NOLXADO 40mg/20 Milligram Prolonged Release Capsules

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE

Boleh didapati daripada:

HCS bvba

INN (Nama Antarabangsa):

OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE

Dos:

40mg/20 Milligram

Borang farmaseutikal:

Prolonged Release Capsules

Jenis preskripsi:

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

Kawasan terapeutik:

02AA55

Status kebenaran:

Authorised

Tarikh kebenaran:

2017-05-19

Risalah maklumat

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Page 1 of 11
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
PAIN RELIEF
You have been prescribed _NOLXADO _for the treatment of severe pain,
which can be adequately managed
only with opioid analgesics.
HOW _NOLXADO_ WORK IN PAIN RELIEF
_NOLXADO _contains oxycodone hydrochloride and naloxone hydrochloride
as active substances.
Oxycodone is responsible for the painkilling effect of _NOLXADO_. It
is a strong analgesic (‘painkiller’)
that belongs to a group of medicines called opioids. Naloxone is
intended to bring relief from some
side effects of treatment with strong painkillers.
2.
WHAT YOU N

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nolxado 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
naloxone hydrochloride as 21.8 mg naloxone hydrochloride dihydrate,
equivalent to 18 mg naloxone.
Excipient with known effect: lactose monohydrate
Each 40 mg/20 mg prolonged-release tablet contains 103.55 mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Brownish yellow, capsule shaped, slightly biconvex, film coated
prolonged-release tablets engraved with “40” on one
side of the tablet (dimensions: 14.0 mm x 6.0 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 of
Nolxado depending on their previous opioid
experience.
The maximum daily dose of Nolxado is 160 mg oxycodone hydrochloride
and 80 mg naloxone hydrochloride. The
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