Nolxado 20 mg/10 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Available from:

KRKA, d.d., Novo mesto

ATC code:

N02AA; N02AA55

INN (International Name):

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

Dosage:

20mg/10 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:

2017-05-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NOLXADO 10 MG/5 MG PROLONGED-RELEASE TABLETS
NOLXADO 20 MG/10 MG PROLONGED-RELEASE TABLETS
NOLXADO 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 Nolxado is and what it is used for
2.
What you need to know before you take Nolxado
3.
How to take Nolxado
4.
Possible side effects
5.
How to store Nolxado
6.
Contents of the pack and other information
1.
WHAT NOLXADO IS AND WHAT IT IS USED FOR
Nolxado 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 Nolxado
_ _
tablets
_ _
for the treatment of severe pain, which can be adequately
managed only with opioid analgesics.
HOW NOLXADO WORK IN PAIN RELIEF
Nolxado contain oxycodone hydrochloride and naloxone hydrochloride as
active substances.
Oxycodone hydrochloride is responsible for the painkilling effect of
Nolxado, and is a potent
analgesic (“painkiller”) of the opioid group.
The second active substance of
Nolxado
, naloxone
hydrochloride is intended to bring relief from some side effects of
treatment with opioid
painkillers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOLXADO
DO NOT TAKE NOLXADO
-
if you are allergic to oxycodone hydrochloride, or naloxone
hydrochloride, or any of the other
ingredients of this medicine (listed in section 6);
-
if your brea

Summary of Product characteristics

Health Products Regulatory Authority
03 August 2022
CRN00CVVV
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nolxado 20 mg/10 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent to 18 mg oxycodone and 10 mg
naloxone hydrochloride as 10.9 mg naloxone hydrochloride dihydrate,
equivalent to 9 mg naloxone.
Excipient with known effect: lactose monohydrate
Each 20 mg/10 mg prolonged-release tablet contains 51.78 mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Light pink, oval, slightly biconvex, film coated tablets
prolonged-release engraved with “20” on one side of the tablet
(dimensions: 9.5 mm x 4.5 mm).
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 bring relief from some side
effects of oxycodone.
Nolxado is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Analgesia
The analgesic efficacy of Nolxado 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,
Nolxado 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.
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