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Metformin Hydrochloride + Rosiglitazone is a combination medicine that helps control blood sugar levels. This medicine is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. It helps in proper utilisation of insulin, thereby lowering the blood sugar level. Metformin Hydrochloride + Rosiglitazone should be taken in the dose and duration as advised by your doctor. It must be taken with food to avoid stomach upset. If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Overdose may lead to low blood sugar (hypoglycemia). Some people may develop common side effects like nausea, loss of appetite, taste changes, stomach pain, diarrhea, edema (swelling), weight gain, bone fracture, blurred vision, and respiratory tract infection. However, these are temporary and usually subside on their own. If these do not resolve or bother you, please consult your doctor. Before taking this medicine, inform your doctor if you have any kidney, liver or heart problems. Pregnant or breastfeeding women should also consult their doctor before taking it. Your doctor will check your kidney function tests before starting treatment with it. Avoid excessive alcohol intake while taking it as this may increase the risk of developing some side effects. Metformin Hydrochloride + Rosiglitazone is a combination of two antidiabetic medicines: Rosiglitazone and Metformin. Rosiglitazone is a thiazolidinedione which works by increasing the body's sensitivity to insulin. Metformin is a biguanide. It works by lowering sugar production in the liver, delaying sugar absorption from intestines and increasing the body's sensitivity to insulin.

• Type 2 diabetes mellitus

Rosiglitazone: Lowers glucose by improving target cell response to insulin without increasing pancreatic cell secretion; activates nuclear peroxisome proliferator-activated receptor gamma, which influences the production of gene products involved in glucose and lipid metabolism. Metformin: Biguanide; acts by decreasing endogenous hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance and lowers both basal and postprandial plasma glucose .

Adult Dose: Oral Type 2 Diabetes The recommended starting dose of Rosiglitazone/Metformin is 2 mg/500 mg once or twice daily. HbA1c >11% or fasting plasma glucose (FPG) >270 mg/dL, a starting dose of 500 mg/2 mg PO BID may be considered May titrate by increments of 500 mg/2 mg at 2-week intervals, not to exceed 2000 mg/8 mg per day For patients inadequately controlled on Metformin monotherapy, the usual starting dose is 4 mg Rosiglitazone (daily dose) plus the dose of Metformin already being taken. For patients inadequately controlled on Rosiglitazone monotherapy, the usual starting dose is 1000 mg Metformin (daily dose) plus the dose of Rosiglitazone already being taken. Child Dose: Safety and efficacy not established Renal Dose: Renal impairment Obtain eGFR before starting metformin eGFR <30 mL/min/1.73 m²: Contraindicated eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly) If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Metformin Hydrochloride + Rosiglitazone is to be taken with food.

Common: • Nausea • Loss of appetite • Taste change • Stomach pain • Diarrhea • Edema (swelling) • Weight gain • Bone fracture • Blurred vision • Respiratory tract infection

[CAUTION] Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur. Take it as per the dose and duration prescribed by your doctor. Monitor your blood sugar level regularly while you are taking this medicine. It can cause hypoglycemia (low blood sugar level) when used with other antidiabetic medicines, alcohol or if you delay or miss a meal. Always carry some sugary food or fruit juice with you in case you experience hypoglycemic symptoms such as cold sweats, cool pale skin, tremor, and anxiety. Your doctor may check your liver function regularly. Inform your doctor if you develop symptoms such as abdominal pain, loss of appetite, or yellowing of the eyes or skin (jaundice). Inform your doctor if you notice weight gain, shortness of breath, irregular heartbeat, or any abnormal swelling.

It is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels .1.5 mg/dl (males), 1.4 mg/dl (females), or abnormal creatinine clearance), acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma & known hypersensitivity to rosiglitazone maleate or metformin HCl.

Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine. Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.

[UNSAFE] It is unsafe to consume alcohol with Metformin Hydrochloride + Rosiglitazone.

[CONSULT YOUR DOCTOR] Metformin Hydrochloride + Rosiglitazone may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Information regarding the use of Metformin Hydrochloride + Rosiglitazone during breastfeeding is not available. Please consult your doctor.

[CAUTION] Metformin Hydrochloride + Rosiglitazone should be used with caution in patients with kidney disease. Dose adjustment of Metformin Hydrochloride + Rosiglitazone may be needed. Please consult your doctor. Use of Metformin Hydrochloride + Rosiglitazone is, however, not recommended in patients with severe kidney disease. Regular monitoring of kidney function test is advisable while you are taking this medicine. [CAUTION] Metformin Hydrochloride + Rosiglitazone should be used with caution in patients with liver disease. Dose adjustment of Metformin Hydrochloride + Rosiglitazone may be needed. Please consult your doctor. Metformin Hydrochloride + Rosiglitazone is generally started with low dose in patients with mild to moderate liver disease and its use is not recommended in patients with severe liver disease.

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