Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 PATIENT INFORMATION LEAFLET Page 1 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP * rifampicin, isniazid, pyrazinamide, ethambutl 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, please ask the dctr, health care prvider r pharmacist. - This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if the signs f their illness are the same as yurs. - If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell the dctr, health care prvider r pharmacist What is in this leaflet: 1. What Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP is and what it is used fr 2. What yu need t knw befre yu take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP 3. Hw t take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP 4. Pssible side effects 5. Hw t stre Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP 6. Cntents f the pack and ther infrmatin 1. WHAT RIFAMPICIN 150 mg/isoniazid 75 mg/pyrazinamide 400 mg/ethambutol HYDROCHLORIDE 275 mg TABLETS USP IS AND WHAT IT IS USED FOR Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP is used fr the initial treatment f tuberculsis. Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP cntains the active substances ethambutl, isniazid, pyrazinamide, and rifampicin. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFAMPICIN 150 mg/isoniazid 75 mg/pyrazinamide 400 mg/ethambutol HYDROCHLORIDE 275 mg TABLETS USP D nt take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP: if yu are allergic (hypersensitive) t - ethambutl, isniazid, pyrazinamide r rifamycins - any f the ingredients f Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP (see sectin 6, What Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets * Trade names are nt prequalified by WHO. This is the natinal medicines regulatry authrity s (NMRA) respnsibility. Thrughut this WHOPAR the prprietary name is given as an example nly. Page 2 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 USP cntains). if yu have acute liver prblems r previusly have had a liver prblem which was caused by drugs, including isniazid, rifampicin r pyrazinamide if yu have had serius side effects frm isniazid r rifampicin such as fever, chills r swelling f the jints if yu have prphyria if yu have acute guty arthritis if yu have severe kidney prblems if yu are taking any f the fllwing medicatins: - vricnazle used fr treating fungal infectin - prtease inhibitrs used fr treating HIV infectin. D nt take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP if any f the abve apply t yu. If yu are nt sure abut anything, ask yur dctr, pharmacist r health care prvider. Take special care with Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP Tell yur dctr r health care prvider if yu have any f the fllwing illnesses befre taking this medicine: Liver prblems and chrnic liver disease Kidney prblems Gut Diabetes mellitus Epilepsy HIV infectin Tingling f the hands and feet (peripheral neurpathy) and inflammatin f peripheral nerves r the ptic nerve (ptic neuritis) Eye defects Chrnic alchlism (drinking alchlic beverages daily) Underfeeding Als tell yur dctr r health care prvider if: yu are pregnant r think yu might be pregnant yu are allergic (hypersensitive) t niacin (nictinic acid) yu use injectin drugs (e.g. herin). Yu shuld nt take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP if yur weigh less than 30 kg. Yu shuld nt interrupt treatment with Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP withut checking with yur dctr r health care prvider. Yu shuld use additinal means f cntraceptin (e.g. barrier methd such as cndms) apart frm taking the pill as lng as yu take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP. Page 3 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 See sectin 4 (Pssible side effects) abut what yu must d if yu get certain side effects Taking ther medicines with Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP Tell yur dctr r health care prvider if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. They may affect hw well Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP wrks r Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP may affect the way the ther medicines wrk. Yu must nt take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP with any f the fllwing medicatins: vricnazle (used fr treating fungal infectin) prtease inhibitrs (used fr treating HIV infectin) Yu shuld als nt take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP with any f the fllwing medicatins: nevirapine (used fr treating HIV infectin) simvastatin (used fr reducing chlesterl) aluminium hydrxide (used fr treating stmach disrders) disulfiram (used in the treatment f alchlism) Tell yur dctr als if yu take ne f the fllwing: Medicines fr HIV infectin like efavirenz, zidvudine, stavudine Medicines t treat fungal infectins like ketcnazle flucnazle and terbinafine Antibitics like chlramphenicl and clarithrmycin Medicines fr malaria like atvaqune and quinine Medicines t suppress the immune system like ciclsprin and tacrlimus Medicines fr heart cnditins like digxin, lidcaine and verapamil Medicines fr bld pressure like amldipine and atenll Medicines fr diabetes like glibenclamide Oral cntraceptive pill r ther hrmnal cntraceptives Medicines fr gut like prbenecid Medicines fr epilepsy like carbamazepine, phenytin and valprate Medicines fr anxiety and sleeping disrders like diazepam Medicines fr depressin like amitriptyline and fr psychiatric cnditins like chlrprmazine and halperidl Medicines t prevent bld clts like warfarin Medicines used during surgery like enflurane Crticsterids like prednislne Hrmne treatments like thyrid hrmnes Medicines fr pain like paracetaml and piids like cdeine and mrphine Aminsalicylic acid (als called para-aminsalicylic acid, a medicine fr tuberculsis), Methadne (a medicine fr herin addicts) Page 4 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 Taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP with fd and drink Take this medicine n an empty stmach at least ne hur befre a meal r tw hurs after a meal. D nt drink any alchl as lng as yu are taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP. Yu shuld avid fd which cntains a large amunt f tyramine (like cheese, red wine) r f histamine (like tuna fish). Taking such fd while yu are being treated with Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP may cause effects such as headache, punding heartbeat, lightheadedness, sweating, itching and flushing. Pregnancy and breastfeeding Tell yur dctr r healthcare prvider as sn as pssible if yu are pregnant r think yu are pregnant. Yur dctr r healthcare prvider will help yu decide if it is pssible t cntinue treatment with Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP. If yu take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP during pregnancy, yur dctr r healthcare prvider shuld give yu pyridxine (vitamin B 6 ) supplements during pregnancy and vitamin K supplements during the last mnth f pregnancy. This medicine ges int breast milk but the amunt is t lw t prtect the breast-fed baby against tuberculsis. The medicine has nt been reprted t harm breast-fed babies f mthers taking the medicine. Tell yur dctr r healthcare prvider if yu are breast-feeding r if yu intend t breastfeed while taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP. Driving and using machines Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP can cause side effects such as dizziness, cnfusin and blurred visin. This may make yu less able t drive r d certain things like using machines. 3. HOW TO TAKE RIFAMPICIN 150 mg/isoniazid 75 mg/pyrazinamide 400 mg/ethambutol HYDROCHLORIDE 275 mg TABLETS USP Always take this medicine exactly as yur dctr r healthcare prvider has tld yu. Yu shuld check with yur dctr, healthcare prvider r pharmacist if yu are nt sure. These dses are fr adults weighing mre than 30 kg and fr children weighing 21 30 kg. Children weighing less than this shuld nt take these tablets. Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP shuld be taken n any empty stmach at least 1 hur befre a meal r 2 hurs after a meal. Swallw the tablets whle with a drink f water. The dse f Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP yu need t take depends n yur bdy weight. The usual dse fr an adult is as fllws: Page 5 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 Yur bdy weight Dse 30 39 kg take 2 tablets nce each day 40 54 kg take 3 tablets nce each day 55 70 kg take 4 tablets nce each day Mre than 70 kg take 5 tablets nce each day Fr children weighing 21 30 kg the dse is 2 tablets nce each day. Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP shuld be given nly t children wh can swallw whle tablets. If yu have kidney disease, yur dctr r healthcare prvider may prescribe the ingredients f this medicine separately. Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP is nt recmmended fr adults with a bdy weight belw 30 kg. Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP is usually given fr 2 mnths at the beginning f tuberculsis treatment but yur dctr r healthcare prvider will decide n hw lng yu need t take this medicine. If yu take mre Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP than yu shuld If yu accidentally take an extra tablet, nthing is likely t happen. If yu accidentally take several tablets t many, cntact yur dctr r healthcare prvider r talk t yur nearest hspital casualty department immediately. If pssible, take yur tablets r the cntainer with yu t shw the dctr r health care prvider what yu have taken. Taking t many tablets can cause vmiting, stmach upset, fever, headache, dizziness, slurred speech, hallucinatins and prblems with visin. If yu frget t take Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP If yu frget t take a dse, take it as sn as pssible. Hwever, if yur next dse within 6 hurs, skip the missed dse and take the next tablet at the usual time. Yu shuld nt take a duble dse t make up fr a missed dse. If yu stp taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP Always keep taking the tablets until the curse is finished, even if yu feel better. If yu stp taking the tablets t sn, the infectin may cme back. Als, the bacteria may becme resistant t the medicine, making it mre difficult t treat the infectin. If yu have any further questins n the use f this prduct, ask the dctr, health care prvider r pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP can cause side effects, but nt everybdy gets them. Tell yur dctr r healthcare prvider abut any change in yur health. Page 6 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 Serius side effects If yu have any f the fllwing symptms f a severe allergic reactin, stp taking this medicine and tell yur dctr r healthcare prvider immediately r g t the casualty department at yur nearest hspital: Sudden difficulty in breathing, speaking and swallwing Swelling f lips, tngue, face r neck Extreme dizziness r cllapse Severe r itchy skin rashes, especially if this shws blistering and there is sreness f the eyes, muth r genital rgans If yu get any f the fllwing side effects cntact yur dctr r healthcare prvider as sn as pssible: Diarrhea that is serius, lasts a lng time r has bld in it with stmach pain r fever: This can be a sign f serius bwel inflammatin. Bruising r unusual bleeding; if yu cntinue taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP, yu are at risk f brain haemrrhage (bleeding) Yellwing f the skin r whites f the eyes, r urine getting darker and stls paler, fatigue, weakness, lss f appetite, nausea r vmiting these are signs f liver prblems (hepatitis). Inflammatin f the pancreas, which causes severe pain in the abdmen and back (pancreatitis). Visin disturbances like blurred visin, eye pain, red-green clur blindness r even lss f visin. Reduced white bld cells, accmpanied by sudden high fever, severe sre thrat and ulcers in the muth (agranulcytsis). These are all serius side effects. Yu may need urgent medical attentin. Serius side effects are rare (affect fewer than 1 in 1000 peple) r very rare (affect fewer than 1 in 10 000 peple). Other cmmn side effects (These can affect at least 1 in every 100 patients treated, but fewer than 1 in every 10 patients treated) Tiredness, drwsiness, headache, lightheadedness, dizziness Tingling, pricking r numbness (peripheral neurpathy) yur dctr r healthcare prvider may prescribe pyridxine (vitamin B6) t prevent these effects Reddish disclratin f bdy fluids and secretins like urine, tear fluid, sweat, sputum, stls and saliva Reddening f the eyes, permanent disclratin f sft cntact lenses Nausea, vmiting, lss f appetite, abdminal discmfrt and pain, blatedness Flushing, itching with r withut skin rash, nettle rash Allergic r ther reactins like skin rash, fever, muscle r jint pain Lss f appetite, nausea, vmiting, fatigue, malaise and weakness indicating liver prblems Bld test shwing increase in liver enzymes Increase in bld uric acid, acute guty arthritis (chills, pain and swelling f jints, especially big te, ankle r knee) Uncmmn side effects (These can affect at least 1 in every 1000 patients treated, but fewer than 1 in every 100 patients treated) Page 7 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 Hallucinatins, disrientatin, cnfusin, malaise Rare side effects (These can affect at least 1 in every 10 000 patients treated, but less than 1 in every 1000 patients treated) Changes f white and red bld cell cunt, changes f platelet cunt, anaemia, disrders f bld cltting, swelling f spleen Oedema r swelling because f water retentin Breathing difficulty and inflammatin f the lungs Metalic taste, diarrhea, flatulence Menstrual disturbances, swelling f breast tissue in men, early puberty, difficulties in diabetes cntrl, high bld sugar, Cushing s syndrme (disease caused by increase f crticsterid hrmnes), inductin f crisis in Addisn s patients (patients with a special frm f hrmnal disrder) Psychsis, hyperactivity, euphria, sleeplessness, cnvulsins Muscle weakness, prblems with c-rdinatin f mvement (ataxia), increase in seizure frequency in patients with epilepsy Disturbances f visin, damage t the ptic nerve (ptic neuritis) Gastritis, jaundice, enlargement and inflammatin f the liver (in rare cases severe) Allergic and ther reactins like dry muth, heartburn, urinatin disrders, rheumatic syndrmes and symptms Pellagra (characterised by gastrintestinal disturbances, reddening f skin, nervus and mental disrders), swelling f lymph ndes, acne, skin rash, light sensitivity Raised kidney enzymes, acute kidney failure, inflammatin f the kidney, prblems with urinatin Inductin f prphyria (a grup f disrders characterised by sensitivity t light, skin lesins, anaemia, psychsis and acute abdminal pain) If yu start taking Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP again after interrupting treatment, a s-called influenza-like syndrme may ccur. It is characterised by fever, shivering and pssibly headache, dizziness, bne and muscle pain. In rare cases bleeding int the skin, breathing difficulties, asthma-like attacks, anaemia, shck and kidney failure might develp. If any f the side effects get serius r if yu ntice any side effects nt listed in this leaflet tell yur dctr, healthcare prvider r pharmacist. 5. HOW TO STORE RIFAMPICIN 150 mg/isoniazid 75 mg/pyrazinamide 400 mg/ethambutol HYDROCHLORIDE 275 mg TABLETS USP Keep ut f the sight and reach f children. Stre belw 25 C, in a dry place. Prtect frm light D nt use Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP after the expiry date stated n the bttle r cartn. The expiry date refers t the last day f that mnth. Medicines shuld nt be dispsed f in wastewater r husehld waste. Ask yur pharmacist hw t dispse f medicines yu n lnger use. These measures will help t prtect the envirnment. Page 8 f 9
Ethambutl Hydrchlride/Isniazid/Pyrazinamide/ (Svizera Eurpe BV), TB193 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP cntains The active ingredients f Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP are: Rifampicin 150 mg Isniazid 75 mg Pyrazinamide 400 mg Ethambutl hydrchlride 275 mg The ther ingredients are: Cre tablet: cllidal silicn dixide, crscarmellse sdium, irn xide red, magnesium stearate, maize starch, micrcrystalline cellulse, purified talc and sdium starch glyclate. Film cat (OPADRY II 31K58902 white): hydrxyprpyl methylcellulse, irn xide red, plyethylene glycl, purified talc and titanium dixide. What Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP lks like and cntents f the pack Rifampicin 150 mg/isniazid 75 mg/pyrazinamide 400 mg/ethambutl Hydrchlride 275 mg Tablets USP are pinkish-brwn, blng, bicnvex, film-cated tablets with a break-line n ne side, supplied as: 1000 tablets packed in plyprpylene bag, packed tgether with a silica gel desiccant in a white square HDPE bttle with aluminium inductin seal and white plyprpylene cap 24 28 tablets in red PVDC/aluminium blisters Supplier Svizera Eurpe BV Antennestraat 43 P.O. Bx 60300 1320 AY Almere The Netherlands Tel: +31 (0) 36 5397 340 Fax:+31 (0) 36 5397 349 E-mail: inf@svizera.rg Manufacturer Svizera Labs Private Ltd Plt D-16/6, TTC Industrial Area Turbhe Navi Mumbai 400 703 India Tel: + 91 22 7617448 Fax: + 91 22 7617449 Email: svizera@vsnl.net This leaflet was last apprved in September 2013. Detailed infrmatin n this medicine is available n the Wrld Health Organizatin (WHO) web site: http://www.wh.int/prequal Page 9 f 9