Fentanyl Generics 400 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FENTANYLDIWATERSTOFCITRAAT SAMENSTELLING overeenkomend met ; FENTANYL

Beschikbaar vanaf:

Generics (UK) Ltd. Station Close EN6 1TL POTTERS BAR, HERTFORDSHIRE (VERENIGD KONINKRIJK)

ATC-code:

N02AB03

INN (Algemene Internationale Benaming):

FENTANYLDIWATERSTOFCITRAAT COMPOSITION corresponding to ; FENTANYL

farmaceutische vorm:

Zuigtablet

Samenstelling:

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)

Toedieningsweg:

Oromucosaal gebruik

Therapeutisch gebied:

Fentanyl

Autorisatie datum:

2019-06-03

Bijsluiter

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PACKAGE LEAFLET
2 de 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENTANYL GENERICS 200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL GENERICS 400 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL GENERICS 600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL GENERICS 800 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR
VOOR OROMUCOSAAL GEBRUIK
FENTANYL GENERICS 1200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE
APPLICATOR VOOR OROMUCOSAAL GEBRUIK
FENTANYL GENERICS 1600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE
APPLICATOR VOOR OROMUCOSAAL GEBRUIK
fentanyl
READ ALL OFTHIS 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 Generics is and what it is used for.
2.
What you need to know before you take Fentanyl Generics
3.
How to take Fentanyl Generics
4.
Possible side effects
5.
How to store Fentanyl Generics
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Fentanyl Generics contains the active substance fentanyl which is a
strong pain-relieving medicine known
as an opioid.
The Fentanyl Generics 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 medicine

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fentanyl Generics 200 microgram zuigtabletten met integrale applicator
voor oromucosaal
gebruik
Fentanyl Generics 400 microgram zuigtabletten met integrale applicator
voor oromucosaal
gebruik
Fentanyl Generics 600 microgram zuigtabletten met integrale applicator
voor oromucosaal
gebruik
Fentanyl Generics 800 microgram zuigtabletten met integrale applicator
voor oromucosaal
gebruik
Fentanyl Generics 1200 microgram zuigtabletten met integrale
applicator voor oromucosaal
gebruik
Fentanyl Generics 1600 microgram zuigtabletten met integrale
applicator voor oromucosaal
gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl Generics 200 microgram compressed lozenges
One compressed lozenge contains 200 micrograms fentanyl (as citrate)
Fentanyl Generics 400 microgram compressed lozenges
One compressed lozenge contains 400 micrograms fentanyl (as citrate)
Fentanyl Generics 600 microgram compressed lozenges
One compressed lozenge contains 600 micrograms fentanyl (as citrate)
Fentanyl Generics 800 microgram compressed lozenges
One compressed lozenge contains 800 micrograms fentanyl (as citrate)
Fentanyl Generics 1200 microgram compressed lozenges
One compressed lozenge contains 1200 micrograms fentanyl (as citrate)
Fentanyl Generics 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.
Fentanyl Generics 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
Fentanyl Generics is indicated for management of break