Lan Capsules (Generic Lansoprazole Capsules)

1. Lan Capsules (Generic Lansoprazole Capsules) © The Swiss Pharmacy

2. Lan Capsules (Generic Lansoprazole Capsules) Lan (Generic Lansoprazole Capsules) is used for treatment of indigestion, heartburn, duodenal ulcer, gastric ulcer, Gastroesophageal Reflux Disease (GERD or reflux esophagitis), erosive esophagitis, and Pathological Hypersecretory Conditions including Zollinger-Ellison syndrome. © The Swiss Pharmacy

3. Lan Capsules (Generic Lansoprazole Capsules) Lan Capsules are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 15 mg and 30 mg. © The Swiss Pharmacy

4. Lan Capsules (Generic Lansoprazole Capsules) Chemical Structure © The Swiss Pharmacy

5. Lan Capsules (Generic Lansoprazole Capsules) The active ingredient contained in Lan capsules is Lansoprazole. Each Lan capsule contains 15 mg or 30 mg of Lansoprazole. © The Swiss Pharmacy

6. Lan Capsules (Generic Lansoprazole Capsules) Uses of Lan 15 mg and 30 mg Capsules: Lan Capsules (Lansoprazole) is used to treat certain conditions where there is too much acid in the stomach. It is used to treat indigestion, heartburn, duodenal and stomach ulcers, stomach ulcers caused by NSAID use, reflux disease, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition wherein the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics (eg, Amoxicillin, Clarithromycin) to treat ulcers associated with an infection caused by H. pylori bacteria. Lansoprazole is also used to treat Zollinger-Ellison syndrome (ZES), which is a condition where the stomach produces too much acid. Lansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach. © The Swiss Pharmacy

7. Lan Capsules (Generic Lansoprazole Capsules) Uses of Lan 15 mg and 30 mg Capsules: Short-Term Treatment of Active Duodenal Ulcer: Lan (Generic Lansoprazole Capsules) are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy (Lansoprazole/Amoxicillin/Clarithromycin): Lansoprazole capsules in combination with Amoxicillin plus Clarithromycin as triple therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual Therapy (Lansoprazole/Amoxicillin): Lansoprazole capsules in combination with amoxicillin as dual therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to Clarithromycin or in whom resistance to Clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

8. Lan Capsules (Generic Lansoprazole Capsules) Uses of Lan 15 mg and 30 mg Capsules: Maintenance of Healed Duodenal Ulcers: Lan (Generic Lansoprazole Capsules) are used to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. Short-Term Treatment of Active Benign Gastric Ulcer: Lansoprazole capsules are indicated for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer. Healing of NSAID-Associated Gastric Ulcer: Lansoprazole capsules are used for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks. Risk Reduction of NSAID-Associated Gastric Ulcer: Lansoprazole capsules are used for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

9. Lan Capsules (Generic Lansoprazole Capsules) Uses of Lan 15 mg and 30 mg Capsules: Short-Term Treatment of Symptomatic GERD: Lan (Generic Lansoprazole Capsules) are used for the treatment of heartburn and other symptoms associated with GERD for up to eight weeks. Short-Term Treatment of Erosive Esophagitis: Lansoprazole capsules are used for short-term treatment (up to eight weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Lansoprazole capsules for eight weeks (5% to 10%), it may be helpful to give an additional eight weeks of treatment. In case there is a recurrence of erosive esophagitis an additional eight week course of Lansoprazole capsules may be considered. Maintenance of Healing of Erosive Esophagitis (EE): Lansoprazole capsules are used to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES): Lansoprazole capsules are used for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

10. Lan Capsules (Generic Lansoprazole Capsules) Recommended Adult Dosage The dose of Lan Capsules Lan Capsules (Generic Lansoprazole Capsules) for various indications is given below: Reflux Oesophagitis: Reflux Oesophagitis: 30 mg Lan (Generic Lansoprazole Capsules) once daily for 4 weeks. The majority of patients will be healed after the first course. For patients who have not fully healed within this time, a further 4 weeks’ treatment using the same dosage regimen is indicated. For long-term management, a maintenance dose of 15 mg or 30 mg once daily can be used dependent upon patient response. Duodenal Ulcer: Duodenal Ulcer: 30 mg Lansoprazole once daily for 4 weeks. For the prevention of relapse, the recommended maintenance dose is 15 mg once daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

11. Lan Capsules (Generic Lansoprazole Capsules) Recommended Adult Dosage Gastric Ulcer: Gastric Ulcer: 30 mg Lansoprazole once daily for 8 weeks. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. Acid-Related Dyspepsia: Acid-Related Dyspepsia: Lansoprazole 15 mg or 30 mg once daily for 2 to 4 weeks, depending on the severity and persistence of symptoms. Patients who do not respond after 4 weeks, or who relapse shortly afterwards, should be investigated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

12. Lan Capsules (Generic Lansoprazole Capsules) Recommended Adult Dosage Eradication Of H. Pylori To Reduce The Risk Of Duodenal Ulcer Eradication Of H. Pylori To Reduce The Risk Of Duodenal Ulcer Recurrence: Recurrence: The following combinations have been shown to be effective when used for 10 or 14 days: Lansoprazole 30 mg twice daily plus two of the following antibiotics: Amoxycillin 1 g twice daily for 10 or 14 days and Clarithromycin 500 mg twice daily for 10 or 14 days. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

13. Lan Capsules (Generic Lansoprazole Capsules) Contraindications ➔Lan capsules are contraindicated in patients with a known hypersensitivity to Lansoprazole, other proton pump inhibitors or any component of the tablet. ➔Administration of Lan capsules is contraindicated in patients with severe hepatic impairment. ➔Concomitant use with Atazanavir. Lansoprazole should not be coadministered with Atazanavir due to a significant reduction in Atazanavir exposure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

14. Lan Capsules (Generic Lansoprazole Capsules) Storage Instructions Lan Capsules (Generic Lansoprazole Capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

15. Lan Capsules (Generic Lansoprazole Capsules) Warnings Gastric Malignancy: In adults, symptomatic response with Lansoprazole capsules (Lan) does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs. Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium-difficile associated diarrhea. 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. Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Lansoprazole capsules (Lan) and refer to specialist for evaluation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

16. Lan Capsules (Generic Lansoprazole Capsules) Warnings Cyanocobalamin (Vitamin B12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. Hypomagnesemia: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Interactions with 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 of Lan capsules. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

17. Lan Capsules (Generic Lansoprazole Capsules) Warnings Patients with Phenylketonuria: Each 15 mg Lansoprazole capsules contains 2.5 mg and each 30 mg Lansoprazole capsules contains 5.1 mg of phenylalanine. Lansoprazole is metabolized substantially by the liver. The results of clinical trials in adult patients with liver disease indicate that the metabolism of Lansoprazole is prolonged in patients with severehepatic impairment. Consider dose adjustment in patients with severe hepatic impairment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

18. Lan Capsules (Generic Lansoprazole Capsules) Lan Capsules and Alcohol Yes, you can drink alcohol with Lansoprazole (Lan Capsules). Although drinking alcohol is not contraindicated when using Lansoprazole, it's best not to drink too much, because drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

19. Lan Capsules (Generic Lansoprazole Capsules) Possible Side Effects Most common Lansoprazole capsules (Lan) side effects with an incidence rate of greater than or equal to 1% are diarrhea, abdominal pain, nausea and constipation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

20. Lan Capsules (Generic Lansoprazole Capsules) Possible Side Effects The following are the possible serious side effects of Lansoprazole capsules (Lan): Acute Interstitial Nephritis, Clostridium difficile- Associated Diarrhea, Bone Fracture, Cutaneous and Systemic Lupus Erythematosus, Cyanocobalamin (Vitamin B12) Deficiency, Hypomagnesemia and Fundic Gland Polyps. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

21. Lan Capsules (Generic Lansoprazole Capsules) Lan Capsules Overdosage Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral Lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs. In the event of overdose, treatment should be symptomatic and supportive. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

22. Lan Capsules (Generic Lansoprazole Capsules) Lan Capsules During Pregnancy Lansoprazole capsules (Lan) has been classified by the US FDA as Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy

23. Lan Capsules (Generic Lansoprazole Capsules) Lan Capsules Lan Capsules (Generic Lansoprazole Capsules) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9591_Lansoprazole-Capsules.html © The Swiss Pharmacy