Fentanyl Qube 400 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik

Land: Holland

Sprog: hollandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv bestanddel:

FENTANYLDIWATERSTOFCITRAAT 628,4 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 400 µg/stuk

Tilgængelig fra:

Proteus Pharma S.L. Camino Labiano 45B- Bajo derecha 31192 MUTILVA (SPANJE)

ATC-kode:

N02AB03

INN (International Name):

FENTANYLDIWATERSTOFCITRAAT 628,4 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 400 µg/stuk

Lægemiddelform:

Zuigtablet

Sammensætning:

AARDAPPELZETMEEL ; AMMONIA (E 527) ; ARABISCHE GOM (E 414) ; ASCORBINEZUUR (L-) (E 300) ; AZIJNZUUR (E 260) ; BLAUWE INKT ; BRILJANTBLAUW FCF (E 133) ; CITROENZUUR 0-WATER (E 330) ; DEXTRATEN ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; EETBARE LIJM ; GLYCEROLTRIACETAAT (E 1518) ; KUNSTMATIGE BESSENSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904)

Indgivelsesvej:

Oromucosaal gebruik

Terapeutisk område:

Fentanyl

Autorisation dato:

2019-06-03

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL QUBE 200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL QUBE 400 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL QUBE 600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL QUBE 800 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL QUBE 1200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL QUBE 1600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
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 Fentanyl Qube is and what it is used for.
2.
What you need to know before you take Fentanyl Qube
3.
How to take FentanylQube.
4.
Possible side effects
5.
How to store Fentanyl Qube
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Fentanyl Qube contains the active substance fentanyl which is a strong
pain-relieving medicine known as an
opioid.
The Fentanyl Qube 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 TAKE FENTANYL QUBE
DO NOT USE FENTANYL Q

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fentanyl Qube 200 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
Fentanyl Qube 400 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
Fentanyl Qube 600 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
Fentanyl Qube 800 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
Fentanyl Qube 1200 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
Fentanyl Qube 1600 microgram zuigtabletten met integrale applicator
voor oromucosaal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl Qube 200 microgram compressed lozenges One compressed lozenge
contains 200 micrograms
fentanyl (as citrate)
Fentanyl Qube 400 microgram compressed lozenges One compressed lozenge
contains 400 micrograms
fentanyl (as citrate)
Fentanyl Qube 600 microgram compressed lozenges One compressed lozenge
contains 600 micrograms
fentanyl (as citrate)
Fentanyl Qube 800 microgram compressed lozenges One compressed lozenge
contains 800 micrograms
fentanyl (as citrate)
Fentanyl
Qube
1200
microgram
compressed
lozenges
One
compressed
lozenge
contains
1200
micrograms fentanyl (as citrate)
Fentanyl
Qube
1600
microgram
compressed
lozenges
One
compressed
lozenge
contains
1600
micrograms fentanyl (as citrate)
Excipients with known effect
One compressed lozenge contains 1.89g of glucose (as hydrated
dextrates) For
the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Compressed lozenge.
is a white or slightly yellowish cylindrical lozenge
of 17 – 20 mm of thickness and 11
– 12 mm of diameter, on which its respective dosage strength is
printed, attached to a plastic handle at the
opposite end also labelled with the dosage strength. The lozenges may
develop brownish spots during
storage.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated for management of breakthrough pain in
patients already receiving
maintenan