natgillin/translations-raw huggingface dataset:
• PritorPlus 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 40 mg • PritorPlus 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 80 mg
• PritorPlus po 40 mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s Pritorjem po 40 mg • PritorPlus po 80 mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s Pritorjem po 80 mg
In patients with mild to moderate hepatic impairment the posology should not exceed PritorPlus 40 mg/ 12.5 mg once daily.
Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka PritorPlusa po 40 mg/ 12, 5 mg 1- krat na dan.
PritorPlus is not indicated in patients with severe hepatic impairment.
PritorPlus ni indiciran za bolnike s hudim jetrnim odpovedovanjem.
PritorPlus 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 PritorPlusa pri otrocih pod 18 let ni priporočljiva.
PritorPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
PritorPlusa ne smemo dajati bolnikom s holestazo, z obolenji z zaporo žolčevoda ali močno zmanjšanim jetrnim delovanjem (glejte poglavje 4. 3), ker se telmisartan v glavnem izloča z žolčem.
In addition, PritorPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
PritorPlus moramo previdno dajati tudi bolnikom z motnjami jetrnega delovanja ali napredujočo jetrno boleznijo, ker lahko že manjše spremembe ravnovesja tekočin in elektrolitov povzročijo jetrno komo.
There is no clinical experience with PritorPlus in patients with hepatic impairment.
S PritorPlusom pri bolnikih z zmanjšanim jetrnim delovanjem ni izkušenj.
PritorPlus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
PritorPlusa ne dajemo bolnikom z močno zmanjšanim ledvičnim delovanjem (kreatininskim očistkom < 30 ml/ min) (glejte poglavje 4. 3).
There is no experience regarding the administration of PritorPlus in patients with recent kidney transplantation.
Z uporabo PritorPlusa pri bolnikih z nedavno presajeno ledvico ni izkušenj.
Experience with PritorPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
S PritorPlusom je malo izkušenj pri bolnikih z blago do zmerno zmanjšanim ledvičnim delovanjem, zato so priporočljivi periodični kontrolni pregledi serumskih ravni kalija, kreatinina in sečne kisline.
Such conditions should be corrected before the administration of PritorPlus.
Tovrstna stanja je treba uravnati pred zdravljenjem s PritorPlusom.
Therefore, the use of PritorPlus is not recommended.
Na splošno se bolniki s primarnim aldosteronizmom ne odzivajo na antihipertenzive, ki delujejo z zaviranjem renin- angiotenzinskega sistema, zato zanje zdravljenja s PritorPlusom ne priporočamo.
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Enako kot za uporabo drugih vazodilatatorjev velja posebna previdnost pri dajanju PritorPlusa bolnikom z zožitvijo aorte ali mitralne zaklopke ali obstruktivno hipertrofično kardiomiopatijo.
3 Metabolic and endocrine effects:
3 Učinki na presnovo in endokrini sistem:
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in PritorPlus, minimal or no effects were reported.
Z zdravljenjem s tiazidnimi diuretiki povezujejo povečanje ravni holesterola in trigliceridov, vendar za odmerek po 12, 5 mg, ki ga vsebuje PritorPlus, poročajo le o minimalnih ali nikakršnih tovrstnih učinkih.
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of PritorPlus, hyperkalaemia might occur.
− Hiperkaliemija Zaradi antagonističnega delovanja telmisartanove sestavine v PritorPlusu na receptorje za angiotenzin II (AT1) je možna tudi hiperkaliemija.
Although clinically significant hyperkalaemia has not been documented with PritorPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
Dejavniki tveganja za njen razvoj so zmanjšano ledvično delovanje ali srčno popuščanje ali obe obolenji in diabetes mellitus.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with PritorPlus (see section 4.5).
Če se bolniki zdravijo s PritorPlusom, moramo biti previdni pri sočasnem dajanju diuretikov, ki varčujejo s kalijem, kalijevih pripravkov ali nadomestkov soli, ki vsebujejo kalij (glejte poglavje 4. 5).
There is no evidence that PritorPlus would reduce or prevent diuretic-induced hyponatraemia.
− Hiponatriemija in hipokloremična alkaloza Ni podatkov, ki bi kazali, da PritorPlus zmanjša ali prepreči hiponatriemijo, ki jo povzročajo diuretiki.
4 Other:
4 Splošno:
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Preobčutljivostne reakcije na hidroklorotiazid se lahko pojavijo pri bolnikih z anamnezo alergije ali bronhialne astme in pri bolnikih brez te anamneze.
Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
O redkih tovrstnih primerih poročajo tudi za antagoniste angiotenzina II vključno z PritorPlusom.
Co-administration of lithium and PritorPlus is not recommended (see section 4.4).
Sočasno dajanje litija in PritorPlusa ne priporočamo (glejte poglavje 4. 4).
- class Ia antiarrythmics (e. g. quinidine, hydroquinidine, disopyramide)
Priporočamo periodično spremljanje ravni kalija v serumu in EKG, kadar dajemo PritorPlus hkrati z zdravili, na delovanje katerih vplivajo motnje serumskega kalija (npr. z glikozidi digitalisa ali antiaritmiki).
- others (e. g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
(npr. bepridil, cisaprid, difemanil, eritromicin iv., halofantrin, mizolastin, pentamidin, sparfloksacin, terfenadin, vinkamin iv.).
Antidiabetic medicinal products (oral agents and insulin):
Antidiabetiki (peroralni antidiabetiki in insulin): včasih je treba prilagoditi odmerek antidiabetika (glejte poglavje 4. 4).
Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Moramo ga dajati previdno zaradi nevarnosti laktatne acidoze, ki jo povzroči funkcionalna motnja ledvičnega delovanja, povezana s hidroklorotiazidom.
Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
5 Holestiramin in holestipolove smole: v prisotnosti anionskih izmenjalnih smol je motena absorpcija hidroklorotiazida.
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Nesteroidna protivnetna zdravila:
There are no adequate data from the use of PritorPlus in pregnant women.
Ni zadostnih podatkov o uporabi PritorPlusa pri nosečnicah.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
6 varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Angiotensin II receptor antagonist therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Ob potrjeni nosečnosti je treba zdavljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija).
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see also sections 4.3 and 4.4).
(glejte tudi poglavje 5. 3).
PritorPlus is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk.
PritorPlus je kontraindiciran za zdravljenje doječe matere, ker ni znano, ali se izloča z mlekom.
Fixed Dose Combination The overall incidence of adverse events reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with PritorPlus.
Čeprav jih v kliničnih preskušanjih niso zasledili, se med zdravljenjem s PritorPlusom lahko pojavijo neželeni učinki, za katere je znano, da spremljajo zdravljenje s posameznima sestavinama zdravila.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po pogostnosti, za katero veljajo naslednji kriteriji: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana pogostnost( ni mogoče oceniti iz razpoložljivih podatkov).
and nutrition disorders
hipokaliemija hiperurikemija, hiponatriemija
Hypokalaemia,
Bolezni živčevja
8 Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
Dodatni podatki o posameznih sestavinah zdravila Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri PritorPlusu, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
Undesirable effects occurred with similar frequency in placebo and telmisartan treated patients.
8 Pojavnost neželenih učinkov je bila enako pogosta kot pri placebu.
haemolytic anaemia, bone marrow failure, 9
9
leukopenia, neutropenia, agranulocytosis, thrombocytopenia
aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija,
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Najizrazitejša učinka po prevelikem odmerku telmisartana sta hipotenzija in tahikardija; poročila navajajo še bradikardijo, vrtoglavico, bruhanje, povečanje ravni kreatinina v serumu in
10 muscle spasms and/ or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Prevelik odmerek hidroklorotiazida povzroči izgubo elektrolitov (hipokaliemija, hipokloremija) in hipovolemijo zaradi prevelike diureze.
PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
PritorPlus je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
PritorPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
PritorPlus v enem odmerku na dan učinkovito in enakomerno znižuje krvni tlak v celotnem razponu odmerjanja.
Therefore, it is not expected to potentiate bradykinin- mediated adverse effects.
Ne zavira angiotenzinske konvertaze (kininaze II) – encima, ki tudi razgrajuje bradikinin, zato predvidoma ne poveča neželenih učinkov, katere povzroča bradikinin.
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
11 Pogostnost suhega kašlja je bila med bolniki, ki so se zdravili s telmisartanom, pomembno manjša kot pri tistih, ki so jemali zaviralce angiotenzinske konvertaze, kar dokazujejo rezultati kliničnih preskušanj, v katerih so neposredno primerjali obe vrsti antihipertenzivov.
11 Hydrochlorothiazide is a thiazide diuretic.
Hidroklorotiazid je tiazidni diuretik.
Following oral administration of PritorPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing.
Po peroralnem dajanju PritorPlusa doseže hidroklorotiazid največjo koncentracijo v plazmi približno v 1, 0 do 3, 0 urah.
About 60% of the oral dose is eliminated as unchanged substance within 48 hours.
Približno 60% peroralnega odmerka se izloči v obliki
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25)
laktoza monohidrat magnezijev stearat
13 Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
13 koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rdeči železov oksid (E172) natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
This medicinal product does not require any special storage conditions.
Glede shranjevanja ni posebnih zahtev.
Blister with 14, 28, 30, 56, 90, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 30, 56, 90 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableto.
22 April 2002 Date of last renewal:
22. april 2002 Datum zadnjega podaljšanja:
22 April 2007
22. april 2007
PritorPlus 80 mg/ 12.5 mg tablets
PritorPlus 80 mg/ 12, 5 mg tablete
PritorPlus fixed dose combination (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
PritorPlus, fiksna kombinacija 80 mg telmisartana in 12, 5 mg hidroklorotiazida, je indicirana za bolnike, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
• PritorPlus 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 40 mg • PritorPlus 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 80 mg
• PritorPlus po 40 mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Pritor po 40 mg • PritorPlus po 80mg/ 12, 5 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Pritor po 80 mg
In patients with mild to moderate hepatic impairment the posology should not exceed PritorPlus 40 mg/ 12.5 mg once daily.
Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka zdravila PritorPlus po 40 mg/ 12, 5 mg 1- krat na dan. PritorPlus ni indiciran za bolnike s hudim jetrnim odpovedovanjem.
PritorPlus is not indicated in patients with severe hepatic impairment.
Tiazide moramo previdno dajati bolnikom z zmanjšanim jetrnim delovanjem (glejte poglavje 4. 4).
PritorPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
Zdravila PritorPlus ne smemo dajati bolnikom s holestazo, z obolenji z zaporo žolčevoda ali močno zmanjšanim jetrnim delovanjem (glejte poglavje 4. 3), ker se telmisartan v glavnem izloča z žolčem.
There is no clinical experience with PritorPlus in patients with hepatic impairment.
Z zdravilom PritorPlus pri bolnikih z zmanjšanim jetrnim delovanjem ni izkušenj.
PritorPlus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Zdravila PritorPlus ne dajemo bolnikom z močno zmanjšanim ledvičnim delovanjem (kreatininskim očistkom < 30 ml/ min) (glejte poglavje 4. 3).
Experience with PritorPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Z zdravilom PritorPlus je malo izkušenj pri bolnikih z blago do zmerno zmanjšanim ledvičnim delovanjem, zato so priporočljivi periodični kontrolni pregledi serumskih ravni kalija, kreatinina in sečne kisline.
Therefore, the use of PritorPlus is not recommended.
Na splošno se bolniki s primarnim aldosteronizmom ne odzivajo na antihipertenzive, ki delujejo z zaviranjem renin- angiotenzinskega sistema, zato zanje zdravljenja z zdravilom PritorPlus ne priporočamo.
16 Metabolic and endocrine effects:
17 Učinki na presnovo in endokrini sistem:
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of PritorPlus, hyperkalaemia might occur.
− Hiperkaliemija Zaradi antagonističnega delovanja telmisartanove sestavine v zdravilu PritorPlus na receptorje za angiotenzin II (AT1) je možna tudi hiperkaliemija.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with PritorPlus (see section 4.5).
Če se bolniki zdravijo z zdravilom PritorPlus, moramo biti previdni pri sočasnem dajanju diuretikov, ki varčujejo s kalijem, kalijevih pripravkov ali nadomestkov soli, ki vsebujejo kalij (glejte poglavje 4. 5).
General:
18 Splošno:
Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
O redkih tovrstnih primerih poročajo tudi za antagoniste angiotenzina II (vključno s PritorPlusom).
Co-administration of lithium and PritorPlus is not recommended (see section 4.4).
Sočasno dajanje litija in PritorPlusa je dovoljeno samo ob skrbnem zdravniškem nadzoru in ga ne priporočamo.
Non-steroidal anti-inflammatory medicinal products:
19 Nesteroidna protivnetna zdravila:
21 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
Dodatni podatki o posameznih sestavinah zdravila Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri PritorPlusu, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
Undesirable effects occurred with similar frequency in placebo and telmisartan treated patients.
Telmisartan 22 Pojavnost neželenih učinkov je bila enako pogosta kot pri placebu.
Immune system disorders
23 Bolezni imunskega sistema Neznana:
Overdose with hydrochlorothiazide is associated with electrolyte depletion
Najpogostejša znaka in
The most common signs and symptoms of overdose are nausea and somnolence.
24 simptoma prevelikega odmerka sta navzea in zaspanost.
24 The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
25 Morebitni ugodni učinki telmisartana na zmanjšanje smrtnosti in zbolevanja za srčnožilnimi boleznimi še niso raziskani.
25 Special populations
Posebne skupine bolnikov
Elderly patients:
26 Starejši bolniki:
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25)
laktoza monohidrat magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rdeči železov oksid (E172)
26 Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
27 natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
27 1.
28 29 1.
PritorPlus 80 mg/ 25 mg tablets
PritorPlus 80 mg/ 25 mg tablete
PritorPlus fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus 80 mg/ 12.5 mg (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
PritorPlus, fiksna kombinacija (80 mg telmisartana in 25 mg hidroklorotiazida), je indicirana za bolnike, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom PritorPlus 80 mg/ 12, 5 mg (80 mg telmisartana in 12, 5 mg hidroklorotiazida) ali za bolnike, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
PritorPlus 80 mg/ 25 mg may be administered in patients whose blood pressure is not adequately controlled by PritorPlus 80 mg/ 12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
PritorPlus 80 mg/ 25 mg lahko dajemo bolnikom, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom PritorPlus 80 mg/ 12, 5 mg, ali bolnikom, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
PritorPlus is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
PritorPlus je na voljo tudi v jakosti 40 mg/ 12, 5 mg in 80 mg/ 12, 5 mg.
28 4.3 Contraindications
30 4. 3 Kontraindikacije
29 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
31 Zožitev aorte in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija:
30 Ethnic differences:
Etnične razlike:
Other:
32 Drugo:
31 Other antihypertensive agents:
Drugi antihipertenzivi:
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
33 Holestiramin in holestipolove smole: v prisotnosti anionskih izmenjalnih smol je motena absorpcija hidroklorotiazida.
32 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
34 nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Fixed Dose Combination The overall incidence and pattern of adverse events reported with PritorPlus 80 mg/ 25 mg was comparable with PritorPlus 80 mg/ 12.5 mg.
Fiksna kombinacija Celokupna pogostnost in vzorec neželenih učinkov, o katerih so poročali v zvezi z zdravilom PritorPlus80 mg/ 25 mg, je primerljiva s pogostnostjo neželenih učinkov zdravila PritorPlus 80 mg/ 12, 5 mg.
33 Infections and infestations
Infekcijske in parazitske bolezni
Anxiety Depression
depresija
Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
36 Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri PritorPlusu, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.