure
•
You have an abnormally slow heart rate or other heart problems
•
You have low blood pressure, especially due to a low volume of fluid
in the blood circulation
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allerg

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BREAKYL 200 microgram
BREAKYL 400 microgram
BREAKYL 600 microgram
BREAKYL 800 microgram
BREAKYL 1200 microgram
BREAKYL Start 200, 400, 600, 800 microgram
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Breakyl 200 microgram buccal film
One buccal film contains: 200 micrograms fentanyl (as fentanyl
citrate),
Breakyl 400 microgram buccal film
One buccal film contains: 400 micrograms fentanyl (as fentanyl
citrate),
Breakyl 600 microgram buccal film
One buccal film contains: 600 micrograms fentanyl (as fentanyl
citrate),
Breakyl 800 microgram buccal film
One buccal film contains: 800 micrograms fentanyl (as fentanyl
citrate),
Breakyl 1200 microgram buccal film
One buccal film contains: 1200 micrograms fentanyl (as fentanyl
citrate).
Excipients with known effect:
Breakyl, strength (microgram)
Excipient
200
400
600
800
1200
propylene glycol (mg)
0.17
0.35
0.52
0.70
1.04
Sodium benzoate (mg)
0.11
0.23
0.34
0.46
0.69
methyl parahydroxybenzoate (E218) (mg)
0.12
0.24
0.36
0.48
0.71
propyl parahydroxybenzoate (E216) (mg)
0.03
0.06
0.09
0.12
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:
Microgram
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.)
2
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