Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets)

1. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) © The Swiss Pharmacy

2. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Lamivir-HBV (Generic Lamivudine-HBV Tablets) is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. © The Swiss Pharmacy

3. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Lamivir-HBV Tablets are manufactured by Cipla Limited, India in the strength of 100 mg. © The Swiss Pharmacy

4. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Chemical Structure © The Swiss Pharmacy

5. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) The active ingredient contained in Lamivir- HBV tablets is Lamivudine. Each Lamivir-HBV tablet contains 100 mg of Lamivudine. © The Swiss Pharmacy

6. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Uses of Lamivir- HBV 100 mg Tablets: Lamivir-HBV tablets (Generic Lamivudine-HBV tablets) are used for the treatment of adults and children aged 2 years and older with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. Lamivudine-HBV tablets are used to treat hepatitis B infection. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others. This medication is a nucleoside reverse transcriptase inhibitor (NRTI) that works by slowing the growth of the virus, thereby decreasing liver damage caused by the virus. The formulation and dosage of lamivudine in Lamivir-HBV Tablets are not appropriate for patients dually infected with hepatitis B virus (HBV) and HIV. If Lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the appropriate prescribing information should be consulted. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

7. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Recommended Adult Dosage The recommended oral dose of Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) for the treatment of chronic hepatitis B in adults is 100 mg once daily. The formulation and dosage of Lamivudine in Lamivir-HBV tablets are not appropriate for patients dually infected with hepatitis B virus (HBV) and HIV. If Lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the appropriate prescribing information should be consulted. Lamivir-HBV Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

8. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Recommended Adult Dosage Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) has not been evaluated in pediatric patients. It is recommended that doses of Lamivudine be adjusted in accordance with renal function. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

9. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Contraindications ➔Lamivir-HBV tablets is contraindicated in patients with a known hypersensitivity to Lamivudine or any component of the tablet. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

10. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Storage Instructions Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) 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=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

11. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Warnings Exacerbations of Hepatitis after Discontinuation of Treatment: Exacerbations of Hepatitis after Discontinuation of Treatment: Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of Lamivudine (Lamivir-HBV Tablets). These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA commonly observed after stopping treatment. Risk of HIV-1 Resistance if Lamivir-HBV Tablets is Used in Patients with Risk of HIV-1 Resistance if Lamivir-HBV Tablets is Used in Patients with Unrecognized or Untreated HIV-1 Infection: Unrecognized or Untreated HIV-1 Infection: Lamivir-HBV tablets and oral solution contain a lower Lamivudine dose than the Lamivudine dose used to treat HIV-1 infection with Lamivir tablets or with Lamivudine-containing antiretroviral fixed-dose combination products. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

12. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Warnings Emergence of Resistance-Associated HBV Substitutions: Emergence of Resistance-Associated HBV Substitutions: Consider a switch to an alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment. Lactic Acidosis and Severe Hepatomegaly with Steatosis: Lactic Acidosis and Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including Lamivudine-HBV Tablets (Lamivir-HBV). A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

13. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Possible Side Effects Most common Lamivudine-HBV (Lamivir-HBV Tablets) side effects with an incidence rate of greater than or equal to 2% 10% and reported at a rate greater than placebo were ear, nose, and throat infections; sore throat; and diarrhea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

14. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Possible Side Effects The following side effects have been identified during post-approval use of Lamivudine 100 mg tablets (Lamivir-HBV Tablets) . Blood and Lymphatic: Anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia. Digestive: Stomatitis. Ear and Labyrinth Disorders:Hearing loss Endocrine and Metabolic: Hyperglycemia. General Weakness. Hepatic and Pancreatic: Lactic acidosis and steatosis , posttreatment exacerbations of hepatitis , pancreatitis. Hypersensitivity: Anaphylaxis, urticaria. Musculoskeletal: Cramps, rhabdomyolysis. Nervous: Paresthesia, peripheral neuropathy. Respiratory: Abnormal breath sounds/wheezing. Skin: Alopecia, pruritus, rash. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

15. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Lamivir-HBV Tablets Overdosage There is no known antidote for an overdose of Lamivudine (Lamivir- HBV Tablets). In case overdose occurs, the patient should be monitored and standard supportive treatment applied, as required. In studies, a negligible amount of Lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis and automated peritoneal dialysis; hence, it is not known if continuous hemodialysis would provide clinical benefit in a Lamivudine overdose event. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

16. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Lamivir-HBV Tablets During Pregnancy Lamivudine Tablets (Lamivir-HBV) has been classified by the US FDA as Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies of Lamivudine Tablets in pregnant women. This medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in pregnant rats and rabbits showed that Lamivudine is transferred to the fetus through the placenta. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy

17. Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) Lamivir-HBV Tablets Lamivir-HBV Tablets (Generic Lamivudine-HBV Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9694_Lamivir-HBV-Tablets.html © The Swiss Pharmacy