FrancophonIA/ELRC3.0 huggingface dataset:
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, Labelling and Package Leaflet is set out in Annex III of the CHMP Opinion for Agopton and associated names (see Annex I of the opinion).
Slovenian: je CHMP priporočil dopolnitev dovoljenja za promet z zdravilom, za katerega so Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo podani v Dodatku III Mnenja CHMP za zdravilo Agopton in z njim povezana imena (glejte Dodatek I mnenja).
English: What Agopton is and what it is used for 2.
Slovenian: Kaj je zdravilo Agopton in za kaj ga uporabljamo 2.
English: 04011 Aprilia (LT), Italy
Slovenian: Via Nettunense 90 04011 Aprilia (LT), Italija
English: Drugs which induces CYP2C19 and CYP3A4
Slovenian: Zdravila, ki inducirajo delovanje CYP2C19 in CYP3A4
English: Sulphone, sulphide and 5-hydroxyl derivatives of lansoprazole have been identified in plasma.
Slovenian: V plazmi so odkrili sulfonske, sulfidne in 5-hidroksilne derivate lansoprazola.
English: If you take more Agopton than you have been told to, seek medical advice quickly <or quickly consult the Toxicological Information Service.>
Slovenian: Če ste vzeli več zdravila Agopton, kot so vam naročili, hitro poiščite zdravniško pomoč <ali se posvetujte pri službi za toksikološke informacije.>
English: Two pivotal studies for the support of the proposed indication in ulcer healing have been presented: Both of them were double-blind, positive-controlled, randomised, parallel group, multi-centre studies designed to evaluate the safety and efficacy of lansoprazole 15 mg and 30 mg o.d. in comparison to ranitidine 150 mg b.d.
Slovenian: V podporo predlagani indikaciji za celjenje razjed sta bili predstavljeni dve osrednji raziskavi: v obeh primerih je šlo za dvojno slepi, pozitivno kontrolirani, randomizirani, multicentrični raziskavi z vzporednima skupinama, katerih cilj je bil vrednotenje varnosti in učinkovitosti lansoprazola 15 mg in 30 mg enkrat dnevno v primerjavi z ranitidinom 150 mg dvakrat dnevno.
English: Therapeutic Indications
Slovenian: Terapevtske indikacije
English: In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
Slovenian: Pri bolnikih z razjedami želodca in dvanajstnika je treba upoštevati možnost okužbe z bakterijo H. pylori kot etiološkega dejavnika.
English: Lansoprazole (like misoprostol) is effective in reducing the risk of gastric or duodenal ulcers in patients who need to continue NSAIDs.
Slovenian: Lansoprazol (podobno kot misoprostol) je učinkovit pri zmanjševanju tveganja za nastanek razjed želodca ali dvanajstnika pri bolnikih, ki nadaljujejo z jemanjem NSAID.
English: Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.
Slovenian: Predloženi sta bili dve osrednji randomizirani, dvojno slepi raziskavi z vzporednima skupinama ter 5 podpornih raziskav, katerih cilj je bil ovrednotiti učinkovitost lansoprazola pri zdravljenju simptomatske gastroezofagealne refluksne bolezni.
English: Empty the granules from one sachet into the glass.
Slovenian: Granule iz ene vrečice dajte v kozarec.
English: Both the lansoprazole 15 and 30 mg dose are effective and the dosing recommendations proposed by the MAH are acceptable.
Slovenian: Tako 15 kot 30 mg odmerek lansoprazola sta učinkovita in priporočila imetnika dovoljenja za promet z zdravilom glede odmerjanja so sprejemljiva.
English: The submitted data needs to be viewed in the context of current clinical practice, which would mandate H. pylori screening and eradication therapy in the treatment of duodenal ulcers.
Slovenian: Predložene podatke je potrebno obravnavati v luči trenutne klinične prakse, ki bi naj predvidevala presejanje in eradikacijsko zdravljenje H. pylori pri zdravljenju razjed dvanajstnika.
English: Proton pump inhibitors reduce the amount of acid that your stomach makes.
Slovenian: Zaviralci protonske črpalke zmanjšajo količino kisline, ki jo proizvaja želodec.
English: If diarrhoea occurs during the treatment with Agopton contact your doctor immediately, as Agopton has been associated with a small increase in infectious diarrhoea.
Slovenian: Če se med zdravljenjem z zdravilom Agopton pojavi driska, takoj obvestite zdravnika, ker je uporaba zdravila Agopton povezana z majhnim povečanjem pogostnosti driske zaradi okužbe.
English: • 4.3 Contraindication
Slovenian: • 4.3 Kontraindikacije
English: <The packaging has been printed with the days of the week to help you keep track of the medicines you have already taken.>
Slovenian: <Na ovojnini so natisnjeni dnevi v tednu, da boste lažje sledili jemanju zdravila.>
English: By reducing gastric acidity, lansoprazole creates an environment in which appropriate antibiotics can be effective against H. pylori.
Slovenian: Lansoprazol zmanjša kislost v želodcu in tako ustvari okolje, v katerem so lahko ustrezni antibiotiki učinkoviti proti H. pylori.
English: If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.
Slovenian: Če imate okužbo s simptomi, kot so zvišana telesna temperatura in hudo poslabšanje splošnega stanja ali zvišana telesna temperatura s simptomi lokalne okužbe, kot je vnetje grla, požiralnika ali ust, ali težave pri uriniranju, morate takoj obiskati zdravnika.
English: Lansoprazole is a racemate of two active enantiomers that are biotransformed into the active form in the acidic environment of the parietal cells.
Slovenian: Lansoprazol je racemat dveh aktivnih enantiomer, ki se v kislem okolju parietalnih celic biološko transformirata v aktivno obliko.
English: Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and benign Leydig cell tumours.
Slovenian: Opazili so tudi intestinalno metaplazijo, hiperplazijo Leydigovih celic in benigne tumorje Leydigovih celic.
English: LANZO United Kingdom: ZOTON FasTab
Slovenian: LANZO Velika Britanija: ZOTON FasTab
English: The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy subjects.
Slovenian: Razpolovni čas izločanja iz plazme po enkratnih ali večkratnih odmerkih je pri zdravih prostovoljcih od ure do dveh ur.
English: Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.
Slovenian: Šest mesecev po uspešnem eradikacijskem zdravljenju je nevarnost ponovne okužbe majhna, zato ponovitev bolezni ni verjetna.
English: Limited data, well known-clinical facts about duodenal ulceration and an class effect of PPIs support the inclusion of duodenal ulcers into the indication.
Slovenian: Omejeni podatki, dobro znana klinična dejstva o ulkusih dvanajstnika in učinkovanje celega razreda zaviralcev protonske črpalke (ZPČ) podpirajo vključitev razjed dvanajstnika v indikacijo.
English: The submitted data on the use of maintenance antisecretory therapy to prevent duodenal ulcer recurrence predates the use of such eradication therapy.s.
Slovenian: Predloženi podatki v zvezi z vzdrževalnim antisekretornim zdravljenjem z namenom preprečevanja ponovitev razjed dvanajstnika pogojujejo uporabo takega eradikacijskega zdravljenja.
English: For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration.
Slovenian: Za bolnike, ki imajo težave s požiranjem, so študije in klinična praksa pokazale, da se za lažjo uporabo kapsule lahko odprejo in zrnca premešajo z malo vode ali jabolčnega/paradižnikovega soka ali pa se potresejo na majhno količino mehke hrane (npr. jogurt, jabolčni pire).
English: If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Slovenian: Po potrebi se priporočajo izpiranje želodca, uporaba aktivnega oglja in simptomatsko zdravljenje.
English: This study was a randomized, parallel-group, active- and placebo-controlled, multi-center, multinational study to evaluate the use of lansoprazole, misoprostol and placebo in the prevention of ulcers and erosions in patients continuing to take NSAIDs.
Slovenian: Šlo je za randomizirano, s primerjalno učinkovino in placebom kontrolirano, multicentrično mednarodno raziskavo z vzporednimi skupinami, katere namen je bil ovrednotenje uporabe lansoprazola, misoprostola in placeba pri preprečevanju razjed in erozije pri bolnikih, ki nadaljujejo z jemanjem NSAID.
English: Peak plasma levels occur within 1.5 to 2.0 hours.
Slovenian: Najvišje koncentracije v plazmi so dosežene po 1,5 do 2 urah.
English: A single oral dose of 30 mg reduces basal secretion by about 70%, and the patients' symptoms are consequently relieved starting from the very first dose.
Slovenian: Enkratni 30miligramski peroralni odmerek zmanjša bazalno izločanje za približno 70 %, posledično pa se že od prvega odmerka ublažijo simptomi pri bolnikih.
English: In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.
Slovenian: Kot pri drugih oblikah zdravljenja razjed je treba med zdravljenjem razjede želodca z lansoprazolom izključiti možnost malignega tumorja želodca, ker lahko lansoprazol prikrije simptome in prepreči pravočasno diagnosticiranje.
English: Daily doses of up to 180 mg have been used.
Slovenian: Lahko se uporabljajo odmerki do 180 mg na dan.
English: The plasma concentrations of lansoprazole increase up to 4-fold.
Slovenian: Koncentracije lansoprazola v plazmi se povečajo do štirikrat.
English: For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.
Slovenian: Pri bolnikih z razjedami, ki se težko zacelijo, ali tveganjem zanje bodo verjetno potrebni daljše zdravljenje ali večji odmerki ali oboje.
English: • Eradication of Helicobacter pylori
Slovenian: • Eradikacija bakterije Helicobacter pylori
English: Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur (see section 4.8).
Slovenian: Lahko se pojavijo neželeni učinki, kot so omotica, vrtoglavica, motnje vida in somnolenca (glejte poglavje 4.8).
English: Swallow the capsule whole with a glass of water.
Slovenian: Kapsule pogoltnite cele, s kozarcem vode.
English: <Prescription>
Slovenian: <Izdaja na recept>
English: A study shows that the plasma concentrations of lansoprazole increase up to 4-fold.
Slovenian: Študija je pokazala, da se koncentracije lansoprazola v plazmi povečajo do štirikrat.
English: Each single dose sachet contains <fine pink granules containing white to off-white pellets>.
Slovenian: Vsaka vrečica z enkratnim odmerkom vsebuje <drobna rožnata zrnca, ki vsebujejo bele do sivo bele pelete>.
English: For the prevention of NSAID associated ulceration, one pivotal study was presented.
Slovenian: Za preprečevanje razjed, povezanih z jemanjem NSAID, je bila predstavljena ena osrednja raziskava.
English: If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine.
Slovenian: Če jih težko pogoltnete, vam bo morda zdravnik predlagal druge načine za jemanje zdravila.
English: Lansoprazole exhibits high (80-90%) bioavailability with a single dose.
Slovenian: Biološka uporabnost enkratnega odmerka lansoprazola je velika (80-90 %).
English: The evaluation of the pharmacokinetics in children aged 10 weeks and above showed similar exposures in comparison to healthy adult volunteers receiving a 30 mg dose either with a body weight or body surface based dosing for babies.
Slovenian: Vrednotenje farmakokinetike pri otrocih, starih 10 tednov in več, je pokazalo podobne izpostavljenosti v primerjavi z zdravimi odraslimi prostovoljci, prejemajočimi 30 mg odmerek, ob odmerjanju za dojenčke na podlagi telesne teže ali telesne površine.
English: A statement indicating the experience with the medicinal product in children is required under section 4.2 of the SPC.
Slovenian: V poglavju 4.2 SPC je potrebna navedba glede izkušenj z uporabo zdravila pri otrocih.
English: If you take more Agopton than prescribed
Slovenian: Če ste vzeli večji odmerek zdravila Agopton, kot so vam predpisali
English: Lansoprazole should not be administered with atazanavir (see section 4.5).
Slovenian: Lansoprazol se ne sme uporabljati skupaj z atazanavirom (glejte poglavje 4.5).
English: The orodispersible tablets can be dispersed in a small amount of water and administered via a nasogastric tube or oral syringe.
Slovenian: Orodisperzibilne tablete se lahko raztopijo v malo vode in dajo po nazogastrični cevki ali peroralni brizgi.
English: Co-administration of lansoprazole and digoxin may lead to increased digoxin plasma levels.
Slovenian: Sočasna uporaba lansoprazola in digoksina lahko poveča ravni digoksina v plazmi.
English: Note: This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 30 referral for lansoprazole containing medicinal products.
Slovenian: Opomba: Ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so bili priloženi k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu z členom 29, za zdravila, ki vsebujejo lansoprazol.
English: Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme and have a narrow therapeutic window.
Slovenian: Pri kombiniranju lansoprazola z zdravili, ki jih presnavlja ta encim in ki imajo ozko terapevtsko okno, je treba biti previden.
English: Do not use Agopton after the expiry date which is stated on each sachet and the carton.
Slovenian: Zdravila Agopton ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsaki vrečici in na škatli.
English: If your doctor has given you Agopton in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully.
Slovenian: Če vam je zdravnik predpisal zdravilo Agopton ob drugih zdravilih za zdravljenje okužbe z bakterijo Helicobacter pylori (antibiotiki) ali skupaj s protivnetnimi zdravili za zdravljenje bolečine ali revmatizma: pozorno preberite tudi navodila za uporabo teh zdravil.
English: What Agopton is and what it is used for Before you take Agopton How to take Agopton Possible side effects How to store Agopton Further information
Slovenian: Kaj je zdravilo Agopton in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Agopton Kako jemati zdravilo Agopton Možni neželeni učinki
English: In patients who continue to take NSAID medication healing is delayed.
Slovenian: Pri bolnikih, ki nadaljujejo z zdravljenjem z NSAID, je celjenje upočasnjeno.
English: The following instructions should be followed if administered via syringe: It is important that the appropriateness of the selected syringe is carefully tested.
Slovenian: Če zdravilo jemljete z brizgo, upoštevajte naslednja navodila: Ustreznost izbrane brizge morate pozorno preveriti.
English: Equivalent AUC has also been shown for granules suspended in apple juice administered through a naso-gastric tube.
Slovenian: Enako vrednost AUC so pokazali tudi pri uporabi zrnc, suspendiranih v jabolčnem soku, danem po nazogastrični cevki.
English: Please follow your doctor's instructions for taking your medicine.
Slovenian: Pri jemanju zdravila upoštevajte zdravnikova navodila.
English: Luxembourg Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgium
Slovenian: Luksemburg Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgija
English: The investigation of a dose of 17 mg/m2 body surface or 1 mg/kg body weight also resulted in comparable exposure of lansoprazole in children aged 2-3 months up to one year of age compared to adults.
Slovenian: Preiskava pri odmerku 17 mg/m2 telesne površine ali 1 mg/kg telesne mase je pokazala, da je izpostavljenost otrok, starih od dva ali tri mesece do enega leta primerljiva z izpostavljenostjo lansoprazolu pri odraslih.
English: It can be expected that normally under fasting conditions gastric emptying of a formulation has taken place 30 minutes post-dose.
Slovenian: Pričakovati je mogoče, da se na tešče formulacija iz želodca odstrani v 30 minutah po prejemu odmerka.
English: [To be included nationally if applicable]
Slovenian: [Izpolni država članica, če je ustrezno.]
English: The time to first recurrence of duodenal ulcer was significantly longer for lansoprazole patients compared to placebo.
Slovenian: Čas do prve ponovitve razjede dvanajstnika je bil pri bolnikih, ki so jemali lansoprazol, bistveno daljši kot ob jemanju placeba.
English: No data regarding of the use of lanzoprazole during preganancy and lactation has been provided.
Slovenian: O uporabi lanzoprazola med nosečnostjo in dojenjem niso bili predloženi nikakršni podatki.
English: Belgium Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgium
Slovenian: Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie 1130 Brussels, Belgija
English: The marketing authorisation holder is: <{Name and address}> <{tel}> <{fax}> <{e-mail}>
Slovenian: Imetnik dovoljenja za promet z zdravilom: <{Ime in naslov}> <{tel.}> <{faks}>
English: For optimal effect, Agopton should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.
Slovenian: Za najboljši učinek je treba zdravilo Agopton jemati enkrat na dan, zjutraj, razen kadar se uporablja za eradikacijo H. pylori.
English: <For countries with prescription use only>
Slovenian: <Za države, kjer je izdaja zdravila samo na recept>
English: The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).
Slovenian: Zdravljenje za preprečevanje peptičnih razjed pri bolnikih, ki potrebujejo neprekinjeno zdravljenje z nesteroidni antirevmatiki, je treba omejiti na bolnike z velikim tveganjem (npr. predhodne krvavitve, perforacija ali razjeda v prebavilih, starost, sočasna uporaba zdravil, ki povečajo verjetnost neželenih učinkov v zgornjih prebavilih [npr. kortikosteroidi ali antikoagulanti], prisotnost resnega dejavnika komorbidnosti ali dolgotrajna uporaba največjih priporočenih odmerkov nesteroidnih antirevmatikov).
English: When reconstituted in water the granules give a pink suspension with a strawberry flavour.
Slovenian: V vodi rekonstituirana zrnca tvorijo rožnato suspenzijo z okusom jagode.
English: WHAT AGOPTON IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO AGOPTON IN ZA KAJ GA UPORABLJAMO
English: The MAH has provided three bioequivalence studies as background documentation on the effect of food intake on the bioavailability of lansoprazole.
Slovenian: Imetnik dovoljenja za promet z zdravilom je kot osnovne informacije o vplivu uživanja hrane na biološko uporabnost lansoprazola predložil tri bioekvivalenčne raziskave.
English: If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated.
Slovenian: Če vam zdravijo okužbo, ker imate razjedo, se razjeda po uspešnem zdravljenju okužbe verjetno ne bo ponovila.
English: Zollinger-Ellison syndrome:
Slovenian: Zollinger-Ellisonov sindrom:
English: Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro je treba lansoprazol uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15 mg of lansoprazole Each capsule contains 30 mg of lansoprazole Excipient(s): Each 15 mg capsule contains 29.9 mg of sucrose
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka kapsula vsebuje 15 mg lansoprazola Vsaka kapsula vsebuje 30 mg lansoprazola Pomožne snovi: Vsaka 15-miligramska kapsula vsebuje 29,9 mg saharoze.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Arthralgia, myalgia
Slovenian: Artralgija, mialgija
English: Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines.
Slovenian: Jemanje tega zdravila lahko zaradi njegovih učinkov ali neželenih učinkov zmanjša sposobnost varnega opravljanja teh dejavnosti.
English: • Dosage and dosing schedule of symptomatic gastroesophageal reflux disease.
Slovenian: • Odmerjanje in shema odmerjanja za simptomatsko gastroezofagealno refluksno bolezen.
English: If you take more Agopton than you have been told to, seek medical advice quickly <or quickly consult the Toxicological Information Service.> [To be completed nationally - Statement and phone number to be inserted based on national requirement for information on a toxicological service.]
Slovenian: Če ste vzeli večji odmerek zdravila Agopton, kot so vam predpisali Če ste vzeli več zdravila Agopton, kot so vam naročili, hitro poiščite zdravniško pomoč <ali se posvetujte pri službi za toksikološke informacije.> [Izpolni država članica - Izjavo in telefonsko številko vnesite glede na lokalne zahteve o informacijah o toksikološki službi.]
English: For healing of gastric ulcers, both the 15 and 30 mg dose were statistically superior to the ranitidine at both 4 and 8 weeks.
Slovenian: Pri celjenju razjed želodca sta bila tako 15 mg kot 30 mg odmerek statistično učinkovitejša od ranitidina tako pri 4 kot 8 tednih.
English: The use of Agopton is not recommended in children as clinical data are limited (see also section 5.2).
Slovenian: Klinični podatki so omejeni, zato uporaba zdravila Agopton pri otrocih ni priporočena (glejte tudi poglavje 5.2).
English: However, daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects.
Slovenian: V preskušanjih so brez pomembnih neželenih učinkov uporabili peroralne odmerke do 180 mg in intravenske do 90 mg lansoprazola na dan.
English: Six months after successful eradication treatment, the risk of re infection is low and relapse is therefore unlikely.
Slovenian: Šest mesecev po uspešnem eradikacijskem zdravljenju je nevarnost vnovične okužbe majhna, zato ponovitev bolezni ni verjetna.
English: Restlessness, vertigo, paresthesia, somnolence, tremor
Slovenian: Nemir, vrtoglavica, parestezija, somnolenca, tremor
English: These metabolites have very little or no antisecretory activity.
Slovenian: Ti presnovki zelo malo ali sploh ne zavirajo izločanja.
English: Very rarely cases of colitis have been reported in patients taking lansoprazole.
Slovenian: Pri bolnikih, ki jemljejo lansoprazol, so zelo redko poročali o primerih kolitisa.
English: If this happens skip the missed dose and take the remaining oro-dispersible tablets as normal.
Slovenian: Če se to zgodi, izpustite pozabljeni odmerek in preostale orodisperzibilne tablete vzemite, kot bi jih sicer.