Oxyargin 40 mg/20 mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Naloxone hydrochloride dihydrate; OXYCODONE HYDROCHLORIDE

Available from:

Generics (UK) Limited

ATC code:

N02AA; N02AA55

INN (International Name):

Naloxone hydrochloride dihydrate; OXYCODONE HYDROCHLORIDE

Dosage:

40 / 20 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Natural opium alkaloids; oxycodone, combinations

Authorization status:

Not marketed

Authorization date:

2017-11-17

Patient Information leaflet

1
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 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 the arms an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxyargin 40 mg/20 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride (equivalent to 36 mg oxycodone) and 20 mg
of naloxone hydrochloride (as 21.8 mg naloxone hydrochloride
dihydrate, equivalent to 18 mg naloxone).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Pink, oblong, biconvex prolonged-release tablet with break scores on
both side, with a length of 14.2 mm, a width of
6.7 mm and a height of 3.6 - 4.6 mm
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Second line 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
Oxycodone/Naloxone 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.
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