SEPAMET® XR (sitagliptin and metformin HCl extended-release) tablets
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SEPAMET® XR (sitagliptin/metformin HCl) tablets contain two oral antihyperglycemic drugs used in the
management of type 2 diabetes: sitagliptin and metformin hydrochloride.
Sepamet XR is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin (Sepamet ®) and extended-release metformin. Sepamet XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Sepamet XR targets 3 key factors to lower blood sugar:
Helps your pancreas make more insulin
Helps your body more effectively use the insulin that it makes
Helps decrease excess sugar that your liver makes
Sepamet XR:
Helps control blood sugar throughout the day, including after meals
Is not likely to cause weight gain and low blood sugar (hypoglycemia) by itself
Important Information
SEPAMET® XR is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when
treatment with both sitagliptin and metformin extended-release is appropriate.
SEPAMET® XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
SEPAMET® XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis
are at increased risk of developing pancreatitis while taking SEPAMET® XR.
SEPAMET® XR is contraindicated in patients with renal impairment (serum creatinine levels greater than or equal to 1.5 mg/dL for men and
greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance); hypersensitivity to metformin hydrochloride; acute or chronic
metabolic acidosis, including diabetic ketoacidosis; or history of a serious hypersensitivity reaction to SEPAMET® XR or sitagliptin,
such as anaphylaxis or angioedema.
About Sepamet XR and Sepamet
Sepamet tablets contain 2 prescription medicines: sitagliptin Sepamet ®) and metformin. Once-daily prescription Sepamet XR tablets contain sitagliptin (the medicine inSepamet ®) and extended-release metformin.
Sepamet or Sepamet XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether Sepamet or Sepamet XR is right for you.
Sepamet or Sepamet XR should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking Sepamet or Sepamet XR.
This site has information about type 2 diabetes and how Sepamet XR and Sepamet work to help lower blood sugar. You will also find tools to track your progress and other resources to help you ask the questions that are important to you at your next doctor appointment.
Also, check out Steps to Diabetes Goals, a program that provides information on type 2 diabetes, including tips and tools that you may find useful.
Talk to your doctor to see whether Sepamet® XR (sitagliptin and metformin HCl extended-release) or Sepamet® (sitagliptin and metformin HCl) could be right for you.
Selected Risk Information About Sepamet and Sepamet XR
Metformin, one of the ingredients in Sepamet and Sepamet XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking Sepamet or Sepamet XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: you feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual on Screen Detectsleepiness or sleep longer than usual; have sudden stomach or intestinal problems with nausea and vomiting or diarrhea; feel cold, especially in your arms and legs; feel dizzy or lightheaded; or have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicines; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; or if you have surgery, a heart attack, severe infection, or stroke.
Pancreatitis is another serious side effect that can happen in people taking Sepamet or Sepamet XR. Pancreatitis may be severe and lead to death. Before you start taking Sepamet or Sepamet XR, tell your doctor if you've ever had pancreatitis. Stop taking Sepamet or Sepamet XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Do not take Sepamet or Sepamet XR if you are allergic to any of the ingredients in Sepamet or Sepamet XR. Allergic reactions, which may be serious, including rash; hives; and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking Sepamet or Sepamet XR and call your doctor right away.
Do not take Sepamet or Sepamet XR if your kidneys are not working properly. Your doctor will do blood tests before and during your treatment to see how well your kidneys are working.
Tell your doctor if you are going to get an injection of dye or contrast agent for an x-ray procedure; Sepamet or Sepamet XR will need to be stopped for a short time.
If you take Sepamet or Sepamet XR with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.
Kidney problems, sometimes requiring dialysis, have been reported.
Common side effects when taking Sepamet or Sepamet XR include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, headache, and low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Supplier
Sepamet XR is manufactured & supplied by:
Taj Pahrmaceuticals Limited.,
P O Box 33242
Newmarket
Auckland
NEW ZEALAND
www.tajpharma.com
CP-TPL-999898-UUBH(4438A)
Copyright © 2014 TAJ PHARMACEUTICALS LIMITED., a subsidiary of Taj Group.,India Inc. All rights reserved. TAJ PHARMA., PLC. (UAE)
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%2Btablets.jpg)
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SEPAMET® XR (sitagliptin/metformin HCl) tablets contain two oral antihyperglycemic drugs used in the
management of type 2 diabetes: sitagliptin and metformin hydrochloride.
Sepamet XR is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin (Sepamet ®) and extended-release metformin. Sepamet XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Sepamet XR targets 3 key factors to lower blood sugar:
Helps your pancreas make more insulin
Helps your body more effectively use the insulin that it makes
Helps decrease excess sugar that your liver makes
Sepamet XR:
Helps control blood sugar throughout the day, including after meals
Is not likely to cause weight gain and low blood sugar (hypoglycemia) by itself
Important Information
SEPAMET® XR is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when
treatment with both sitagliptin and metformin extended-release is appropriate.
SEPAMET® XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
SEPAMET® XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis
are at increased risk of developing pancreatitis while taking SEPAMET® XR.
SEPAMET® XR is contraindicated in patients with renal impairment (serum creatinine levels greater than or equal to 1.5 mg/dL for men and
greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance); hypersensitivity to metformin hydrochloride; acute or chronic
metabolic acidosis, including diabetic ketoacidosis; or history of a serious hypersensitivity reaction to SEPAMET® XR or sitagliptin,
such as anaphylaxis or angioedema.
About Sepamet XR and Sepamet
Sepamet tablets contain 2 prescription medicines: sitagliptin Sepamet ®) and metformin. Once-daily prescription Sepamet XR tablets contain sitagliptin (the medicine inSepamet ®) and extended-release metformin.
Sepamet or Sepamet XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether Sepamet or Sepamet XR is right for you.
Sepamet or Sepamet XR should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking Sepamet or Sepamet XR.
This site has information about type 2 diabetes and how Sepamet XR and Sepamet work to help lower blood sugar. You will also find tools to track your progress and other resources to help you ask the questions that are important to you at your next doctor appointment.
Also, check out Steps to Diabetes Goals, a program that provides information on type 2 diabetes, including tips and tools that you may find useful.
Talk to your doctor to see whether Sepamet® XR (sitagliptin and metformin HCl extended-release) or Sepamet® (sitagliptin and metformin HCl) could be right for you.
Selected Risk Information About Sepamet and Sepamet XR
Metformin, one of the ingredients in Sepamet and Sepamet XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking Sepamet or Sepamet XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: you feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual on Screen Detectsleepiness or sleep longer than usual; have sudden stomach or intestinal problems with nausea and vomiting or diarrhea; feel cold, especially in your arms and legs; feel dizzy or lightheaded; or have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicines; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; or if you have surgery, a heart attack, severe infection, or stroke.
Pancreatitis is another serious side effect that can happen in people taking Sepamet or Sepamet XR. Pancreatitis may be severe and lead to death. Before you start taking Sepamet or Sepamet XR, tell your doctor if you've ever had pancreatitis. Stop taking Sepamet or Sepamet XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Do not take Sepamet or Sepamet XR if you are allergic to any of the ingredients in Sepamet or Sepamet XR. Allergic reactions, which may be serious, including rash; hives; and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking Sepamet or Sepamet XR and call your doctor right away.
Do not take Sepamet or Sepamet XR if your kidneys are not working properly. Your doctor will do blood tests before and during your treatment to see how well your kidneys are working.
Tell your doctor if you are going to get an injection of dye or contrast agent for an x-ray procedure; Sepamet or Sepamet XR will need to be stopped for a short time.
If you take Sepamet or Sepamet XR with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.
Kidney problems, sometimes requiring dialysis, have been reported.
Common side effects when taking Sepamet or Sepamet XR include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, headache, and low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Supplier
Sepamet XR is manufactured & supplied by:
Taj Pahrmaceuticals Limited.,
P O Box 33242
Newmarket
Auckland
NEW ZEALAND
www.tajpharma.com
CP-TPL-999898-UUBH(4438A)
Copyright © 2014 TAJ PHARMACEUTICALS LIMITED., a subsidiary of Taj Group.,India Inc. All rights reserved. TAJ PHARMA., PLC. (UAE)
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