Dexlansoprazole 30 mg delayed-release capsules What dexlansoprazole is used for: It is a proton pump inhibitor (PPI). The delayed-release capsules are indicated in adults for: • Healing of all grades of erosive esophagitis (EE) • Maintaining healing of EE and relief of heartburn • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) The SoluTab delayed-release orally disintegrating tablets are indicated in adults for: • Maintaining healing of EE and relief of heartburn • Treating heartburn associated with GERD Do not use dexlansoprazole: • Patients with known hypersensitivity to any component of the formulation • Patients receiving rilpivirine-containing products Warnings and precautions: • Gastric Malignancy: Symptomatic response with dexlansoprazole does not preclude the presence of gastric malignancy • Acute Interstitial Nephritis: Observed in patients taking PPIs • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin • Clostridium difficile Associated Diarrhea: PPI therapy may be associated with increased risk • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine • Hypomagnesemia: Reported rarely with prolonged treatment with PPIs • Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors • Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal. Possible side effects: Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Other medicines and dexlansoprazole: Tell your doctor or pharmacist if you are taking: • Antiretrovirals • Warfarin • Methotrexate • Digoxin • Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenoloate mofetil, ketoconazole/itraconazole) • Tacrolimus • CYP2C19 or CYP3A4 Inhibitors • CYP2C19 or CYP3A4 Inducers How to use dexlansoprazole: Recommended Adult Dosage: Two 30 mg SoluTab are not interchangeable with one 60 mg capsule Dexlansoprazole capsules • Healing of EE: 60 mg once daily for up to 8 weeks • Maintenance of healed EE: 30 mg once daily for up to 6 months • Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks Dexlansoprazole SoluTab • Maintenance of healed EE: 30 mg once daily for up to 6 months • Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks Administration Instructions: Dexlansoprazole capsules • Take without regard to food • Swallow whole; do not chew Dexlansoprazole SoluTab • Take at least 30 minutes before a meal How to store dexlansoprazole: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store between 20°C to 25°C. Store in the original container. Keep the container tightly closed. Do not use if you notice any deterioration or damage to the outer packaging. Do not throw away any medicines via wastewater or household waste.