Package leaflet: Infrmatin fr the patient Imuran Pwder fr Slutin fr Injectin r Infusin 50mg azathiprine Read all f this leaflet carefully befre yu start taking 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 Imuran Pwder fr Slutin fr Injectin r Infusin 50mg, which will be called Imuran Injectin thrughut this leaflet. What is in this leaflet 1. What Imuran Injectin is and what it is used fr 2. What yu need t knw befre yu take Imuran Injectin 3. Hw t take Imuran Injectin 4. Pssible side effects 5. Hw t stre Imuran Injectin 6. Cntents f the pack and ther infrmatin 1. What Imuran Injectin is and what it is used fr Imuran Injectin cntains the active substance azathiprine. It belngs t a grup f medicines called immunsuppressives. This means that it reduces the strength f yur immune system. Imuran Injectin may be used t help yur bdy accept an rgan transplant, such as a new kidney, heart r liver, r t treat sme diseases where yur immune system is reacting against yur wn bdy (autimmune diseases). Autimmune diseases may include: severe rheumatid arthritis (a disease where the immune system attacks cells lining the jints causing swelling, pain, stiffness f the jints), systemic lupus erythematsus (a disease where the immune system attacks many f the bdy's rgans and tissues, including skin, jints, kidneys, brain, and ther rgans causing severe fatigue, fever, stiffness and jint pain), dermatmysitis and plymysitis (a grup f diseases causing inflammatin f the muscles, muscle weakness and skin rash), aut-immune chrnic active hepatitis (a disease in which the immune system attacks liver cells causing liver inflammatin, fatigue, muscle aches, yellwing f the skin and fever), pemphigus vulgaris (a disease in which the immune system attacks skin cells causing severe blistering f the skin, muth, nse, thrat and genitals), plyarteritis ndsa (a rare disease that causes inflammatin f the bld vessels), aut-immune haemlytic anaemia (a serius bld disrder where the bdy destrys red bld cells quicker than it can prduce them, with symptms f weakness and shrtness f breath),
chrnic refractry idipathic thrmbcytpenic purpura (a cnditin with lw platelet cunts, that can cause easy r excessive bruising and bleeding). Imuran Injectin may als be used t treat inflammatry bwel disease (Crhn's disease r ulcerative clitis). Yur dctr has chsen this medicine t suit yu and yur cnditin. Imuran Injectin may be used n its wn, but it is mre ften used in cmbinatin with ther medicines. 2. What yu need t knw befre yu take Imuran Injectin D nt take Imuran Injectin: if yu are allergic t azathiprine r any f the ther ingredients f this medicine (listed in sectin 6) if yu are allergic t mercaptpurine (a medicine which is similar t azathiprine the active substance cntained in Imuran Injectin. Warnings and precautins Talk t yur dctr r pharmacist befre taking Imuran Injectin: if yu have recently received, r are due t receive, a vaccinatin (vaccine). If yu take Imuran Injectin, yu shuld nt have a live rganism vaccine (fr example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe t d s by yur dctr. This is because sme vaccines may give yu an infectin if yu receive them while yu are taking Imuran Injectin. if yu have a genetic cnditin knwn as Lesch-Nyhan Syndrme. This is a rare cnditin that runs in families caused by a lack f smething called HPRT r hypxanthine-guaninephsphribsyltransferase if yu have liver r kidney prblems if yu have a genetic cnditin called TPMT deficiency (where yur bdy prduces t little f an enzyme called thipurine methyltransferase) if yu have ever had chickenpx r shingles if yu have had hepatitis B (a liver disease caused by a virus) if yu are ging t have an peratin (this is because medicines including tubcurarine, r succinylchline used as muscle relaxants during peratins may interact with Imuran Injectin). Yu shuld infrm yur anaesthesilgist f yur treatment with Imuran Injectin prir t surgery. NUDT15-gene mutatin If yu have an inherited mutatin in the NUDT15-gene (a gene which is invlved in the break-dwn f Imuran in the bdy), yu have a higher risk f infectins and hair lss and yur dctr may in this case give yu a lwer dse. If yu are nt sure if any f the abve applies t yu, talk t yur dctr, nurse r pharmacist befre taking Imuran Injectin.
Yur dctr will want t take regular bld samples while yu are taking Imuran Injectin, t check fr any changes (see sectin 3 Hw t take Imuran Injectin ). The frequency f yur bld tests will usually decrease the lnger yu cntinue t take Imuran Injectin. Yur dctr may als perfrm genetic testing (i.e. lking at yur TPMT and/r NUDT15 genes) befre r during yur treatment t determine if yur respnse t this medicatin may be affected by yur genetics. Yur dctr may change yur dse f Imuran after these tests. If yu are receiving immunsuppressive therapy, taking Imuran Injectin culd put yu at greater risk f: tumurs, including skin cancer. Therefre, when taking Imuran Injectin, avid excessive expsure t sunlight, wear prtective clthing and use prtective sunscreen with a high prtectin factr. lymphprliferative disrders treatment with Imuran Injectin increases yur risk f getting a type f cancer called lymphprliferative disrder. With treatment regimen cntaining multiple immunsuppressants (including thipurines), this may lead t death. A cmbinatin f multiple immunsuppressants, given cncmitantly increases the risk f disrders f the lymph system due t a viral infectin (Epstein-Barr virus (EBV)- assciated lymphprliferative disrders). develping a serius cnditin called Macrphage Activatin Syndrme (excessive activatin f white bld cells assciated with inflammatin), which usually ccurs in peple wh have certain types f arthritis severe chickenpx r shingles infectin. Therefre, when taking Imuran Injectin, avid cntact with peple wh have chickenpx r shingles. a previus hepatitis B infectin becming active again ther infectins such as PML (Prgressive Multifcal Leukencephalpathy) which is an pprtunistic infectin. If yu experience any signs f infectin please cntact yur dctr (see Sectin 4 Pssible side effects ). Other medicines and Imuran Injectin Tell yur dctr if yu are taking, have recently taken r might take any ther medicines. This is because Imuran Injectin can affect the way sme medicines wrk. Als sme ther medicines can affect the way Imuran Injectin wrks. In particular, tell yur dctr if yu are taking, r are planning t take: ribavirin (used t treat viral infectins) methtrexate (mainly used t treat cancers) allpurinl, xipurinl, thipurinl r ther xanthine xidase inhibitrs, such as febuxstat (mainly used t treat gut) penicillamine (mainly used in the treatment f rheumatid arthritis) ACE inhibitr (mainly used t treat high bld pressure hypertensin) anticagulants such as warfarin r acencumarl (used t prevent bld clts) cimetidine (used t treat stmach ulcers and indigestin) indmethacin (used as a pain killer and anti-inflammatry) cytstatic drugs (drugs used t treat varius types f cancer) aminsalicylates e.g. lsalazine, mesalazine r sulfasalazine (mainly used in the treatment f ulcerative clitis and Crhn s disease) c-trimxazle (an antibitic, used t treat infectins caused by bacteria)
infliximab (mainly used in the treatment f ulcerative clitis and Crhn s disease) muscle relaxants e.g. tubcurarine r succinylchline (used during peratins) as they may interact with Imuran Injectin. Yu shuld infrm yur anaesthesilgist f yur treatment with Imuran Injectin prir t surgery. If yu are nt sure if any f the abve applies t yu, talk t yur dctr r pharmacist befre taking Imuran Injectin. Having vaccines while yu are taking Imuran Injectin If yu are due t receive a vaccinatin (vaccine) speak t yur dctr r nurse befre yu d s. If yu take Imuran Injectin, yu shuld nt have a live vaccine (fr example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe t d s by yur dctr. This is because sme vaccines may give yu an infectin if yu receive them while yu are taking Imuran Injectin. Pregnancy, breast-feeding and fertility If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t becme pregnant, ask yur dctr fr advice befre taking this medicine. Pregnancy If yu are pregnant yur dctr will carefully cnsider whether t give yu this medicine, based n the risks and benefits f treatment. Breast-feeding Small amunts f Imuran Injectin may pass int the breast milk. It is recmmended that wmen receiving Imuran Injectin shuld avid breastfeeding unless the benefits utweighs the ptential risks t the child. Ask yur dctr fr advice befre breastfeeding. Fertility The effects f Imuran Injectin n fertility are nt knwn. Driving and using machines Imuran Injectin is nt knwn t affect yur ability t drive r use machinery. If yu experience any side effect frm this medicine, yu may nt be able t drive r perate machinery. Imuran Injectin cntains sdium Each 50 mg vial f Imuran Injectin cntains apprximately 4.5 mg (0.2 meq) sdium. This shuld be taken int cnsideratin by patients n a sdium cntrlled diet. 3. Hw t take Imuran Injectin Imuran Injectin is given as an intravenus injectin (int a vein) r after dilutin as an intravenus infusin (fr a lnger time). It will usually be given by yur dctr r nurse.
The amunt f Imuran Injectin taken may vary frm patient t patient and will be prescribed by yur dctr. The dse depends n the cnditin fr which yu are being treated. When yu take Imuran Injectin, yur dctr will take regular bld tests. This is t check the number and type f cells in yur bld, and t ensure yur liver is wrking crrectly Yur dctr may als ask fr ther bld and urine tests t mnitr hw yur kidneys are wrking and t measure uric acid levels. Uric acid is a natural substance made in yur bdy and levels f uric acid can rise while yu are taking Imuran Injectin. High levels f uric acid may damage yur kidneys The recmmended dse is: Adults wh have had an rgan transplant: On the first day f treatment, the usual dse is up t 5 mg per kilgram f bdy weight, then a usual daily dse f 1 mg t 4 mg per kilgram f bdy weight. During treatment yur dctr will adjust the dse depending n yur reactin t the medicine. Adults with ther cnditins: The usual starting dse is 1 mg t 3 mg per kilgram f bdy weight, then a usual daily dse f less than 1 mg t 3 mg per kilgram f bdy weight. During treatment yur dctr will adjust the dse depending n yur reactin t the medicine. Elderly patients may need a reduced dse. Patients with kidney r liver prblems may need a reduced dse. Use in children Children wh have had rgan transplant: The dsing fr children wh have had an rgan transplant is the same as adults. Children with ther cnditins: The dsing fr children with ther cnditins is the same as adults. Children wh are cnsidered t be verweight may require a higher dse. If yu take mre Imuran Injectin than yu shuld Yur dctr r nurse will give yu Imuran Injectin, s it is unlikely that yu will receive t much. If yu think yu have been given t much r have missed a dse, tell yur dctr r nurse. If yu have any further questins n the use f this prduct, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines, Imuran Injectin can cause side effects, althugh nt everybdy gets them. The fllwing side effects may happen with this medicine: Stp taking Imuran Injectin and see a dctr straight away, if yu ntice any f the fllwing serius side effects, yu may need urgent medical treatment: allergic reactins, (these are uncmmn side effects which may affect up t 1 in 100 peple) the signs may include general tiredness, dizziness, feeling sick (nausea), being sick (vmiting), diarrhea r abdminal pain swelling f the eyelids, face r lips
redness f the skin r a skin rash (including blisters, itching r peeling skin) pain in the muscles r jints sudden wheeziness, cughing r difficulty breathing In severe cases these reactins may be life-threatening (this is rare which may affect up t 1 in 10,000 peple). prblems with yur bld and bne marrw, signs include weakness, tiredness, paleness, bruising easily, unusual bleeding, r infectins (these may be very cmmn side effects which may affect mre than 1 in 10 peple) yu have a high temperature (fever) r ther signs f an infectin such as sre thrat, sre muth, urinary prblems, r chest infectin causing breathlessness and cugh (these may be very cmmn side effects which may affect mre than 1 in 10 peple) prblems with yur liver, signs include yur skin r the whites f yur eyes turn yellw (jaundice) (these may be uncmmn side effects which may affect up t 1 in 100 peple) If yu ntice any f the abve, see a dctr straight away. Other side effects include: Cmmn (may affect up t 1 in 10 peple) nausea (feeling sick) Uncmmn (may affect up t 1 in 100 peple) pancreatitis (inflammatin f the pancreas), which may cause severe upper stmach pain, Rare (may affect up t 1 in 1,000 peple) varius types f cancers including bld, lymph, and skin cancers (see sectin 2 Warnings and precautins ). yu might ntice sme hair lss while taking Imuran Injectin. Often hair des grw again, even if yu carry n taking Imuran Injectin. If yu are wrried ask yur dctr. Very Rare (may affect up t 1 in 10,000 peple) prblems with yur bwels leading t diarrhea, abdminal pain, cnstipatin, feeling r being sick (bwel perfratin) when Imuran Injectin is used in cmbinatin with ther immunsuppressives yu may get a virus which causes damage t yur brain. This may cause headaches, changes in behaviur, impaired speech, wrsening f abilities such as memry, attentin and decisin making (cgnitive decline) and may be fatal (cnditin knwn as JC virus assciated Prgressive Multifcal Leukencephalpathy) Nt knwn (frequency cannt be estimated frm the available data): Sweet s syndrme (als knwn as acute febrile neutrphilic dermatsis). Yu may develp a rash (raised red, pink r purple lumps which are sre t tuch), particularly n yur arms, hands, fingers, face and neck, which may als be accmpanied by a fever (high temperature) phtsensitivity (sensitivity t light r sunlight) a certain type f lymphma (hepatsplenic T-cell lymphma)
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: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre Imuran Injectin Keep this medicine ut f the sight and reach f children. Stre belw 25 C. Stre in riginal package in rder t prtect frm light. D nt use this medicine after the expiry date which is stated n the cartn after EXP. The expiry date refers t the last day f that mnth. 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 Imuran Injectin cntains The active substance is azathiprine. Each vial f Imuran Injectin cntains 50mg azathiprine. The ther ingredient is: sdium hydrxide What Imuran injectin lks like and cntents f the pack Each pack cntains ne Imuran injectin in a glass vial. Marketing Authrisatin Hlder and Manufacturer Marketing Authrisatin Hlder: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland +353 1 630 8400 Manufacturer GlaxSmithKline Manufacturing S.p.A, Strada Prvinciale Aslana 90, 43056 San Pl di Trrile, Parma, Italy This leaflet was last revised in