Dancex SR 80 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE

Available from:

Rowex Ltd

ATC code:

N02AA; N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

Dosage:

80 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

Authorization status:

Not marketed

Authorization date:

2012-09-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DANCEX SR 40 MG PROLONGED-RELEASE TABLETS
DANCEX SR 80 MG PROLONGED-RELEASE TABLETS
oxycodone 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 the 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 is and what it is used for
2.
What you need to know before you take Dancex SR
3.
How to take Dancex SR
4.
Possible side effects
5.
How to store Dancex SR
6.
Contents of the pack and other information
1.
WHAT DANCEX SR IS AND WHAT IT IS USED FOR
Dancex SR contains the active substance oxycodone hydrochloride which
is a centrally acting, strong
painkiller of the group of opioids.
Dancex SR is used in adults and adolescents aged 12 years and older to
treat severe pain, which can be
adequately managed only with opioid analgesics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DANCEX SR
DO NOT TAKE DANCEX SR IF YOU
•
are allergic to oxycodone hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
•
have breathing problems, such as severely depressed breathing
(respiratory depression), severe
chronic obstructive lung disease, or severe bronchial asthma. Symptoms
may include
breathlessness, coughing or breathing more slowly or weakly than
expected.
•
have elevated carbon dioxide blood levels
•
have a heart problem after long-term lung disease (cor pulmonale)
•
suffer from intestinal paralysis (paralytic ileus). Signs may be that
your stomach empties more
slowly than it should (delayed gastric emptying) or you have severe
pain in your abdomen.
WARNING

Summary of Product characteristics

Health Products Regulatory Authority
25 March 2024
CRN00F4ZY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dancex SR 80 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 80 mg oxycodone hydrochloride
equivalent to 71.8 mg oxycodone.
Excipient with known effect
Each prolonged-release tablet contains 86.5 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Green, round, biconvex film coated prolonged-release tablets,
diameter: 9.8 mm -10.4 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Dancex SR prolonged-release tablets are indicated in adults and
adolescents aged 12 years and older
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
For doses not practicable with this medicinal product other strengths
are available.
_Adults and adolescents (12 years of age and older)_
_Starting dose_
The usual starting dose for an opioid-naïve patient is 10 mg
oxycodone hydrochloride per dose at intervals of 12 hours. Some
patients may benefit from a starting dose of 5 mg to minimise the
incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher
doses of Dancex SR taking into account their experience
with former opioid therapies.
10 to 13 mg oxycodone hydrochloride correspond to approximately 20 mg
of morphine sulphate, both in the
prolonged-release formulation.
_Dose adjustment_
Some patients who take Dancex SR prolonged-release tablets following a
fixed schedule need rapid-release analgesics as
rescue medication in order to control breakthrough pain. Dancex SR is
not intended for therapy of breakthrough pain. The
single dose of the rescue medication should amount to 1/6 of the
equianalgesic daily dose of Dancex SR prolonged-release
tablets.