Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DEXLANSOPRAZOLE
Takeda Pharma A/S
DEXLANSOPRAZOLE
30 Milligram
Capsules Modified Release
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Realized by: QUALITY SYSTEM - ISO 9001:2008 ARTWORK PDF 1.5 ISSUE DATE 24/03/2014 OPERATOR RI007M DRAFT 01 SEPARATIONS: ( BLACK ) MEASURES (mm): 185X297 DECA CODE (mm): (X=1,5mm /I=0,5mm/spazi=1 mm) FONT TYPE: HELVETICA MEDIUM Size: 9 PT THIS ARTWORK IS PROPERTY OF: TAKEDA CLIENT APPROVAL DATE SIGNATURE PRODUCT NAME: I-DEXLANSOPRAZOLO 30 MG - 60 MG PRODUCT CODE: ZTAK039 EURPACK GRAFIFARMA GRAFIFLEX - APRILIA (LT) tel. +39 06 92732420 produzione@grafifarma.it - ROBECCO S/N (MI) tel. +39 02 94974002 milano@grafifarma.it 10 mm 20 30 40 50 60 70 80 90 Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints chromatic results could be different depending on support and used technique. - La responsabilità della EURPACK GRAFIFARMA GRAFIFLEX Srl, termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present document. - Vietato l’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl. It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl. v.01-2013 FPO FPO PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXLANSOPRAZOLE TAKEDA 30 MG MODIFIED‑RELEASE CAPSULES, HARD DEXLANSOPRAZOLE TAKEDA 60 MG MODIFIED‑RELEASE CAPSULES, HARD Dexlansoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effect Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexlansoprazole Takeda 30mg modified-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of dexlansoprazole. Excipients with known effect: Each 30 mg modified -release capsule contains 68 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsule, hard Each 30mg capsule (size 3) is opaque with a blue cap and a grey body with ‘TAP’ imprinted on the cap and '30' on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dexlansoprazole Takeda is indicated in adults for the following: - Treatment of erosive reflux oesophagitis - Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn - Short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastro- oesophageal reflux disease (GORD) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology -Treatment of erosive reflux oesophagitis The recommended dose is 60 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. - Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn. The recommended dose is 30 mg once daily for up to 6 months in patients where prolonged acid suppression is needed. -Symptomatic non-erosive gastro-oesophageal reflux disease (GORD) The recommended dose is 30 mg once daily for up to 4 weeks. Special populations _Elderly_ Due to reduced clearance of dexlansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 60 mg should not be exceeded in the elderly unless there are compelling clinical indications (see sec Přečtěte si celý dokument