FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate and extent of absorption of amlodipine/valsartan are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Croatian: Brzina i opseg apsorpcije amlodipina/valsartana jednaki su bioraspoloživosti valsartana i amlodipina kada se primjenjuju kao pojedinačne tablete.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Amlodipine/Valsartan Mylan containing the same component doses.
Croatian: Bolesnici koji primaju valsartan i amlodipin u odvojenim tabletama/kapsulama, mogu se radi jednostavnosti prebaciti na Amlodipin/Valsartan Mylan koji sadrži iste doze sastojaka.
English: Bottle:
Croatian: Boca:
English: How to store Amlodipine/Valsartan Mylan Contents of the pack and other information
Croatian: Kako čuvati Amlodipin/Valsartan Mylan Sadržaj pakiranja i druge informacije
English: • Concomitant use of Amlodipine/Valsartan Mylan with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and
Croatian: • Istodobna primjena lijeka Amlodipin/Valsartan Mylan s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
English: NDMA Limit in ng/day
Croatian: NDMA Graničn a vrijednos t u ng/dan
English: Amlodipine/Valsartan
Croatian: Amlodipin/ Valsartan
English: What you need to know before you take Amlodipine/Valsartan Mylan
Croatian: Što morate znati prije nego počnete uzimati Amlodipin/Valsartan Mylan
English: NDEA Limit in ng/day
Croatian: NDEA Graničn a vrijednos t u ng/dan
English: Therefore Amlodipine/Valsartan Mylan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Stoga se Amlodipin/Valsartan Mylan tijekom dojenja ne preporučuje te se savjetuje alternativno liječenje s bolje utvrđenim sigurnosnim profilom tijekom dojenja, posebno kod dojenja novorođenčeta ili nedonoščeta.
English: Amlodipine/Valsartan Mylan tablets contain two active substances called amlodipine and valsartan.
Croatian: Amlodipin/Valsartan Mylan tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
English: ACE inhibitors and angiotensin II receptor blockers (ARBs) should not be used concomitantly in patients with diabetic nephropathy.
Croatian: ACE inhibitori i blokatori angiotenzin II receptora (ARB-ovi) ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
English: Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
Croatian: - Teške kožne reakcije, uključujući intenzivan kožni osip, koprivnjaču, crvenilo kože po čitavom tijelu, jaki svrbež, stvaranje mjehurića, ljuštenje i oticanje kože, upalu sluznica (StevensJohnsonov sindrom, toksičnu epidermalnu nekrolizu) ili druge alergijske reakcije.
English: ACE inhibitors and angiotensin II receptor blockers (ARBs) should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).
Croatian: ACE inhibitori i blokatori angiotenzin II receptora (ARB-ovi) stoga se ne smiju istodobno primjenjivati u bolesnika s dijabetičkom nefropatijom (vidjeti dio 4.4).
English: There is no experience of overdose with amlodipine/valsartan.
Croatian: Nema iskustva s predoziranjem amlodipinom/valsartanom.
English: If any of these apply to you, tell your doctor before taking Amlodipine/Valsartan Mylan.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Amlodipin/Valsartan Mylan.
English: The usual dose of Amlodipine/Valsartan Mylan is one tablet per day.
Croatian: Uobičajena doza lijeka Amlodipin/Valsartan Mylan je jedna tableta na dan.
English: If any of the above applies to you, do not take Amlodipine/Valsartan Mylan and talk to your doctor.
Croatian: Ako se bilo što od navedenog odnosi na Vas, nemojte uzeti Amlodipin/Valsartan Mylan i obavijestite svog liječnika.
English: Within 2 years after Commission Decision
Croatian: U roku od dvije godine od
English: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Croatian: Dvostruka blokada RAAS s ARB-ovima, ACE inhibitorima ili aliskirenom Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora (ARBova) ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) Postoje dokazi da istodobna primjena ACE inhibitora, blokatora angiotenzin II receptora (ARB-ova) ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95 % CI [0.89-1.02] p=0.20.
Croatian: Međutim, kad je riječ o smrtnosti od svih uzroka, između terapije temeljene na amlodipinu i terapije temeljene na klortalidonu nije bilo značajne razlike OR 0,96 95% CI [0,89-1,02] p=0,20.
English: medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, talithromycin); clarithromycin (for infections caused by bacteria); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); tacrolimus (used to control your body's immune response, enabling your body to accept the transplanted organ); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Croatian: gospina trava; nitroglicerin i drugi nitrati, ili drugi lijekovi koji se nazivaju „vazodilatatori“; lijekovi koji se primjenjuju za liječenje HIV infekcije/SIDA (npr. ritonavir, indinavir, nelfinavir); lijekovi za liječenje gljivičnih infekcija (npr. ketokonazol, itrakonazol); lijekovi za liječenje bakterijskih infekcija (npr. rifampicin, eritromicin, talitromicin); klaritromicin (za infekcije uzrokovane bakterijama); verapamil, diltiazem (lijekovi za srce); simvastatin (lijekovi koji se koriste za kontrolu visokih razina kolesterola); takrolimus (upotrebljava se za kontrolu imunološkog odgovora vašeg tijela, što omogućuje vašem tijelu da prihvati transplantirani organ); dantrolen (infuzija za teške poremećaje tjelesne temperature); lijekovi koji se koriste kao zaštita od odbacivanja transplantata (ciklosporin).
English: Hepatic impairment Amlodipine/valsartan is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Oštećenje jetre Amlodipin/Valsartan Mylan je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine/Valsartan Mylan.
Croatian: Grejp i sok od grejpa u nekih bolesnika može dovesti do povećanja razina djelatne tvari amlodipina u krvi, što može uzrokovati neočekivano pojačani učinak lijeka Amlodipin/Valsartan Mylan na snižavanje krvnog tlaka.
English: For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Croatian: Nije bilo dokaza mutagenosti, klastogenosti ni kancerogenosti pojedinačnih komponenti.
English: Amlodipine/Valsartan Mylan is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Croatian: Amlodipin/Valsartan Mylan se primjenjuje za liječenje povišenog krvnog tlaka u odraslih osoba čiji krvni tlak nije dovoljno kontroliran bilo samo amlodipinom ili samo valsartanom.
English: Other possible side effects of Amlodipine/Valsartan Mylan:
Croatian: Ostale moguće nuspojave lijeka Amlodipin/Valsartan Mylan:
English: Excessive hypotension was seen in 0.4 % of patients with uncomplicated hypertension treated with amlodipine/valsartan in placebo-controlled studies.
Croatian: U placebo-kontroliranim ispitivanjima, u 0,4% bolesnika s nekompliciranom hipertenzijom liječenih amlodipinom/valsartanom viđena je izražena hipotenzija.
English: There is a risk of increased tacrolimus blood levels when co administered with amlodipine.
Croatian: Postoji rizik od povišene razine takrolimusa u krvi kada se primjenjuje istodobno s amlodipinom.
English: Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Croatian: Amlodipin/Valsartan Mylan je indiciran u odraslih osoba čiji krvni tlak nije odgovarajuće kontroliran monoterapijom amlodipinom ili valsartanom.
English: Pharyngolaryngeal pain
Croatian: Faringolaringealna bol
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of
Croatian: Takve doze u štakora (200 i 600 mg/kg/dan) otprilike su 6 i 18 puta veće od najviše preporučene doze za ljude izražene u mg/m
English: In this study (baseline blood pressure 171/113 mmHg), an amlodipine/valsartan regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Croatian: U tom ispitivanju (početni krvni tlak 171/113 mmHg), liječenje amlodipinom/valsartanom 5 mg/160 mg titriranim do 10 mg/160 mg snizilo je krvni tlak u sjedećem položaju za 36/29 mmHg, u usporedbi s 32/28 mmHg kod liječenja lizinoprilom/hidroklorotiazidom 10 mg/12,5 mg titriranim do 20 mg/12,5 mg.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Amlodipine/Valsartan Mylan or observed with a higher frequency than with Amlodipine/Valsartan Mylan:
Croatian: Prijavljene nuspojave s amlodipinom ili valsartanom primijenjenima samostalno ili uopće nisu opažene s lijekom Amlodipin/Valsartan Mylan ili su opažene s većom učestalošću nego s lijekom Amlodipin/Valsartan Mylan:
English: Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling.
Croatian: Somnolencija, omaglica, palpitacije, bol u abdomenu, mučnina, oticanje gležnjeva.
English: Similar changes were also seen in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).
Croatian: Slične promjene su također viđene u skupini koja je bila samo na valsartanu (izloženost 8,5-11,0 puta veća od izloženosti kliničkom dozom od 160 mg valsartana).
English: Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzymes increased*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity.
Croatian: Vrlo rijetko Leukocitopenija, trombocitopenija, alergijske reakcije, hiperglikemija, hipertonija, periferna neuropatija, infarkt miokarda, aritmija (uključujući bradikardiju, ventrikularnu tahikardiju i fibrilaciju atrija), vaskulitis, pankreatitis, gastritis, hiperplazija gingive, hepatitis, žutica, povišenje jetrenih enzima*, angioedem, multiformni eritem, urtikarija, eksfolijativni dermatitis, Stevens-Johnsonov sindrom, Quinckeov edem, fotosenzitivnost.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora osigurati da se pregledaju proizvodni procesi djelatnih tvari njegovih lijekova kako bi se utvrdio potencijalni rizik od nastanka N-nitrozamina te da se prema potrebi promijene kako bi se kontaminacija nitrozaminom svela na najmanju moguću mjeru.
English: Amlodipine/Valsartan Mylan can be used with or without food.
Croatian: Amlodipin/Valsartan Mylan se može primjenjivati s hranom ili bez nje.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or amlodipine/valsartan, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Croatian: Prilikom prebacivanja starijih hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) na amlodipin ili amlodipin/valsartan, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
English: The active substances of Amlodipine/Valsartan Mylan are amlodipine (as amlodipine besilate) and valsartan.
Croatian: Djelatne tvari u lijeku Amlodipin/Valsartan Mylan su amlodipin (u obliku amlodipinbesilata) i valsartan.
English: If you take more Amlodipine/Valsartan Mylan than you should If you have taken too many tablets of Amlodipine/Valsartan Mylan, or if someone else has taken your tablets, consult a doctor immediately.
Croatian: Ako ste uzeli previše tableta lijeka Amlodipin/Valsartan Mylan, ili ako je netko drugi uzeo Vaše tablete, odmah se posavjetujte s liječnikom.
English: Caution should be exercised when administering amlodipine/valsartan to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Croatian: Nužan je oprez kod primjene amlodipina/valsartana bolesnicima s oštećenjem jetre ili opstruktivnim bolestima žučnog sustava (vidjeti dio 4.4).
English: What Amlodipine/Valsartan Mylan contains
Croatian: Što Amlodipin/Valsartan Mylan sadrži
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an angiotensin II receptor blocker (ARB).
Croatian: ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s blokatorima angiotenzin II receptora (ARB-ovima).
English: Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.
Croatian: Preporučeno doziranje amlodipina nije ustanovljeno u bolesnika s blagim do umjerenim oštećenjem jetre.
English: Similar changes were found in the valsartan alone group (exposure 8.5-11.0 times the clinical dose of 160 mg valsartan).
Croatian: Slične su promjene nađene i u skupini koja je bila samo na valsartanu (izloženost 8,511,0 puta viša od izloženosti kliničkom dozom od 160 mg valsartana).
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or amlodipine/valsartan, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Croatian: Prilikom prebacivanja hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) s oštećenjem jetre na amlodipin ili amlodipin/valsartan, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
English: Particular caution should be exercised when administering amlodipine/valsartan to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Croatian: Nužan je poseban oprez kod primjene amlodipina/valsartana bolesnicima s blagim do umjerenim oštećenjem jetre ili opstruktivnim poremećajima žučnog sustava.
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Croatian: valsartan 320 losartan 150 olmesartan 40 irbesartan 300 kandesarta n * Te granične vrijednosti nisu primjenjive za serije gdje je utvrđeno istodobno postojanje više od jednog od prethodno navedenih N-nitrozamina; takve serije treba odbaciti.
English: Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light;
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): Smanjen broj bijelih krvnih stanica, smanjen broj krvnih pločica što može rezultirati stvaranjem neuobičajenih modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica); povišen šećer u krvi (hiperglikemija), oticanje desni, nadutost u trbuhu (gastritis), nepravilna jetrena funkcija, upala jetre (hepatitis), žutilo kože (žutica), povišeni jetreni enzimi što može imati učinak na neke medicinske testove, povećana napetost mišića, upala krvnih žila često s kožnim osipom, osjetljivost na svjetlost.
English: You can take Amlodipine/Valsartan Mylan with or without food.
Croatian: Amlodipin/Valsartan Mylan možete uzimati s hranom ili bez nje.
English: The effect of amlodipine/valsartan on infants is unknown.
Croatian: Učinak amlodipina na dojenčad nije poznat.
English: Posology The recommended dose of Amlodipine/Valsartan Mylan is one tablet per day.
Croatian: Preporučena doza lijeka Amlodipin/Valsartan Mylan je jedna tableta na dan.
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78 % of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67 % of patients remaining on amlodipine 10 mg.
Croatian: Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju <90 mmHg na kraju ispitivanja) u 78% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg, u usporedbi s 67% bolesnika koji su ostali na amlodipinu 10 mg.
English: Common (may affect up to 1 in 10 people): Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia (weakness); redness and warm feeling of the face and/or neck.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): Influenca (gripa); začepljen nos, grlobolja i osjećaj nelagode pri gutanju; glavobolja; oticanje ruku, šaka, nogu, gležnjeva ili stopala; umor; astenija (slabost); crvenilo i osjećaj topline u licu i/ili vratu.
English: Hypromellose Titanium dioxide (E171) Macrogol 8000
Croatian: Ovojnica: hipromeloza titanijev dioksid (E171) makrogol 8000 talk žuti željezov oksid (E172)
English: Active-controlled trials in patients who were non-responders to monotherapy A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75 % of patients treated with amlodipine/valsartan 10 mg/160 mg and 62 % of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53 % of patients remaining on valsartan 160 mg.
Croatian: Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani valsartanom 160 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju <90 mmHg na kraju ispitivanja) u 75% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg i 62% bolesnika liječenih amlodipinom/valsartanom 5 mg/160 mg, u usporedbi s 53% bolesnika koji su ostali na valsartanu 160 mg.
English: Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): Promjene raspoloženja, tjeskoba, depresija, pospanost, drhtanje, poremećaji okusa, nesvjestica, gubitak osjećaja boli; poremećaji vida, oštećenje vida, zvonjava u ušima; niski krvni tlak; kihanje/curenje iz nosa uzrokovano upalom sluznice nosa (rinitis); loša probava, povraćanje; ispadanje kose, pojačano znojenje, svrbljiva koža, promjena boje kože; poremećaj mokrenja, pojačana potreba za mokrenjem noću, povećan broj mokrenja, nemogućnost postizanja erekcije, nelagoda ili povećanje dojki u muškaraca, bol, loše osjećanje, bol u mišićima, grčevi u mišićima; povećanje ili smanjenje tjelesne težine.
English: Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba): Osjećaj tjeskobe; zvonjava u ušima (tinitus); nesvjestica; pojačano mokrenje ili pojačan nagon na mokrenje; nemogućnost postizanja ili održavanja erekcije; osjećaj težine; niski krvni tlak sa simptomima poput omaglice, omamljenosti; pojačanog znojenja; kožni osip po čitavom tijelu; svrbež; grč mišića.
English: Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine:
Croatian: Odmah se javite liječniku ako osjetite bilo koju od sljedećih vrlo rijetkih, teških nuspojava nakon uzimanja ovog lijeka: - Iznenadno piskanje pri disanju, bol u prsima, nedostatak zraka ili otežano disanje.