Armoneve 10 mg/5 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

N02AA; N02AA55

INN (International Name):

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Dosage:

10/5 mg/mg

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:

2018-03-05

Patient Information leaflet

30
PACKAGE LEAFLET: INFORMATION FOR THE USER
5 MG/2.5 MG PROLONGED-RELEASE TABLETS
10 MG/5 MG PROLONGED-RELEASE TABLETS
20 MG/10 MG PROLONGED-RELEASE TABLETS
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains oxycodone hydrochloride and naloxone
hydrochloride as active substances.
is only for use in adults.
Pain relief
is used for the treatment of severe pain, which can be
adequately managed only with
opioid analgesics
How works in pain relief
Oxycodone hydrochloride is responsible for the pain-killing effect of
, and is a potent
analgesic (“painkiller”) of the opioid group. The second active
substance of , naloxone
hydrochloride, is intended to counteract constipation. Bowel
dysfunction (e.g. constipation) is a typical side
effect of treatment with opioid painkillers.
Restless legs syndrome
is used for the second line symptomatic treatment of
severe to very severe restless legs
syndrome in people who can’t be treated with dopamine medicines.
People

Summary of Product characteristics

Health Products Regulatory Authority
15 October 2019
CRN009DJ5
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Armoneve 10 mg/5 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged‑release tablet contains 10 mg of oxycodone
hydrochloride equivalent to 9 mg oxycodone and 5 mg naloxone
hydrochloride as 5.45 mg of naloxone hydrochloride dihydrate
equivalent to 4.5 mg naloxone.
Excipient with known effect: Each prolonged‑release tablet contains
64.3 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged‑release tablet
White, capsule shaped tablets, with a nominal length of 9.5 mm and
with a film coating, embossed “OXN” on one side and “10”
on the other side.
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.
Armoneve is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Analgesia
The analgesic efficacy of Armoneve 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.
Armoneve 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.
Lower strengths are available to facilitate dose titration when
initiating opioid therapy and for individual dose adjustment.
Health Products Regulatory Authority
15 October 2019
CRN009DJ5
Page 2 of 16
Patients already receiving opioids may be started on higher doses
depending on their previous opioid experience.
The maximu