natgillin/translations-raw huggingface dataset:
Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Temozolomid SUN se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
Temozolomide SUN contains a medicine called temozolomide.
Temozolomid SUN sadrži lijek pod nazivom temozolomid.
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p=0.33).
Medijan preživljenja bio je 7,34 mjeseca u skupini koja je primala TMZ, odnosno 5,66 mjeseci u skupini koja je primala prokarbazin (log-rang p = 0,33).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BLISTER
Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Liječnik će možda odlučiti smanjiti dozu, ili privremeno odnosno trajno prekinuti liječenje.
prolonged pancytopenia, aplastic anaemia†
dugotrajna pancitopenija, aplastična anemija†
Sodium starch glycolate (Type B) Tartaric acid
laktoza natrijev škroboglikolat (vrste B) tartaratna kiselina stearatna kiselina
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
U oba je ispitivanja primarna mjera ishoda bilo vrijeme preživljenja bez progresije bolesti (engl. progression-free survival, PFS), određeno nalazom magnetske rezonancije
Temozolomide SUN may cause permanent infertility.
Temozolomid može uzrokovati trajnu neplodnost.
- in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
- u djece u dobi od 3 godine i starije te u odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom.
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Temozolomid je triazen koji se pri fiziološkom pH brzo kemijski pretvara u aktivni spoj monometil triazenoimidazol-karboksamid (MTIC).
930 & 180 mg
930 i 180 mg
Somnolence, dizziness, paresthesia
somnolencija, omaglica, parestezija
Temozolomide SUN contains lactose (a kind of sugar).
Temozolomid SUN tvrde kapsule sadrže laktozu (vrstu šećera).
This adds up to a 28-day treatment cycle.
Ciklus liječenja traje 28 dana.
Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Temozolomid SUN u kombinaciji sa zračenjem u liječenju novodijagnosticiranog multiformnog glioblastoma
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity
Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past.
Ona ovisi o Vašoj veličini (visini i težini) te o tome je li se tumor ponovno pojavio i jeste li ranije već primali kemoterapiju.
The cap is imprinted with ‘929'.
Na kapici je otisnuta oznaka '929'.
Your doctor will work out your dose of Temozolomide SUN.
Vaš liječnik će izračunati dozu Temozolomid SUN-a primjerenu za Vas.
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption,
Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba): crvenilo kože, urtikarija (koprivnjača), kožni osip, alergijska reakcija.
See package leaflet for further information.
Sadržaj pakiranja druge informacije
- as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
- jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
The cap is imprinted with ‘930'.
Na kapici je otisnuta oznaka '930'.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na temelju rezultata analize populacijske farmakokinetike u kliničkim ispitivanjima faze II, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom,
890 & 5 mg
890 i 5 mg
If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days.
Ako ste ranije već liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Bolesnici koji su u pilot istraživanju istodobno primali TMZ i RT prema produljenom 42-dnevnom režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane Pneumocystis jirovecii.
In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.
ispitivanju s 288 ispitanika s novodijagnosticiranim multiformnim glioblastomom neutropenija stupnja 4 nastupila je u 3% žena naspram 0% muškaraca, a trombocitopenija stupnja 4 u 1% žena naspram 0%
If you have not been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days.
Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomid SUN-a bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity
CTC stupanj 4b a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
- thrombocyte count ≥ 100 x 109/l
- broj trombocita ≥ 100 x 109/l
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l ), 9 % vs 3 %, in women vs men in the first cycle of therapy.
U prvom ciklusu terapije učestalost neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bila je viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
4.2 Doziranje i način primjene Temozolomid SUN smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
SUN Pharma logo
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SUN Pharma logo
Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 163,441 mg laktoze.
893 & 250 mg
893 i 250 mg
Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 127,121 mg laktoze.
Sun Pharmaceutical Industries Europe B.V.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
- nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria, CTC) ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
Always take this medicine exactly as your doctor or pharmacist has told you.
Kako uzimati Temozolomid SUN Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
892 & 100 mg
892 i 100 mg
How to take Temozolomide SUN
Kako uzimati Temozolomid SUN
The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p=< 0.01 to 0.03).
2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (log-rang p = < 0,01 do 0,03).
Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick), constipation (difficulty passing stools), tiredness.
Vrlo česte (mogu se javiti u više od 1 na 10 osoba): smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija), gubitak teka, glavobolja, povraćanje, mučnina (osjećaj mučnine), zatvor (otežano pražnjenje crijeva), umor.
Erythema multiforme, erythroderma, urticaria, exanthema
multiformni eritem, eritrodermija, urtikarija, egzantem
891 & 20 mg
891 i 20 mg
How to store Temozolomide SUN
Kako čuvati Temozolomid SUN
The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
HR = 1,33-1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
Excipient with known effect Each hard capsule contains 90.801 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 90,801 mg laktoze.
Hepatic enzymes increased,
povišene vrijednosti jetrenih enzima,
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Tablica 4. Štetni događaji koji su se pojavili tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom Organski sustav
Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 18,16 mg laktoze.
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja,
Frequency not known:
Učestalost nepoznata:
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Tablica 5. Nuspojave u bolesnika s recidivirajućim ili progresivnim malignim gliomom Infekcije i infestacije
Convulsions, consciousness
konvulzije, smanjena razina svijesti,
Newly-diagnosed glioblastoma multiforme
Novo dijagnosticirani multiformni glioblastom
TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
TMZ se primjenjuje peroralno u dozi od 75 mg/m2 na dan tijekom 42 dana uz istodobnu radioterapiju
Side effects from clinical studies
Nuspojave iz kliničkih ispitivanja:
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Peroralno primijenjen TMZ ispitivan je u pedijatrijskih bolesnika (u dobi od 3 do 18 godina) s recidivirajućim gliomom moždanog debla ili recidivirajućim astrocitomom visokog stupnja, prema režimu doziranja jednom na dan tijekom pet dana, svakih 28 dana.
Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 227,001 mg laktoze.
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8% žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
neutropenija ili limfopenija (stupanj 3-4),
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jiroveciipneumonia (PCP).
Pneumonija uzrokovana s Pneumocystis jirovecii Bolesnici koji su u pilot istraživanju istodobno primali TMZ i RT prema produljenom 42-dnevnom režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane Pneumocystis jirovecii.
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
impotencija vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Temozolomide SUN 20 mg
Temozolomid SUN 20 mg
Temozolomide SUN 5 mg
Temozolomid SUN 5 mg
Cytotoxic.
TMZ-a.
Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Česte (mogu se javiti u do 1 na 10 osoba): gubitak tjelesne težine, pospanost, omaglica, trnci, nedostatak zraka, proljev, bol u trbuhu, želučane tegobe, osip, svrbež, gubitak kose, vrućica, slabost, drhtavica, loše osjećanje, bol, promjene osjeta okusa.
Temozolomide SUN 250 mg
Temozolomid SUN 250 mg
of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
Allergic reaction, fever, radiation injury, pain, taste perversion
promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Laboratorijski nalazi Trombocitopenija stupnja 3 ili 4 razvila se u 19%, a neutropenija stupnja 3 ili 4 u 17% bolesnika liječenih zbog malignog glioma, što je dovelo do hospitalizacije i/ili obustave liječenja TMZ-om u 8% odnosno 4% bolesnika.
Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
stomatitis, proljev, bolovi u abdomenu, dispepsija, disfagija stomatitis, proljev, dispepsija,
Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).
neuropathy, paresthesia, speech disorder, tremor neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor
The cap is imprinted with ‘890'.
Na kapici je otisnuta oznaka '890'.
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Temozolomide SUN 140 mg
Temozolomid SUN 140 mg
In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
U bolesnika koji prethodno nisu liječeni kemoterapijom, TMZ se primjenjuje peroralno u dozi od 200 mg/m2 jedanput na dan tijekom prvih 5 dana, nakon čega slijede
Excipient with known effect Each hard capsule contains 30.97 mg of lactose.
Jedna tvrda kapsula sadrži 30,97 mg laktoze.
The cap is imprinted with ‘891'.
Na kapici je otisnuta oznaka '891'.
Temozolomide SUN 180 mg
Temozolomid SUN 180 mg
- if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Što morate znati prije nego počnete uzimati Temozolomid SUN Nemojte uzimati Temozolomid SUN - ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Manje česte (mogu se javiti u do 1 na 100 osoba): smanjen broj krvnih stanica (pancitopenija,
Sun Pharma Laboratorios, S.L.
Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55
The cap is imprinted with ‘892'.
Na kapici je otisnuta oznaka '892'.
The cap is imprinted with ‘893'.
Na kapici je otisnuta oznaka '893'.
Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
limfopenija, leukopenija febrilna neutropenija, trombocitopenija, anemija, leukopenija
The body is imprinted with '20 mg' and two stripes.
Na tijelu je otisnuta oznaka '20 mg' i dvije crte.
Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Kad se jednom poveća, doza ostaje na razini od 200 mg/m2 na dan tijekom prvih 5
Temozolomide SUN monotherapy in recurrent or progressive glioma
Monoterapija Temozolomid SUN-om u bolesnika s ponovnom pojavom ili pogoršanjem glioma
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/
Nederland/Pays-Bas/Niederlande/Нидерландия /Nizozemsko/
Temozolomide SUN 100 mg
Temozolomid SUN 100 mg
Pneumocystis jiroveciipneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Tijekom radioterapije i kombiniranog liječenja TMZ-om morala se primijeniti profilaksa protiv Pneumocystis jirovecii pneumonije.
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Davanje TMZ-a može se nastaviti tijekom 42 dana faze istodobnog liječenja (do najviše
The body is imprinted with ‘140 mg' and two stripes.
Na tijelu je otisnuta oznaka '140 mg' i dvije crte.
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom:
decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
parestezije, poremećaj govora, tremor hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 %
Prema podacima za 400 ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8%
Contains lactose.
Progutati ih cijele.
Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurred vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Česte (mogu se javiti u do 1 na 10 osoba): infekcije usne šupljine, infekcija rane, smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija), povišena razina šećera u krvi, gubitak tjelesne težine, promjena psihičkog stanja ili budnosti, tjeskoba/depresija, pospanost, otežan govor, poremećaj ravnoteže, omaglica, smetenost, zaboravljivost, poteškoće s koncentracijom, nemogućnost da bolesnik zaspi ili spava, trnci, stvaranje modrica, drhtanje, poremećen ili zamagljen vid, dvostruke slike, oštećenje sluha, nedostatak zraka, kašalj, krvni ugrušak u nogama, zadržavanje tekućine, otečene noge, proljev, bol u želucu ili trbuhu, žgaravica, želučane tegobe, otežano gutanje, suha usta, nadraženost ili crvenilo kože, suha koža, svrbež, mišićna slabost, bolni zglobovi, tupi bolovi i probadanja u mišićima, učestalo mokrenje, poteškoće sa zadržavanjem urina, alergijska reakcija, vrućica, ozljeda zbog zračenja, oticanje lica, bol, promjena osjeta okusa, odstupanja od normalnih vrijednosti testova funkcije jetre.
Hearing impairment, tinnitus
oštećenje sluha oštećenje sluha, tinitus
The body is imprinted with ‘5 mg' and two stripes.
Na tijelu je otisnuta oznaka '5 mg' i dvije crte.
The body is imprinted with ‘250 mg' and two stripes.
Na tijelu je otisnuta oznaka '250 mg' i dvije crte.
The body is imprinted with ‘180 mg' and two stripes.
Na tijelu je otisnuta oznaka '180 mg' i dvije crte.
Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Manje česte (mogu se javiti u do 1 na 100 osoba): simptomi nalik gripi, crvene potkožne mrlje, niska razina kalija u krvi, povećanje tjelesne težine, promjene raspoloženja, halucinacije i poremećaj pamćenja, djelomična paraliza, poremećaj koordinacije, poremećaj osjeta, djelomičan gubitak vida, suhe ili bolne oči, gluhoća, infekcija srednjeg uha, zvonjava u ušima, bol u uhu, palpitacije (osjećaj lupanja srca), krvni ugrušak u plućima, visok krvni tlak, upala pluća, upala sinusa, bronhitis, prehlada ili gripa, oticanje trbuha, poteškoće s kontroliranjem stolice, hemoroidi, ljuštenje kože, povećana osjetljivost kože na sunčevu svjetlost, promjena boje kože, pojačano znojenje, oštećenje mišića, bol u leđima, poteškoće s mokrenjem, vaginalno krvarenje, impotencija, izostanak ili obilne menstruacije, nadraženost rodnice, bol u dojkama, navale vrućine, drhtavica, promjena boje jezika, promjena osjeta mirisa, žeđ, promjene na zubima.