Package leaflet: Infrmatin fr the patient 600 mg/200 mg/245 mg, filmmhulde tabletten Efavirenz/Emtricitabine/Tenfvir disprxil 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 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 is and what it is used fr 2. What yu need t knw befre yu take 3. Hw t take 4. Pssible side effects 5. Hw t stre 6. Cntents f the pack and ther infrmatin 1. What is and what it is used fr cntains three active substances that are used t treat human immundeficiency virus (HIV) infectin: - Efavirenz is a nn-nucleside reverse transcriptase inhibitr (NNRTI) - Emtricitabine is a nucleside reverse transcriptase inhibitr (NRTI) - Tenfvir is a nucletide reverse transcriptase inhibitr (NtRTI) Each f these active substances, als knwn as antiretrviral medicines, wrk by interfering with an enzyme (reverse transcriptase) that is essential fr the virus t multiply. is a treatment fr Human Immundeficiency Virus (HIV) infectin in adults aged 18 years and ver wh have previusly been treated with ther antiretrviral medicines and have their HIV-1 infectin under cntrl fr at least three mnths. Patients must nt have experienced failure f a previus HIV therapy. 2. What yu need t knw befre yu take D nt take - if yu are allergic t efavirenz, emtricitabine, tenfvir, tenfvir disprxil r any f the ther ingredients f this medicine (listed in sectin 6). - if yu have severe liver disease. - if yu are currently taking any f the fllwing medicines: astemizle r terfenadine (used t treat hay fever r ther allergies) bepridil (used t treat heart disease) cisapride (used t treat heartburn) ergt alkalids (fr example, ergtamine, dihydrergtamine, ergnvine, and 1
methylergnvine) (used t treat migraines and cluster headaches) midazlam r triazlam (used t help yu sleep) pimzide (used t treat certain mental cnditins) St. Jhn s wrt (Hypericum perfratum) (a herbal preparatin used fr depressin and anxiety) vricnazle (used t treat fungal infectins) If yu are taking any f these medicines, tell yur dctr immediately. Taking these medicines with culd cause serius r life-threatening side effects r stp these medicines frm wrking prperly. Warnings and precautins Talk t yur dctr r pharmacist befre taking this medicine. - Yu can still pass n HIV when taking this medicine, althugh the risk is lwered by effective antiretrviral therapy. Discuss with yur dctr the precautins needed t avid infecting ther peple. This medicine is nt a cure fr HIV infectin. While taking this medicine yu may still develp infectins r ther illnesses assciated with HIV infectin. - Yu must remain under the care f yur dctr while taking this medicine. - Tell yur dctr: if yu are taking ther medicines that cntain efavirenz, emtricitabine, tenfvir disprxil, tenfvir alafenamide r lamivudine r adefvir dipivxil. This medicine shuld nt be taken with any f these medicines. if yu have r have had kidney disease, r if tests have shwn prblems with yur kidneys. This medicine is nt recmmended if yu have mderate t severe kidney disease. This medicine may affect yur kidneys. Befre starting treatment, yur dctr may rder bld tests t assess kidney functin. Yur dctr may als rder bld tests during treatment t mnitr yur kidneys. This medicine is nt usually taken with ther medicines that can damage yur kidneys (see Other medicines and ). If this is unavidable, yur dctr will mnitr yur kidney functin nce a week. if yu have a histry f mental illness, including depressin, r f substance r alchl abuse. Tell yur dctr immediately if yu feel depressed, have suicidal thughts r have strange thughts (see sectin 4, Pssible side effects). if yu have a histry f cnvulsins (fits r seizures) r if yu are being treated with anticnvulsant therapy such as carbamazepine, phenbarbital and phenytin. If yu are taking any f these medicines, yur dctr may need t check the level f anticnvulsant medicine in yur bld t ensure that it is nt affected while taking this medicine. Yur dctr may give yu a different anticnvulsant. if yu have a histry f liver disease, including chrnic active hepatitis. Patients with liver disease including chrnic hepatitis B r C, wh are treated with cmbinatin antiretrvirals, have a higher risk f severe and ptentially lifethreatening liver prblems. Yur dctr may cnduct bld tests in rder t 2
check hw well yur liver is wrking r may switch yu t anther medicine. If yu have severe liver disease, d nt take (see earlier in sectin 2, D nt take ). If yu have hepatitis B infectin, yur dctr will carefully cnsider the best treatment regimen fr yu. Tenfvir disprxil and emtricitabine, tw f the active substances in this medicine, shw sme activity against hepatitis B virus althugh emtricitabine is nt apprved fr the treatment f hepatitis B infectin. Symptms f yur hepatitis may becme wrse after discntinuatin f this medicine. Yur dctr may then cnduct bld tests at regular intervals in rder t check hw well yur liver is wrking (see sectin 3, If yu stp taking ). Independent f a histry f liver disease, yur dctr will cnsider regular bld tests t check hw yur liver is wrking. if yu are ver 65. Insufficient numbers f patients ver 65 years f age have been studied. If yu are ver 65 years f age and are prescribed this medicine, yur dctr will mnitr yu carefully. - Once yu start taking, lk ut fr: signs f dizziness, difficulty sleeping, drwsiness, difficulty cncentrating r abnrmal dreaming. These side effects may start in the first 1 r 2 days f treatment and usually g away after the first 2 t 4 weeks. any signs f skin rash. Rashes may be caused by this medicine. If yu see any signs f a severe rash with blistering r fever, stp taking and tell yur dctr at nce. If yu had a rash while taking anther NNRTI, yu may be at higher risk f getting a rash with this medicine. any signs f inflammatin r infectin. In sme patients with advanced HIV infectin (AIDS) and a histry f pprtunistic infectin, signs and symptms f inflammatin frm previus infectins may ccur sn after anti-hiv treatment is started. It is believed that these symptms are due t imprvement in the bdy s immune respnse, enabling the bdy t fight infectins that may have been present with n bvius symptms. If yu ntice any symptms f infectin, please tell yur dctr at nce. In additin t the pprtunistic infectins, autimmune disrders (a cnditin that ccurs when the immune system attacks healthy bdy tissue) may als ccur after yu start taking medicines fr the treatment f yur HIV infectin. Autimmune disrders may ccur many mnths after the start f treatment. If yu ntice any symptms f infectin r ther symptms such as muscle weakness, weakness beginning in the hands and feet and mving up twards the trunk f the bdy, palpitatins, tremr r hyperactivity, please infrm yur dctr immediately t seek necessary treatment. bne prblems. Sme patients taking cmbinatin antiretrviral therapy may develp a bne disease called stenecrsis (death f bne tissue caused by lss f bld supply t the bne). The length f cmbinatin antiretrviral therapy, crticsterid use, alchl cnsumptin, severe immunsuppressin, higher bdy mass index, amng thers, may be sme f the many risk factrs fr develping this disease. Signs f stenecrsis are jint stiffness, aches and pains (especially f the hip, knee and shulder) and difficulty in mvement. If yu ntice any f these symptms please infrm yur dctr. 3
Bne prblems (smetimes resulting in fractures) may als ccur due t damage t kidney tubule cells (see sectin 4, Pssible side effects). Children and adlescents - D nt give t children and adlescents under 18 years f age. The use f this medicine in children and adlescents has nt been studied. Other medicines and Yu must nt take with certain medicines. These are listed under D nt take, at the start f sectin 2. They include sme cmmn medicines and sme herbal preparatins (including St. Jhn s wrt) which can cause serius interactins. Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines. Als, this medicine shuld nt be taken with any ther medicines that cntain efavirenz (unless recmmended by yur dctr), emtricitabine, tenfvir disprxil, tenfvir alafenamide r lamivudine r adefvir dipivxil. Tell yur dctr if yu are taking ther medicines which may damage yur kidneys. Sme examples include: - aminglycsides, vancmycin (medicines fr bacterial infectins) - fscarnet, ganciclvir, cidfvir (medicines fr viral infectins) - amphtericin B, pentamidine (medicines fr fungal infectins) - interleukin-2 (t treat cancer) - nn-steridal anti-inflammatry drugs (NSAIDs, t relieve bne r muscle pains) may interact with ther medicines, including herbal preparatins such as Ginkg bilba extracts. As a result, the amunts f this medicine r ther medicines in yur bld may be affected. This may stp yur medicines frm wrking prperly, r may make any side effects wrse. In sme cases, yur dctr may need t adjust yur dse r check yur bld levels. It is imprtant t tell yur dctr r pharmacist if yu are taking any f the fllwing: - Medicines cntaining didansine (fr HIV infectin): Taking this medicine with ther antiviral medicines that cntain didansine can raise the levels f didansine in yur bld and may reduce CD4 cell cunts. Inflammatin f the pancreas and lactic acidsis (excess lactic acid in the bld), which smetimes caused death, have been reprted rarely when medicines cntaining tenfvir disprxil and didansine were taken tgether. Yur dctr will carefully cnsider whether t treat yu with medicines cntaining tenfvir and didansine. - Other medicines used fr HIV infectin: The fllwing prtease inhibitrs: darunavir, indinavir, lpinavir/ritnavir, ritnavir, r ritnavir bsted atazanavir r saquinavir. Yur dctr may cnsider giving yu an alternative medicine r changing the dse f the prtease inhibitrs. Als, tell yur dctr if yu are taking maravirc. - Medicines used t treat infectin with the hepatitis C virus: bceprevir, telaprevir, simeprevir, sfsbuvir/velpatasvir. - Medicines used t lwer bld fats (als called statins): Atrvastatin, pravastatin, simvastatin. This medicine can reduce the amunt f statins in yur bld. Yur dctr will check yur chlesterl levels and will cnsider changing the dse f yur statin, if needed. - Medicines used t treat cnvulsins/seizures (anticnvulsants): Carbamazepine, phenytin, phenbarbital. can reduce the amunt f the anticnvulsant in 4
yur bld. Carbamazepine can reduce the amunt f efavirenz, ne f the cmpnents f this medicine, in yur bld. Yur dctr may need t cnsider giving yu a different anticnvulsant. - Medicines used t treat bacterial infectins, including tuberculsis and AIDSrelated mycbacterium avium cmplex: Clarithrmycin, rifabutin, rifampicin. Yur dctr may need t cnsider changing yur dse r giving yu an alternative antibitic. In additin, yur dctr may cnsider giving yu an additinal dse f efavirenz t treat yur HIV infectin. - Medicines used t treat fungal infectins (antifungals): Itracnazle r psacnazle. This medicine can reduce the amunt f itracnazle r psacnazle in yur bld. Yur dctr may need t cnsider giving yu a different antifungal. - Medicines used t treat malaria: Atvaqune/prguanil r artemether/lumefantrine. This medicine may reduce the amunt f atvaqune/prguanil r artemether/lumefantrine in yur bld. - Hrmnal cntraceptive, such as birth cntrl pills, an injected cntraceptive (fr example, Dep-Prvera), r a cntraceptive implant (fr example, Implann): Yu must als use a reliable barrier methd f cntraceptin (see Pregnancy and breast-feeding). may make hrmnal cntraceptives less likely t wrk. Pregnancies have ccurred in wmen taking efavirenz, a cmpnent f this medicine, while using a cntraceptive implant, althugh it has nt been established that the efavirenz therapy caused the cntraceptive t fail. - Methadne, a medicine used t treat piate addictin, as yur dctr may need t change yur methadne dse. - Sertraline, a medicine used t treat depressin, as yur dctr may need t change yur dse f sertraline. - Buprpin, a medicine used t treat depressin r t help yu stp smking, as yur dctr may need t change yur dse f buprpin. - Diltiazem r similar medicines (called calcium channel blckers): When yu start taking this medicine, yur dctr may need t adjust yur dse f the calcium channel blcker. - Medicines used t prevent rgan transplant rejectin (als called immunsuppressants), such as cyclsprine, sirlimus r tacrlimus. When yu start r stp taking this medicine yur dctr will clsely mnitr yur plasma levels f the immunsuppressant and may need t adjust its dse. - Warfarin r acencumarl (medicines used t reduce cltting f the bld): Yur dctr may need t adjust yur dse f warfarin r acencumarl. - Ginkg bilba extracts (herbal preparatin). Pregnancy and breast-feeding If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking this medicine. Wmen shuld nt get pregnant during treatment with and fr 12 weeks thereafter. Yur dctr may require yu t take a pregnancy test t ensure yu are nt pregnant befre starting treatment with this medicine. If yu culd get pregnant while receiving, yu need t use a reliable frm f barrier cntraceptin (fr example, a cndm) with ther methds f cntraceptin including ral (pill) r ther hrmnal cntraceptives (fr example, implants, injectin). Efavirenz, ne f the active cmpnents f this medicine, may remain in yur bld fr a time after therapy is stpped. Therefre, yu shuld cntinue t use cntraceptive measures, as abve, fr 12 weeks after yu stp taking this medicine. 5
Tell yur dctr immediately if yu are pregnant r intend t becme pregnant. If yu are pregnant, yu shuld take nly if yu and yur dctr decide it is clearly needed. Serius birth defects have been seen in unbrn animals and in the babies f wmen treated with efavirenz during pregnancy. Ask yur dctr r pharmacist fr advice befre taking any medicine. If yu have taken during yur pregnancy, yur dctr may request regular bld tests and ther diagnstic tests t mnitr the develpment f yur child. In children whse mthers tk NRTIs during pregnancy, the benefit frm the prtectin against HIV utweighed the risk f side effects. D nt breast-feed during treatment with. Bth HIV and the ingredients f this medicine may pass thrugh breast milk and cause serius harm t yur baby. Driving and using machines may cause dizziness, impaired cncentratin and drwsiness. If yu are affected, d nt drive and d nt use any tls r machines. 3. Hw t take Always take this medicine exactly as yur dctr r pharmacist has tld yu. Check with yur dctr r pharmacist if yu are nt sure. The recmmended dse is: One tablet taken each day by muth. shuld be taken n an empty stmach (cmmnly defined as 1 hur befre r 2 hurs after a meal) preferably at bedtime. This may make sme side effects (fr example, dizziness, drwsiness) less trublesme. Swallw the tablet whle with water. must be taken every day. If yur dctr decides t stp ne f the cmpnents f this medicine, yu may be given efavirenz, emtricitabine and/r tenfvir disprxil separately r with ther medicines fr the treatment f yur HIV infectin. If yu take mre than yu shuld If yu accidentally take t many tablets yu may be at increased risk f experiencing pssible side effects with this medicine (see sectin 4, Pssible side effects). Cntact yur dctr r nearest emergency department fr advice. Keep the tablet bttle with yu s that yu can easily describe what yu have taken. If yu frget t take It is imprtant nt t miss a dse f. If yu d miss a dse f within 12 hurs f when it is usually taken, take it as sn as yu can, and then take yur next dse at its regular time. 6
If it is almst time (less than 12 hurs) fr yur next dse anyway, d nt take the missed dse. Wait and take the next dse at the regular time. D nt take a duble dse t make up fr a frgtten tablet. If yu thrw up the tablet (within 1 hur after taking ), yu shuld take anther tablet. D nt wait until yur next dse is due. Yu d nt need t take anther tablet if yu were sick mre than 1 hur after taking the tablet. If yu stp taking Dn t stp taking withut talking t yur dctr. Stpping this medicine can seriusly affect yur respnse t future treatment. If this medicine is stpped, speak t yur dctr befre yu restart taking tablets. Yur dctr may cnsider giving yu the cmpnents f this medicine separately if yu are having prblems r need yur dse adjusted. When yur supply f starts t run lw, get mre frm yur dctr r pharmacist. This is very imprtant because the amunt f virus may start t increase if the medicine is stpped fr even a shrt time. The virus may then becme harder t treat. If yu have bth HIV infectin and hepatitis B, it is especially imprtant nt t stp yur treatment withut talking t yur dctr first. Sme patients have had bld tests r symptms indicating that their hepatitis has gt wrse after stpping emtricitabine r tenfvir disprxil (tw f the three cmpnents f this medicine). If this medicine is stpped yur dctr may recmmend that yu resume hepatitis B treatment. Yu may require bld tests t check hw yur liver is wrking fr 4 mnths after stpping treatment. In sme patients with advanced liver disease r cirrhsis, stpping treatment is nt recmmended as this may lead t wrsening f yur hepatitis, which may be life-threatening. Tell yur dctr immediately abut new r unusual symptms after yu stp treatment, particularly symptms yu assciate with hepatitis B infectin. If yu have any further questins n the use f this medicine, ask yur dctr r pharmacist. 4. Pssible side effects During HIV therapy there may be an increase in weight and in levels f bld lipids and glucse. This is partly linked t restred health and life style, and in the case f bld lipids smetimes t the HIV medicines themselves. Yur dctr will test fr these changes. Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. Pssible serius side effects: tell yur dctr immediately Lactic acidsis (excess lactic acid in the bld) is a rare (may affect up t 1 in 1,000 peple) but serius side effect that can be fatal. The fllwing side effects may be signs f lactic acidsis: deep rapid breathing drwsiness feeling sick (nausea), being sick (vmiting) and stmach pain. If yu think yu may have lactic acidsis, cntact yur dctr immediately. Other pssible serius side effects 7
The fllwing side effects are uncmmn (may affect up t 1 in every 100 peple): - allergic reactin (hypersensitivity) that may cause severe skin reactins (Stevens- Jhnsn syndrme, erythema multifrme, see sectin 2) - swelling f the face, lips, tngue r thrat - angry behaviur, suicidal thughts, strange thughts, parania, unable t think clearly, md being affected, seeing r hearing things that are nt really there (hallucinatins), suicide attempts, persnality change (psychsis) - pain in the abdmen (stmach), caused by inflammatin f the pancreas - frgetfulness, cnfusin, fitting (seizures), incherent speech, tremr (shaking) - yellw skin r eyes, itching, r pain in the abdmen (stmach) caused by inflammatin f the liver - damage t kidney tubules Psychiatric side effects in additin t thse listed abve include delusins (false beliefs), neursis. Sme patients have cmmitted suicide. These prblems tend t ccur mre ften in thse wh have a histry f mental illness. Always ntify yur dctr immediately if yu have these symptms. Side effects t the liver: If yu are als infected with hepatitis B virus, yu may experience a wrsening f hepatitis after discntinuatin f treatment (see sectin 3). The fllwing side effects are rare (may affect up t 1 in 1,000 peple): - liver failure, in sme cases leading t death r liver transplant. Mst cases ccurred in patients wh already had liver disease, but there have been a few reprts in patients withut any existing liver disease - inflammatin f the kidney, passing a lt f urine and feeling thirsty - back pain caused by kidney prblems, including kidney failure. Yur dctr may d bld tests t see if yur kidneys are wrking prperly - sftening f the bnes (with bne pain and smetimes resulting in fractures) which may ccur due t damage t the kidney tubule cells - fatty liver If yu think that yu may have any f these serius side effects, talk t yur dctr. Mst frequent side effects The fllwing side effects are very cmmn (may affect mre than 1 in 10 peple) - dizziness, headache, diarrhea, feeling sick (nausea), being sick (vmiting) - rashes (including red spts r bltches smetimes with blistering and swelling f the skin), which may be allergic reactins - feeling weak Tests may als shw: - decreases in phsphate levels in the bld - increased levels f creatine kinase in the bld that may result in muscle pain and weakness Other pssible side effects The fllwing side effects are cmmn (may affect up t 1 in 10 peple) - allergic reactins - disturbances f crdinatin and balance - feeling wrried r depressed - difficulty sleeping, abnrmal dreams, difficulty cncentrating, drwsiness - pain, stmach pain 8
- prblems with digestin resulting in discmfrt after meals, feeling blated, wind (flatulence) - lss f appetite - tiredness - itching - changes in skin clur including darkening f the skin in patches ften starting n hands and sles f feet Tests may als shw: - lw white bld cell cunt (a reduced white bld cell cunt can make yu mre prne t infectin) - liver and pancreas prblems - increased fatty acids (triglycerides), bilirubin r sugar levels in the bld The fllwing side effects are uncmmn (may affect up t 1 in 100 peple): - breakdwn f muscle, muscle pain r weakness - anaemia (lw red bld cell cunt) - a feeling f spinning r tilting (vertig), whistling, ringing r ther persistent nise in the ears - blurred visin - chills - breast enlargement in males - decreased sexual drive - flushing - dry muth - increased appetite Tests may als shw: - decreases in ptassium in the bld - increases in creatinine in the bld - prteins in urine - increased chlesterl in the bld The breakdwn f muscle, sftening f the bnes (with bne pain and smetimes resulting in fractures), muscle pain, muscle weakness and decreases in ptassium r phsphate in the bld may ccur due t damage t kidney tubule cells. The fllwing side effects are rare (may affect up t 1 in 1,000 peple) - itchy rash t the skin caused by a reactin t sunlight Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the Nederlands Bijwerkingen Centrum Lareb, Website: www.lareb.nl. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre - 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 bttle and cartn after {EXP}. The expiry date refers t the last day f that mnth. - This medicine des nt require any special strage cnditins. - Use within 30 days after first pening. - D nt thrw away any medicines via wastewater r husehld waste. Ask yur 9
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 cntains - The active substances are efavirenz, emtricitabine and tenfvir disprxil. Each film-cated tablet cntains 600 mg f efavirenz, 200 mg f emtricitabine and 245 mg f tenfvir disprxil (as succinate). - The ther ingredients in the tablet are cellulse, micrcrystalline (E460), crscarmellse sdium, Type A (E468), hydrxyprpylcellulse (E463), sdium laurilsulfate (E487), magnesium stearate (E470b), plxamer 407 and irn xide red (E172). - The ther ingredients in the tablet film cating are ply(vinyl alchl) (E1203), titanium dixide (E171), macrgl 3350 (E1521), talc (E553b), irn xide red (E172) and irn xide black (E172). What lks like and cntents f the pack film-cated tablets are pink, capsule shaped tablets, plain n bth sides with dimensins f 11 mm x 22 mm apprximately. They are supplied in bttles cntaining 30 tablets, packed in a cartn. Each bttle cntains a silica gel desiccant that must be kept in the bttle t help prtect yur tablets. The silica gel desiccant is cntained in a separate canister and shuld nt be swallwed. The fllwing pack sizes are available: 30 (1 x 30) film-cated tablets 90 (3 x 30) film-cated tablets Nt all pack sizes may be marketed. Marketing Authrisatin Hlder and Manufacturer Marketing Authrisatin Hlder Sandz B.V. Veluwezm 22 1327 AH Almere Nederland Manufacturer Remedica Ltd Aharnn Street, Limassl Industrial Estate Limassl, 3056, Cyprus Lek Pharmaceuticals d.d. Vervškva 57 1526 Ljubljana Slvenië In het register ingeschreven nder: RVG 120163 This medicinal prduct is authrised in the Member States f the EEA under the fllwing names: 10
Netherlands: Austria: Belgium: Cyprus: Germany: Denmark: Estnia: Finland: Hungary: Iceland: Ireland: Italy: Latvia: Lithuania: Nrway: Pland: Prtugal: Rmania: Sweden: Slvenia: 600 mg/200 mg/245 mg, filmmhulde tabletten 600 mg/200 mg/245 mg Filmtabletten 600 mg/200 mg/245 mg filmmhulde tabletten 600 mg/200 mg/245 mg, Επικαλυμμένα με λεπτό υμένιο δισκία 600 mg/200 mg/245 mg Filmtabletten 600 mg/200 mg/245 mg kalvpäällysteiset tabletit 600 mg/200 mg/245 mg filmtabletta 600 mg/200 mg/245 mg filmuhúðaðar töflur 600 mg/200 mg/245 mg film-cated tablets 600 mg/200 mg/245 mg apvalktās tabletes 600 mg/200 mg/245 mg plėvele dengts tabletės 600 mg/200 mg/245 mg cmprimate filmate 600 mg/200 mg/245 mg filmdragerade tabletter 600 mg/200 mg/245 mg filmsk blžene tablete This leaflet was last revised in Nvember 2017. 11