Kazano (Alogliptin/Metformin)

Serious Warnings and Precautions

KAZANO contains metformin which can rarely cause lactic acidosis. Lactic acidosis can cause death and must be treated in the hospital. Since alcohol may increase the risk of lactic acidosis caused by metformin you should not drink a lot of alcohol if you take KAZANO.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you have any of the following side effects:

Stomach and intestinal side effects, such as nausea, diarrhea, stomach upset, abdominal bloating, gas and appetite loss, are very common with metformin—one of the active ingredients in KAZANO.

The Common side effects that may occur are:

• cold or flu-like symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, body aches, dry cough

• shortness of breath

• pink eye: itchy and red eye(s), with or without discharge

• dry, itchy skin with or without hives, rash

• headache

• indigestion, heartburn

• abdominal pain

• swollen or irritated blood vessels in the anus and rectum (hemorrhoids)

• gallstones

• kidney stones

• bruise

• back pain

• joint pain

• muscle and/or bone pain (including of the chest)

• cramp

• difficulty sleeping

• a metallic taste in your mouth

• stomach pain

• constipation

• nausea

• toothache

• vomiting

• tiredness (fatigue)

• swelling of extremities

• sensation of “pins and needles” or numbness (paresthesia)

• pain, weakness, numbness, or tingling in the leg (sciatica)

• coughing, wheezing shortness of breath, difficulty breathing, with or without fever

• high blood pressure (hypertension)

The Uncommon side effects that may occur are:

• allergic reaction (including severe rash, facial swelling and hives)

• upper abdominal pain that radiates into the back, with or without vomiting, due to a swelling of the pancreas (pancreatitis)

In very rare cases, metformin, one of the medicines in KAZANO can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. You should also stop using KAZANO and call your physician right away if you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital.

The Unknown side effects that may occur are:

• serious rash, involving skin reddening, pain, swelling of lips, eyes or mouth, skin peeling and flu-like symptoms (Stevens-Johnson Syndrome)

• liver problems

KAZANO CAN CAUSE ABNORMAL BLOOD TEST RESULTS. YOUR DOCTOR WILL DECIDE WHEN TO PERFORM TESTS AND WILL INTERPRET THE RESULTS.

Tell your doctor about all the medicines you take, have recently taken or might take including prescription and nonprescription medicines, vitamins, and herbal supplements.

In particular tell your doctor or pharmacist if you are taking any of the following:

• hydrocortisone and prednisolone (corticosteroids) used to treat diseases that involve inflammation like asthma and arthritis

• other diabetes drugs such as glyburide

• furosemide

• nifedipine

• cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)

• other drugs tend to produce hyperglycemia (high blood sugar) and may lead to a loss of blood sugar control. Some example of drugs that can increase the blood sugar include:

  • thiazide and other diuretics (water pills)

  • corticosteroids

  • phenothiazines

  • thyroid products

  • estrogens or estrogens plus progestogen

  • oral contraceptives

  • phenytoin

  • nicotinic acid

  • sympathomimetics

  • calcium channel blocking drugs

  • isoniazid

• cimetidine, used to treat stomach problems

• bronchodilators (beta-2 agonists) which are used to treat asthma

• ramipril, lisinopril and enalapril (ACE inhibitors) used to treat high blood pressure

• iodinated contrast agents or medicines containing alcohol