Package leaflet: Information for the user. Dacepton 5 mg/ml Solution for infusion Apomorphine hydrochloride hemihydrate

Transcription

1 Package leaflet: Infrmatin fr the user Daceptn 5 mg/ml Slutin fr infusin Apmrphine hydrchlride hemihydrate Read all f this leaflet carefully befre yu start using this medicine because it cntains imprtant infrmatin fr yu. - Keep this leaflet. Yu may need t read it again. - If yu have any further questins, ask yur dctr<, nurse> r pharmacist. - This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if their signs f illness are the same as yurs. - If yu get any side effects, talk t yur dctr<, nurse> r pharmacist. This includes any pssible side effects nt listed in this leaflet. See sectin 4. The name f yur medicine is Daceptn 5 mg/ml Slutin fr infusin, which will be referred t as Daceptn 5 mg/ml thrughut this leaflet. What is in this leaflet 1. What Daceptn 5 mg/ml is and what it is used fr 2. What yu need t knw befre yu use Daceptn 5 mg/ml 3. Hw t use Daceptn 5 mg/ml 4. Pssible side effects 5. Hw t stre Daceptn 5 mg/ml 6. Cntents f the pack and ther infrmatin 1. What Daceptn 5 mg/ml is and what it is used fr Apmrphine hydrchlride hemihydrate belngs t a grup f medicines knwn as dpamine agnists. Daceptn 5 mg/ml is used t treat Parkinsn s disease. Apmrphine helps t reduce the amunt f time spent in an ff r immbile state in peple wh have previusly been treated fr Parkinsn s disease with levdpa (anther treatment fr Parkinsn s disease) and/r ther dpamine agnists. Yur dctr <r nurse> will help yu t recgnise the signs f when t use yur medicine. 2. What yu need t knw befre yu use Daceptn 5 mg/ml D NOT use Daceptn 5 mg/ml - if yu are under 18 years f age - if yu have breathing difficulties r suffer frm asthma - if yu have dementia r Alzheimer s disease - if yu suffer frm cnfusin, hallucinatins, r any ther similar prblems - if yu have liver prblems - if yu have severe dyskinesia (invluntary mvements) r severe dystnia (inability t mve) n accunt f the treatment with levdpa - if yu are allergic t apmrphine r any f the ther ingredients f this medicine (listed in sectin 6). - if yu r smene in yur family are knwn t have an abnrmality f electrcardigram (ECG) called lng QT syndrme. Tell yur dctr. Warnings and precautins Talk t yur dctr<, nurse> r pharmacist befre using Daceptn 5 mg/ml: - if yu have kidney prblems - if yu have lung prblems - if yu have heart prblems

2 - if yu have lw bld pressure r feel faint and dizzy when yu stand - if yu are taking any medicines t treat high bld pressure - if yu feel sick r suffer frm being sick - if yu have any mental disrders when Daceptn is started - if yu are elderly r frail - when driving r perating machinery since apmrphine may cause sleepiness including sudden sleep nset episdes (yu must nt drive r perate machinery if Daceptn makes yu sleepy) - yur dctr shuld check yur bdy regularly when taking Daceptn with levpda (anther treatment fr Parkinsn s disease). - Tell yur dctr if yu r yur family/carer ntices that yu are develping urges r cravings t behave in ways that are unusual fr yu and yu cannt resist the impulse, drive r temptatin t carry ut certain activities that culd harm yurself r thers. These are called impulse cntrl disrders and can include behaviurs such as addictive gambling, excessive eating r spending, an abnrmally high sex drive r an increase in sexual thughts r feelings. Yur dctr may need t adjust r stp yur dse. If any f the abve situatins applies t yu, please infrm yur dctr r nurse. Check with yur dctr r pharmacist befre taking yur medicine if: Yu are using medicines that are knwn t affect the way yur heart beats. This includes medicines used fr heart rhythm prblems (such as quinidine and amidarne), fr depressin (including tricyclic antidepressants such as amitriptyline and imipramine) and fr bacterial infectins ( macrlide antibitics such as erythrmycin, azithrmycin and clarithmycin) and dmperidne. Other medicines and Daceptn 5 mg/ml Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines, including medicines btained withut prescriptin. If yu use Daceptn 5 mg/ml with ther medicines the effect f thse medicines may be altered. This is especially true fr: - Medicines such as clzapine t treat sme mental disrders - Medicines t lwer yur bld pressure - Other medicines fr Parkinsn s disease Yur dctr will tell yu if yu need t adjust the dse f yur apmrphine r any f yur ther medicines. If yu are taking levdpa (anther medicine fr Parkinsn s disease) as well as apmrphine yur dctr shuld check yur bld regularly. Daceptn 5 mg/ml with fd and drink Fd and drink d nt affect Daceptn 5 mg/ml. Pregnancy and breast-feeding If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t have a baby, ask yur dctr<, nurse> r pharmacist fr advice befre taking this medicine. Daceptn 5 mg/ml shuld nt be used during pregnancy unless clearly necessary. Check with yur dctr <r nurse> befre using Daceptn 5 mg/ml if yu are pregnant, think yu may be pregnant r yu are planning t becme pregnant.

3 It is nt knwn whether Daceptn 5 mg/ml is transferred t breast milk. Talk t yur dctr if yu are breast-feeding r intend t breast-feed. Yur dctr will explain t yu, whether yu shuld cntinue/discntinue breast-feeding r cntinue/discntinue taking this medicine. Driving and using machines Daceptn 5 mg/ml can cause drwsiness and a strng desire t sleep. D nt drive r use any tls r machinery if Daceptn 5 mg/ml makes yu sleepy. Daceptn 5 mg/ml cntains sdium metabisulphite which may rarely cause severe hypersensitivity reactins and brnchspasm with symptms such as rash r itchy skin, difficulty breathing, puffiness f the eyelids, face r lips, swelling r redness f the tngue. If yu experience these side effects, immediately g t the nearest hspital casualty department. Daceptn 5 mg/ml cntains 3.4 mg sdium per ml. T be taken int cnsideratin by patients n a cntrlled sdium diet 3. Hw t use Daceptn 5 mg/ml Always use this medicine exactly as yur dctr has tld yu. Check with yur dctr<, nurse> r pharmacist if yu are nt sure. D nt use Daceptn 5 mg/ml if - The slutin has turned green. - The slutin is cludy r yu can see particles in it. Where t inject yur Daceptn 5 mg/ml Inject yur Daceptn 5 mg/ml int an area under the skin (subcutaneusly) as shwn by yur dctr <r nurse>. D nt inject Daceptn 5 mg/ml int a vein Hw much t use Bth the amunt f Daceptn 5 mg/ml yu shuld use and the ttal amunt f time yu shuld receive yur medicine each day, will depend upn yur persnal needs. Yur dctr will discuss this with yu and tell yu hw much f yur medicine yu shuld administer. The amunt that will wrk best fr yu will have been determined during yur visit t the specialist clinic. - The average infusin dse per hur is between 1 mg and 4 mg apmrphine hydrchlride. - Usually this is given t yu when yu are awake and generally stpped befre yu g t sleep. - The amunt f apmrphine hydrchlride that yu receive each day shuld nt exceed 100mg - Yur dctr <r nurse> will decide which dse is best fr yu - A different site fr each infusin shuld be used every 12 hurs. There is n need t dilute Daceptn befre use. In additin, it shuld nt be mixed with ther medicines. Daceptn has been designed fr cntinuus infusin with a minipump r syringe driver. It is nt t be used fr intermittent injectin. The chice f which minipump and r syringe-driver t use, and the dsage settings required will be determined by the physician in accrdance with the particular needs f the patient.

4 If yu have any further questins n the use f this medicine, ask yur dctr <r nurse>. If yu use mre Daceptn 5 mg/ml than yu shuld - Tell yur dctr r cntact yur nearest hspital emergency department immediately. - It is imprtant t administer the crrect dse f Daceptn and nt t use mre than the amunt recmmended by yur dctr. Higher dses may cause a slw heart rate, excessive sickness, excessive sleepiness and/r difficulty breathing. Yu may als feel faint r dizzy particularly when yu stand up, due t lw bld pressure. Lying dwn and raising yur feet will help t treat lw bld pressure. If yu frget t use Daceptn 5 mg/ml Take it when yu next require it. D nt take a duble dse t make up fr a frgtten dse. If yu stp using Daceptn 5 mg/ml Cntact yur dctr befre stpping treatment and discuss whether this apprpriate r nt. If yu have any further questins n the use f this medicine, ask yur dctr<, nurse> r pharmacist. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. Tell yur dctr if yu think yur medicine is making yu feel unwell r if yu get any f the fllwing: Very cmmn side effects (may affect mre than 1 in 10 users): - Lumps under the skin at the site f injectin which are sre, trublesme and may be red and itchy. In rder t avid getting these lumps, it is advisable t change the site f injectin every time yu insert the needle. Cmmn side effects (may affect up t 1 in 10 users): Feeling sick r being sick, particularly when starting Daceptn 5 mg/ml. Dmperidne shuld be started at least 2 days befre Daceptn 5 mg/ml t stp yu feeling r being sick. - lf yu are taking dmperidne and still feel sick, r if yu are nt taking dmperidne and yu have sickness, tell yur dctr <r nurse> as sn as pssible - Feeling tired r excessive sleepy - Cnfusin r hallucinatins - Yawning - Feeling dizzy r light-headed when standing up Uncmmn side effects (may affect up t 1 in 100 users): - Increased invluntary mvements r increased shakiness during n perids - Haemlytic anaemia, an abnrmal breakdwn f red bld cells in the bld vessels r elsewhere in the bdy. This is an uncmmn side effect that can ccur in patients als taking levdpa. - Suddenly falling asleep - Rashes - Breathing difficulties - Injectin site ulceratin - Reductin in red bld cells which can make the skin pale yellw and cause weakness r breathlessness - Reductin in bld platelets, which increases the risk f bleeding r bruising Rare side effects (may affect up t 1 in 1000 users):

5 - An allergic reactin such as difficulty breathing r tightness f the chest, puffiness f eyelids, face r lips, swelling r redness f the tngue - Esinphilia, an abnrmally high amunt f white bld cells in the bld r in bdy tissues. Side effects with unknwn frequency (frequency cannt be estimated frm the available data): - Swelling f the legs, feet r fingers - inability t resist the impulse, drive r temptatin t perfrm an actin that culd be harmful t yu r thers, which may include: Strng impulse t gamble excessively despite serius persnal r family cnsequences. Altered r increased sexual interest and behaviur f significant cncern t yu r t thers, fr example, an increased sexual drive. Uncntrllable excessive shpping r spending binge eating (eating large amunts f fd in a shrt time perid) r cmpulsive eating (eating mre fd than nrmal and mre than is needed t satisfy yur hunger) Tell yur dctr if yu experience any f these behavirs; she r he will discuss ways f managing r reducing the symptms If yu get any side effects, talk t yur dctr<, nurse> r pharmacist. This includes any side effects nt listed in this leaflet. Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist <r nurse>. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the natinal reprting system listed in Appendix V. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre Daceptn 5 mg/ml Keep this medicine ut f the sight and reach f children. Keep the vial in the uter cartn in rder t prtect frm light. D nt refrigerate r freeze. After pening and filling the drug prduct in syringes attached with infusin sets: chemical and physical in-use stability has been demnstrated fr 7 days at 25 C. Frm a micrbilgical pint f view, unless the methd f pening and further handling precludes the risk f micrbial cntaminatin, the prduct shuld be used immediately. If nt used immediately, in-use strage times and cnditins are the respnsibility f the user. D nt use this medicine after the expiry date which is stated n the cartn and label after EXP.. The expiry date refers t the last day f that mnth. D nt use this medicine if yu ntice that the slutin has turned green. It shuld nly be used if the slutin is clear, clurless t slightly yellw and free f particles. Used syringes and needles shuld be discarded in a Sharps bin r ther suitable cntainer. When yur Sharps bin r cntainer is full, please give it t yur dctr r pharmacist fr safe dispsal. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help t prtect the envirnment.

6 6. Cntents f the pack and further infrmatin What Daceptn 5 mg/ml cntains The active substance is apmrphine hydrchlride hemihydrate. Each millilitre f Daceptn 5 mg/ml cntains 5 mg f apmrphine hydrchlride hemihydrate. Daceptn 5 mg/ml is available in 20 ml vials cntaining 100 mg f apmrphine hydrchlride hemihydrate. The ther ingredients are: - Sdium metabisulphite (E223) - Sdium chlride - Hydrchlric acid (fr ph-adjustment) - Water fr Injectins Refer t Sectin 2: Daceptn 5 mg/ml cntains metabisulphite and sdium chlride regarding sdium metabisulphite and sdium chlride. What Daceptn 5 mg/ml lks like and cntents f the pack Daceptn 5 mg/ml is a clear and clurless t slightly yellw slutin fr infusin. Glass vials cntaining 20 ml slutin fr infusin, in packs f 1 r 5 vials. Bundle packs: 5 x 1, 10 x 1, 30 x 1, 2 x 5 and 6 x 5 Nt all pack sizes may be marketed. Marketing Authrisatin Hlder EVER Neur Pharma GmbH Marketing Authrisatin Number AT/H/0364/002/DC Manufacturer EVER Neur Pharma GmbH This leaflet was last revised in {MM/YYYY} 01/2014