Breakyl 400microgram buccal films

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Fentanyl citrate

Disponibil de la:

Meda Pharmaceuticals Ltd

Codul ATC:

N02AB03

INN (nume internaţional):

Fentanyl citrate

Dozare:

400microgram

Forma farmaceutică:

Buccal film

Calea de administrare:

Buccal

Clasă:

Schedule 2 (CD)

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04070200

Prospect

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 Breakyl (for a full list of ingredients see “Further
infor
mation” at the end of this leaflet).
•
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 asthma).
•
if you are not regularly using a prescribed opioid medicine (e.g.
codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine),
every day on a regular schedule, for at least a week, to control your
persistent pain. If you have not been using these medicines you
must not use Breakyl, because it may increase the risk that breathing
could become dangerously slow and/or shallow, or even stop.
•
if you suffer from short-term pain other than breakthrough pain.
Warnings and Precautions
Talk to your doctor before starting Breakyl, if you have any of the
following, as your doctor will need to take account of this when
pre
scribing your dose:
•
Your other opioid pain medicine taken for your chronic cancer pain
is not stabilised yet
•
You are suffering from any condition that has an effect on your
breathing.
•
You have a head injury or if your doctor has diagnosed an increased
cranial pressure.
•
You have problems with your heart, especially slow heart rate, or
other heart problems.
•
You have low blood pressure, especially due to a low amount of
fluid in the circulation.
•
You have liver or kidney problems, as these organs have an effect
on the way in which your system breaks down the medicine.
•
You are suffering from oral mucositis
•
You take antidepressants or antipsychotics, please refer to the
section ‘Other medicines and Breakyl’
For more information see section 3.
Children and adolescents
Do not give this medicine to children between the ages of 0 and 18
years.
Breakyl contains fentanyl in an amo

Caracteristicilor produsului

OBJECT 1
BREAKYL 400MCG BUCCAL FILM
Summary of Product Characteristics Updated 22-Jun-2015 | Meda
Pharmaceuticals
1. Name of the medicinal product
BREAKYL 400 microgram, buccal film
2. Qualitative and quantitative composition
Breakyl 400 microgram buccal film
One buccal film contains:
400 micrograms fentanyl (as fentanyl citrate),
Excipients with known effect:
Breakyl, strength (microgram)
Excipient
400
propylene glycol (E1520) (mg)
0.35
sodium benzoate (E211) (mg)
0.23
methyl parahydroxybenzoate (E218) (mg)
0.24
propyl parahydroxybenzoate (E216) (mg)
0.06
For a 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:
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 equi-analgesic dose of another
opioid for a week or longer.
4.2 Posology and method of administration
Treatment has to be initiated by and maintained under the guidance of
a physician experienced in the
management of opioid therapy in cancer patients. In order to minimise
the risks of opioid-related
undesirable effects and to identify the “successful“ dose, it