natgillin/translations-raw huggingface dataset:
If you take more Kinzalkomb than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
71 Če pomotoma vzamete preveč tablet, morate nemudoma poklicati svojega zdravnika, farmacevta, ali oddelek za nujno pomoč v najbližji bolnišnici.
Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hidroklorotiazid 72 Pri bolnikih, ki so jemali samo hidroklorotiazid, so poročali še o naslednjih neželenih učinkih:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions; (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, and fat in the blood.
Neželeni učinki neznane pogostosti: vnetje žleze slinavke; zmanjšanje števila krvnih celic, tudi majhno število rdečih in belih krvničk; nizko število trombocitov (trombocitopenija); resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija); vnetje žil (nekrotizirajoči vasculitis); zmanjšan tek ali izguba teka; nemir; oslabelost; vrtoglavica; zamegljen vid ali rumenkasta obarvanost; vnetje trebušne slinavke; želodčne težave; porumenelost kože ali oči (zlatenica); kožne motnje, kot vnetje žil v koži; povečana občutljivost za sončno svetlobo ali nastajanje mehurjev in luščenje kožne povrhnjice (toksična epidermalna nekroliza); vnetje ledvic ali okvara ledvičnega delovanja; zvišana telesna temperatura; moteno elektrolitsko ravnovesje; visoka raven holesterola; zmanjšan krvni volumen; sladkor v urinu (glikozurija); povečana raven glukoze, sečne kisline ali maščob v krvi.
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Ena tableta vsebuje 80 mg telmisartana in 12, 5 mg hidroklorotiazida.
Kinzalkomb 80 mg/ 12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number'H8 '.
Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete Kinzalkomb po 80 mg/ 12, 5 mg so rdeče in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H8'.
Not all pack sizes may be available in your country.
Imetnik dovoljenja za promet z zdravilom in izdelovalec
71 Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen
This leaflet was last approved in
Sverige Bayer AB, Pharma Box 5237 Drakegatan 1 S- 402 24 Göteborg Tel: +46 - (0) 31- 839800
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
United Kingdom Bayer plc, Pharmaceutical Division Bayer House Strawberry Hill, Newbury Berkshire RG14 1JA - UK Tel: +44 - (0) 1635- 563000
73 PACKAGE LEAFLET:
Navodilo je bilo odobreno {datum}
INFORMATION FOR THE USER
76 NAVODILO ZA UPORABO
Do not take Kinzalkomb • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see “ Further Information” for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder), or any other severe liver disease. • if you have severe kidney disease.
Ne jemljite zdravila Kinzalkomb • če ste alergični na (preobčutljivi za) telmisartan ali katerkoi sestavino zdravila Kinzalkomb (za seznam drugih sestavin glejte Dodatne informacije), • če ste alergični na (preobčutljivi za) hidroklorotiazid ali katerokoli drugo sulfonamidno zdravilo, • zadnjih šest mesecev nosečnosti (glejte poglavje Nosečnost in dojenje), • če dojite,
74 • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
77 • če imate hude jetrne težave kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz žolčnika) ali katerokoli drugo hudo jetrno bolezen, • če imate hudo jetrno bolezen, • če imate hudo ledvično bolezen, • če vaš zdravnik odkrije, da imate nizko raven kalija ali visoko raven kalcija v krvi in da tega stanja zdravljenje ne izboljša.
tablets'), laxatives (e. g. castor oil), corticosteroids (e. g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
(tablete za odvajanje vode), odvajala (npr. ricinusovo olje), kortikosteroidi (npr. prednizon), ACTH
75
78 (hormon), amfotericin (antimikotik), karbenoksolon (za zdravljenje razjed v ustih), natrijev penicilin G (antibiotik) in salicilna kislina in njeni derivati,
If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
79 Če imate motnje jetrnega delovanja, običajni odmerek ne sme prekoračiti 40 mg/ 12, 5 mg 1- krat na dan.
76 If you take more Kinzalkomb than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Če ste vzeli večji odmerek zdravila Kinzalkomb, kot bi smeli Če pomotoma vzamete preveč tablet, morate nemudoma poklicati svojega zdravnika, farmacevta, ali oddelek za nujno pomoč v najbližji bolnišnici.
Upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e. g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure; weakness; decreased haemoglobin (a blood protein), ineffectiveness of telmisartan.
Neželeni učinki neznane pogostnosti: okužba zgornjih dihal (npr. angina, vnetje sinusov, navadni prehlad), okužbe sečil; povečanje števila nekaterih belih krvničk (eozinofilija), pomanjkanje rdečih krvničk (anemija), majhno število trombocitov (trombocitopenija); resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija, medikamentni izpuščaj); visoka raven kalija; počasen srčni utrip
77 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
80 (bradikardija); želodčne težave; ekcem (kožna bolezen); vnetje kit; ledvična okvara, tudi akutna ledvična odpoved; oslabelost; znižana raven hemoglobina (krvne beljakovine), neučinkovitost telmisartana.
Side effects of unknown frequency may include:
Hidroklorotiazid Pri bolnikih, ki so jemali samo hidroklorotiazid, so poročali še o naslednjih neželenih učinkih:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising); decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, and fat in the blood.
Neželeni učinki neznane pogostosti: vnetje žleze slinavke; zmanjšanje števila krvnih celic, tudi majhno število rdečih in belih krvničk; nizko število trombocitov (trombocitopenija); resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija); vnetje žil (nekrotizirajoči vasculitis);; zmanjšan tek ali izguba teka; nemir; oslabelost; vrtoglavica; zamegljen vid ali rumenkasta obarvanost; vnetje trebušne slinavke; želodčne težave; porumenelost kože ali oči (zlatenica); kožne motnje, kot vnetje žil v koži; povečana občutljivost za sončno svetlobo ali nastajanje mehurjev in luščenje kožne povrhnjice (toksična epidermalna nekroliza); vnetje ledvic ali okvara ledvičnega delovanja; zvišana telesna temperatura; moteno elektrolitsko ravnovesje; visoka raven holesterola; zmanjšan krvni volumen; sladkor v urinu (glikozurija); povečana raven glukoze, sečne kisline ali maščob v krvi.
You do not need to take any action need be taken if this happens.
Če se to zgodi, ni treba storiti ničesar.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
Pomožne snovi so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon (K25), rumen železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta A) in sorbitol (E420).
Kinzalkomb 80 mg/ 25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code'H9 '.
Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete Kinzalkomb po 80 mg/ 25 mg so rumene in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H9'.
Kinzalkomb is available in blister packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
Kinzalkomb je na voljo v pretisnih omotih po 14, 28, 30, 56, 98 tablet ali pretisnih omotih za enkratni odmerek po 28 x 1 tableta.
78 Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
81 Bayer HealthCare AG D- 51368 Leverkusen Nemčija
Tel: +43-(0)1-711 46-0 Polska Bayer Sp. z o. o.
Aleje Jerozolimskie 158 PL- 02- 326 Warszawa
It is available as white tablets (round:
Na voljo je v obliki belih tablet (okroglih:
20 mg; oblong:
20 mg; podolgovatih:
40 and 80 mg).
40 in 80 mg).
Kinzalmono is used in adults who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Zdravilo Kinzalmono se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
Kinzalmono is taken by mouth, with or without food.
Zdravilo Kinzalmono se zaužije peroralno, s hrano ali brez nje.
The usual recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Priporočeni odmerek znaša 40 mg enkrat dnevno, toda za nekatere bolnike zadostuje že 20- miligramski odmerek.
If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Če ne dosežemo želene vrednosti krvnega tlaka, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je denimo hidroklorotiazid.
The active substance in Kinzalmono, telmisartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Kinzalmono, telmisartan, je „ antagonist receptorjev angiotenzina II “, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Telmisartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar privede do razširitve krvnih žil.
Kinzalmono has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Zdravilo Kinzalmono so raziskali pri 1 647 bolnikih, ki so bili zdravljeni bodisi samo s telmisartanom ali pa s telmisartanom v kombinaciji s hidroklorotiazidom.
Kinzalmono was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Zdravilo Kinzalmono so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenolol, lizinopril, enalapril in amlodipin).
Kinzalmono was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Zdravilo Kinzalmono je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje povišanega krvnega tlaka.
However, the following side effects are seen in between 1 and 10 patients in 1,000: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain.
Vendar so bili pri 1 do 10 bolnikih izmed 1 000 opaženi naslednji naslednji neželeni učinki: hiperkaliemija (visoke ravni kalija v krvi), sinkopa (kratkotrajna izguba zavesti), nespečnost, vrtoglavica, hipotenzija (nizek krvni tlak), dispneja (oteženo dihanje), bolečine v trebuhu, driska, suha usta, disepsija (zgaga), napenjanje, hiperhidroza (prekomerno potenje), pruritus (srbenje), miaglija (bolečine v mišicah), okvara ledvic, vključno z njihovo odpovedjo, in bolečine v prsih..
For the full list of all side effects reported with Kinzalmono, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kinzalmono, glejte navodilo za uporabo.
Kinzalmono should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Zdravila Kinzalmono ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalmono’ s benefits are greater than its risks for the treatment of essential hypertension in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Kinzalmono pri zdravljenju esencialne hipertenzije pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Kinzalmono be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Kinzalmono odobri dovoljenje za promet.
Other information about Kinzalmono:
Druge informacije o zdravilu Kinzalmono:
The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalmono on 16 December 1998.
Evropska komisija je dovoljenje za promet z zdravilom Kinzalmono, veljavno po vsej Evropski uniji, odobrila dne 16. decembra 1998.
The marketing authorisation was renewed on 16 December 2003 and on 16 December 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 16. decembra 2003 in 16. decembra 2008.
The marketing authorisation holder is Bayer Healthcare AG.
Imetnik dovoljenja za promet je družba Bayer Healthcare AG.
The full EPAR for Kinzalmono is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kinzalmono je na voljo tukaj.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
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Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
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blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC) pretisni omot (PA/ alu/ PVC)
14 tablets 28 tablets 56 tablets 98 tablets 14 tablets 28 tablets 56 tablets 98 tablets 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 28 x 1 tablets
14 tablet 28 tablet 56 tablet 98 tablet 14 tablet 28 tablet 56 tablet 98 tablet 14 tablet 28 tablet 56 tablet 98 tablet 28 x 1 tableta 28 x 1 tableta
Each tablet contains 84 mg sorbitol (E420).
Pomožne snovi: ena tableta vsebuje 84 mg sorbitola (E420).
White round tablets engraved with the code number '50H 'on one side and the company logo on the other side.
Bele, okrogle tablete z vtisnjeno kodno številko 50H na eni in logom podjetja na drugi strani.
When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Ko presojamo o povečanju odmerka, moramo upoštevati, da doseže zdravilo največji antihipertenzivni učinek večinoma štiri do osem tednov po začetku zdravljenja (glejte poglavje 5. 1).
Telmisartan may be taken with or without food.
Telmisartan se lahko jemlje s hrano ali brez.
A lower starting dose of 20 mg is recommended in these patients (see section 4.4).
Pri teh bolnikih priporočamo nižji začetni odmerek 20 mg (glejte poglavje 4. 4).
In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
Odmerek za bolnike z blago do zmerno jetrno okvaro ne sme prekoračiti 40 mg 1- krat na dan (glejte poglavje 4. 4).
Elderly No dose adjustment is necessary for elderly patients.
Starejši bolniki Starejšim bolnikom odmerka ni treba prilagajati.
Paediatric patients Kinzalmono is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pediatrični bolniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Kinzalmona pri otrocih pod 18 let ni priporočljiva.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1)
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1) • drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6)
2 • Second and third trimester of pregnancy (see sections 4.4 and 4.6) • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
2 • dojenje (glejte poglavje 4. 6) • obolenja z zaporo žolčevoda • huda jetrna okvara
Kinzalmono is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Kinzalmonoa se ne daje bolnikom, ki imajo holestazo, obolenja z zaporo žolčevoda ali hudo jetrno okvaro (glejte poglavje 4. 3), ker se telmisartan pretežno izloča z žolčem.
Kinzalmono should be used only with caution in patients with mild to moderate hepatic impairment.
Kinzalmono moramo previdno dajati bolnikom z zmerno hudo do hudo jetrno okvaro.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Pri bolnikih z obojestransko zožitvijo ledvične arterije ali zožitvijo arterije samo ene delujoče ledvice zdravljenje z zdravili, ki delujejo na renin- angiotenzin- aldosteronski sistem, poveča nevarnost hude hipotenzije in zmanjšanja ledvičnega delovanja.
When Kinzalmono is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Kadar bolnike z ledvično okvaro zdravimo s Kinzalmonoom, moramo periodično nadzorovati serumski ravni kalija in kreatinina.
Symptomatic hypotension, especially after the first dose of Kinzalmono, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pri bolnikih z zmanjšanim volumnom krvi in/ ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku Kinzalmonoa lahko pojavi simptomatična hipotenzija.
Such conditions should be corrected before the administration of Kinzalmono.
Tovrstna stanja moramo uravnati pred zdravljenjem s Kinzalmonoom.
Volume and/ or sodium depletion should be corrected prior to administration of Kinzalmono.
Pomanjkanje volumna ali natrija ali obe stanji moramo uravnati pred začetkom zdravljenja s Kinzalmonoom.
Dual blockade of the renin-angiotensin-aldosterone system:
Dvojno zaviranje renin- angiotenzin- aldosteronskega sistema:
As a consequence of inhibiting the renin- angiotensin-aldosterone system, hypotension and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
Pri občutljivih posameznikih so poročali o hipotenziji in spremembah ledvičnega delovanja (tudi akutni ledvični odpovedi) kot posledicah zaviranja renin- angiotenzin- aldosteronskega sistema, zlasti pri uporabi kombinacije zdravil, ki delujejo na ta sistem.
Dual blockade of the renin-angiotensin-aldosterone system (e. g. by adding an ACE- inhibitor to an angiotensin II receptor antagonist) is therefore not recommended in patients with already controlled blood pressure and should be limited to individually defined cases with close monitoring of renal function.
Dvojnega zaviranja renin- angiotenzin - aldosteronskega sistema (npr. z dodajanjem zaviralca ACE antagonistu receptorjev angiotenzina II) zato ne priporočamo pri bolnikih z že uravnanim krvnim tlakom, njegovo uporabo pa je treba omejiti na individualno opredeljene bolnike, pri katerih natančno spremljamo ledvično delovanje.
In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Pri bolnikih, pri katerih sta žilni tonus in ledvična funkcija pretežno odvisna od delovanja renin - angiotenzin- aldosteronskega sistema (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem ali ledvično boleznijo, tudi zožitvijo ledvične arterije), povezujejo zdravljenje z drugimi zdravili, katera delujejo na ta sistem, kot telmisartan, z akutno hipotenzijo, s hiperazotemijo, oligurijo in, redko, z akutno ledvično okvaro (glejte poglavje 4. 8).