Zanoglide 4/30 mg - 30 Tablet

Antidiabetic combination therapy consisting of a sulfonylurea agent and a thiazolidinedione agent used in the treatment of type 2 diabetes mellitus.

Administer once daily with the first main meal of the day.

Side effects due to glimepiride: Hypoglycemia, dizziness, headache, nausea, increased serum ALT, flu-like symptoms, agranulocytosis, alopecia, anaphylaxis, angioedema, aplastic anemia, cholestatic jaundice, diarrhea, disulfiram-like reaction, dysgeusia, dyspnea, erythema, gastrointestinal pain, hemolytic anemia, hepatic failure, hepatic insufficiency, hepatic porphyria, hepatitis, hypersensitivity, hypersensitivity angiitis, hyponatremia, hypotension, immune thrombocytopenia, leukopenia, maculopapular rash, morbilliform rash, pancytopenia, porphyria cutanea tarda, pruritus, shock, skin photosensitivity, Stevens-Johnson syndrome, thrombocytopenia, urticaria, vomiting and weight gain. Side effects due to pioglitazone: -Pioglitazone may increase the risk of bladder carcinoma, thiazolidinediones (TZDs) may increase the risk of bone fractures, pioglitazone has been with associated with an increased risk of cardiac failure and acute hepatic failure has been reported with pioglitazone. -Edema, hypoglycemia, upper respiratory tract infection, cardiac failure, headache, back pain, bone fracture, myalgia, pharyngitis, sinusitis, bladder carcinoma, increased serum alanine aminotransferase, increased creatine phosphokinase in blood specimen, decreased serum triglycerides, increased HDL cholesterol, weight gain and decreased hemoglobin.

-Should not be given to patients suffering from hypersensitivity to glimepiride or pioglitazone. -Thiazolidinediones, including pioglitazone, may cause or exacerbate heart failure (HF); closely monitor for signs and symptoms of heart failure (eg, rapid weight gain, dyspnea, edema), particularly after initiation or dose increases. -Not for use in patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus. -Use with caution in preexisting anemia (pioglitazone is associated with decreases in hemoglobin and hematocrit and increasing plasma volume). -Avoid use of pioglitazone in patients with active bladder cancer. -In case of patients who has undergone bariatric surgery: Use an antidiabetic agent without the potential for hypoglycemia if possible; hypoglycemia may occur after gastric bypass, sleeve gastrectomy. -Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at an increased risk of sulfonylurea-induced hemolytic anemia. -There is an increased incidence of bone fractures has been observed in females treated with pioglitazone. -Hepatic failure has been reported with pioglitazone use. -Macular edema has been reported with thiazolidinedione use, including pioglitazone. -Use with caution and reduce dosage in patients with renal impairment to avoid hypoglycemia. -Use with caution in elderly patients because, are more likely to develop hypoglycemia. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

-Store at room temperature. -Interactions due to Pioglitazone: -Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents. -Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Inhibitors of the Proton Pump (PPIs and PCABs): May enhance the adverse/toxic effect of Thiazolidinediones. -Insulins: Pioglitazone may enhance the adverse/toxic effect of Insulins. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. -Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Pregabalin: May enhance the fluid-retaining effect of Thiazolidinediones. -Quinolones: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Salicylates: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. -Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents. -Topiramate: May decrease the serum concentration of Pioglitazone.

Interactions due to Glimepiride: -Alcohol (Ethyl): Sulfonylureas may enhance the adverse/toxic effect of alcohol (Ethyl). -Alpha-lipoic acid: May enhance the hypoglycemic effect of antidiabetic agents. -Amiodarone: May enhance the hypoglycemic effect of Sulfonylureas. -Antidiabetic Agents: May enhance the hypoglycemic effect of hypoglycemia-associated agents. -Beta-Blockers: May enhance the hypoglycemic effect of Sulfonylureas. -Carbocisteine: Sulfonylureas may enhance the adverse/toxic effect of carbocisteine. -Chloramphenicol (Systemic): May increase the serum concentration of Sulfonylureas. -Clarithromycin: May enhance the hypoglycemic effect of Sulfonylureas. -Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Sulfonylureas. -Miconazole (Oral): May enhance the hypoglycemic effect of Sulfonylureas. -Monoamine oxidase inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Quinolones: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Salicylates: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Selective serotonin reuptake inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Sulfonamide antibiotics: May enhance the hypoglycemic effect of Sulfonylureas. -Tetracyclines: May enhance the hypoglycemic effect of Sulfonylureas. -Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents. -Vitamin K antagonists (eg, warfarin): Sulfonylureas may enhance the anticoagulant effect of vitamin K antagonists. -Voriconazole: May increase the serum concentration of Sulfonylureas. -For the rest of interactions refer to Storage.

-Information related to the use of glimepiride and pioglitazone during pregnancy is limited. agents other than glimepiride and pioglitazone are currently recommended to treat diabetes mellitus in pregnancy. -It is not known if glimepiride and pioglitazone are present in breast milk. the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. -Ask your physician before taking any medication during pregnancy and lactation.

EVA PHARMA