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ALOGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated


  1. Patient Information
  2. Call Your Doctor Right Away If You Have Any Of The Following Symptoms, Which Could Be Signs Of Lactic Acidosis:
  3. Most People Who Have Had Lactic Acidosis With Metformin Have Other Things That, Combined With Metformin, Led To The Lactic Acidosis. Tell Your Doctor If You Have Any Of The Following, Because You Have A Higher Chance For Getting Lactic Acidosis With Alogliptin And Metformin Hcl Tablets If You:
  4. Do Not Take Alogliptin And Metformin Hcl Tablets If You:
  5. Before You Take Alogliptin And Metformin Hcl Tablets, Tell Your Doctor If You:
  6. How Should I Take Alogliptin And Metformin Hcl Tablets?
  7. Alogliptin And Metformin Hcl Tablets Can Cause Serious Side Effects, Including:
  8. Active Ingredients:
  9. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

  • Inform patients of the potential risks and benefits of alogliptin and metformin HCl tablets.
  • The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted inWarnings and Precautions (5.1), should be explained to patients. Patients should be advised to discontinue alogliptin and metformin HCl tablets immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of alogliptin and metformin HCl tablets, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to recur. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
  • Patients should be informed that acute pancreatitis has been reported during use of alogliptin. Patients should be informed that persistent, severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue alogliptin and metformin HCl tablets and contact their physician if persistent severe abdominal pain occurs.
  • Patients should be informed of the signs and symptoms of heart failure. Before initiating alogliptin and metformin HCl tablets, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Patients should be instructed to contact their healthcare providers as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight, or swelling of the feet.
  • Patients should be informed that allergic reactions have been reported during use of alogliptin and metformin. If symptoms of allergic reactions (including skin rash, hives and swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing) occur, patients should be instructed to discontinue alogliptin and metformin HCl tablets and seek medical advice promptly.
  • Patients should be informed that postmarketing reports of liver injury, sometimes fatal, have been reported during use of alogliptin. If signs or symptoms of liver injury occur, patients should be instructed to discontinue alogliptin and metformin HCl tablets and seek medical advice promptly.
  • Patients should be informed about the importance of regular testing of renal function and hematological parameters when receiving treatment with alogliptin and metformin HCl tablets.
  • Instruct patients to inform their doctor that they are taking alogliptin and metformin HCl tablets prior to any surgical or radiological procedure, as temporary discontinuation of alogliptin and metformin HCl tablets may be required until renal function has been confirmed to be normal[seeWarnings and Precautions (5.1)].
  • Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving alogliptin and metformin HCl tablets.
  • Inform patients that hypoglycemia can occur, particularly when an insulin secretagogue or insulin is used in combination with alogliptin and metformin HCl tablets. Explain the risks, symptoms and appropriate management of hypoglycemia.
  • Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs.
  • Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur[seeWarnings and Precautions (5.10)].
  • Instruct patients to take alogliptin and metformin HCl tablets only as prescribed twice daily. Alogliptin and metformin HCl tablets should be taken with food. If a dose is missed, advise patients not to double their next dose.
  • Patients should be informed that the tablets must never be split.
  • Inform female patients that treatment with metformin may result in an unintended pregnancy in some premenopausal anovulatory females due to its effects on ovulation[seeUse in Specific Populations (8.3)].

Instruct patients to read the Medication Guide before starting alogliptin and metformin HCl tablets therapy and to reread each time the prescription is refilled. Instruct patients to inform their healthcare provider if an unusual symptom develops or if a symptom persists or worsens.

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Call Your Doctor Right Away If You Have Any Of The Following Symptoms, Which Could Be Signs Of Lactic Acidosis: 

  • you feel cold in your hands or feet
  • you feel dizzy or lightheaded
  • you have a slow or irregular heartbeat
  • you feel very weak or tired
  • you have unusual (not normal) muscle pain
  • you have trouble breathing
  • you feel sleepy or drowsy
  • you have stomach pains, nausea or vomiting

Most People Who Have Had Lactic Acidosis With Metformin Have Other Things That, Combined With Metformin, Led To The Lactic Acidosis. Tell Your Doctor If You Have Any Of The Following, Because You Have A Higher Chance For Getting Lactic Acidosis With Alogliptin And Metformin Hcl Tablets If You: 

  • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
  • have liver problems
  • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking
  • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids
  • have surgery
  • have a heart attack, severe infection, or stroke

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems listed above. You doctor may decide to stop alogliptin and metformin HCl tablets for a while if you have any of these things.

Alogliptin and metformin HCl tablets can have other serious side effects.

  • Alogliptin and metformin HCl tablets contain 2 prescription diabetes medicines, alogliptin (NESINA) and metformin hydrochloride.
  • Alogliptin and metformin HCl tablets are a prescription medicine used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
  • Alogliptin and metformin HCl tablets are not for people with type 1 diabetes.
  • Alogliptin and metformin HCl tablets are not for people with diabetic ketoacidosis (increased ketones in blood or urine).

It is not known if alogliptin and metformin HCl tablets are safe and effective in children under the age of 18.

Do Not Take Alogliptin And Metformin Hcl Tablets If You: 

  • have severe kidney problems
  • have a condition called metabolic acidosis or have had diabetic ketoacidosis (increased ketones in your blood or urine)
  • are going to get an injection of dye or contrast agents for an x-ray procedure, alogliptin and metformin HCl tablets may need to be stopped for a short time. Talk to your doctor about when you should stop alogliptin and metformin HCl tablets and when you should start alogliptin and metformin HCl tablets again
  • are allergic to alogliptin or metformin or any of the ingredients in alogliptin and metformin HCl tablets or have had a serious allergic (hypersensitivity) reaction to alogliptin or metformin.

Before You Take Alogliptin And Metformin Hcl Tablets, Tell Your Doctor If You: 

  • have or have had inflammation of your pancreas (pancreatitis)
  • have severe kidney or liver problems
  • have heart problems, including congestive heart failure
  • are going to get an injection of dye or contrast agents for an x-ray procedure, alogliptin and metformin HCl tablets may need to be stopped for a short time. Talk to your doctor about when you should stop alogliptin and metformin HCl tablets and when you should start alogliptin and metformin HCl tablets again
  • drink alcohol very often or drink a lot of alcohol in short-term "binge" drinking
  • have other medical conditions
  • are pregnant or plan to become pregnant. It is not known if alogliptin and metformin HCl tablets will harm your unborn baby. Talk with your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known whether alogliptin and metformin pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking alogliptin and metformin HCl tablets

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist before you start any new medicine.

Alogliptin and metformin HCl tablets may affect the way other medicines work, and other medicines may affect how alogliptin and metformin HCl tablets work. Contact your doctor before you start or stop other types of medicines.

How Should I Take Alogliptin And Metformin Hcl Tablets? 

  • Take alogliptin and metformin HCl tablets exactly as your doctor tells you to take it.
  • Take alogliptin and metformin HCl tablets 2 times each day.
  • Take alogliptin and metformin HCl tablets with food to lower your chances of having an upset stomach.
  • Do not break or cut alogliptin and metformin HCl tablets before swallowing.
  • Your doctor may need to change your dose of alogliptin and metformin HCl tablets to control your blood glucose. Do not change your dose unless told to do so by your doctor.
  • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular time. Do not take 2 doses of alogliptin and metformin HCl tablets at the same time.
  • If you take too many alogliptin and metformin HCl tablets, call your doctor or go to the nearest hospital emergency room right away.
  • If your body is under stress, such as from fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
  • Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
  • Your doctor may do certain blood tests before you start alogliptin and metformin HCl tablets and during treatment as needed. Your doctor may ask you to stop taking alogliptin and metformin HCl tablets based on the results of your blood tests due to how well your kidneys are working.
  • Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

What are the possible side effects of alogliptin and metformin HCl tablets?

Alogliptin And Metformin Hcl Tablets Can Cause Serious Side Effects, Including: 

    • Store alogliptin and metformin HCl tablets at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep the container of alogliptin and metformin HCl tablets tightly closed.

    Keep alogliptin and metformin HCl tablets and all medicines out of the reach of children.

    General information about the safe and effective use of alogliptin and metformin HCl tablets

    Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not take alogliptin and metformin HCl tablets for a condition for which it was not prescribed. Do not give alogliptin and metformin HCl tablets to other people, even if they have the same symptoms you have. They may harm them.

    This Medication Guide summarizes the most important information about alogliptin and metformin HCl tablets. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about alogliptin and metformin HCl tablets that is written for health professionals.

    For more information go to www.perrigo.com or call 1-877-TAKEDA-7 (1-877-825-3327).

Active Ingredients: 

alogliptin and metformin hydrochloride

Inactive Ingredients: 

mannitol, microcrystalline cellulose, povidone, crospovidone and magnesium stearate; the tablets are film-coated with hypromellose 2910, talc, titanium dioxide and ferric oxide yellow.

Distributed By
Perrigo
Allegan, MI 49010 www.perrigo.com

All trademarks are the property of their respective owners

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This Medication Guide has been approved by the U.S. Food and Drug Administration.
2/2017



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