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ALOGLIPTIN tablet, film coated


  1. Serious Side Effects Can Happen To People Taking Alogliptin Tablets, Including:
  2. Tell Your Doctor If You Have Ever Had:
  3. Before You Start Taking Alogliptin Tablets:
  4. Contact Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms:
  5. What Is Alogliptin Tablets?
  6. Do Not Take Alogliptin Tablets If You:
  7. Before You Take Alogliptin Tablets, Tell Your Doctor If You:
  8. How Should I Take Alogliptin Tablets?
  9. Alogliptin Tablets Can Cause Serious Side Effects, Including:
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. Patient Information

Serious Side Effects Can Happen To People Taking Alogliptin Tablets, Including: 

  1. Inflammation of the pancreas (pancreatitis): Alogliptin tablets may cause pancreatitis which may be severe.

    Certain medical conditions make you more likely to get pancreatitis.

Tell Your Doctor If You Have Ever Had: 

  • pancreatitis
  • kidney problems
  • liver problems

Stop taking alogliptin tablets 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.

Before You Start Taking Alogliptin Tablets: 

Tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.

Contact Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms: 

  • increasing shortness of breath or trouble breathing especially when lying down
  • an unusually fast increase in weight
  • swelling of feet, ankles, or legs

These may be symptoms of heart failure.

What Is Alogliptin Tablets? 

  • Alogliptin tablets is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
  • Alogliptin tablets are unlikely by themselves to cause your blood sugar to be lowered to a dangerous level (hypoglycemia). However, hypoglycemia may still occur with alogliptin tablets.
  • Alogliptin tablets are not for people with type 1 diabetes.
  • Alogliptin tablets are not for people with diabetic ketoacidosis (increased ketones in blood or urine).

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

Do Not Take Alogliptin Tablets If You: 

  • Are allergic to any ingredients in alogliptin tablets or have had a serious allergic (hypersensitivity) reaction to alogliptin tablets.

Before You Take Alogliptin Tablets, Tell Your Doctor If You: 

  • have or have had inflammation of your pancreas (pancreatitis)
  • have kidney or liver problems
  • have other medical conditions
  • are pregnant or plan to become pregnant.It is not known if alogliptin tablets can 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 passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking alogliptin 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 tablets may affect the way other medicines work, and other medicines may affect how alogliptin tablets work. Contact your doctor before you start or stop other types of medicines.

How Should I Take Alogliptin Tablets? 

  • Take alogliptin tablets exactly as your doctor tells you to take it.
  • Take alogliptin tablets 1 time each day with or without food.
  • 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 nottake 2 doses of alogliptin tablets at the same time.
  • If you take too many alogliptin 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 tablets and during treatment as needed. Your doctor may change your dose of alogliptin 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.

Alogliptin Tablets Can Cause Serious Side Effects, Including: 

Store alogliptin tablets at room temperature between 68 F to 77 F (20 C to 25 C).

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

General information about the safe and effective use of alogliptin tablets

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

This Medication Guide summarizes the most important information about alogliptin tablets. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about alogliptin 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 Ingredient: 

alogliptin

Inactive Ingredients: 

mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate. In addition, the film-coating contains the following inactive ingredients: hypromellose, titanium dioxide, ferric oxide (red or yellow) and polyethylene glycol and is marked with gray F1 printing ink

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

All trademarks are the property of their respective owners.

ALO332 R5

This Medication Guide has been approved by the U.S. Food and Drug Administration.
12/2016

Patient Information 

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

Inform patients of the potential risks and benefits of alogliptin tablets.

Patients should be informed that acute pancreatitis has been reported during use of alogliptin tablets. 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 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 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 tablets. 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 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 tablets. If signs or symptoms of liver injury occur, patients should be instructed to discontinue alogliptin tablets and seek medical advice promptly.

Inform patients that hypoglycemia can occur, particularly when an insulin secretagogue or insulin is used in combination with alogliptin 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 (5.7)].

Instruct patients to take alogliptin tablets only as prescribed. If a dose is missed, advise patients not to double their next dose.

Instruct patients to read the Medication Guide before starting alogliptin 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.

ALO332 R5



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