Web www.pribalovy-letak.cz nezodpovídá za aktuálnost obsahu příbalových letáků. Kompletní a aktuální informace o léčivých přípravcích naleznete na webových stránkách Státního ústavu pro kontrolu léčiv Jedna tableta dvakrát denně společně s dvěma tabletami jednoho z těchto antibiotik: amoxicilinu,klaritromycinu nebo metronidazolu (či tinidazolu) – z nichž každá se užívá dvakrát denně s tabletoupantoprazolu. Treatment Duration Results Comments Study No. CSR No. Primary Objective Secondary Objective N ITT 4 weeks 344 BY1023BGI022 2572004 Pan 20, Ran 150 bid Relief of heartburn in GORD Stage 0I at day 14 Relief of heartburn in GORD Stage 0I at day 28 Results are similar to published studies FK3059, VMG306, FK3034 and BGSA006 Pantoprazole was superior to ranitidine in the relief of GORD symptoms 331 BY1023BF010 298E99 Pan 20, Ome 10 48 weeks Relief of heartburn in GORD Stage 0 Quality of life, Time to heartburn relief Both medications were similarly effective Published studies showed non-inferiority of pantoprazole compared to other PPIs Study VMG305 and M3-320 2 weeks 521 BY1023VMG309 3232004 Pan 20, Ome 10 Relief of GORD symptoms, Time to heartburn relief Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment Published studies suggest non-inferiority of pantoprazole compared to other PPIs Study VMG305 and M3-320 Both PPIs were comparably effective pantoprazole was non-inferior to omeprazole, non-significant primary endpoint

Potisk:šelak, červený oxid železitý (E172), černý oxid železitý (E172), žlutý oxid železitý (E172), roztok amoniaku 30%. However, you may take CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed. Dacă luaţi în acelaşi timp cu pantoprazol un medicament care conţine atazanavir (pentru tratarea infecţiei cu HIV), cereţi sfatul medicului. Serious skin reactions (frequency not known: frequency cannot be estimated from the available data) :The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with ?P20? on one side.

Tratarea simptomelor (de exemplu, pirozis, regurgitarea acidului stomacal, durere la deglutiţie) asociate bolii de reflux gastroesofagianShort-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. What is Controloc Control? Nu există date relevante cu privire la utilizarea pantoprazolului la femeile gravide. Nu se cunoaşte dacă pantoprazolul este excretat în laptele matern uman. Dacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului sau farmacistului pentru recomandări înainte de a lua acest medicament. Trebuie să utilizaţi acest medicament numai dacă medicul dumneavoastră consideră că beneficiul pe care acesta vi-l poate aduce dumneavoastră este mai mare decât riscul potenţial pentru fătul sau pentru copilul dumneavoastră. Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults. Acid reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid regurgitation (acid flowing up into the mouth). the CHMP concluded that the studies BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309 submitted by the applicant for which the claim of one year data exclusivity is sought, were not relevant and necessary to the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ?medicinal product not subject to medical prescription?. BF010 (CSR 298E/99) This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy. No day 14 data was available in the study report. In the non-prescription product setting, the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14, making this study of limited value in the non-prescription context. Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole. The study contained a treatment phase C; days 29-56, but again, this is not relevant to a non-prescription indication of no more than 28 days. Overall this study provides no relevant data analogous to the initial non-prescription medication period of up to 14 days. Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320).

Controloc conţine substanţa activă pantoprazol (sub formă de sesquihidrat de sodiu).Controloc este un „inhibitor selectiv de pompă de protoni”, un medicament care reduce cantitatea de acid produsă de stomac. Acesta este utilizat pentru tratarea afecţiunilor stomacului şi intestinului asociate cu aciditatea. Indicații Controloc 20 mg comprimate gastro-rezistente:Controloc este utilizat pentru a trata adulţii şi adolescenţii cu vârsta de minim 12 ani pentru: zvýšená hladina bilirubinu, zvýšená hladina tuků v krvi; prudký pokles kolujících bílých krvinek v krvi, spojený s vysokou horečkou. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.The justification of the applicant was based on 6 ?non-published? studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309). It was stated that these 6 studies support the proposed new indication and treatment duration by providing at least one symptom recording point of reflux-related symptoms during the first 14 days of treatment with pantoprazole and therefore are considered significant for the application. Study BY1023/BGI022 was particularly emphasised. During the procedure, the applicant further substantiated the justification. The applicant emphasised that these studies demonstrated efficacy in the non-prescription setting regarding the proposed indication and related posology which differs from that of the prescription product. The applicant, in addition to study BGI022 (CSR 257/2004), referred to study MEX020 (CSR 200/2004). The applicant also referred to studies BF010 (CSR 298E/99) and VMG309 (CSR 323/2004) which were considered to provide data for early onset of relief of reflux symptoms. Overall the applicant considered that the new data from the aforementioned studies added significant support to the classification as non-prescription product as they provided both effect and relevance to the assessment. The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed. How does Controloc Control work? Rare side effects: disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in blood (seen in blood tests). jestliže užíváte Controloc 40 mg déle než 3 měsíce, mohlo by u Vás dojít k poklesu hladiny hořčíku v krvi. Nízké hladiny hořčíku se projevují únavou, nechtěnými záškuby svalů, dezorientací, křečemi, závratěmi a zrychlenou srdeční akcí. Pokud se u Vás vyskytne některý z těchto příznaků, vyhledejte ihned lékaře. CONTROLOC Control may stop certain other medicines from working properly. Tell yourdoctor or pharmacist if you are using anymedicines containing one of the following active substances: