PACKAGE LEAFLET: INFORMATION FOR THE USER Spranx 10mg/ml Oral Slutin (itracnazle) 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 r pharmacist. This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them even if their symptms 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. What is in this leaflet: 1. What Spranx ral slutin is and what it is used fr 2. What yu need t knw befre yu use Spranx ral slutin 3. Hw t use Spranx ral slutin 4. Pssible side effects 5. Hw t stre Spranx ral slutin 6. Cntents f the pack and ther infrmatin 1. What Spranx ral slutin is and what it is used fr Spranx is ne f a grup f medicines called antifungals. These medicines are used t treat and stp yu frm getting infectins caused by fungi including yeasts. Yu may be given Spranx t: treat yeast infectins f the muth, thrat r gullet if yu have a pr immune system stp yu frm getting certain fungal infectins if yu have a pr immune system due t a majr bld disrder r bne marrw transplantatin. 2. What yu need t knw befre yu use Spranx ral slutin D nt use Spranx ral slutin if yu are: allergic (hypersensitive) t itracnazle r t any f the ingredients in Spranx ral slutin (listed in Sectin 6 Cntents f the pack and ther infrmatin) pregnant, think yu might be pregnant r culd becme pregnant (see the sectin n Pregnancy) taking any f the fllwing medicines: terfenadine r mizlastine (antihistamines fr allergies) bepridil, ivabradine r ranlazine - used t treat angina (crushing chest pain) nisldipine, lercanidipine r eplerenne (used fr high bld pressure) cisapride (used fr stmach upsets) dmperidne (fr nausea and vmiting) midazlam by muth r triazlam (used t help yu sleep r fr anxiety) lvastatin r simvastatin (used t lwer chlesterl) pimzide r sertindle (fr cnditins affecting thughts, feelings and/r behaviur) dihydrergtamine r ergtamine (fr migraine headaches) ergmetrine (ergnvine) r methylergmetrine (methylergnvine) used after giving birth Page 1
dispyramide, drnedarne, quinidine r dfetilide (fr irregular heart beat rhythms) clchicine (fr gut) when used in patients with kidney r liver prblems halfantrine (fr malaria) irintecan (fr cancer) dabigatran (fr bld thinning) quetiapine (fr psychsis) aliskiren (fr hypertensin) festerdine (fr irritated urinary bladder) when used in patients with certain kidney r liver prblems sildenafil (fr pulmnary arterial hypertensin) slifenacin (fr irritated urinary bladder) when used in patients with certain kidney r liver prblems vardenafil (fr erectile dysfunctin) when used in men lder than 75 years f age Als, upn cmpleting yur curse f Spranx ral slutin, d nt take any f the medicines listed abve fr 2 weeks. Warnings and precautins Stp taking Spranx and see yur dctr immediately if any f the fllwing symptms f severe liver prblems appear during yur curse f treatment: Severe lack f appetite, feeling sick, being sick, unusual tiredness, abdminal (stmach) pain, unusually dark urine r pale stls. Tell yur dctr immediately: If yu have any unusual feelings f tingling, numbness r weakness in yur hands r feet whilst taking Spranx. If yu experience any hearing lss symptms. In very rare cases patients taking Spranx have reprted temprary r permanent hearing lss. Tell yur dctr if yu have: had an allergic reactin t any ther antifungal medicines a heart prblem, including heart failure (als called cngestive heart failure r CHF), Spranx culd make it wrse. If yur dctr decides t give yu Spranx, yu shuld be tld abut the symptms listed belw t watch ut fr. If yu get any f the fllwing stp taking Spranx and tell yur dctr straight away. These may be signs f heart failure: -shrtness f breath -unexpected weight gain -swelling f yur legs r stmach -feel unusually tired -wake up shrt f breath at night a liver prblem, such as jaundice (yellwing f the skin) as yur dse f Spranx may have t be changed. Yur dctr shuld give yu instructins n symptms t watch ut fr. If yu have t take Spranx cntinuusly fr mre than ne mnth, yur dctr may want t check yur liver by ding bld tests. In additin, there may be specific medicatin yu may nt be able t take. a kidney disrder as yur dse f Spranx may have t be changed. In additin, there may be specific medicatin yu may nt be able t take. Other medicines and Spranx ral slutin There are sme medicines that yu shuld nt take whilst taking Spranx. These are listed abve under the heading D nt use Spranx ral slutin if yu are: Page 2
Tell yur dctr if yu are using the fllwing medicines as they may stp Spranx ral slutin frm wrking prperly: rifampicin, rifabutin r isniazid (antibitics used fr tuberculsis) phenytin, carbamazepine r phenbarbital (anti-epileptics) efavirenz r nevirapine (medicines used fr HIV/AIDS) St. Jhn s wrt (a herbal medicine) D nt use Spranx ral slutin within 2 weeks f taking these medicines. Tell yur dctr if yu are using the fllwing medicines as they are nt recmmended with Spranx ral slutin unless yur dctr feels it is necessary: medicines fr cancer (namely dasatinib, lapatinib, niltinib, r trabectedin) rifabutin (fr tuberculsis) carbamazepine (fr epilepsy) clchicine (fr gut) everlimus r temsirlimus (given after an rgan transplant) fentanyl (fr pain) rivarxaban (fr bld clts) salmeterl (fr breathing prblems) tamsulsin (fr male urinary incntinence) vardenafil (fr erectile dysfunctin) when used in men 75 years f age and yunger atrvastatin (fr lwering levels f chlesterl) ciclesnide (fr inflammatin, asthma and allergies) ebastine (fr allergies) eletriptan (fr migraine headaches) tlterdine (fr irritated urinary bladder) feldipine (fr the heart r bld vessels) Als, upn cmpleting yur curse f Spranx ral slutin, d nt take any f the medicines listed abve fr 2 weeks. Tell yur dctr befre taking any f the fllwing medicines as the dse f Spranx ral slutin r ther treatments may need t be altered: ciprflxacin, clarithrmycin r erythrmycin (antibitics fr infectins) medicines that act n the heart r bld vessels (digxin, nadll, calcium channel-blckers such as, dihydrpyridines, verapamil) medicines that slw dwn bld cltting r thin the bld, such as the cumarins (eg, warfarin) r cilstazl methylprednislne, budesnide, fluticasne r dexamethasne, medicines given by muth and injectin fr inflammatin, asthma and allergies ciclsprine, tacrlimus r rapamycin (als knwn as sirlimus), which are usually given after an rgan transplant medicines used in HIV-infected patients, such as maravirc, ritnavir, ritnavir-bsted darunavir, ritnavir-bsted fsamprenavir, indinavir and saquinavir medicines fr cancer (such as brtezmib, busulphan, dcetaxel, erltinib, gefitinib, imatinib, ixabepilne, trimetrexate r a grup f medicines knwn as vinca alkalids) alfentanil, buprenrphine, r xycdne (fr pain) methadne fr treatment f drug abuse (piid-dependency) buspirne, alprazlam, brtizlam, perspirne r midazlam when given by injectin int a vein (fr anxiety r t help yu sleep) rebxetine (fr depressin) repaglinide r saxagliptin (fr diabetes) Page 3
aripiprazle, halperidl r risperidne (fr psychsis) aprepitant (fr nausea and vmiting) festerdine r slifenacin (fr irritated urinary bladder) sildenafil r tadalafil (fr erectile dysfunctin) praziquantel (fr fluke and tapewrms) melxicam (fr jint inflammatin and pain) cinacalcet (fr an ver active parathyrid) tlvaptan (fr lw bld sdium levels) alitretinin (ral) (fr eczema) Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. Spranx ral slutin with fd and drink D nt take Spranx with fd r drink as it reduces yur bdy s ability t absrb the medicine. Always take Spranx ral slutin ne hur befre any fd r drink as this helps the bdy absrb the medicine. Children and the elderly Spranx is nt nrmally given t children r the elderly. Yur dctr may prescribe it in special cases. Pregnancy D nt take Spranx if yu are pregnant, unless yur dctr has tld yu t. If yu are f child bearing age and culd becme pregnant, yu shuld use cntraceptives t make sure that yu d nt becme pregnant while yu are taking yur medicine. As Spranx remains in the bdy fr sme time after yu stp taking it, yu shuld cntinue t use sme frm f cntraceptin until yur next perid after yur treatment with Spranx has finished. If yu d find that yu are pregnant after starting a curse f Spranx, stp taking it and tell yur dctr straight away. Befre taking any medicine - always tell yur dctr if yu are pregnant, think yu might be pregnant r are trying t becme pregnant. Breast-feeding If yu are breast-feeding d nt take Spranx, as small amunts f the medicine culd be present in yur breast milk. Driving and using machines Spranx can smetimes cause dizziness, blurred/duble visin r hearing lss. If yu have these symptms, d nt drive r use machines. Spranx ral slutin cntains srbitl Tell yur dctr if yu are intlerant t fructse (a type f sugar) as this is in srbitl, ne f the ingredients f Spranx ral slutin. 3. Hw t use Spranx ral slutin Always take Spranx ral slutin ne hur befre any fd r drink as this helps the bdy absrb the medicine. Yu shuld swish the ral slutin arund in yur muth fr apprximately 20 secnds befre swallwing it. D nt rinse yur muth after swallwing the ral slutin. Page 4
Always take Spranx exactly as yur dctr has tld yu. Yu shuld check with yur dctr r pharmacist if yu are nt sure. A measuring cup graduated t indicate 10ml is prvided. Ensure yu fill the cup t the 10ml mark. Hw t take Spranx ral slutin Treatment f yeast infectins f the muth, thrat r gullet The usual dse is 2 measuring cups (20ml) per day fr ne week. This may be taken either all at nce r in tw divided dses during the day. If after ne week f using Spranx, yur infectin has nt cleared, yur dctr may decide t cntinue yur treatment fr ne mre week. Treatment f yeast infectins f the muth, thrat r gullet, that have already been treated with anther antifungal but have still nt cleared The usual dse is 1-2 measuring cups (10-20ml) twice daily fr tw weeks. The treatment may be cntinued fr an additinal tw weeks, if the infectin des nt clear in the initial tw weeks f treatment. Fr patients n the higher dse f 400mg (4 measuring cups) daily, treatment shuld be limited t 14 days, if there are n signs f imprvement during this time. Preventin f fungal infectins The dse is calculated accrding t yur bdy weight (5mg per kg) given in tw divided dses. Yur dctr will tell yu exactly hw much yu shuld take. Directins fr pening the bttle The bttle cmes with a child-prf cap, and shuld be pened as fllws: push the plastic screw cap dwn, while turning it cunter clckwise. Fig. 1 1 2 Hw t use the measuring cup Use the measuring cup just as it sits n the bttle. Make sure that the side with the graduatins (the side that hlds less) is uppermst; that is the side yu have t fill. When the arrw n the side pints up, the crrect side is uppermst. If yu take t much Spranx ral slutin If yu, r anyne else, take mre Spranx than yu were tld t, cntact yur dctr r lcal hspital withut delay. If yu frget t take Spranx ral slutin If yu frget t take yur medicine, take the next dse as usual and cntinue yur medicine as directed by yur dctr. D nt take a duble dse. Page 5
If yu have any further questins n the use f Spranx, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines, Spranx ral slutin can cause side effects, althugh nt everybdy gets them. Medicines can cause serius allergic reactins. Stp taking Spranx and cntact yur dctr immediately if yu have: any sudden wheeziness, difficulty in breathing, swelling f the face, rash, itching (especially affecting the whle bdy) r a severe skin disrder (widespread rashes with peeling skin and blisters in the muth, eyes and genitals, r rashes with small pustules r blisters). severe lack f appetite, feeling sick, being sick, unusual tiredness, abdminal (stmach) pain, unusually dark urine, r pale stls. These may be symptms f severe liver prblems. Yu shuld als let yur dctr knw immediately if yu have any f the side effects belw: Symptms that resemble heart failure such as shrtness f breath, unexpected weight gain, swelling f the legs, unusual fatigue (tiredness), repeated waking at night. A tingling sensatin, sensitivity t light, numbness r weakness in the limbs. Blurred visin/duble visin, ringing in yur ears, lse the ability t cntrl yur urine r increased need t urinate (pass water) If yu experience any hearing lss symptms severe upper stmach pain, ften with nausea and vmiting due t inflammatin f the pancreas (pancreatitis) Other side effects include: Cmmn side effects (ccur in less than 1 in 10 patients) are: headache stmach ache, feeling sick (nausea), being sick (vmiting), diarrhea, indigestin, unpleasant taste rash fever r high temperature shrtness f breath dizziness cugh Uncmmn side effects (ccur in less than 1 in 100 patients) are: certain bld disrders which may increase the risk f bleeding r bruising (pssible symptms f lw levels f platelets), r infectins (pssible symptm f lw levels f white bld cells) cnstipatin itching, hives general swelling muscle cramps r irregular heart beat (pssible symptms f lw bld levels f ptassium) muscle pain, painful jints abnrmal menstrual bleeding decreased feeling r sensitivity, especially in the skin The fllwing side effects have been reprted in patients taking Spranx with unknwn frequency: excess f triglycerides (fats) in the bld hair lss increase in bld creatine phsphkinase levels Page 6
The fllwing side effects have been reprted in patients taking ther frmulatins f Spranx: infectin f the upper respiratry tract inflammatin f the nse inflammatin f the sinuses certain bld disrder which may increase the risk f infectins (pssible symptm f lw levels f granulcytes) high bld sugar levels muscle cramps r irregular heart beat (pssible symptms f lw bld levels f magnesium) muscle cramps r irregular heart beat (pssible symptms f high bld levels f ptassium) cnfusin sleepiness tremrs increase in heart rate high bld pressure lw bld pressure fluid in the lungs difficulty speaking excess gas in the intestinal tract increases in specific liver functin tests (hepatic enzyme increased) inflammatin f the liver (hepatitis) yellwing f the skin (jaundice) excess sweating kidney prblems excessive urine prductin erectile dysfunctin general swelling facial swelling chest pain pain chills fatigue increase in bld urea levels abnrmal urine findings 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. In the UK, yu can als reprt side effects directly via the Yellw Card Scheme at: www.mhra.gv.uk/yellwcard In Ireland, 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 Spranx ral slutin Keep ut f the reach and sight f children. D nt stre Spranx ral slutin abve 25 C. Page 7
D nt use the Spranx ral slutin after the expiry date printed n the packaging. The expiry date refers t the last day f that mnth. The ral slutin shuld nt be used fr lnger than 1 mnth after the bttle has first been pened. Always return any left ver medicine t yur pharmacist. Only keep it if yur dctr tells yu t. 6. Cntents f the pack and ther infrmatin What Spranx ral slutin cntains: The active ingredient is itracnazle (10mg f itracnazle per ml). The ther ingredients are hydrxyprpyl-β-cycldextrin, srbitl, prpylene glycl, hydrchlric acid, cherry flavur, caramel flavur, sdium saccharin, sdium hydrxide and water. What Spranx ral slutin lks like and the cntents f the pack: Spranx ral slutin is a clear, yellw t slightly amber slutin. It is available in bttles cntaining 150ml tgether with a measuring cup. Marketing Authrisatin Hlder: The UK Prduct Licence and Irish Prduct Authrisatin fr this medicine are held by: Janssen-Cilag Ltd 50-100 Hlmers Farm Way High Wycmbe Buckinghamshire HP12 4EG UK Manufacturer: Spranx ral slutin is manufactured by: Janssen Pharmaceutica NV, Turnhutseweg 30, B-2340 Beerse, Belgium. This medicinal prduct is authrised in the member states f the EEA under the fllwing names: Austria: SPORANOX Belgium: SPORANOX Germany: SEMPERA Spain: SPORANOX Finland: SPORANOX Ireland: SPORANOX Italy: SPORANOX Luxemburg: SPORANOX Netherlands: TRISPORAL Prtugal: SPORANOX Sweden: SPORANOX UK: SPORANOX Registered trademark Page 8
This leaflet was last revised in September 2016 Page 9