Pioglumet 15/500 mg - 10 F.C. Tablets

Antidiabetic combination therapy consisting of an agent that belongs to Biguanide group (metformin) and an agent that belongs to Thiazolidinedione group (Pioglitazone), used in the treatment of type 2 diabetes mellitus.

-Administer with meals. -Extended release tablets should be swallowed whole; do not crush, split, or chew.

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. Side effects due to Metformin: -Diarrhea, nausea, flatulence, dyspepsia, vomiting, and abdominal pain, lactic acidosis, vitamin B12 deficiency and subsequent anemia and neuropathy. -Chest discomfort, flushing, palpitations, diaphoresis, hypoglycemia, abdominal distention, abdominal distress, abdominal pain, abnormal stools, dyspepsia, heartburn, chills, dizziness, headache, asthenia, myalgia, dyspnea, flu-like symptoms, upper respiratory tract infection, hemolytic anemia, hepatic injury and encephalopathy.

-Should not be given to patients suffering from Hypersensitivity to pioglitazone or metformin. -Should not be given to patients suffering from heart failure. -Should not be given to patients suffering from severe renal impairment (eg, eGFR <30 mL/minute/1.73 m2). -Should not be given to patients suffering from metabolic acidosis, including diabetic ketoacidosis. -Should not be given to patients suffering from serious hepatic impairment. -Should not be given to patients suffering from active bladder cancer or a history of bladder cancer. -May decrease hemoglobin/hematocrit; effects may be related to increased plasma volume. -The risk of hypoglycemia is increased when pioglitazone is combined with insulin or other diabetic medications; dosage adjustment of concomitant hypoglycemic agents may be necessary. -Macular edema has been reported with thiazolidinedione use, including pioglitazone. -Dose-related weight gain was observed with the use of pioglitazone. -Not indicated for use in patients with type 1 diabetes mellitus or with diabetic ketoacidosis. -Administration of iodinated contrast agents has been associated with postcontrast acute kidney injury (AKI); acute decreases in renal function have been associated with an increased risk of lactic acidosis due to reduced metformin excretion. -Intensive glucose control (HbA1c <6.5%) has been linked to increased risk for cardiovascular mortality and hypoglycemia requiring assistance. -Older adults are more likely to experience vitamin B12 deficiency with long-term use of metformin. -There is an increased incidence of bone fractures in females treated with pioglitazone. -Metformin may cause lactic acidosis. -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 Metformin: -Alcohol (Ethyl): May enhance the adverse/toxic effect of Metformin. -Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents. -Beta-blockers: May enhance the hypoglycemic effect of antidiabetic agents. Symptoms of hypoglycemia, particularly tachycardia, may be also be blunted. -Cephalexin: May increase the serum concentration of Metformin. -Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Iodinated Contrast Agents: May enhance the adverse/toxic effect of Metformin. -Lamotrigine: May increase the serum concentration of Metformin. -Levoketoconazole: May increase the serum concentration of Metformin. -Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Metformin. -Ondansetron: May increase the serum concentration of Metformin. -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 enhance the adverse/toxic effect of Metformin. -Trimethoprim: May increase the serum concentration of Metformin. -Verapamil: May diminish the therapeutic effect of Metformin. -Vitamin K antagonists (eg, warfarin): Metformin may diminish the anticoagulant effect of Vitamin K antagonists.

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. -For the rest of interactions refer to Storage.

-Metformin crosses the placenta, information related to the use of pioglitazone in pregnancy is limited. Agents other than metformin and pioglitazone are currently recommended to treat diabetes mellitus in pregnancy. -It is not known if pioglitazone is present in breast milk. Metformin is 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 the benefits of treatment to the mother. -Ask your physician before taking any medication during pregnancy and lactation.

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