Oxyargin 5 mg /2.5 mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Naloxone hydrochloride dihydrate; OXYCODONE HYDROCHLORIDE

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

N02AA; N02AA55

INN (International Name):

Naloxone hydrochloride dihydrate; OXYCODONE HYDROCHLORIDE

Dosage:

5 mg/ 2.5 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Natural opium alkaloids; oxycodone, combinations

Authorization status:

Not marketed

Authorization date:

2017-11-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYARGIN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
OXYARGIN 10 MG/5 MG PROLONGED-RELEASE TABLETS
OXYARGIN 20 MG/10 MG PROLONGED-RELEASE TABLETS
OXYARGIN 30 MG/15 MG PROLONGED-RELEASE TABLETS
OXYARGIN 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 Oxyargin is and what it is used for
2.
What you need to know before you take Oxyargin
3.
How to take Oxyargin
4.
Possible side effects
5.
How to store Oxyargin
6.
Contents of the pack and other information
1.
WHAT OXYARGIN IS AND WHAT IT IS USED FOR
You have been prescribed Oxyargin for the symptomatic treatment of
severe pain, which can be
adequately managed only with opioid analgesics.
How Oxyargin relieves pain
Oxyargin contains oxycodone hydrochloride and naloxone hydrochloride
as active substances.
Oxycodone hydrochloride is responsible for the pain-killing effect of
Oxyargin,and is a potent
analgesic (“painkiller”) of the opioid group.
Restless Legs Syndrome
You have been prescribed Oxyargin as a secondary treatment for severe
to very severe restless legs
syndrome that cannot be treated adequately with dopaminergic
medication. Patients with restless legs
syndrome have unpleasant sensations in the legs, and more rarely also
in the arms. These sensations
start as soon as the person rests, for example when sitting or lying
down, and can only be relieved
through the irresistible urge to move the legs and sometimes also th

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2020
CRN009DCW
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxyargin 5 mg /2.5 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
(equivalent to 4.5 mg oxycodone) and 2.5 mg of
naloxone hydrochloride (as 2.74 mg naloxone hydrochloride dihydrate,
equivalent to 2.25 mg naloxone).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, biconvex prolonged-release tablet with a diameter of 4.7
mm and a height of 2.9 - 3.9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Second line symptomatic treatment of patients with severe to very
severe idiopathic restless legs syndrome after failure of
dopaminergic therapy.
The opioid antagonist naloxone is added to counteract opioid-induced
constipation by blocking the action of oxycodone at
opioid receptors locally in the gut.
Oxyargin is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ANALGESIA
The analgesic efficacy of Oxyargin is equivalent to oxycodone
hydrochloride prolonged-release formulations.
The dose should be adjusted to the intensity of pain and the
sensitivity of the individual patient. Unless otherwise prescribed,
Oxyargin should be administered as follows:
_Adults _
The usual starting dose for opioid naive patients 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
Oxyargin depending on their previous opioid experience.
Oxyargin 5 mg/2.5 mg is intended for dose titration when initiating
opioid therapy and individual dose adjustment.
The maximum daily dose of Oxyargin is 160 mg oxycodone hydrochloride
and 840 mg naloxone hydrochloride. The maximum
daily dose is reserved for patients who have previously been
maintained on a stable