PACKAGE LEAFLET: INFORMATION FOR THE USER. Moapar mg powder and solvent for prolonged-release suspension for injection triptorelin

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Mapar mg pwder and slvent fr prlnged-release suspensin fr injectin triptrelin 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 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, r pharmacist. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet: 1. What Mapar is and what it is used fr 2. What yu need t knw befre yu use Mapar 3. Hw t use Mapar 4. Pssible side effects 5. Hw t stre Mapar 6. Cntents f the pack and ther infrmatin 1. WHAT MOAPAR IS AND WHAT IT IS USED FOR Mapar cntains triptrelin, which is similar t a hrmne called gnadtrpin releasing hrmne (GnRH analgue). It is a lng acting frmulatin designed t slwly deliver mg f triptrelin ver twelve weeks. It acts by lwering the levels f the male hrmne, teststerne, in the bdy. Mapar is used t decrease sexual drive in adult men with severe sexual deviatins. The treatment with Mapar is t be initiated and cntrlled by a psychiatrist. The treatment shuld be given in cmbinatin with psychtherapy, in rder t decrease deviating sexual behaviur. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOAPAR D nt use Mapar - if yu suffer frm serius steprsis (a cnditin that weakens yur bnes). - if yu are allergic t triptrelin, ther medicines that regulate the prductin and release f sex hrmnes, r any f the ther ingredients f this medicine (listed in sectin 6). Warning and precautins At the beginning f treatment there will be an increased amunt f teststerne in yur bdy. This might result in an increase in sexual drive. Yur dctr may give yu sme medicine (an anti-andrgen) t cunteract this effect. Talk t yur dctr: - if yu develp a depressed md while taking Mapar. There have been reprts f depressin in patients taking Mapar which may be severe. - if yu are using anticagulants (medicines that inhibit the bld cltting ability), since yu may experience bruises at the site f injectin. PIL 1

2 - if yu are a heavy drinker, a smker, have steprsis (a cnditin that weakens yur bnes) r have a family histry f steprsis, have a pr diet r take anticnvulsants (medicines fr epilepsy r fits) r crticsterids. When Mapar is used fr a lng perid f time the risk f develping weak bnes is increased, especially if any f the abve applies. In rder t prevent brittleness f the bnes, a healthy lifestyle including n smking, mderatin f alchl cnsumptin and regular weight bearing exercises that put a lad n and strengthens the skeletn, is recmmended ( e.g. walking, jgging, ther frms f sprts that put a lad n the skeletn). Adequate dietary calcium and vitamin D intake shuld als be maintained. - if yu are abut t take a diagnstic test f pituitary gnadal functin. The result can be misleading if yu are n Mapar treatment r after discntinuatin f Mapar treatment. - if yu experience sudden headache, vmiting, prblems with eye sight and paralysis f the eye muscles. This can be signs f a benign tumur f the pituitary gland which may becme evident under treatment with Mapar. - if yu have diabetes, r if yu suffer frm heart r vascular prblems. - Any heart r bld vessel cnditins, including heart rhythm prblems (arrhythmia), r are being treated with medicines fr these cnditins. The risk f heart rhythm prblems may be increased when using Mapar. When the treatment is stpped, teststerne will return t nrmal levels and yur sexual drive may increase again. Therfre, yur dctr may give yu an ther medicine in rder t cntrl this effect. Children and adlescents Mapar is nt indicated fr use in nenates, infants, children and adlescents. Other medicines and Mapar When Mapar is taken with medicines which affect the release f hrmnes frm the pituitary, yur dctr may need t d additinal checks. Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines. Mapar might interfere with sme medicines used t treat heart rhythm prblems (e.g. quinidine, prcainamide, amidarne and stall) r might increase the risk f heart rhythm prblems when used with sme ther drugs (e.g. methadne (used fr pain relief and part f drug addictin detxificatin), mxiflxacin (an antibitic), antipsychtics used fr serius mental illnesses). Pregnancy and breast-feeding Mapar is nt t be used by wmen. Driving and using machines Yu may feel dizzy, tired r have prblems with yur sight such as blurred visin. These are pssible side effects f treatment. If yu experience any f these side effects yu shuld nt drive r use machines. Mapar cntains sdium This medicinal prduct cntains sdium but less than 1 mml (23 mg) sdium per vial. This medicine is almst sdium-free and may be taken with a lw sdium diet. 3. HOW TO USE MOAPAR Mapar is prepared by and is always given t yu by a dctr r nurse.

3 The usual dse is mg (in ne vial) f Mapar, given as a single injectin int a muscle every twelve weeks. If yu think the effect f Mapar is t strng r t weak, cntact yur dctr. If yu have any further questins n the use f this prduct, ask yur dctr r pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medecine can cause side effects, althugh nt everybdy gets them. Many f the side effects are expected, due t the change in the level f teststerne in yur bdy. These effects include ht flushes and imptence. In rare cases (may affect up t 1 in 1,000 peple) yu may experience a severe allergic reactin and cmmnly (may affect up t 1 in 10 peple) yu may experience an allergic reactin. Stp taking Mapar and cntact a dctr r g t yur nearest emergency department immediately if yu experience any f the fllwing symptms: swallwing r breathing prblems, swelling f yur lips, face, thrat r tngue, r a rash. Other side effects that may ccur: Very cmmn: may affect mre than 1 in 10 peple Ht flushes Weakness Excessive sweating Back pain Pins and needles sensatin in the legs Reduced libid Imptence Cmmn: may affect up t 1 in 10 peple Nausea, dry muth Pain,bruising, redness and swelling at injectin site; muscle and bne pain; pain in the arms and legs; edema (build up f fluid in the bdy tissues), lwer adbminal pain High bld pressure Increase in weight Dizziness, headache Lss f libid, depressin, md changes Uncmmn: may affect up t 1 in 100 peple Increase in the amunt f bld platelet Feeling yur heartbeat Ringing in the ears, vertig (sensatin f spinning r whirling mtin), Blurred visin Pain in abdmen, cnstipatin, diarrhea, vmiting, Drwsiness, severe shivering assciated with sweating and a fever, sleepiness, pain Sme bld tests affected (including raised liver functin tests) Increased bld pressure Weight lss,

4 Lss f appetite, increase f appetite, gut (severe pain and swelling in the jints usually in the big te), diabetes, excessive lipids in the bld Jint pain, muscle cramps, muscle weakness, muscle pain, swelling and tenderness, bne pain Tingling r numbness Inability t sleep, irritability Develpment f enlarged breasts, breast pain, reductin in testicular size, pain in the testicles, Difficulty in breathing, Acne, hair lss, itching, rash, redness f skin, hives T wake up t pass urine, prblems passing urine Nsebleeds Rare: may affect up t 1 in 1,000 peple Red r purple disclratins n the skin Abnrmal sensatin in the eye, r disturbance in visin Distended abdmen, flatulence, abnrmal sense f taste Chest pain Difficulty in standing Flu-like illness, fever Inflammatin f the nse/thrat Increase in an enzyme present in e.g. bne and liver Increased bdy temperature Stiff jints, jint swelling, musculskeletal stiffness, stearthritis Memry impairment, Feeling cnfused, decreased activity, having a feeling f elatin Shrtness f breath when lying flat Blisters Lw bld pressure Nt knwn: frequency cannt be estimated frm the available data: changes in ECG (QT prlngatin), general discmfrt, anxiety, urinary incntinence. An increase in white bld cell cunt may be fund, as with ther GnRH analgues, in patients being treated with Mapar mg. Reprting f side effects If yu get any side effects, talk t yur dctr. This includes any pssible side effects nt listed in this leaflet. Yu can reprt side effects directly via the natinal reprting system listed in Appendix V*. By reprting side effects yu can help prvideing mre infrmatin n the safety f this medicine. 5. HOW TO STORE MOAPAR Keep this medicine ut f the sight and reach f children. D nt use this medicine after the expiry date which is stated n the cartn, vial and ampule after EXP. The expiry date refers t the last day f that mnth.

5 D nt stre abve 25 C. Chemical and physical in-use stability has been demnstrated fr 24 hurs at 25 C. Frm a micrbilgical pint f view, the prduct shuld be used immediately. If nt used immediately, in-use strage times and cnditins prir t use are the respnsibility f the user and wuld nrmally nt be lnger than 24 hurs at 2 t 8 C. 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION What Mapar cntains The active substance is triptrelin One vial f pwder cntains mg f triptrelin, as triptrelin embnate. Recnstituted suspensin (2 ml) cntains mg f triptrelin, as triptrelin embnate. The ther ingredients are: Pwder : ply (d, l-lactide-c-glyclide), mannitl, carmellse sdium and plysrbate 80. Slvent : water fr injectins. What Mapar lks like and cntents f the package Mapar is a white t ff-white pwder. The slvent is a clear slutin. The package cntains: 1 vial with pwder, 1 ampule with 2 ml f slvent, 1 injectin syringe, 2 needles. Marketing Authrisatin Hlder and Manufacturer Marketing Authrisatin Hlder Labratires Sdia Avenue Rbert Schuman Reims France

6 Manufacturer Ipsen Pharma Bitech Parc d' Activité du Plateau de signes Chemin Départemental n Signes France This medicinal prduct is authrised in the Member States f the EEA under the fllwing names: Sweden: Mapar mg Belgium, Germany, Denmark, Finland, Netherlands, United Kingdm, Austria, Ireland, Pland and France: Salvacyl LP Nrway, Greece: Salvapar This leaflet was last revised in

7 < The fllwing infrmatin is intended fr healthcare prfessinals nly (please see sectin 3): 1 PREPARATION OF THE PATIENT BEFORE RECONSTITUTION Prepare the patient by disinfecting his gluteus at the injectin site. This peratin needs t be perfrmed first because nce recnstituted, the drug shuld be injected immediately. 2 PREPARATION OF THE INJECTION Tw needles are prvided in the bx : Needle 1 : a 20G needle (38mm f length) withut safety device t be used fr recnstitutin Needle 2 : a 20G needle (38mm f length) with safety device t be used fr injectin The presence f bubbles n tp f the lyphilisate is a nrmal appearance f the prduct. 2a Take ut the ampule cntaining the slvent. Tap any slutin within the tip f the ampule back t the main bdy f the ampule. Screw Needle 1 (withut safety device) nt the syringe. D nt remve the needle prtectin yet. Break pen the ampule with dt face up. Remve the needle prtectin frm Needle 1. Insert the needle in the ampule and draw up all the slvent int the syringe. Put aside the syringe cntaining the slvent. 2b Take ut the vial cntaining the pwder; Tap any pwder which has accumulated at the tp f the vial back t the bttm f the vial. Remve the plastic tab n the tp f vial. Take back the syringe cntaining the slvent and insert the needle thrugh the rubber stpper vertically int the vial. Inject the slvent slwly, s that, if pssible, it washes dwn the entire upper part f the vial. 2c Pull up Needle 1 abve the liquid level. D nt remve the needle frm the vial. Recnstitute the suspensin by swirling gently frm side t side. D nt invert the vial. Make sure that the agitatin is lng enugh t btain a hmgeneus and milky suspensin. Imprtant: Check there is n unsuspended pwder in the vial (if any pwder clumps are present, cntinue swirling until they

8 disappear). 2d When the suspensin is hmgeneus, pull dwn the needle withut inverting the vial, draw up all f the suspensin. A small amunt will remain in the vial and shuld be discarded. An verage is included t allw fr this lss. Grasp the clured hub t discnnect needle. Remve Needle 1 used fr the recnstitutin frm the syringe. Screw n t the syringe Needle 2. Mve the safety sheath away frm the needle and twards the syringe barrel. The safety sheath remains in the psitin yu set. Remve the needle prtectin frm the needle. Prime the needle t remve air frm the syringe and inject immediately. 3- INTRAMUSCULAR INJECTION T avid precipitatin, inject immediately int the gluteal muscle previusly disinfected 4 AFTER USE Activatin f the safety system using a ne-handed technique, Nte : Keep yur finger behind the tab at all times There are tw alternatives t activate the safety system. Methd A : push the tab frward with yur finger r Methd B : push the sheath t a flat surface In bth cases press dwn with a firm quick mtin until a distinct audible click is heard. Visually cnfirm that the needle is fully engaged under the lck. Used needles, any unused suspensin r ther waste material shuld be dispsed f in accrdance with lcal requirements. r