natgillin/translations-raw huggingface dataset:
49 This medicine has been authorised under “ Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „ izjemnih okoliščinah “.
There are also links to other websites about rare diseases and treatments.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju. ------------------------------------------------------------------------------------------------------------------
Pritor 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 Pritor se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
Pritor is taken by mouth, with or without food.
Zdravilo Pritor se zaužije peroralno, s hrano ali brez nje.
The active substance in Pritor, 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 Pritor, 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 pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Posledica tega je znižanje krvnega tlaka in zmanjšanje tveganja za poškodbe, ki jih povzroča visok krvni tlak, kot je denimo kap.
Pritor has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Zdravilo Pritor so raziskali pri 1 647 bolnikih, ki so bili zdravljeni bodisi samo s telmisartanom ali pa s telmisartanom v kombinaciji s hidroklorotiazidom.
Pritor was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Zdravilo Pritor so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenolol, lizinopril, enalapril in amlodipin).
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.
Pri 1 do 10 bolnikih izmed 1 000 so bili opaženi 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 (slaba prebava in 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 Pritor, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pritor, glejte navodilo za uporabo.
Pritor should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Zdravila Pritor 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 Pritor’ 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 Pritor pri zdravljenju esencialne hipertenzije pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Pritor be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pritor odobri dovoljenje za promet.
Other information about Pritor:
Druge informacije o zdravilu Pritor:
The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Evropska komisija je dovoljenje za promet z zdravilom Pritor, veljavno po vsej Evropski uniji, odobrila dne 11. decembra 1998.
The marketing authorisation was renewed on 11 December 2003 and on 11 December 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 11. decembra 2003 in 11. decembra 2008.
The full EPAR for Pritor is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pritor je na voljo tukaj.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta
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 Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
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) 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) 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 280 tablets 14 tablets 28 tablets 56 tablets 98 tablets 280 tablets 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 28 x 1 tablets 90 tablets 90 tablets 90 tablets 30 tablets 30 tablets 30 tablets
14 tablet 28 tablet 56 tablet 98 tablet 280 tablet 14 tablet 28 tablet 56 tablet 98 tablet 280 tablet 14 tablet 28 tablet 56 tablet 98 tablet 28 x 1 tableta 28 x 1 tableta 90 tablet 90 tablet 90 tablet 30 tablet 30 tablet 30 tablet
White round tablets engraved with the code number '50H 'on one side and the company logo on the other side.
Bela, okrogla tableta z vtisnjeno kodno številko 50H na eni in logom podjetja na drugi strani.
Paediatric patients Pritor is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Pritorja pri otrocih pod 18 let ni priporočljiva.
Pritor 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.
Pritorja ne dajemo bolnikom, ki imajo holestazo, obolenja z zaporo žolčevoda ali hudo jetrno okvaro (glejte poglavje 4. 3), ker se telmisartan pretežno izloča z žolčem.
Pritor should be used only with caution in patients with mild to moderate hepatic impairment.
Pritor moramo previdno dajati bolnikom z zmerno hudo do hudo jetrno okvaro.
When Pritor 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 Pritorjom, moramo periodično nadzorovati serumski ravni kalija in kreatinina.
There is no experience regarding the administration of Pritor in patients with recent kidney transplantation.
Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo Pritorja.
Symptomatic hypotension, especially after the first dose of Pritor, 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 Pritoja lahko pojavi simptomatična hipotenzija.
Such conditions should be corrected before the administration of Pritor.
Tovrstna stanja moramo uravnati pred zdravljenjem s Pritorjom.
Volume and/ or sodium depletion should be corrected prior to administration of Pritor.
Pomanjkanje volumna ali natrija ali obe stanji moramo uravnati pred začetkom zdravljenja s Pritorjom.
Patients with rare hereditary problems of fructose intolerance should not take Pritor.
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati Pritorja.
A
Zlasti veliko je pri kombinaciji z diuretiki, ki zadržujejo kalij, in če jih kombiniramo z nadomestki soli s kalijem. Na primer kombinacija z zaviralci ACE ali nesteroidnimi protivnetnimi zdravili je manj tvegana, če natančno upoštevamo previdnostne ukrepe za uporabo.
Potassium sparing diuretics e. g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Če je
If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
4 sočasna uporaba indicirana zaradi potrjene hipokaliemije, jih je treba uporabljati previdno in pogosto spremljati raven kalija v serumu.
There are no adequate data from the use of Pritor in pregnant women.
Ni zadostnih podatkov o uporabi Pritorja pri nosečnicah.
The adverse drug reactions listed below have been accumulated from all clinical trials including 5788 hypertensive patients treated with telmisartan.
Našteti so neželeni učinki iz vseh kliničnih preskušanjanj, v katerih je skupno sodelovalo 5788 bolnikov s hipertenzijo, ki so se zdravili s telmisartanom.
Upper respiratory tract infection including pharyngitis and sinusitis
okužba zgornjih dihal, tudi faringitis in sinuzitis
Urinary tract infection including cystitis
okužba sečil, tudi cistitis
Eye disorders
6 Očesne bolezni
Abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence Stomach upset, vomiting
želodčne motnje, bruhanje
Hyperhidrosis, pruritus Erythema, angioedema, urticaria Drug eruption, toxic skin eruption, rash, eczema
hiperhidroza, pruritus eritem, angioedem, urtikarija medikamenti izpuščaj, toksični kožni izpuščaj, izpuščaj, ekcem
Myalgia Arthralgia, back pain (e. g. sciatica), muscle cramps, pain in limb, weakness
mialgija artralgija, bolečina v hrbtu (npr. išias), mišični krči, bolečina v okončini, oslabelost
Drug ineffective
Bolečina v prsih gripi podobna bolezen neučinkovitost zdravila
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
8 Po nenadni ukinitvi zdravljenja s telmisartanom se krvni tlak v nekaj dneh postopno poveča na vrednosti pred zdravljenjem, ne da bi prišlo do povratne hipertenzije.
Linearity/ non-linearity:
Linearnost / nelinearnost:
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed.
9 Pri bolnikih z blago do zmerno in hudo ledvično okvaro so opazili podvojitev plazemske koncentracije.
Aluminium/ aluminium blisters (PA/ PA/ Al/ PVC/ Al).
Pretisni omoti iz aluminija/ aluminija (PA/ PA/ Al/ PVC/ Al).
Blister with 14, 28, 30, 56, 90 or 98 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 30, 56, 90 ali 98 tablet.
EU/ 1/ 98/ 089/ 011 (14 tablets) EU/ 1/ 98/ 089/ 012 (28 tablets) EU/ 1/ 98/ 089/ 020 (30 tablets) EU/ 1/ 98/ 089/ 013 (56 tablets) EU/ 1/ 98/ 089/ 019 (90 tablets) EU/ 1/ 98/ 089/ 014 (98 tablets)
EU/ 1/ 98/ 089/ 011 (14 tablet) EU/ 1/ 98/ 089/ 012 (28 tablet) EU/ 1/ 98/ 089/ 020 (30 tablet) EU/ 1/ 98/ 089/ 013 (56 tablet) EU/ 1/ 98/ 089/ 019 (90 tablet) EU/ 1/ 98/ 089/ 014 (98 tablet)
11 December 1998 Date of last renewal:
11. december 1998 Datum zadnjega podaljšanja:
White oblong tablets engraved with the code number '51H '' on one side.
Bele, podolgovate tablete z vtisnjeno kodno številko 51 H na eni strani.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1) • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1) • drugo in tretje trimesečje nosečnosti (glejte poglavji4. 4 in 4. 6) • dojenje (glejte poglavje 4. 6)
12 • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
12 • obolenja z zaporo žolčevoda • huda jetrna okvara
Pritor 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.
Pritorja ne dajemo bolnikom, ki imajo holestazo, obolenja z zaporo žolčevoda ali hudo jetrno okvaro delovanje (glejte poglavje 4. 3), ker se telmisartan pretežno izloča z žolčem.
Symptomatic hypotension, especially after the first dose of Pritor, 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 Pritorja lahko pojavi simptomatična hipotenzija.
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).
13 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Zožitev aorte in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija:
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
13 Hiperkaliemija Zdravila, ki učinkujejo na renin- angiotenzin- aldosteronski sistem, lahko povzročijo hiperkaliemijo.
14 Concomitant use not recommended
Sočasne uporabe ne priporočamo
If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
14 sočasna uporaba indicirana zaradi potrjene hipokaliemije, jih je treba uporabljati previdno in pogosto spremljati raven kalija v serumu.
15 Pregnancy (see section 4.3 and 4.4):
Uporaba med nosečnostjo (glejte poglavje 4. 3 in 4. 4):
Eye disorders
16 Očesne bolezni
Chest pain Influenza-like illness Drug ineffective
Neznana:
17
17 Simptomi:
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Najizrazitejša pričakovana znaka prevelikega odmerjanja telmisartana sta hipotenzija in tahikardija; poročali so tudi o bradikardiji, omotici, zvišani ravni kreatinina v serumu in akutni ledvični odpovedi.
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
18 Po nenadni ukinitvi zdravljenja s telmisartanom se krvni tlak v nekaj dneh postopno poveča na vrednosti pred zdravljenjem, ne da bi prišlo do povratne hipertenzije.
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed.
19 Pri bolnikih z blago do zmerno in hudo ledvično okvaro so opazili podvojitev plazemske koncentracije.
6.5 Nature and contents of container
20 6. 5 Vrsta ovojnine in vsebina
Blister with 14, 28, 30, 56, 90, 98 or 280 tablets or perforated unit dose blisters with 28 x 1 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 30, 56, 90, 98 ali 280 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableta.
EU/ 1/ 98/ 089/ 001 (14 tablets) EU/ 1/ 98/ 089/ 002 (28 tablets) EU/ 1/ 98/ 089/ 021 (30 tablets) EU/ 1/ 98/ 089/ 003 (56 tablets) EU/ 1/ 98/ 089/ 017 (90 tablets) EU/ 1/ 98/ 089/ 004 (98 tablets) EU/ 1/ 98/ 089/ 005 (280 tablets) EU/ 1/ 98/ 089/ 015 (28 x 1 tablets)
EU/ 1/ 98/ 089/ 001 (14 tablet) EU/ 1/ 98/ 089/ 002 (28 tablet) EU/ 1/ 98/ 089/ 021 (30 tablet) EU/ 1/ 98/ 089/ 003 (56 tablet) EU/ 1/ 98/ 089/ 017 (90 tablet) EU/ 1/ 98/ 089/ 004 (98 tablet) EU/ 1/ 98/ 089/ 005 (280 tablet) EU/ 1/ 98/ 089/ 015 (28 x 1 tableta)
White oblong tablets engraved with the code number '52H 'on one side.
Bele, podolgovate tablete z vtisnjeno kodno številko 52 H na eni strani.
Pritor 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 Pritorja pri otrocih pod 18 let ni priporočljiva.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1) • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1) • drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6) • dojenje (glejte poglavje 4. 6)
22 • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
22 • obolenja z zaporo žolčevoda • huda jetrna okvara
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Zdravila ali terapevtske skupine zdravil, ki lahko povzročijo hiperkaliemijo so nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij, zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2), heparin; imunosupresivi (ciklosporin ali takrolimus) in trimetoprim;
24 Concomitant use not recommended
Sočasne uporabe ne priporočamo
If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
24 sočasna uporaba indicirana zaradi potrjene hipokaliemije, jih je treba uporabljati previdno in pogosto spremljati raven kalija v serumu.
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Ob uvedbi telmisartana sta možni posledici predhodnega zdravljenja z visokimii odmerki diuretikov, kot sta furosemid (diuretik zanke) in hidroklorotiazid (tiazidni diuretik), izguba zunajcelične tekočine in nevarnost hipotenzije.
25 Pregnancy (see section 4.3 and 4.4):
Uporaba med nosečnostjo (glejte poglavje 4. 3 in 4. 4):
Eye disorders
26 Očesne bolezni
Chest pain Influenza-like illness Drug ineffective
Bolečina v prsih gripi podobna bolezen neučinkovitost zdravila
27 Investigations
Preiskave
Symptoms:
27 Simptomi:
28 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Telmisartan pri hipertenzivnih bolnikih znižuje sistolični in diastolični krvni tlak, ne da bi vplival na srčni utrip.
29 Elderly patients:
Starejši bolniki:
EU/ 1/ 98/ 089/ 006 (14 tablets) EU/ 1/ 98/ 089/ 007 (28 tablets) EU/ 1/ 98/ 089/ 022 (30 tablets) EU/ 1/ 98/ 089/ 008 (56 tablets) EU/ 1/ 98/ 089/ 018 (90 tablets) EU/ 1/ 98/ 089/ 009 (98 tablets) EU/ 1/ 98/ 089/ 010 (280 tablets) EU/ 1/ 98/ 089/ 016 (28 x 1 tablets)
EU/ 1/ 98/ 089/ 006 (14 tablet) EU/ 1/ 98/ 089/ 007 (28 tablet) EU/ 1/ 98/ 089/ 022 (30 tablet) EU/ 1/ 98/ 089/ 008 (56 tablet) EU/ 1/ 98/ 089/ 018 (90 tablet) EU/ 1/ 98/ 089/ 009 (98 tablet) EU/ 1/ 98/ 089/ 010 (280 tablet) EU/ 1/ 98/ 089/ 016 (28 x 1 tableta)
32 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ United Kingdom
SmithKline Beecham Pharmaceuticals Manor Royal Crawley West Sussex RH10 2QJ Velika Britanija
This medicinal product does not require any special storage conditions.
36 Za shranjevanje zdravila ni posebnih navodil.
Any non 7 count blister
Pretisni omot za enkratni odmerek ali vsi tisti pretisni omoti, ki ne vsebujejo po 7 tablet
Unit dose blister (28 x 1 tablets pack) or any non 7 count blister
Perforiran pretisni omot za enkratni odmerek (28 x 1 tableta) ali katerikoli tisti pretisni omoti, ki ne vsebujejo po 7 tablet
INFORMATION FOR THE USER Pritor 20 mg tablets Telmisartan
48 NAVODILO ZA UPORABO Pritor 20 mg tablete Telmisartan
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Pred uporabo natančno preberite navodilo.
What Pritor is and what it is used for 2.
Kaj je zdravilo Pritor in za kaj ga uporabljamo 2.
How to take Pritor 4.
Kaj morate vedeti, preden boste vzeli zdravilo Pritor 3 Kako jemati zdravilo Pritor 4.
How to store Pritor 6.
Shranjevanje zdravila Pritor 6.
WHAT PRITOR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PRITOR IN ZA KAJ GA UPORABLJAMO
Pritor belongs to a class of medicines known as angiotensin II receptor antagonists.
Pritor sodi v skupino zdravil, ki jih imenujemo antagonisti angiotenzina II.
Pritor blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Pritor zavira učinek angiotenzina II in tako sprosti krvne žile, zato se vam krvni tlak zniža.
Pritor is used to treat essential hypertension (high blood pressure). ‘ Essential’ means that the high blood pressure is not caused by any other condition.
'Esencialna' pomeni, da visokega krvnega tlaka ne povzroča drugo bolezensko stanje.
BEFORE YOU TAKE PRITOR
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PRITOR
Do not take Pritor
Ne jemljite zdravila Pritor: