Gliptadalo Plus 50/1000 mg - 30 F.C. Tablet

Antidiabetic combination therapy consisting of an agent that belongs to Biguanide group (Metformin) and an agent that belongs to Dipeptidyl Peptidase 4 (DPP-4) Inhibitor group (Sitagliptin) used in the treatment of type 2 diabetes mellitus.

-Administer with meals, at the same time each day (preferably with the evening meal for extended release tablets). -Swallow extended release tablets whole; do not split, crush, or chew; do not split or divide immediate release tablets.

Side effects due to sitagliptin: -Arthralgia may occur within 1 day to years after treatment initiation, bullous pemphigoid, Stevens-Johnson syndrome or toxic epidermal necrolysis, anaphylaxis and angioedema, acute pancreatitis, chronic pancreatitis and pancreatic cancer especially in the patients with a prior history of pancreatitis or patients with acute pancreatitis due to any cause. -Hypoglycemia, nasopharyngitis, constipation, oral mucosa ulcer, stomatitis, vomiting, increased liver enzymes, anaphylaxis, angioedema, headache, myalgia, acute renal failure. 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 sitagliptin or metformin. -Should not be given to patients suffering from severe renal impairment (if the glomerular filtration rate <30 mL/minute/1.73 m2) -Should not be given to patients suffering from acute or chronic metabolic acidosis including diabetic ketoacidosis. -Should not be given to patients suffering from severe hepatic dysfunction. -Use cautiously in patients with heart failure. -Severe and disabling arthralgia has been reported with DPP-4 inhibitor use; onset may occur within one day to years after treatment initiation and may resolve with discontinuation of therapy. -DPP-4 inhibitor use has been associated with development of bullous pemphigoid; cases have typically resolved with topical or systemic immunosuppressive therapy and discontinuation of DPP-4 inhibitor therapy. -Rare hypersensitivity reactions (including anaphylaxis, angioedema and/or severe dermatologic reactions, such as Stevens-Johnson syndrome) have been reported. -Metformin may cause lactic acidosis. -Acute pancreatitis have been reported with the use of sitagliptin, so use with caution in patients with a history of pancreatitis. -May cause worsening of renal function. -Long-term metformin use is associated with vitamin B12 deficiency. -Use with caution in elderly; as the risk of metformin associated lactic acidosis increases with age. -Not indicated for use in patients with type 1 diabetes mellitus. -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. -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 Sitagliptin: -Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents. -Angiotensin-Converting Enzyme Inhibitors: Dipeptidyl Peptidase-IV Inhibitors may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. -Digoxin: sitagliptin may increase the serum concentration of digoxin. -Direct acting antiviral agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Hypoglycemia-associated agents: Antidiabetic agents may enhance the hypoglycemic effect of hypoglycemia-associated agents. -Insulins: Dipeptidyl Peptidase-IV Inhibitors may enhance the hypoglycemic effect of insulins. -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. -Sulfonylureas: Dipeptidyl Peptidase-IV Inhibitors may enhance the hypoglycemic effect of Sulfonylureas. -Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents. -For the rest of interactions refer to Storage.

-Metformin crosses the placenta, information related to the use of sitagliptin in pregnancy is limited. Agents other than metformin and sitagliptin are currently recommended to treat diabetes mellitus in pregnancy. -Metformin is present in breast milk. It is not known if sitagliptin 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.