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PACKAGE LEAFLET: INFORMATION FOR THE USERDancex SR 5 mg, 10 mg & 20 mg Prolonged-Release TabletsActive substance: Oxycodone hydrochlorideRead all of this leaflet carefully before you starttaking this medicine.• Keep this leaflet. You may need to read it again.• If you have any further questions, ask your doctoror pharmacist.• This medicine has been prescribed for you. Do notpass it on to others. It may harm them, even if theirsymptoms are the same as yours.• If any of the side effects gets serious, or if younotice any side effects not listed in this leaflet,please tell your doctor or pharmacist.In this leaflet:1. What Dancex SR is and what it is used for2. Before you take Dancex SR3. How to take Dancex SR4. Possible side effects5. How to store Dancex SR6. Further information1What Dancex SR is and what it is usedforDancex SR is a centrally acting, strong painkiller from thegroup of opioids.Dancex SR is used to treat severe pain, which can beadequately managed only with opioid analgesics.decrease of blood clotting have been observed ifanticoagulants of the coumarin type (medicinalproducts against blood clotting) are co-applied withOxycodone Hydrochloride.Taking Dancex SR with food and drinkAlcohol enhances the impairment of alertness andreactivity and may enhance potential side effects such asdrowsiness and depressed breathing.Pregnancy and breast-feedingPregnancyYou must not take Dancex SR during pregnancy. Thereare no adequate data from the use of oxycodone inpregnant women.Oxycodone crosses the placenta into the bloodcirculation of the baby. Prolonged use of oxycodoneduring pregnancy can cause withdrawal symptoms innewborns. Use of oxycodone during delivery can causerespiratory depression in the newborn.Breast-feedingYou must not use Dancex SR when you arebreast-feeding as oxycodone passes into breast milk.Ask your doctor or pharmacist for advice before takingany medicine.2 Before you take Dancex SR Driving and using machinesOxycodone impairs alertness and reactivity to such anextent that the ability to drive and operate machinery isDo not take Dancex SRaffected or ceases altogether. To look at the possible side- if you are allergic (hypersensitive) to oxycodoneeffects affecting the motor skills and concentration seehydrochloride or any of the other ingredients ofsection 4. “Possible side effects”. With stable therapy, aDancex SRgeneral ban on driving a vehicle may not be necessary.- if you suffer from severely depressed breathingThe treating physician must assess the individual situation.(respiratory depression) with too little oxygen in thePlease discuss with your doctor whether or under whatblood (hypoxia) and/or too much carbon dioxideconditions you can drive a vehicle.(hypercapnia) in the blood- if you suffer from severe chronic obstructive lungImportant information about some of thedisease, cor pulmonale (cardiac changes due toingredients of Dancex SRchronic overload of lung circulation) or acute, severeThis medicinal product contains lactose. If you have beenbronchial asthmatold by your doctor that you have an intolerance to some- if you suffer from intestinal paralysis (paralytic ileus)sugars contact your doctor before taking this medicinal- if you have an acute abdomen or suffer from aproduct.delayed gastric emptying- during pregnancy and breast-feeding.How to take Dancex SR3Take special care with Dancex SR- if you are older or debilitatedAlways take Dancex SR exactly as your doctor has told- if your lung, liver or kidney function is severelyyou. You should check with your doctor or pharmacist ifimpairedyou are not sure.- if you suffer from myxoedema (certain illnesses of thethyroid gland), impaired function of the thyroid glandFor doses not realisable/practicable with this medicinal- if you suffer from adrenal insufficiency (Addison’sproduct other strengths and medicinal products aredisease)available.- if you suffer from enlargement of the prostate (prostatichypertrophy)The usual dose is- if you suffer from alcoholism or are undergoingDancex SR 5 mgalcohol withdrawalAdults and adolescents (over 12 years of age)- if you suffer from known opioid-dependenceThe usual initial dose is two prolonged-release tablets (10- if you suffer from inflammation of the pancreasmg of oxycodone hydrochloride) in 12 hourly intervals.(pancreatitis)- in conditions with increased brain pressureFurther determination of the daily dose, the division into- if you suffer from disturbances of circulatory regulationthe single doses and any dose adjustments during the- if you suffer from colic of the bile duct and ureterfurther course of therapy are performed by the treating- if you suffer from epilepsy or have a seizure tendencyphysician and depend on the previous dosage.- if you take MAO inhibitors (for the treatment ofdepression).Patients who have already taken opioids can starttreatment with higher dosages taking into account theirPlease talk to your doctor if any of these apply to you or ifexperience with opioid treatment.any of these conditions applied to you in the past.Some patients who receive Dancex SR 5 mg accordingDancex SR has a primary dependence potential. Whento a fixed schedule need rapidly acting painkillers asused for a long time, tolerance to the effects andrescue medication to control breakthrough pain. Dancexprogressively higher doses may be required to maintainSR 5 mg is not intended for the treatment of breakthroughpain control.pain.Chronic use of Dancex SR may lead to physicalFor the treatment of non-cancer pain, a daily dosedependence and a withdrawal syndrome may occurof twice daily 20 mg of oxycodone hydrochloride isupon abrupt cessation. When a patient no longergenerally sufficient, but higher dosages may berequires therapy with oxycodone hydrochloride, it maynecessary. Patients with cancer pain usually requirebe advisable to taper the dose gradually to preventdosages from 80 to 120 mg of oxycodone hydrochloridesymptoms of withdrawal.which may be increased up to 400 mg in individualcases.When used as directed in patients suffering from chronicThe treatment needs to be controlled regularly withpain, the risk of developing physical or psychologicalregard to pain relief and other effects in order to achievedependence is markedly reduced and needs to bethe best pain therapy possible as well as to be able toweighed against the potential benefit. Please discuss thistreat any occurring side effects in good time and towith your doctor.decide whether treatment should be continued.Drinking alcohol whilst taking Dancex SR may make youDancex SR 10 mgfeel more sleepy or increase the risk of serious sideAdults and adolescents (over 12 years of age)effects such as shallow breathing with a risk of stoppingThe usual initial dose is one prolonged-release tablet (10breathing and loss of consciousness. It is recommendedmg of oxycodone hydrochloride) in 12 hourly intervals.not to drink alcohol whilst you’re taking Dancex SR.Further determination of the daily dose, the division intoOxycodone Hydrochloride should be avoided in patientsthe single doses and any dose adjustments during thewith a history of or present alcohol and drug abuse.further course of therapy are performed by the treatingphysician and depend on the previous dosage.Children under 12 years of ageOxycodone Hydrochloride has not been investigated inPatients who have already taken opioids can startchildren under 12 years. Safety and efficacy have nottreatment with higher dosages taking into account theirbeen established. Therefore, the use in children under 12experience with opioid treatment.years of age is not recommended.Some patients who receive Dancex SR 10 mg accordingElderly patientsto a fixed schedule need rapidly acting painkillers asIn elderly patients without impairment of kidney and/orrescue medication to control breakthrough pain. Dancexliver function a dose adjustment is usually not necessary.SR 10 mg is not intended for the treatment ofbreakthrough pain.Taking other medicinesPlease tell your doctor or pharmacist if you are taking orFor the treatment of non-cancer pain a daily dosehave recently taken any other medicines, includingof 4 prolonged-release tablets (twice daily 20 mg ofmedicines obtained without a prescription.oxycodone hydrochloride) is generally sufficient,but higher dosages may be necessary. Patients- Medicines that dampen the activity of the centralwith cancer pain usually require dosages from 80 tonervous system e.g.120 mg of oxycodone hydrochloride which may be• sleeping pills or tranquillizers (sedatives, hypnotics)increased up to 400 mg in individual cases.• other medicines that act on the nervous system(phenothiazines, neuroleptics)The treatment needs to be controlled regularly with• medicines used to treat allergies or vomitingregard to pain relief and other effects in order to achieve(antihistamines, antiemetics)the best pain therapy possible as well as to be able to• other opioids or alcohol can enhance the side effectstreat any occurring side effects in good time and toof oxycodone, in particular depressed breathingdecide whether treatment should be continued.(respiratory depression).Dancex SR 20 mg- Medicines with an anticholinergic effect e.g.Adults and adolescents (over 12 years of age)• other medicines that act against parasympathetic andThe usual initial dose is 10 mg oxycodone hydrochloridecholinergic nerve fibres on the central nervous systemin 12 hourly intervals. Your doctor will prescribe the dose(psychotropic medicines)required to treat pain.• medicines used to treat allergies (antihistamines) orFurther determination of the daily dose, the division intovomiting (antiemetics)the single doses and any dose adjustments during the• medicines used to treat Parkinson’s disease canfurther course of therapy are performed by the treatingenhance certain side effects of oxycodone (e.g.physician and depend on the previous dosage.constipation, dry mouth or urinary disturbances).Patients who have already taken opioids can start- Cimetidine can inhibit the metabolism of oxycodone.treatment with higher dosages taking into account theirThe influence of other medicines that can markedlyexperience with opioid treatment.affect the metabolism of oxycodone has not beeninvestigated.Some patients who receive Dancex SR 20 mg accordingto a fixed schedule need rapidly acting painkillers as- Monoamine oxidase inhibitors (MAOIs) can enhancerescue medication to control breakthrough pain. Dancexthe side effects of oxycodone (e.g. excitation, decreaseSR 20 mg is not intended for the treatment ofor increase in blood pressure).breakthrough pain.- In individuals a clinically relevant increase orcontinued on the next page >>

pharmacodeFor the treatment of non-cancer pain a daily dose of twoprolonged-release tablets (twice daily 20 mg ofoxycodone hydrochloride) is generally sufficient, buthigher dosages may be necessary. Patients with cancerpain usually require dosages from 80 to 120 mg ofoxycodone hydrochloride which may be increased up to400 mg oxycodone hydrochloride in individual cases.The treatment needs to be controlled regularly with regardto pain relief and other effects in order to achieve the bestpain therapy possible as well as to be able to treat anyoccurring side effects in good time and to decide whethertreatment should be continued.Risk patientsIf you have impaired kidney and/or liver function orif you have a low body weight your doctor mayprescribe a lower starting dose.Method and duration of administrationSwallow the prolonged-release tablets whole with asufficient amount of liquid (½ glass of water) with orwithout food in the morning and in the evening followinga fixed schedule (e.g. at 8 a.m. and 8 p.m).The prolonged-release tablets must not be crushed orchewed as this leads to rapid oxycodone release due tothe damage of the prolonged release properties. Theadministration of chewed or crushed Dancex SR leads toa rapid release and absorption of a potentially fatal doseof oxycodone (see section “If you take more Dancex SRthan you should”).Dancex SR is for oral use only. In case of abusiveinjection (injection in a vein) the tablet excipients maylead to destruction (necrosis) of the local tissue, changeof lung tissue (granulomas of the lung) or other serious,potentially fatal events.Your doctor will adjust the dosage depending on thepain intensity and how you respond to the treatment.Take the number of prolonged-release tablets determinedby your doctor twice daily.If you take more Dancex SR than you shouldIf you have taken more Dancex SR as prescribed youshould inform your doctor or your local poison controlcentre immediately. The following symptoms may occur:constricted pupils (miosis), depressed breathing (respiratorydepression), skeletal muscle flaccidity and drop in bloodpressure. In severe cases circulatory collapse, mental andmotor inactivity (torpor), unconsciousness (coma) slowingof the heart rate and accumulation of water in the lungs(non-cardiogenic lung oedema) may occur; abuse of highdoses of strong opioids such as oxycodone can be fatal. Inno case you should expose yourself to situations requiringelevated concentration e.g. driving a car.If you forget to take Dancex SRIf you use a smaller dose of Dancex SR than directed oryou miss the intake of the tablets, pain relief willconsequently be insufficient or cease altogether.You can make up for a forgotten tablet if the next regularintake is not due for at least another 8 hours. You canthen continue to take the tablets as directed.You should also take the prolonged-release tabletsif the time to the regular next intake is shorter, butpostpone the next intake by 8 hours. In principle,you should not take Dancex SR more than once every 8hours.5Do not take a double dose to make up for a forgottentablet.6FurtherIf you stop taking Dancex SRDo not stop treatment without informing your doctor.When a patient no longer requires therapy with DancexSR, it may be advisable to taper the dose gradually toprevent symptoms of withdrawal.If you have any further questions on the use of thisproduct, ask your doctor or pharmacist.4 Possible side effectsLike all medicines, Dancex SR can cause side effects,although not everybody gets them.Assessment of the side effects is based on the followingfrequencies:Very common: more than 1 patient in 10Common: 1 to 10 patients in 100Uncommon: 1 to 10 patients in 1,000Rare: 1 to 10 patients in 10,000Very rare: less than 1 patient in 10,000Not known: cannot be estimated from theavailable data- abnormally acute sense of hearing (hyperacousis)- both increased and decreased muscle tone- trembling (tremor)- tics- reduced sense of touch (hypaesthesia)- coordination disturbances- feeling unwell- accelerated pulse- widening of the blood vessels (vasodilatation)- increased coughing- pharyngitis- runny nose- voice changes- biliary colics- oral ulcers- inflammation of the gums- inflamed mouth (stomatitis)- flatulence- disturbances of sexual function- injuries due to accidents- pain (e.g. chest pain)- excessive fluid in the tissues (oedema)- migraine- physical dependence with withdrawal symptoms- allergic reactions- changes in tear secretion- constriction of the pupilRare- lymph node disease (lymphadenopathy)- lack of water in the body (dehydration)- seizures, in particular in patients suffering from epilepsyor with a tendency to seizures- muscle spasms (involuntary contraction of the muscle)- gum bleeding- increased appetite- tarry stool- tooth staining and damage- dry skin- herpes simplex (disorder of the skin and mucosa)- blood in urine (haematuria)- absence of menstrual bleeding (amenorrhoea)- changes in body weight (loss or rise)- cellulitisVery rare- severe hypersensitivity reactions (anaphylactic reactions)Tolerance and dependence may develop.Counteractive measuresIf you observe any of the above listed side effects yourdoctor usually will take appropriate measures. The sideeffect constipation may be prevented by fibre enricheddiet and increased drinking. If you are suffering fromsickness or vomiting your doctor will prescribe you anappropriate medicine.If any of the side effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctoror pharmacist.How to store Dancex SRKeep out of the reach and sight of children.Do not use Dancex SR after the expiry date which isstated on the blister/bottle and the carton after “EXP”. Theexpiry date refers to the last day of that month.This medicinal product does not require any specialstorage conditions.Medicines should not be disposed of via wastewater orhousehold waste. Ask your pharmacist how to dispose ofmedicines no longer required. These measures will helpto protect the environment.What Dancex SR containsThe active substance is oxycodone hydrochloride.Each prolonged-release tablet contains 5 mg/10 mg/20 mg oxycodone hydrochloride equivalent to4.5 mg/9.0 mg/ 17.9 mg oxycodone.The other ingredients are:Tablet core: hydrogenated castor oil, copovidone,behenoyl polyoxyglycerides, lactose monohydrate,magnesium stearate, maize starch, colloidal anhydroussilica, triglycerides, medium-chainTablet coating: microcrystalline cellulose, hypromellose,stearic acid, titanium dioxide (E 171) (Dancex SR 5 mg:indigo carmine aluminium salt; Dancex SR 20 mg: ironoxide red (E 172)).What Dancex SR looks like and contents ofthe packDancex SR 5 mg are blue, round, biconvex prolongedreleasetablets.Dancex SR 10 mg are white, round, biconvex prolongedreleasetablets.informationI.M. L/369a+b+c 06-12Significant side effects or signs to consider and measuresto be taken when these side effects or signs occur:If you experience any of the following side effects, stoptaking Dancex SR and contact your doctor immediately.Depressed breathing is the most significant risk inducedby opioids and is most likely to occur in elderly ordebilitated patients. As a consequence, in predisposedpatients opioids can cause severe drops in bloodpressure.Apart from this oxycodone can cause constricted pupils,bronchial spasms and spasms in smooth muscles andsuppress the cough reflex.Other possible side effectsVery common- sedation (tiredness to drowsiness)- dizziness- headache- constipation- nausea- vomiting- itchingCommon- feeling weak (asthenia)- several psychological side effects such as•changes in mood (e.g. anxiety, depression, euphoria)•changes in activity (mostly sedation, sometimesaccompanied by lethargy, occasionally increase withrestlessness, nervousness and sleep disorders)•changes in performance (thought process disorder,confusion, amnesia, isolated cases of speechdisorders)- pins and needles (paraesthesia)- lowering of blood pressure, rarely accompanied bysymptoms such as pounding or racing heartbeat- fainting- depressed breathing (dyspnoea)- bronchospasm (difficulty in breathing or wheezing)- dry mouth, rarely accompanied by thirst and difficultyswallowing- gastrointestinal disorders such as bellyache, diarrhoea,belching, upset stomach (dyspepsia), loss of appetite- skin disorders such as rash, rarely increased sensitivity tolight (photosensitivity), in isolated cases itchy (urticaria)or scaly rash (exfoliative dermatitis)- urinary disorders (urinary retention, but also frequenturination)- sweating- chillsUncommon- change in perception such as depersonalisation,hallucinations- change in taste- visual disturbancesDancex SR 20 mg are pink, round, biconvex prolongedreleasetablets.Dancex SR is available in packs of 7, 10, 14,20, 28, 30, 50, 56, 60, 98, 100, 100x1 and 112prolonged-release tablets in blisters and 100 and250 prolonged-release tablets in HDPE bottles.Not all pack sizes may be marketed.Marketing Authorisation HolderRowex Ltd., Bantry, Co. Cork, Ireland.ManufacturersSalutas Pharma GmbH, Otto-von-Guericke Allee 1,39179 Barleben, Germany.Salutas Pharma GmbH, Dieselstraße 5, 70839Gerlingen, Germany.Lek Pharmaceutical d.d., Verovš kova 57, 1526 Ljubljana.Slovenia.This medicinal product is authorised in the MemberStates of the EEA under the following names:Germany:Denmark:Ireland:TabletsGermany:Denmark:Ireland:TabletsGermany:Denmark:Ireland:TabletsOxycodon - HCI HEXAL 5 mgRetardtablettenOxyxalDancex SR 5 mg Prolonged-ReleaseKancodal HEXAL 10 mg RetardtablettenOxyxalDancex SR 10 mg Prolonged-ReleaseKancodal HEXAL 20 mg RetardtablettenOxyxalDancex SR 20 mg Prolonged-ReleaseThis leaflet was last approved in 06/2011.46087057