FrancophonIA/ELRC3.0 huggingface dataset:
English: Twynsta is available in a folding box containing 14, 28, 56, 98 tablets in aluminium/aluminium blisters or containing 30 x 1, 90 x 1, 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters.
Slovenian: Zdravilo Twynsta je na voljo v škatlah po 14, 28, 56 ali 98 tablet v pretisnih omotih iz aluminija ali po 30 x 1, 90 x 1 tableta ali 360 (4 x 90 x 1) tablet v perforiranih pretisnih omotih za enkratni odmerek iz aluminija.
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Twynsta:
Slovenian: Neželeni učinki, ki so jih opazili pri učinkovinah zdravila telmisartanu ali amlodipinu in se lahko pojavijo tudi pri zdravilu Twynsta:
English: Very rare myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Slovenian: Zelo redki miokardni infarkt, aritmija, prekatna tahikardija, fibrilacija preddvorov
English: In one rat study, adverse effects were found on male fertility (see section 5.3).
Slovenian: V eni študiji na podganah so opazili škodljive vplive na plodnost pri samcih (glejte poglavje 5.3).
English: It is recommended to take Twynsta with some liquid.
Slovenian: Priporočeno ga je jemati z nekaj tekočine.
English: If you forget to take Twynsta
Slovenian: Če ste pozabili vzeti zdravilo Twynsta
English: generalised oedema, and oedema) were consistently lower in patients who received Twynsta as compared to patients who received amlodipine 10 mg.
Slovenian: Z edemom povezani dogodki (periferni edem, generalizirani edem in edem) so bili dosledno manj pogosti pri bolnikih, ki so jemali zdravilo Twynsta, kot pri bolnikih, ki so jemali amlodipin v odmerkih po 10 mg.
English: • if you suffer from heart failure after a heart attack.
Slovenian: • če imate po srčni kapi srčno popuščanje;
English: 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
Slovenian: Uporabo zaviralca ACE v kombinaciji z blokatorjem receptorjev angiotenzina II so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
English: Remove your Twynsta tablet from the blister only directly prior to intake.
Slovenian: Tableto zdravila Twynsta vzemite iz pretisnega omota tik, preden jo boste zaužili.
English: Patients with cardiac failure
Slovenian: Bolniki s srčnim popuščanjem
English: The concomitant use of telmisartan/amlodipine with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and
Slovenian: Sočasna uporaba telmisartana/amlodipina in zdravil, ki vsebujejo aliskiren je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 2) (glejte poglavji 4.5 in 5.1).
English: Cardiac disorders Uncommon bradycardia, palpitations
Slovenian: Srčne bolezni Občasni bradikardija, palpitacije
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 14, 28, 56, 98 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in a carton containing 30 x 1, 90 x 1 tablets and multipacks containing 360 (4 packs of 90 x 1) tablets.
Slovenian: Pretisni omoti iz aluminija (PA/Al/PVC/Al) v kartonski škatli po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek iz aluminija (PA/A1/PVC/Al) v kartonski škatli po 30 x 1, 90 x 1 tableta ter skupinsko pakiranje po 360 (4 pakiranja po 90 x 1) tablet.
English: Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
Slovenian: Posebnih študij o vplivu na sposobnost razmnoževanja s kombinacijo telmisartana in amlodipina niso izvajali.
English: Do not take Twynsta
Slovenian: Ne jemljite zdravila Twynsta
English: In patients with mild to moderate hepatic impairment telmisartan/amlodipine should be administered with caution.
Slovenian: Bolnikom z blago do zmerno jetrno okvaro je treba telmisartan/amlodipin dajati previdno.
English: This medicine contains 337.28 mg sorbitol in each tablet.
Slovenian: To zdravilo vsebuje 337,28 mg sorbitola v eni tableti.
English: If you stop taking Twynsta
Slovenian: Če ste prenehali jemati zdravilo Twynsta
English: Twynsta is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali se je prezgodaj rodil.
English: Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses in one tablet once daily.
Slovenian: Bolniki, ki jemljejo telmisartan in amlodipin v dveh ločenih tabletah, lahko začnejo enkrat na dan jemati tablete zdravila Twynsta, ki vsebujejo enaka odmerka obeh učinkovin v eni tableti.
English: This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine in some patients and may increase the blood pressure lowering effect of Twynsta.
Slovenian: Grenivka in grenivkin sok lahko pri nekaterih bolnikih povečata količino učinkovine amlodipina v krvi in okrepita učinek zdravila Twynsta na znižanje krvnega tlaka.
English: In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7-51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
Slovenian: V podskupini 1050 bolnikov z zmerno do hudo hipertenzijo (DKT ≥ 100 mm Hg) je pri 32,7 do 51,8 % bolnikov krvni tlak dovolj znižala monoterapija s telmisartanom ali amlodipinom.
English: Reproductive system and breast disorders Uncommon erectile dysfunction gynaecomastia
Slovenian: Motnje reprodukcije in dojk Občasni erektilna disfunkcija ginekomastija
English: In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and ≤119 mmHg), treatment with each combination dose of Twynsta resulted in significantly greater diastolic and systolic blood pressure reductions and higher control rates compared to the respective monotherapy components.
Slovenian: V 8-tedenski, multicentrični, dvojno slepi, s placebom nadzorovani faktorski študiji pri paralelnih skupinah naključno izbranih bolnikov, ki je zajela 1461 bolnikov z blago do hudo hipertenzijo (srednji diastolični krvni tlak v sedečem položaju so imeli ≥ 95 in < 119 mm Hg), sta bila znižanje diastoličnega in sistoličnega krvnega tlaka ter odstotek uravnanega krvnega tlaka med zdravljenjem s kombiniranimi odmerki zdravila Twynsta značilno večja kot med zdravljenjem s posamičnima učinkovinama.
English: Rare vomiting, gingival hypertrophy, dyspepsia, dry mouth stomach discomfort
Slovenian: Redki bruhanje, hipertrofija dlesni, dispepsija, suha usta neprijeten občutek v želodcu
English: • in adult patients whose blood pressure is not controlled enough with amlodipine alone.
Slovenian: • pri odraslih bolnikih, katerim sam amlodipin ne zadošča za uravnavanje krvnega tlaka,
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Slovenian: Bolniki s sladkorno boleznijo, ki se zdravijo z insulinom ali antidiabetiki Pri bolnikih s sladkorno boleznijo, ki se zdravijo z insulinom ali peroralnimi antidiabetiki in telmisartanom, se lahko pojavi hipoglikemija.
English: Blood and lymphatic system disorders: Uncommon anaemia
Slovenian: Bolezni krvi in limfatičnega sistema Občasni anaemija
English: Twynsta tablets contain two active substances called telmisartan and amlodipine.
Slovenian: Zdravilo Twynsta vsebuje dve učinkovini, telmisartan in amlodipin.
English: Rare thrombocytopenia, eosinophilia
Slovenian: Redki trombocitopenija, eozinofilija
English: Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants.
Slovenian: Zdravila, ki zaradi svojih farmakoloških lastnosti lahko povečajo hipotenzivne učinke vseh antihipertenzivov, tudi tega zdravila, so na primer baklofen, amifostin, nevroleptiki ali antidepresivi.
English: In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Slovenian: Da bi preprečili toksični učinek takrolimusa, je treba pri bolniku, ki se z njim zdravi, med sočasno uporabo amlodipina spremljati raven takrolimusa v krvi in, če je potrebno, prilagoditi njegov odmerek.
English: These pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Slovenian: Te farmakološke neželene učinke, ki so jih odkrile predklinične študije tako pri zaviralcih angiotenzinske konvertaze kot antagonistih receptorjev angiotenzina II, so preprečili s peroralnim dajanjem fiziološke raztopine.
English: General disorders and administration site condition Common peripheral oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogostni periferni edem
English: Uncommon somnolence, migraine, headache, paraesthesia
Slovenian: Občasni somnolenca, migrena, glavobol, parestezija
English: If hypotension occurs with telmisartan/amlodipine, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Slovenian: Bolnika, pri katerem se med zdravljenjem s telmisartanom/amlodipinom pojavi hipotenzija, je treba namestiti v ležeč položaj in mu, če je potrebno, dati intravensko infuzijo fiziološke raztopine.
English: In an amlodipine long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1).
Slovenian: V dolgotrajni, s placebom nadzorovani študiji z amlodipinom pri bolnikih s hudim srčnim popuščanjem (III. in IV. stopnja po NYHA), so bila poročila o pljučnem edemu pogostejša pri bolnikih, ki so jemali amlodipin, kot v skupini s placebom (glejte poglavje 5.1).
English: Due to risk of hyperkalemia, it is recommended that the coadministration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Slovenian: Zaradi nevarnosti pojava hiperkaliemije se je pri bolnikih, ki so občutljivi za maligno hipertermijo, in pri zdravljenju maligne hipertermije priporočljivo izogibati sočasni uporabi zaviralcev kalcijevih kanalčkov, kot je amlodipin.
English: In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.
Slovenian: V drugi študiji na podganah, kjer so samcem 30 dni dajali amlodipinijev besilat v odmerkih, ki so primerljivi z odmerki pri ljudeh izražemini v mg/kg, so ugotovili upad folikle stimulirajočega hormona in testosterona v plazmi ter zmanjšanje gostote sperme in zmanjšanje števila zrelih spermatid in Sertolijevih celic.
English: Rare side effects (may affect up to 1 in 1,000 people): Confusion.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): zmedenost.
English: Immune system disorders: Rare hypersensitivity, anaphylactic reaction
Slovenian: Bolezni imunskega sistema Redki preobčutljivost, anafilaktična reakcija
English: Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers 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).
Slovenian: Druga antihipertenzivna zdravila, ki delujejo na sistem renin-angiotenzin-aldosteron (RAAS) Podatki kliničnih preskušanj so pokazali, da je dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).
English: Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed.
Slovenian: Študij o vplivu na sposobnost razmnoževanja pri živalih s telmisartanom/amlodipinom niso izvajali.
English: No data from controlled clinical studies with the fixed dose combination or with the individual components are available.
Slovenian: O uporabi fiksne kombinacije ali posameznih sestavin ni na voljo podatkov iz nadzorovanih kliničnih študij.
English: Investigations Uncommon hepatic enzymes increased blood creatinine increased weight increased, weight decreased
Slovenian: Preiskave Občasni povečana raven jetrnih encimov zvišana raven kreatinina v krvi povečana telesna masa, zmanjšana telesna masa
English: Talk to your doctor before taking Twynsta:
Slovenian: Pred začetkom jemanja zdravila Twynsta se posvetujte z zdravnikom:
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
Slovenian: Bolniki, ki jemljejo telmisartan in amlodipin v dveh ločenih tabletah, lahko začnejo jemati tablete zdravila Twynsta, ki vsebujejo enaka odmerka obeh učinkovin.
English: Twynsta contains sorbitol This medicine contains 337.28 mg sorbitol in each tablet.
Slovenian: Zdravilo Twynsta vsebuje sorbitol To zdravilo vsebuje 337,28 mg sorbitola v eni tableti.
English: Respiratory, thoracic and mediastinal disorders Uncommon cough dyspnoea dyspnoea, rhinitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni kašelj dispneja dispneja, rinitis
English: Metabolism and nutrition disorders Uncommon hyperkalaemia
Slovenian: Presnovne in prehranske motnje Občasni hiperkaliemija
English: Contains sorbitol (E420).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sorbitol (E420).
English: What Twynsta contains
Slovenian: Kaj vsebuje zdravilo Twynsta
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Slovenian: Diuretiki, ki zadržujejo kalij, ali kalijevi nadomestki Antagonisti receptorjev angiotenzina II, kot je telmisartan, zmanjšajo izgubo kalija, ki jo povzročajo diuretiki.
English: In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Twynsta (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg).
Slovenian: V drugi multicentrični, dvojno slepi raziskavi z aktivnim primerjalnim zdravilom in paralelnimi skupinami je 947 naključnih bolnikov z neustrezno uravnano blago do hudo hipertenzijo med zdravljenjem z 10-mg odmerkom amlodipina jemalo zdravilo Twynsta (40 mg/10 mg ali 80 mg/10 mg) ali amlodipin kot samostojno zdravilo (10 mg).
English: The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day.
Slovenian: Največji priporočeni odmerek je ena tableta po 80 mg telmisartana/10 mg amlodipina na dan.
English: How to take Twynsta
Slovenian: Kako jemati zdravilo Twynsta
English: Progressive scarring of lung tissue (interstitial lung disease [mainly pneumonia of the interstitium and pneumonia with excess eosinophils])
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): Napredujoče brazgotinjenje pljučnega tkiva (intersticijska pljučna bolezen [pretežno pljučnica intersticija in pljučnica s povečanim številom eozinofilcev]).
English: In animal studies, reproductive toxicity was observed at high doses (see section 5.3).
Slovenian: Študije na živalih so pri velikih odmerkih pokazale škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5 mg received Twynsta (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg).
Slovenian: V multicentrični, dvojno slepi študiji z aktivnim primerjalnim zdravilom in paralelnimi skupinami je 1097 naključno izbranih bolnikov z blago do hudo neustrezno uravnano hipertenzijo med zdravljenjem s 5 mg amlodipina jemalo zdravilo Twynsta (40 mg/5 mg ali 80 mg/5 mg) ali amlodipin kot samostojno zdravilo (5 mg ali 10 mg).
English: Musculoskeletal and connective tissue disorders Common ankle swelling
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti otekanje gležnjev
English: Common side effects (may affect up to 1 in 10 people): Altered bowel habits, diarrhoea, constipation, visual disturbances, double vision, ankle swelling.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): spremenjeno iztrebljanje, driska, težavno izločanje blata, motnje vida, dvojni vid, otekanje gležnjev.
English: Furthermore it was shown that some patients not adequately controlled with Twynsta 40 mg/10 mg had additional blood pressure reduction by up-titration to Twynsta 80 mg/10 mg.
Slovenian: Poleg tega se je pri nekaterih bolnikih, pri katerih zdravilo Twynsta v odmerkih po 40 mg/10 mg ni ustrezno uravnalo krvnega tlaka, izkazalo, da se je le ta dodatno znižal, ko so odmerek zdravila Twynsta povečali na 80 mg/10 mg.
English: In the factorial design trial the oedema rates were 1.3 % with Twynsta 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Twynsta 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg.
Slovenian: V preskušanju z več dejavniki je bila pogostnost edemov pri zdravilu Twynsta po 40 mg/5 mg in 80 mg/5 mg 1,3 %, pri zdravilu Twynsta po 40 mg/10 mg in 80 mg/10 mg 8,8 % in pri amlodipinu po 10 mg 18,4 %.
English: Very rare hyperglycaemia
Slovenian: Zelo redki hiperglikemija
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene.
Slovenian: Pri živalih so po dajanju verapamila in intravenske infuzije dantrolena opazili ventrikularno defibrilacijo in kardiovaskularni kolaps s smrtnim izidom v povezavi s hiperkaliemijo.
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium,
Slovenian: • zdravila, ki lahko zvišajojo raven kalija v krvi, na primer nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij (nekatere 'tablete za odvajanje vode');
English: Rare eczema, erythema, rash angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Slovenian: Redki ekcem, eritem, izpuščaj angioedem (lahko povzroči tudi smrt), medikamentni izpuščaj, toksični kožni izpuščaj, urtikarija
English: Colloidal anhydrous silica Brilliant blue FCF (E133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi koloidni brezvodni silicijev dioksid briljantno modro FCF (E133) črni železov oksid (E172) rumeni železov oksid (E172) magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon K25 predgelirani škrob (pripravljen iz koruznega škroba) natrijev hidroksid sorbitol (E420)
English: Grapefruit juice and grapefruit should not be consumed when you take Twynsta.
Slovenian: Ko jemljete zdravilo Twynsta, ne smete piti grenivkinega soka ali jesti grenivke.
English: Vascular disorders Uncommon hypotension, orthostatic hypotension, flushing
Slovenian: Žilne bolezni Občasni hipotenzija, ortostatska hipotenzija, vročinski oblivi
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 8 times* the maximum recommended human dose of 10 mg/day on an mg/m2 basis).
Slovenian: Peroralni odmerki amlodipinijevega maleata do 10 mg amlodipina na kilogram na dan (odmerek, ki je približno 8-krat* večji od največjega priporočenega odmerka za ljudi 10 mg na dan na osnovi mg/m niso vplivali na plodnost podgan (samci 64 dni in samice 14 dni pred parjenjem).
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure.
Slovenian: Rezultati študij kažejo na nakazano povezanost med odmerkom in časom, v katerem se povrnejo začetne vrednosti sistoličnega krvnega tlaka.
English: Twynsta showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of 21.8/ 16.5 mmHg (40 mg/5 mg), 22.1/ 18.2 mmHg (80 mg/5 mg), 24.7/ 20.2 mmHg (40 mg/10 mg) and 26.4/ 20.1 mmHg (80 mg/10 mg).
Slovenian: Zdravilo Twynsta je odvisno od velikosti odmerkov, ki so bili znotraj terapevtskega razpona odmerjanja, znižalo sistolični in diastolični krvni tlak, in sicer za -21,8/-16,5 mm Hg (40 mg/5 mg), -22,1/-18,2 mm Hg (80 mg/5 mg), -24,7/-20,2 mm Hg (40 mg/10 mg) in -26,4/-20,1 mm Hg (80 mg/10 mg).
English: Consideration should be given for monitoring cyclosporine levels in renal transplant patients on amlodipine, and cyclosporine dose reductions should be made as necessary.
Slovenian: Pri bolnikih s presajenimi ledvicami je treba presoditi, ali je med zdravljenjem z amlodipinom treba spremljati raven ciklosporina in odmerek slednjega po potrebi zmanjšati.
English: Uncommon abdominal pain, diarrhoea, nausea flatulence
Slovenian: Občasni abdominalna bolečina, driska,
English: Very rare interstitial lung disease Gastrointestinal disorder Common altered bowel habits (including diarrhoea and constipation)
Slovenian: Bolezni prebavil Pogosti spremenjeno iztrebljanje (vključno z diarejo in konstipacijo)
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects (see section
Slovenian: Hkratnega uživanja grenivke ali pitja grenivkinega soka z amlodipinom bolnikom ne priporočajo, ker se pri nekaterih lahko poveča amlodipinova biološka uporabnost, kar poveča njegove hipotenzivne učinke (glejte poglavje 4.5).
English: Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov ): omotica, otekanje gležnjev (edem).
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea, or vomiting.
Slovenian: ali imate pomanjkanje soli zaradi diuretičnega zdravljenja ('tablet za odvajanje vode'), dieto z majhno vsebnostjo soli, drisko ali bruhate;
English: • The active substances are telmisartan and amlodipine.
Slovenian: - Učinkovini sta telmisartan in amlodipin.
English: Uncommon arthralgia, muscle spasms (cramps in legs), myalgia
Slovenian: Občasni artralgija, mišični krči (krči v nogah), mialgija