natgillin/translations-raw huggingface dataset:
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax capsules should not be opened or crushed.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, kapsul zdravila Myfenax ne smemo odpreti ali drobiti.
Inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules should be avoided.
Vdihavanju ali neposrednemu stiku praška, ki ga vsebujejo kapsule zdravila Myfenax, s kožo ali sluznico se je treba izogibati.
If such contact occurs, soap and water should be used to wash thoroughly and the eyes should be rinsed with plain water.
Če pride do stika s praškom, je potrebno temeljito izpiranje z vodo in milom, oči pa izpiramo le z vodo.
EU/ 1/ 07/ 438/ 001 (100 capsules) EU/ 1/ 07/ 438/ 002 (300 capsules)
EU/ 1/ 07/ 438/ 001 (100 kasul) EU/ 1/ 07/ 438/ 002 (300 kapsul)
21 February 2008 13 10.
21. februar 2008
Myfenax tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose).
Tablete zdravila Myfenax lahko predpišemo samo bolnikom, katerih telesna površina je večja od 1, 5 m2, v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
Adults: oral Myfenax should be initiated within 5 days following transplantation.
Odrasli: v začetku damo zdravilo Myfenax peroralno v 5 dneh po presaditvi.
Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Otroci in mladostniki: za otroke s srčnim presadkom podatki niso znani, zato uporaba zdravila Myfenax v
15 Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Odrasli: prve 4 dni po presaditvi jeter je treba dajati mofetilmikofenolat intravensko, takoj ko je bolnik sposoben požirati, pa nadaljujemo s peroralno obliko mofetilmikofenolata.
Use in elderly (≥ 65 years)
Uporaba pri starejših bolnikih (stari 65 let ali več):
Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
16 Bolnikom, ki prejemajo zdravilo Myfenax, naročimo, da morajo takoj poročati o kakršnemkoli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Myfenax, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4. 8).
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider 16 in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Zdravniki naj pomislijo nanju pri ugotavljanju diagnoze pri imunosuprimiranih bolnikih, pri katerih se slabša delovanje ledvic ali so prisotni nevrološki simptomi.
In view of the significant reduction in the area under the curve (AUC) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.
Ker holestiramin značilno zmanjša AUC (površino pod krivuljo) mikofenolne kisline, dajemo zdravilo Myfenax previdno bolnikom, ki sočasno jemljejo druga zdravila, ki vplivajo na enterohepatični obtok zaradi možnosti zmanjšanja učinkovitosti zdravila Myfenax.
Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e. g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Ker so pri ledvični okvari koncentracije mikofenolglukuronida in aciklovirja v plazmi povečane, obstaja možnost, da med mofetilmikofenolatom in aciklovirjem ali njegovim predzdravilom, npr. valaciklovirjem, prihaja do kompeticije pri tubularni sekreciji in do možnih nadaljnjih
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID) of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4, and section 5.2).
Holestiramin: če dajemo holestiramin 4 dni v odmerku 4 g trikrat na dan, ta zmanjša AUC mikofenolne kisline po enkratnem peroralnem vnosu 1, 5 g mofetilmikofenolata za približno 40% (glejte poglavje 4. 4 in poglavje 5. 2).
17 In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Če pa sočasno zdravljenje s ciklosporinom prekinemo, lahko pričakujemo povečanje AUC mikofenolne kisline za približno 30%.
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co administration of mycophenolate (see also section 5.2).
Peroralni kontraceptivi: sočasno jemanje mofetilmikofenolata ni vplivalo na farmakokinetiko in farmakodinamiko peroralnih kontraceptivov (glejte poglavje 5. 2).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Rifampicin: pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0- 12h) za 18 d0 70%.
Sirolimus: in renal transplant patients, concomitant administration of mycophenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of mycophenolate mofetil (see also section 4.4).
Sirolimus: pri bolnikih z ledvičnim presadkom je sočasno dajanje mofetilmikofenolata in ciklosporina A povzročilo manjšo izpostavljenost mikofenolni kislini za 30 do 50% v primerjavi z bolniki, ki so prejeli kombinacijo sirolimusa in podobnih odmerkov zdravila Myfenax (glejte tudi poglavje 4. 4).
Sevelamer: decrease in MPA Cmax and AUC0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: pri sočasnem dajanju mofetilmikofenolata in sevelamerja so opazili zmanjšanje cmax mikofenolne kisline za 30% in AUC0- 12h mikofenolne kisline za 25%, kliničnih posledic (zavrnitve presadka) pa ni bilo.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Takrolimus: pri bolnikih z jetrnim presadkom, pri katerih so uvedli mofetilmikofenolat in takrolimus,
In renal transplant patients, the tacrolimus concentration did not appear to be altered by mycophenolate mofetil.
18 sprememba AUC in cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day, morning and evening[BID) were administered to patients taking tacrolimus (see also section 4.4).
(glejte tudi poglavje 4. 4).
18 It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Pred začetkom zdravljenja z zdravilom Myfenax je treba izključiti nosečnost.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Bolniki, ki prejemajo imunosupresivna zdravila, obsegajoč kombinacije zdravil, vključno z
However, the following treatment-related adverse events were more frequent in the paediatric population, 19 particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Naslednji neželeni učinki povezani z zdravljenjem pa so bili v primerjavi z odraslimi pogostejši pri otrocih in mladostnikih, zlasti pri otrocih, mlajših od 6 let: driska, sepsa, levkopenija, anemija in okužba.
Adverse drug reactions
hipertrofija kože, izpuščaj, akne, alopecija
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
sepsa, gastrointestinalna kandidoza, okužba urinarnega trakta, herpes simpleks, herpes zoster
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pljučnica, gripa, okužba respiratornega trakta, respiratorna
Hepatobiliary disorders Psychiatric disorders
Bolezni jeter, žolčnika in
Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
V oklepajih je navedena njihova 22 pogostnost, če je znana.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4). There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Pri bolnikih, ki so se zdravili z mofetilmikofenolatom, so poročali o primerih aplastične anemije in depresije kostnega mozga, nekateri od teh so bili smrtni.
22 Congenital disorders: see further details in section 4.6.
Kongenitalne okvare: glejte poglavje 4. 6.
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4). If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
Če se pojavi nevtropenija, je treba odmerjanje zdravila Myfenax prekiniti ali odmerek zmanjšati (glejte poglavje 4. 4).
Orally administered radiolabelled mycophenolate mofetil results in complete recovery of the administered dose; with 93%
Peroralno zaužit in radioaktivno označen mofetilmikofenolat se je skoraj popolnoma izločil, od tega 93% s sečem in 6% z blatom.
However, at high MPAG plasma concentrations (> 100μ g/ ml), small amounts of PAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplants patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
V zgodnjem obdobju po presaditvi (do 40. dneva po presaditvi) je srednja AUC mikofenolne kisline pri bolnikih z ledvičnim, srčnim ali jetrnim presadkom za približno 30% manjša, Cmax pa za približno 40% manjša v primerjavi s poznejšim obdobjem po presaditvi (3 do 6 mesecev po presaditvi).
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/ skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml• mim- 1• 1, 73 m- 2) srednji AUC mikofenolne kisline v plazmi za 28 do 75% večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
24 Pri prostovoljcih z alkoholno jetrno cirozo procesi glukuronidacije mikofenolne kisline v jetrih niso bili pomembno spremenjeni zaradi bolezni jetrnega parenhima.
24 In experimental models, mycophenolate mofetil was not tumourigenic.
Mofetilmikofenolat v eksperimentalnih modelih ni bil kancerogen.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Najvišji preizkušani odmerek v živalskih študijah karcinogenosti je povzročil približno 2 - do 3- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih z ledvičnim presadkom, ki so prejemali priporočeni klinični odmerek 2 g na dan, in 1, 3 - do 2- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih s srčnim presadkom, ki so prejemali priporočeni klinični odmerek 3 g na dan.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg1 day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
25 V študijah teratogenosti pri podganah in kuncih so se pojavile malformacije in resorpcija zarodka pri odmerkih 6 mg• kg- 1• dan- 1 pri podganah (vključno z anoftalmijo, agnatijo in hidrocefalijo) ter pri odmerkih 90 mg• kg- 1• dan- 1 pri kuncih (vključno s kardiovaskularnimi motnjami in motnjami delovanja ledvic, kot so ektopija srca in ledvic ter preponska in popkovna kila), pri materah pa škodljivih učinkov ni bilo.
25 Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Obloga tablete: hipromeloza (E464) titanov dioksid (E171) makrogol smukec indigotin (E132) črni železov oksid (E172) rdeči železov oksid (E172)
This medicinal product does not require any special storage conditions.
26 Za shranjevanje zdravila niso potrebna posebna navodila.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax film- coated tablets should not be crushed.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, filmsko obloženih tablet zdravila Myfenax ne smemo drobiti.
EU/ 1/ 07/ 438/ 003 (50 tablets) EU/ 1/ 07/ 438/ 004 (150 tablets)
EU/ 1/ 07/ 438/ 003 (50 tablet) EU/ 1/ 07/ 438/ 004 (150 tablet)
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu 26 ANNEX II
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
28 Risk Management Plan No description of Risk Management Plan has been provided by the applicant.
Načrt upravljanja tveganja Predlagatelj ni predložil opisa načrta upravljanja tveganja.
30 A. LABELLING
30 DODATEK III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Izogibajte se vdihavanju ali neposrednemu stiku praška s kožo.
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 PODATKI NA ZUNANJI OVOJNINI
36 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
37 B. PACKAGE LEAFLET
DRUGI PODATKI
Myfenax 250 mg hard capsules Mycophenolate mofetil
Myfenax 250 mg trde kapsule mofetilmikofenolat
Further information
1 Kaj je zdravilo Myfenax in za kaj ga uporabljamo 2 Kaj morate vedeti, preden boste vzeli zdravilo Myfenax 3 Kako jemati zdravilo Myfenax 4 Možni neželeni učinki 5 Shranjevanje zdravila Myfenax 6 Dodatne informacije
WHAT MYFENAX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MYFENAX IN ZA KAJ GA UPORABLJAMO
It is used in combination with other medicines with a similar function (i. e. ciclosporin and corticosteroids).
Zdravilo Myfenax uporabljamo skupaj z drugimi zdravili s podobnim delovanjem( to so ciklosporin in kortikosteroidi).
BEFORE YOU TAKE MYFENAX
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO MYFENAX
Do not take Myfenax
Ne jemljite zdravila Myfenax:
- if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- če ste alergični na (preobčutljivi za) mofetilmikofenolat, mikofenolno kislino ali katerokoli
other ingredients of Myfenax.
sestavino zdravila Myfenax;
Take special care with Myfenax You should inform your doctor immediately:
Svojega zdravnika morate nemudoma obvestiti:
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- če opazite znake okužbe (npr. zvišana telesna temperatura, vneto grlo), nepričakovane
bleeding
podplutbe in/ ali krvavitve;
Therefore you should limit your exposure to sunlight and ultra violet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Ker zdravilo Myfenax zmanjša obrambno sposobnost vašega organizma, obstaja zvečana možnost nastanka kožnega raka, zato se je treba izogibati sončni svetlobi in UV- žarkom z uporabo zaščitnih oblačil in sončne kreme z visokim zaščitnim faktorjem.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which
- Ali morda jemljete zdravila, ki vsebujejo azatioprin ali druga imunosupresivna zdravila (bolniki jih
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients 39 with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal kidney failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
včasih prejmejo po presaditveni operaciji), holestiramin (uporabljajo ga za zdravljenje bolnikov z visokim holesterolom), rifampicin (antibiotic), antacid, fosfatne vezalce (uporabljajo jih za zmanjšanje absorpcije fosfatov pri bolnikih s kronično ledvično odpovedjo) ali druga zdravila (vključno s tistimi, ki ste jih dobili brez recepta), za katera vaš zdravnik ne ve?
indicated for you
Jemanje zdravila Myfenax skupaj s hrano in pijačo:
Taking Myfenax with food and drink Taking food and drink has no influence on your treatment with Myfenax.
Jemanje skupaj s hrano in pijačo nima vpliva na zdravljenje z zdravilom Myfenax.
Pregnancy and breast-feeding Do not take Myfenax if you are breast feeding.
Ne jemljite zdravila Myfenax, če dojite.
Your doctor should advise you about using contraception before taking Myfenax, whilst taking Myfenax, and for 6 weeks after you have stopped taking Myfenax.
Vaš zdravnik vam bo svetoval glede uporabe kontracepcijske zaščite pred in med jemanjem zdravila Myfenax in šest tednov po prekinitvi jemanja zdravila Myfenax.
Myfenax may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Zdravilo Myfenax lahko povzroči spontani splav ali poškoduje vašega (še) nerojenega otroka, vključno z nepravilno razvitostjo ušes.
Driving and using machines Myfenax has not been shown to impair your ability to drive or operate machines.
Za zdravilo Myfenax ni bilo pokazano, da vpliva na sposobnost za upravljanje vozil ali strojev.
HOW TO TAKE MYFENAX
KAKO JEMATI ZDRAVILO MYFENAX
Your doctor will decide the most appropriate dose based on body surface area (height and weight).
Zdravnik bo določil najbolj ustrezen odmerek glede na 2 telesno površino (višina in telesna masa).
No data are available to recommend the use of Myfenax in children and adolescents who have received a heart transplant.
Podatki o priporočenem odmerjanju zdravila Myfenax pri otrocih in mladostnikih, ki so prejeli srčni presadek, niso na voljo.
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
Prvi peroralni odmerek zdravila Myfenax boste prejeli vsaj 4 dni po presaditvenem posegu in takoj, ko boste lahko jemali zdravila peroralno.
The recommended daily dose is 12 capsules (3 g of the
Priporočeni dnevni odmerek je 12 kapsul (3 g učinkovine), razdeljenih na dva posamezna odmerka.
No data are available to recommend the use of Myfenax in children and adolescents who have received a liver transplant.
Podatki o priporočenem odmerjanju zdravila Myfenax pri otrocih in mladostnikih, ki so prejeli jetrni presadek, niso na voljo.
If you take more Myfenax than you should It is important not to take too many capsules.
Če ste vzeli večji odmerek zdravila Myfenax, kot bi smeli:
If you forget to take Myfenax If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite, in nato nadaljujte kot običajno.
If you stop taking Myfenax Do not stop taking Myfenax because you feel better.
Če ste prenehali jemati zdravilo Myfenax:
It is important to take the medicine for as long as the doctor has told you to.
Zdravljenja z zdravilom Myfenax ne prekinjajte, ker se počutite bolje.
Like all medicines, Myfenax can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Myfenax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects likely to affect more than 1 in 10 people: • Diarrhoea, vomiting, feeling sick • Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness • Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles
Zelo pogosti neželeni učinki prizadenejo 1 od 10 bolnikov: • Driska, bruhanje, slabost. • Zmanjšano število različnih krvnih celic, ki lahko povzroči povečano tveganje za okužbe, modrice, krvavitve, zasoplost in šibkost. • Bakterijske, glivične in virusne okužbe prebavnega in sečnega trakta, herpes febrilis, pasasti izpuščaj.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose
Pogosti neželeni učinki prizadenejo manj kot 1 od 10, vendar več kot 1 od 100 bolnikov: • Spremembe različnih laboratorijskih parametrov, vključno z zvišanimi vrednostmi jetrnih encimov, ledvičnimi parametri, kot so kreatinin, kalij, krvni sladkor, lipidi v krvi, holesterol, fosfataze, magnezij, kalcij in sečna kislina. • Težave z ledvicami z zvišanimi vrednostmi sečnine.