Actiq 400 micrograms compressed lozenge with integral oromucosal applicator

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Fentanyl

Disponible depuis:

Teva Pharma B.V.

Code ATC:

N02AB; N02AB03

DCI (Dénomination commune internationale):

Fentanyl

Dosage:

400 microgram(s)

forme pharmaceutique:

Compressed lozenge

Type d'ordonnance:

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

Domaine thérapeutique:

Phenylpiperidine derivatives; fentanyl

Statut de autorisation:

Marketed

Date de l'autorisation:

2002-01-23

Notice patient

2
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
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 schedule, for
at least a week, to control your
persistent pain. If you have not been using these medicines you
MUST NOT
use ACTIQ, because it may
increase the risk that breathing could become dangerously slow and/or
shallow, or even st

Résumé des caractéristiques du produit

Health Products Regulatory Authority
09 October 2023
CRN00DJ1Q
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actiq 400 micrograms compressed lozenge with integral oromucosal
applicator
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 400 micrograms fentanyl (as citrate).
Excipient with known effect:
One lozenge contains approximately 1.89 g glucose and 20-36 mg
sucrose.
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
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 indicated for the use of
breakthrough cancer pain, as the pharmacokinetic profiles and/or
dosing schedules of these products are significantly different.
Patients should be instructed not to use more than one short‑acting
fentanyl product concurrently for t