Package Leaflet: Information for the user

Transcription

1 Package Leaflet: Infrmatin fr the user Decapeptyl 6-mnth 22.5 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, pharmacist r nurse. 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, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet 1. What Decapeptyl 6 Mnth is and what it is used fr 2. What yu need t knw befre yu use Decapeptyl 6 Mnth 3. Hw t use Decapeptyl 6 Mnth 4. Pssible side effects 5. Hw t stre Decapeptyl 6 Mnth 6. Cntents f the pack and ther infrmatin 1. What Decapeptyl 6 Mnth is and what it is used fr Decapeptyl 6 Mnth cntains triptrelin, which is similar t a hrmne called gnadtrpin releasing hrmne (GnRH analgue). Triptrelin belngs t a grup f medicines called GnRH analgues. It is a lng acting frmulatin designed t slwly deliver 22.5 mg f triptrelin ver a 6-mnth perid (twenty fur weeks). In men, triptrelin lwers the levels f the hrmne teststerne. In wmen, it lwers the levels f the hrmne estrgen. In men: Decapeptyl 6 Mnth is used t treat bth lcally advanced prstate cancer (limited in the prstate gland itself) and prstate cancer which has spread t ther parts f the bdy (metastatic cancer). In children: Decapeptyl 6 Mnth is used t treat puberty that ccurs at 2 years f age r lder, i.e. befre 8 years f age in girls and 10 years f age in bys (preccius puberty). This is called early puberty in the rest f this leaflet. 2. What yu need t knw befre yu use Decapeptyl 6 Mnth D nt use Decapeptyl 6 Mnth Dcument replaced: 30.1_DEC22._IE Page 1 f 12

2 If yu are allergic (hypersensitive) t triptrelin pamate, gnadtrpin releasing hrmne (GnRH), ther GnRH analgues r any f the ther ingredients f this medicine (listed in Sectin 6). If yu are pregnant r breast-feeding. Warnings and precautins Talk t yur dctr r pharmacist befre taking Decapeptyl 6-mnth.There have been reprts f depressin in patients taking Decapeptyl 6 Mnth which may be severe. If yu are taking Decapeptyl 6 Mnth and develp depressed md, infrm yur dctr. If yu are using medicines fr preventing yur bld cltting, since yu may experience bruising at the site f injectin. The prduct shuld nly be injected in the muscle. In men: At the beginning f treatment there will be an increased amunt f teststerne in yur bdy. This may cause the symptms f the cancer t wrsen. Cntact yur dctr if this happens. The dctr may give yu sme medicine (an anti-andrgen) t prevent yur symptms frm getting wrse. During the first weeks f treatment, Decapeptyl 6 Mnth may, as with ther GnRH agnists, in islated cases, cause the spinal crd t cmpress r the urethera (where yu pass urine) t blck. Yu will be mnitred by yur dctr and given treatment fr these cnditins if they ccur. Yu shuld nt receive Decapeptyl 6 Mnth if yu have had an peratin t remve yur testicles. Treatment with Decapeptyl 6 Mnth, as with ther GnRH analgues, may increase the risk f develping thin r weak bnes, especially if yu are a heavy drinker, a smker, have a family histry f steprsis (a cnditin that affects the strength f yur bnes), have a pr diet r take anticnvulsants (medicines fr epilepsy r fits) r crticsterids (sterids). If yu have anything wrng with yu that affects yur bnes, such as steprsis, tell yur dctr. This may affect the way yur dctr decides t treat yu. If yu need any tests t check yur hrmne functin during r after yur Decapeptyl 6 Mnth treatment, the results may be misleading. Please tell yur dctr yu have been treated with Decapeptyl 6 Mnth This type f hrmne therapy that yu are receiving has been assciated with metablic changes such as glucse intlerance and an increased risk f cardivascular disease. Tell yur dctr if yu have diabetes. Tell yur dctr if yu have 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 Decapeptyl 6 Mnth. If yu have an enlargement (benign tumur) f the pituitary gland that yu were unaware f, this may be discvered during treatment with Decapeptyl 6 Mnth. Symptms include sudden headache, vmiting, prblems with eye sight and paralysis f the eye muscles. In children: If yu have a prgressive brain tumur, tell yur dctr. This may affect the way yur dctr decides t treat yu. Girls wh have an early puberty may have sme vaginal bleeding in the first mnth f treatment. Dcument replaced: 30.1_DEC22._IE Page 2 f 12

3 Please talk with yur dctr if yu are cncerned abut any f the abve. Other medicines and Decapeptyl 6 Mnth Please tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines, including medicines btained withut a prescriptin. Decapeptyl 6 Mnth 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 D nt take Decapeptyl 6 Mnth if yu are pregnant. D nt take Decapeptyl 6 mnth if yu are breast-feeding. 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 r frm the underlying disease. If yu experience any f these side effects yu shuld nt drive r use machines. Imprtant infrmatin abut sme f the ingredients f Decapeptyl 6 Mnth Decapeptyl 6 Mnth is essentially sdium free since it cntains less than 1 mml sdium (23mg) per dse and may be taken if yu are n a lw sdium diet. 3. Hw t use Decapeptyl 6 Mnth Decapeptyl 6 Mnth will be administered t yu under the supervisin f a physician. In men: Therapy f prstrate cancer with Decapeptyl 6 Mnth requires lng term treatment. The usual dse is 1 vial f Decapeptyl 6 Mnth injected int a muscle every 6 mnths (24 weeks). Decapeptyl 6 mnth is fr injectin int the muscle nly. Decapeptyl 6 Mnth will be given t yu regularly t reduce teststerne levels. Yur dctr will determine the treatment duratin. Bld tests may be perfrmed by yur dctr t measure hw effective the treatment is. In children: Yu will usually receive an injectin int a muscle every 6 mnths (24 weeks). Decapeptyl 6 mnth is fr injectin int the muscle nly. Yur dctr will decide when treatment shuld be stpped (nrmally when yu are abut years ld if yu are a girl and abut years ld if yu are a by). Dcument replaced: 30.1_DEC22._IE Page 3 f 12

4 If yu think the effect f Decapeptyl 6 Mnth 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. Pssible side effects Like all medicines, this medicine may cause side effects, althugh nt everybdy gets them. In men: As seen fllwing treatment with ther GnRH agnist therapies r after surgical castratin, the mst cmmnly bserved adverse events related t triptrelin treatment were due t its expected pharmaclgical effects. These effects included ht flushes and decreased libid. Increased lymphcyte cunt has been reprted with patients underging GnRH analgue treatment. With the exceptin f immun-allergic reactins and injectin site reactins, all adverse events are knwn t be related t changed teststerne levels. As with ther GnRH agnist, hypersensitivity and allergic (anaphylactic) reactins have been reprted with triptrelin. In ther triptrelin prducts, uncmmnly pressure sensitive infiltratin at the injectin site have been reprted after subcutaneus injectin. In rare cases yu may experience a severe allergic reactin. Tell yur dctr immediately if yu develp symptms such as swallwing r breathing prblems, swelling f yur lips, face, thrat r tngue, a rash. Side effects which are very cmmn (may affect mre than 1 in 10 peple) are: Ht flushes Weakness Excessive sweating Back pain Pins and needles sensatin in the legs Reduced libid Imptence. Side effects which are cmmn (may affect up t 1 in 10 peple) are: 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 abdminal pain High bld pressure Allergic reactin Increase in weight Dcument replaced: 30.1_DEC22._IE Page 4 f 12

5 Dizziness, headache Lss f libid, depressin, md changes. Side effects which are uncmmn (may affect up t 1 in 100 peple) are: Increase f bld platelets Feeling yur heartbeat Ringing in the ears, vertig, 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) Bld pressure increased Weight lss Lss r 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 cramp, muscle weakness, muscle pain, swelling and tenderness, bne pain Tingling r numbness Inability t sleep, irritability Develpment f enlarged breasts in men, breast pain, reductin in testicular size, pain in testicles Difficulty in breathing Acne, hair lss, itching, rash, redness f the skin, hives Waking up at night t pass urine, prblems passing urine Nsebleeds. Side effects which are rare (may affect up t 1 in 1000 peple) are: Red r purple disclratins n the skin Abnrmal sensatin in the eye, blurring r disturbance in visin Sensatin f fullness in the abdmen, flatulence, abnrmal sense f taste Chest pain Difficulty in standing Flu-like symptms, fever Anaphylactic reactin (serius allergic reactin which can cause dizziness r difficulty in breathing) Inflammatin f the nse/thrat Increased bdy temperature Stiff jints, jint swelling, musculskeletal stiffness, stearthritis Memry lss Feeling cnfused, decreased activity, having a feeling f elatin Shrtness f breath when lying flat Blisters Lw bld pressure. During pst-marketing surveillance the fllwing side effects have als been reprted: Dcument replaced: 30.1_DEC22._IE Page 5 f 12

6 Anaphylactic reactin (serius allergic reactin which causes difficulty in breathing r dizziness), changes in ECG (QT prlngatin), general discmfrt, anxiety and rapid frmatin f wheals due t swelling f the skin r mucus membranes and urinary incntinence. In children: Side effects which are very cmmn (may affect mre than 1 in 10 peple) are: Vaginal bleeding which may ccur in girls in the first mnth f treatment. Side effects which are cmmn (may affect up t 1 in 10 peple) are: Acne Headache Ht flushes Weight gain Pain in the abdmen Hypersensitvity reactins Pain, redness and swelling at injectin site. Side effects that are uncmmn (may affect up t 1 in 100 peple) are: Itching Neck pain Nsebleeds Cnsitipatin Blurred visin Rash r hives Nausea, vmiting Weight increased Pain in the breast Changes in md General discmfrt. During pst-marketing surveillance, the fllwing side effects have als been reprted: High bld pressure, abnrmal visin, anaphylactic reactin (serius allergic reactin which causes difficulty in breathing r dizziness), sme bld tests affected including hrmne levels, rapid frmatin f wheals due t swelling f the skin r mucus membranes, muscle pain, md disrders, depressin and nervusness. Yur dctr will determine the cuntermeasures be t taken. Reprting f side effects If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via HPRA Pharmacvigilance, Earlsfrt Terrace, IRL- Dublin 2; Tel: ; Fax Website: medsafety@hpra.ie. By reprting side effects, yu can help prvide mre infrmatin n the safety f this medicine. Dcument replaced: 30.1_DEC22._IE Page 6 f 12

7 5. Hw t stre Decapeptyl 6 Mnth 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 bx and n the labels after EXP. The expiry date refers t the last day f that mnth. Once pened/recnstituted, immediate use is recmmended. Stre belw 25 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 prtect the envirnment. 6. Cntents f the pack and ther infrmatin What Decapeptyl 6 Mnth cntains The active substance f Decapeptyl 6 Mnth is triptrelin. Each vial cntains the quantity f triptrelin (as triptrelin pamate) t ensure that the minimum triptrelin quantity injected is 22.5 mg. The ther ingredients are ply (D,L-lactide-c-glyclide), mannitl, carmellse sdium, plysrbate 80. The slvent cntains water fr injectins. What Decapeptyl 6 Mnth lks like and the cntents f the pack Decapeptyl 6 Mnth is supplied as an ff-white pwder in a clear glass vial. Each vial cntains enugh prduct fr ne injectin. The slvent cntains 2mL f a clear, clurless liquid in a glass ampule. Once recnstituted, arund 2mL f milky liquid is frmed. After dispersin in 2mL slvent, 1mL f the recnstituted suspensin cntains 11.25mg triptrelin. Decapeptyl 6 Mnth is available in bxes f: 1 vial, 1 ampule and 1 blister cntaining 1 injectin syringe and 2 injectin needles. Marketing Authrisatin Hlder Ipsen Pharmaceuticals Limited, Blanchardstwn Industrial Park, Blanchardstwn, Dublin 15, Ireland. Manufacturer Ipsen Pharma Bitech Parc d Activites du Plateau de Signes Signes France. Dcument replaced: 30.1_DEC22._IE Page 7 f 12

8 The leaflet was last revised in [insert n HA apprval] Is this leaflet hard t see r read? Phne t ask fr help. Dcument replaced: 30.1_DEC22._IE Page 8 f 12

9 The fllwing infrmatin is intended fr medical r healthcare prfessinals nly: INSTRUCTIONS FOR RECONSTITUTION 1. PREPARATION OF THE PATIENT BEFORE RECONSTITUTION Prepare the patient by disinfecting 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 (38 mm f length) withut safety device t be used fr recnstitutin Needle 2 : a 20G needle (38 mm 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) n t 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 tp f the 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 Dcument replaced: 30.1_DEC22._IE Page 9 f 12

10 gently frm side t side. D nt invert the vial. Cntinue swirling lng enugh t btain a hmgenus and milky suspensin. Imprtant: Check there is n unsuspended pwder in the vial (if any pwder clumps are present, cntinue swirling until they disappear). 2d When the suspensin is hmgeneus, pull dwn the needle and withut inverting the vial, draw up all f the suspensin. A small amunt will remain in the vial and shuld be discarded. An verfill is included t allw fr this lss. Grasp the clured hub t discnnect the 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 Dcument replaced: 30.1_DEC22._IE Page 10 f 12

11 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 materials shuld be dispsed f in accrdance with lcal requirements. Dcument replaced: 30.1_DEC22._IE Page 11 f 12

12 DETACH HERE AND GIVE INFORMATION TO PATIENT Dcument replaced: 30.1_DEC22._IE Page 12 f 12