Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
DEXLANSOPRAZOLE
TAKEDA ISRAEL LTD
A02BC06
MODIFIED RELEASE CAPSULES
DEXLANSOPRAZOLE 60 MG
PER OS
Required
TAKEDA GMBH, GERMANY
DEXLANSOPRAZOLE
Dexilant 60 is indicated in adults and in adolescents aged 12 to 17 years for the following:• Treatment of erosive reflux oesophagitis
2021-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon physician’s prescription only DEXILANT™ 30 MG, MODIFIED-RELEASE CAPSULES DEXILANT™ 60 MG, MODIFIED-RELEASE CAPSULES COMPOSITION: ACTIVE INGREDIENT _ _ - each capsule of Dexilant 30 mg contains 30 mg of dexlansoprazole._ _ - each capsule of Dexilant 60 mg contains 60 mg of dexlansoprazole._ _ INACTIVE INGREDIENTS AND ALLERGENS: See chapter 2 “BEFORE USING THIS MEDICINE” under “Important information about some of this medicine’s ingredients” and chapter 6 “ADDITIONAL INFORMATION”. _ _ READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains summary information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. The medicine is intended for adults and adolescents over the age of 12 years. 1. WHAT IS THIS MEDICINE INTENDED FOR? Dexilant 60 mg is intended for the use of adults and adolescents aged 12 to 17 years for the following: - Treatment of erosive reflux oesophagitis (inflammation with damage to the lining of the oesophagus (food pipe)). Dexilant 30 mg is intended for the use of adults and adolescents aged 12 to 17 years for the following: - Maintenance treatment of healed erosive reflux oesophagitis and maintenance treatment following relief of heartburn. - Short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastro-oesophageal reflux disease (GORD). GORD is a condition where stomach acid leaks out of the stomach and comes up into the oesophagus (acid reflux). Such leakage may cause a sensation of burning in the chest or throat, may create a sour taste or cause belching. By reducing the amount of stomach acid, Dexilant can heal the damage caused to the oesophagus and relieve symptoms that can ha Lugege kogu dokumenti
PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT DEXILANT (dexlansoprazole) modified-release capsules, for oral use. DEXILANT is available as capsules in 30 mg and 60 mg strengths. 2 THERAPEUTIC INDICATIONS Dexilant 30 mg is indicated in adults and in adolescents aged 12 to 17 years for the following: • 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). Dexilant 60 mg is indicated in adults and in adolescents aged 12 to 17 years for the following: • Treatment of erosive reflux oesophagitis 3 DOSAGE AND ADMINISTRATION 3.1 Recommended Dosage in Adults and adolescents aged 12 to 17 years DEXILANT is available as capsules in 30 mg and 60 mg strengths for adult and adolescents aged 12 to 17 years use. Directions for use in each indication are summarized in Table 1. Table 1. Recommended DEXILANT Capsules dosage regimen by indication in Adults and adolescents aged 12 to 17 years Indication Dosage of DEXILANT Capsules Duration Treatment of erosive reflux oesophagitis One 60 mg capsule once daily . Up to 8 weeks . Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn One 30 mg capsule once daily . Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age . Symptomatic non-erosive gastro- oesophageal reflux disease (GORD) One 30 mg capsule once daily . 4 weeks . _ _ 3.2 Dosage Adjustment in Patients with Hepatic Impairment For the treatment of erosive reflux oesophagitis For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg DEXILANT once daily for up to eight weeks. DEXILANT is not recommended in patients with severe hepatic impairment (Child- Pugh Class C) [ _see_ _Use in Specific Populations (9.5)_ ]. 3.3 Important Administration Information • Take without regard to food. • Missed doses: If a dose is Lugege kogu dokumenti