JANUMET (Janumet)1000/50 mg – 30 tablet

Sitagliptin and Metformin Information

What is this drug used for?

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

Possible side effects

Sitagliptin and Metformin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Stomach pain or heartburn.
• Upset stomach or throwing up.
• Diarrhea.
• Gas.
• Feeling tired or weak.
• Headache.
• Signs of a common cold.
• Nose or throat irritation.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

All products:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Severe and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. This could happen at any time during treatment. Signs of pancreatitis include very bad stomach pain, very bad back pain, or very upset stomach or throwing up. Call your doctor right away if you have any of these signs.
• It is common to have stomach problems like upset stomach, throwing up, or diarrhea when you start taking this drug. If you have stomach problems later during treatment, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis).
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Drugs like this one may cause joint pain that can be very bad and disabling. Call your doctor right away if you have very bad joint pain or any joint pain that does not go away.

Extended-release tablets:

• You may see something that looks like the tablet in your stool. If you see tablets in your stool a lot, talk with your doctor.

Medication Safety Issues

Sound-alike/look-alike issues:

Storage and Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Adverse Reactions

Also see individual agents.

1% to 10%:

Central nervous system: Headache (6%)

Gastrointestinal: Diarrhea (8%), nausea (5%), abdominal pain (3%), vomiting (2%)

Respiratory: Upper respiratory tract infection (6%)

<1%, postmarketing and/or case reports: Arthralgia, back pain, constipation, hypersensitivity reaction (including anaphylaxis, angioedema, skin rash, urticaria, hypersensitivity angiitis, exfoliative skin conditions [including Stevens-Johnson syndrome]), increased liver enzymes, lactic acidosis, limb pain, myalgia, oral mucosa ulcer, pancreatitis (including hemorrhagic or necrotizing), pemphigoid, pruritus, renal failure, renal insufficiency, severe arthralgia (FDA Safety Alert, Aug 28, 2015), stomatitis –