DANCEX SR 60 Milligram Tablet Prolonged Release

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

OXYCODONE HYDROCHLORIDE

Pieejams no:

Rowex Ltd

ATĶ kods:

N02AA05

SNN (starptautisko nepatentēto nosaukumu):

OXYCODONE HYDROCHLORIDE

Deva:

60 Milligram

Zāļu forma:

Tablet Prolonged Release

Receptes veids:

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

Ārstniecības joma:

Natural opium alkaloids

Autorizācija statuss:

Authorised

Autorizācija datums:

2012-09-24

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DANCEX SR 60 MG PROLONGED-RELEASE TABLETS 

Active substance: 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 onto 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 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 is a centrally acting, strong painkiller from the
group of opioids. 

Dancex SR is used 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) 
- 
if you suffer from severely depressed
breathing (respiratory depression) 
- 
if you suffer from severe chronic obstructive lung disease,
cor pulmonale (cardiac changes due to 
chronic overload of lung circulation) or acute, severe
bronchial asthma 
- 
if you suffer from intestinal paralysis (paralytic ileus) 
- 
if you suffer from elevated carbon dioxide levels.  

WARNINGS AND PRECAUTIONS 
Talk to your doctor or pharmacist before taking Dancex SR 
- 
if

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dancex SR 60 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 60 mg oxycodone hydrochloride equivalent to 53.9 mg oxycodone.
Excipients:
Each prolonged-release tablet contains 64.9 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Red, round, biconvex film coated prolonged-release tablets, diameter: 8.8 mm – 9.4 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment. For doses not
realisable/practicable with this medicinal product other strengths are available.
The following general dosage recommendations apply:
Adults and adolescents (12 years of age and older)
_Dose titration and adjustment_
In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours.
Some patients may benefit from a starting dose of 5 mg to minimize the incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with
former opioid therapies.
10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-
release formulation.
Because of individual differences in sensitivity for different opioids, it is recommended that patients should start
conservatively with Dancex SR prolonged-release tablets after conversion from other opioids, with 50-75% of the
calculated oxycodone dose.
Some patients who take Dancex SR prolong