Dancex SR Plus 40 mg/20 mg Prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Available from:

Rowex Ltd

ATC code:

N02AA; N02AA55

INN (International Name):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Dosage:

40/20 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:

Not marketed

Authorization date:

2016-04-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DANCEX SR PLUS 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
DANCEX SR PLUS 10 MG/5 MG PROLONGED-RELEASE TABLETS
DANCEX SR PLUS 20 MG/10 MG PROLONGED-RELEASE TABLETS
DANCEX SR PLUS 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 Dancex SR Plus is and what it is used for
2.
What you need to know before you take Dancex SR Plus
3.
How to take Dancex SR Plus
4.
Possible side effects
5.
How to store Dancex SR Plus
6.
Contents of the pack and other information
1.
WHAT DANCEX SR PLUS IS AND WHAT IT IS USED FOR
Dancex SR Plus 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 Dancex SR Plus 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
Dancex SR Plus contains oxycodone hydrochloride and naloxone
hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the pain-killing effect of
Dancex SR Plus, and is a potent
analgesic (“painkiller”) of the opioid group.
The second active substance of Dancex SR Plus, naloxone hydrochloride,
is intended to counteract
constipation. Bowel dysfunction (e.g. constipation) is a typical side
effect of treatment with

Summary of Product characteristics

Health Products Regulatory Authority
27 June 2023
CRN00DNZN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dancex SR Plus 40 mg/20 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride (equivalent to 36mg oxycodone) and 20 mg of
naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate,
equivalent to 18 mg naloxone).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Pink, oblong, biconvex prolonged-release tablet with break scores on
both side, with a length of 14.2 mm, a width of 6.7 mm
and a height of 3.6 - 4.6 mm. The tablet can be divided into equal
doses.
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.
Dancex SR Plus is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Analgesia_
The analgesic efficacy of Dancex SR Plus is equivalent to oxycodone
hydrochloride prolonged-release formulations.
The dose should be adjusted to the intensity of pain and the
sensitivity of the individual patient. Unless otherwise prescribed,
Dancex SR Plus 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
Dancex SR Plus depending on their previous opioid
experience.
Dancex SR Plus 5 mg/2.5 mg is intended for dose titration when
initiating opioid therapy and individual dose adjustment.
The maximum daily dose of Dancex SR Plus 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