Effentora 100microgram buccal tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Fentanyl citrate

Tilgjengelig fra:

Teva UK Ltd

ATC-kode:

N02AB03

INN (International Name):

Fentanyl citrate

Dosering :

100microgram

Legemiddelform:

Buccal tablet

Administreringsrute:

Buccal

Klasse:

Schedule 2 (CD)

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070200; GTIN: 5060093001228 5060093000849

Informasjon til brukeren

1 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 other ingredie

Preparatomtale

FENTANYL EFFENTORA 100 MCG BUCCAL TABLETS
Summary of Product Characteristics Updated 02-Feb-2017 | Teva Pharma
B.V.
1. Name of the medicinal product
Effentora 100 micrograms buccal tablets
2. Qualitative and quantitative composition
Effentora 100 micrograms buccal tablets
Each buccal tablet contains 100 micrograms fentanyl (as citrate).
Excipient(s) with known effect: Each tablet contains 10 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”.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Treatment should be initiated by and remain under the guidance of a
physician experienced in the
management of opioid therapy in cancer patients. Physicians should
keep in mind the potential of abuse
of fentanyl. Patients should be instructed not to use two different
formulations of fentanyl concurrently
for the treatment of breakthrough pain, and to dispose of any fentanyl
product prescribed for BTP when
switching to Effentora. The number of tablet strengths available to
the patients at any time should be
minimised to prevent confusion and potential overdose.
Posology
_Dose titration_
Effentora should be individually titrated to an “effective” dose
that provides adequate analgesia and
minimises ad