Armoneve 30 mg/15 mg prolonged-release tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Διαθέσιμο από:

Mundipharma Pharmaceuticals Limited

Φαρμακολογική κατηγορία (ATC):

N02AA; N02AA55

INN (Διεθνής Όνομα):

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Δοσολογία:

30/15 mg/mg

Φαρμακοτεχνική μορφή:

Prolonged-release tablet

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Natural opium alkaloids; oxycodone, combinations

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2018-03-05

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
2.5 MG/1.25_ _MG PROLONGED-RELEASE TABLETS
15 MG/7.5_ _MG PROLONGED-RELEASE TABLETS
30 MG/15_ _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.
is used for the treatment of severe pain, which can be
adequately managed only with
opioid analgesics.
How works
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
- if you are allergic to oxycodone hydrochloride, naloxone
hydrochloride or any of the other ingredients
of this medicine (listed in section 6),
- if your breathing is not able to supply

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
15 October 2019
CRN009DJR
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Armoneve 30 mg/15 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 30 mg of oxycodone
hydrochloride equivalent to 27 mg oxycodone and 15 mg
naloxone hydrochloride as 16.48 mg of naloxone hydrochloride dihydrate
equivalent to 13.5 mg naloxone
Excipient with known effect: Each prolonged-release tablet contains
38.4 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Brown, capsule shaped tablets, with a nominal length of 9.5 mmand with
a film coating, embossed “OXN” on one side and “30”
on the other.
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.
Armoneve is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 naïve 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.
Patients already receiving opioids may be started on higher doses
depending on their previous opioid experience.
The maximum daily dose 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. Spec