Actiq 1600 micrograms compressed lozenge with integral oromucosal applicator

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

FENTANYL CITRATE

Prieinama:

Teva Pharma B.V.

ATC kodas:

N02AB; N02AB03

INN (Tarptautinis Pavadinimas):

FENTANYL CITRATE

Dozė:

1600 microgram(s)

Vaisto forma:

Lozenge

Recepto tipas:

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

Gydymo sritis:

Phenylpiperidine derivatives; fentanyl

Autorizacija statusas:

Not marketed

Leidimo data:

2002-01-23

Pakuotės lapelis

23
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIQ 200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
ACTIQ 400 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
ACTIQ 600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
ACTIQ 800 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
ACTIQ 1,200 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
ACTIQ 1,600 MICROGRAMS COMPRESSED LOZENGE WITH INTEGRAL OROMUCOSAL
APPLICATOR
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 ACTIQ is and what it is used for
2.
What you need to know before you use ACTIQ
3.
How to use ACTIQ
4.
Possible side effects
5.
How to store ACTIQ
6.
Contents of the pack and other information
1.
WHAT ACTIQ IS AND WHAT IT IS USED FOR
ACTIQ contains the active substance fentanyl which is a strong
pain-relieving medicine known as an opioid.
The ACTIQ unit comes as a lozenge on a stick.
•
It is used to treat breakthrough pain in adults and adolescents aged
16 years and above with cancer
who are already taking other opioid pain medicines for their
persistent (around-the-clock) cancer pain.
Breakthrough pain is additional sudden pain that occurs suddenly in
spite of your having taken your
usual opioid pain-relieving medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIQ
DO NOT USE ACTIQ:
•
if you are not regularly using a prescribed opioid medicine (e.g.
codeine, fentanyl, hydromorphone,
morphine, oxycodone, pethidine), every day on a regular sc

Prekės savybės

Health Products Regulatory Authority
17 December 2018
CRN008KR0
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actiq 1600 micrograms compressed lozenge with integral oromucosal
applicator.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 1600 micrograms fentanyl (as citrate).
Excipients(s) with known effect:
Each lozenge contains dextrates (equivalent to approximately 2 grams
of glucose),
sucrose (approximately 30 milligrams confectioner’s sugar) and
propylene glycol
(part of the artificial berry flavour and imprinting ink) as
excipients.
_For the full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Compressed lozenge with integral oromucosal applicator.
Actiq is formulated as a white to off-white compressed powder
medicinal product
matrix attached using edible glue to a fracture resistant radio opaque
plastic
applicator. The dosage strength is marked on the lozenge and on the
plastic
applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Actiq is indicated for the management of breakthrough pain in patients
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
Posology
Health Products Regulatory Authority
17 December 2018
CRN008KR0
Page 2 of 19
In order to minimise the risks of opioid‑related adverse reactions
and to identify the
successful dose, it is imperative that patients be monitored closely
by health
professionals during the titration process.
ACTIQ is not interchangeable on a mcg to mcg basis with other
short‑acting fentanyl
products that are indicat