Aristiga 40 mg/20 mg prolonged release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Available from:

Ethypharm

ATC code:

N02AA; N02AA55

INN (International Name):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Dosage:

40 mg / 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:

Authorised

Authorization date:

2017-03-10

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ARISTIGA 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
ARISTIGA 10 MG/5 MG PROLONGED-RELEASE TABLETS
ARISTIGA 20 MG/10 MG PROLONGED-RELEASE TABLETS
ARISTIGA 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 Aristiga is and what it is used for
2.
What you need to know before you take Aristiga
3.
How to take Aristiga
4.
Possible side effects
5.
How to store Aristiga
6.
Contents of the pack and other information
1.
WHAT ARISTIGA IS AND WHAT IT IS USED FOR
Aristiga is a prolonged-release tablet, which means that its active
substances are released over an
extended period. Their action lasts for 12 hours.
These tablets are only for use in adults.
Pain relief
You have been prescribed Aristiga for the treatment of severe pain,
which can be adequately managed
only with opioid analgesics. Naloxone hydrochloride is added to
counteract constipation.
How these tablets work in pain relief
These tablets contain oxycodone hydrochloride and naloxone
hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the pain-killing effect of
Aristiga, and is a potent
analgesic (“painkiller”) of the opioid group. The second active
substance of Aristiga, naloxone
hydrochloride, is intended to counteract constipation. Bowel
dysfunction (e.g. constipation) is a typical
side effect of treatment with opioid painkillers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARISTIGA
DO NOT TAK

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aristiga 40 mg/20 mg prolonged release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent to 36 mg oxycodone, and 20 mg
naloxone hydrochloride as 22 mg of naloxone hydrochloride dihydrate,
equivalent to 18.02 mg naloxone.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Yellow, 11x5.5mm, elliptic, biconvex coated tablet, engraved with
“40”on one side.
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.
Aristiga is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Analgesia
The analgesic efficacy of Aristiga 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, Aristiga should be administered as follows:
_Adults:_
The usual starting dose for an opioid naive 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
Aristiga depending on their previous opioid
experience.
Aristiga 5 mg/2.5 mg is intended for dose titration when initiating
opioid therapy and individual dose adjustment.
The maximum daily dose of these tablets 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 and who have
become in need of an increased dose. Special attention should be given
to patients with compromised renal function
and patients with mild hepatic impairment if an increased dose is
considered. For patients requiring higher doses,
administration of supplemental pro