Recivit 533 micrograms, sublingual tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Fentanyl

Boleh didapati daripada:

Ethypharm

Kod ATC:

N02AB; N02AB03

INN (Nama Antarabangsa):

Fentanyl

Dos:

533 microgram(s)

Borang farmaseutikal:

Sublingual tablet

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Phenylpiperidine derivatives; fentanyl

Status kebenaran:

Not marketed

Tarikh kebenaran:

2015-08-28

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RECIVIT 67 MICROGRAMS, SUBLINGUAL TABLETS
RECIVIT 133 MICROGRAMS, SUBLINGUAL TABLETS
RECIVIT 267 MICROGRAMS, SUBLINGUAL TABLETS
RECIVIT 400 MICROGRAMS, SUBLINGUAL TABLETS
RECIVIT 533 MICROGRAMS, SUBLINGUAL TABLETS
RECIVIT 800 MICROGRAMS, SUBLINGUAL TABLETS
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 Recivit is and what it is used for
2.
What you need to know before you take Recivit
3.
How to take Recivit
4.
Possible side effects
5.
How to store Recivit
6.
Contents of the pack and other information
1.
WHAT RECIVIT IS AND WHAT IT IS USED FOR
Recivit contains the active ingredient fentanyl, which belongs to a
group of strong pain-relieving medicines
called opioids.
Recivit 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 even though
you have taken your usual opioid pain-
relieving medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RECIVIT
DO NOT TAKE RECIVIT:

if you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in section 6);

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 Recivit, because

Ciri produk

Health Products Regulatory Authority
26 March 2019
CRN008HTW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Recivit 533 micrograms, sublingual tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 840 micrograms of fentanyl citrate, equivalent to
533 micrograms of fentanyl.
Excipient with known effect:
Each tablet contains 0.651 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet
This medicine is presented in the form of a white, convex, triangular
tablet, height of 5.6 mm, printed with '5' in black ink on
one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Recivit 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 Recivit. The
number of tablet strengths available to the patients at any
time should be minimised to prevent confusion and potential overdose.
Recivit should be administered directly under the tongue at the
deepest part.
Recivit should not be swallowed, but allowed to completely dissolve in
the sublingual cavity without chew