Effentora

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

fentanyl

Διαθέσιμο από:

Teva B.V.

Φαρμακολογική κατηγορία (ATC):

N02AB03

INN (Διεθνής Όνομα):

fentanyl

Θεραπευτική ομάδα:

Analgesics

Θεραπευτική περιοχή:

Pain; Cancer

Θεραπευτικές ενδείξεις:

Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP 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. ,

Περίληψη προϊόντος:

Revision: 28

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-04-04

Φύλλο οδηγιών χρήσης

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFFENTORA 100 MICROGRAMS BUCCAL TABLETS
EFFENTORA 200 MICROGRAMS BUCCAL TABLETS
EFFENTORA 400 MICROGRAMS BUCCAL TABLETS
EFFENTORA 600 MICROGRAMS BUCCAL TABLETS
EFFENTORA 800 MICROGRAMS BUCCAL TABLETS
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 Effentora is and what it is used for
2.
What you need to knowbefore you use Effentora
3.
How to use Effentora
4.
Possible side effects
5.
How to store Effentora
6.
Contents of the pack and other information
1.
WHAT EFFENTORA IS AND WHAT IT IS USED FOR
The active substance of Effentora is fentanyl citrate. Effentora is a
pain-relieving medicine known as
an opioid, which is used to treat breakthrough pain in adult patients
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 in spite of
you having taken your usual opioid
pain-relieving medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EFFENTORA
DO NOT USE EFFENTORA:
•
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 Effentora,
because it may increase the risk that breathing could become
dangerously slow and/or shallow, or
even stop.
•
If you are allergic to fentanyl or any of the ot

Αρχείο Π.Χ.Π.

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Effentora 100 micrograms buccal tablets
Effentora 200 micrograms buccal tablets
Effentora 400 micrograms buccal tablets
Effentora 600 micrograms buccal tablets
Effentora 800 micrograms buccal tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Effentora 100 micrograms buccal tablets
Each buccal tablet contains 100 micrograms fentanyl (as citrate).
Excipient with known effect: Each tablet contains 10 mg of sodium.
Effentora 200 micrograms buccal tablets
Each buccal tablet contains 200 micrograms fentanyl (as citrate).
Excipient with known effect: Each tablet contains 20 mg of sodium.
Effentora 400 micrograms buccal tablets
Each buccal tablet contains 400 micrograms fentanyl (as citrate).
Excipient with known effect: Each tablet contains 20 mg of sodium.
Effentora 600 micrograms buccal tablets
Each buccal tablet contains 600 micrograms fentanyl (as citrate).
Excipient with known effect: Each tablet contains 20 mg of sodium.
Effentora 800 micrograms buccal tablets
Each buccal tablet contains 800 micrograms fentanyl (as citrate).
Excipient with known effect: Each tablet contains 20 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Buccal tablet.
Effentora 100 micrograms buccal tablets
Flat-faced, white, round bevelled-edge tablet, embossed on one side
with a “C” and on the other side
with “1”.
Effentora 200 micrograms buccal tablets
Flat-faced, white, round bevelled-edge tablet, embossed on one side
with a “C” and on the other side
with “2”.
Effentora 400 micrograms buccal tablets
Flat-faced, white, round bevelled-edge tablet, embossed on one side
with a “C” and on the other side
with “4”.
Effentora 600 micrograms buccal tablets
Flat-faced, white, round bevelled-edge tablet, embossed on one side
with a “C” and on the other side
with “6”.
3
Effentora 800 micrograms buccal tablets
Flat-faced, white, round bevelled-edge tablet, embossed on one side
with a “C” and on