Janumet (as a combination product containing Metformin, Sitagliptin)

Name: Janumet (as a combination product containing Metformin, Sitagliptin)

What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Metformin may cause side effects. Tell your doctor if any of these symptoms are severe, do not go away, go away and come back, or do not begin for some time after you begin taking metformin:

  • diarrhea
  • bloating
  • stomach pain
  • gas
  • indigestion
  • constipation
  • unpleasant metallic taste in mouth
  • heartburn
  • headache
  • flushing of the skin
  • nail changes
  • muscle pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency treatment:

  • chest pain
  • rash

Metformin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include hypoglycemia symptoms as well as the following:

  • extreme tiredness
  • weakness
  • discomfort
  • vomiting
  • nausea
  • stomach pain
  • decreased appetite
  • deep, rapid breathing
  • shortness of breath
  • dizziness
  • lightheadedness
  • abnormally fast or slow heartbeat
  • flushing of the skin
  • muscle pain
  • feeling cold

Brand names of combination products

  • Actoplus Met® (containing Metformin, Pioglitazone)
  • Avandamet® (containing Metformin, Rosiglitazone)
  • Invokamet® (containing Canagliflozin, Metformin)
  • Janumet® (containing Metformin, Sitagliptin)
  • Jentadueto® (containing Linagliptin, Metformin)
  • Kombiglyze® XR (containing Metformin, Saxagliptin)
  • Metaglip® (containing Glipizide, Metformin)
  • Prandimet® (containing Metformin, Repaglinide)
  • Xigduo® XR (containing Dapagliflozin, Metformin)

How should this medicine be used?

Sitagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take sitagliptin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sitagliptin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sitagliptin helps to control high blood sugar but does not cure diabetes. Continue to take sitagliptin even if you feel well. Do not stop taking sitagliptin without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before taking sitagliptin,

  • tell your doctor and pharmacist if you are allergic to sitagliptin or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin (Lanoxicaps, Lanoxin); insulin; and certain oral medications for diabetes including acetohexamide, chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glycron, Micronase), tolazamide (Tolinase), and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had diabetes , diabetic ketoacidosis (a serious condition that may occur when blood sugar is too high), pancreatitis (swelling of the pancreas), gallstones, high levels of triglycerides (fatty substances) in your blood, or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sitagliptin, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sitagliptin.
  • talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar.
  • talk to your doctor about the symptoms of high and low blood sugar and other complications of diabetes, what to do if you develop these symptoms, and how to prevent these conditions.

What special dietary instructions should I follow?

Be sure to follow all diet and exercise recommendations made by your doctor or dietician.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Brand names

  • Januvia®
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