Submena 100 microgram, tabletten voor sublinguaal gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FENTANYLDIWATERSTOFCITRAAT 157 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 100 µg/stuk

INN (Algemene Internationale Benaming):

FENTANYLDIWATERSTOFCITRAAT 157 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 100 µg/stuk

farmaceutische vorm:

Tablet voor sublinguaal gebruik

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551)

Toedieningsweg:

Sublinguaal gebruik

Autorisatie datum:

2021-10-08

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUBMENA 100 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
SUBMENA 200 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
SUBMENA 300 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
SUBMENA 400 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
SUBMENA 600 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
SUBMENA 800 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK
fentanyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Subema is and what it is used for
2.
What you need to know before you take Subema
3.
How to take Subema
4.
Possible side effects
5.
How to store Subema
6.
Contents of the pack and other information
1.
WHAT SUBEMA
IS AND WHAT IT IS USED FOR
Subema is a treatment for adults
WHO MUST ALREADY REGULARLY BE TAKING STRONG PAIN-RELIEVING
MEDICINE (OPIOIDS)
for their persistent cancer pain, but require treatment for their
breakthrough pain.
If you are not sure, talk to your doctor.
Breakthrough pain is pain which occurs suddenly, even though you have
taken or used your usual
opioid pain-relieving medicine.
The active substance in Submena sublingual tablets is fentanyl.
Fentanyl belongs to a group of strong
pain-relieving medicines called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SUBEMA
_ _
DO NOT TAKE SUBEMA
-
If you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in section 6)
- If you have severe breathing problems
- If you are not regularly using a prescribed opioid medicine (e.g
codeine, fentanyl,
hydromorphone, mor

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Submena 100 microgram, tabletten voor sublinguaal gebruik
Submena 200 microgram, tabletten voor sublinguaal gebruik
Submena 300 microgram, tabletten voor sublinguaal gebruik
Submena 400 microgram, tabletten voor sublinguaal gebruik
Submena 600 microgram, tabletten voor sublinguaal gebruik
Submena 800 microgram, tabletten voor sublinguaal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains:
157 micrograms of fentanyl citrate equivalent to 100 micrograms of
fentanyl
314 micrograms of fentanyl citrate equivalent to 200 micrograms of
fentanyl
471 micrograms of fentanyl citrate equivalent to 300 micrograms of
fentanyl
628 micrograms of fentanyl citrate equivalent to 400 micrograms of
fentanyl
943 micrograms of fentanyl citrate equivalent to 600 micrograms of
fentanyl
1275 micrograms of fentanyl citrate equivalent to 800 micrograms of
fentanyl
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
100 microgram sublingual tablet is a 6 mm white round tablet
200 microgram sublingual tablet is a 7 x 5 mm white oval-shaped tablet
300 microgram sublingual tablet is a 6 x 6 mm white triangle-shaped
tablet
400 microgram sublingual tablet is a 9 x 7 mm white diamond-shaped
tablet
600 microgram sublingual tablet is a 9 x 6 mm white “D”-shaped
tablet
800 microgram sublingual tablet is a 10 x 6 mm white capsule-shaped
tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of breakthrough pain in adult patients using opioid therapy
for chronic cancer pain.
Breakthrough pain is a transient exacerbation of otherwise controlled
chronic background pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Submena should only be administered to patients who are considered
tolerant to their opioid therapy
for persistent cancer pain. Patients can be considered opioid tolerant
if they take at least 60 mg of oral
morphine daily, at least 25 micrograms of transdermal fentanyl per
hour, at least 30