Epethinan 5 mg/2.5 mg prolonged release tablet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Saatavilla:

Acino AG

ATC-koodi:

N02AA; N02AA55

INN (Kansainvälinen yleisnimi):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Annos:

5 / 2.5 milligram(s)

Lääkemuoto:

Prolonged-release tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Natural opium alkaloids; oxycodone, combinations

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2016-05-20

Pakkausseloste

Var. SE/H/1510/001-004/IB/008 changes without in green
Var. SE/H/1510/001/IB/009 changes are marked in yellow
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPETHINAN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
EPETHINAN 10 MG/5 MG PROLONGED-RELEASE
TABLETS
EPETHINAN 20 MG/10 MG PROLONGED-RELEASE TABLETS
EPETHINAN 40 MG/20 MG PROLONGED-RELEASE TABLETS
oxycodone hydrochloride / naloxone hydrochloride
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 Epethinan is and what it is used for
2.
What you need to know before you take Epethinan
3.
How to take Epethinan
4.
Possible side effects
5.
How to store Epethinan
6.
Contents of the pack and other information
1.
WHAT EPETHINAN IS AND WHAT IT IS USED FOR
Epethinan is a prolonged-release tablet, which means that its active
substances are released over an extended
period. Their action lasts for 12 hours.
PAIN RELIEF
You have been prescribed Epethinan for the treatment of severe pain,
which can be adequately managed only
with opioid analgesics. Naloxone is added to counteract constipation.
How Epethinan works in pain relief
Epethinan tablets contain oxycodone and naloxone as active substances.
Oxycodone is responsible for the pain
relieving effect of Epethinan. It is a strong analgesic
(“painkiller”) that belongs to a group of medicines called
opioids. Naloxone is intended to counteract constipation. Constipation
is a typical side effect of treatment with
opioid painkillers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPETHINAN
DO NOT TAKE EPETHINAN TABLETS

if y

Valmisteyhteenveto

Health Products Regulatory Authority
19 January 2021
CRN00C459
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epethinan 5 mg/2.5 mg prolonged release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
equivalent to 4.5 mg oxycodone and naloxone
hydrochloride dihydrate equivalent to 2.5 mg naloxone hydrochloride
and 2.25 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains
16.0 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
_Epethinan 5 mg/2.5 mg prolonged-release tablet_
Light blue, round, convex, film-coated tablets with a nominal diameter
of 6.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
The opioid antagonist naloxone is added to counteract opioid-induced
constipation by blocking the action of oxycodone at
opioid receptors locally in the gut.
Epethinan is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Analgesia
The analgesic efficacy of Epethinan is equivalent to oxycodone
hydrochloride prolonged-release formulations.
The dosage should be adjusted to the intensity of pain and the
sensitivity of the individual patient. Unless otherwise prescribed,
Epethinan should be administered as follows:
_Adults_
The usual starting dose for an opioid naïve patient is 10 mg/5 mg of
oxycodone hydrochloride/naloxone hydrochloride at 12
hourly intervals.
Patients already receiving opioids may be started on higher doses of
Epethinan depending on their previous opioid experience.
Epethinan 5 mg/2.5 mg is intended for dose titration when initiating
opioid therapy and individual dose adjustment.
The maximum daily dose of Epethinan is 160 mg oxycodone hydrochloride
and 80 mg naloxone hydrochloride. The maximum
daily dose is reserved for patients who have previously been
maintained on a stable daily dose of oxycodone/naloxone and
who h