MEDICATION GUIDE
Alogliptin Tablets

Read this Medication Guide carefully before you start taking alogliptin tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about alogliptin tablets, ask your doctor or pharmacist.

What is the most important information I should know about alogliptin tablets?

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.

   Before you start taking alogliptin tablets:

   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.

2. Heart failure:

    

   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.

Who should not take alogliptin tablets?

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. See the end of this Medication Guide for a complete list of the ingredients in alogliptin tablets.

  Symptoms of a serious allergic reaction to alogliptin tablets may include:

  swelling of your face, lips, throat and other areas on your skin raised, red areas on your skin (hives)

  difficulty with swallowing or breathing skin rash, itching, flaking or peeling

  If you have any of these symptoms, stop taking alogliptin tablets and contact your doctor or go to the nearest hospital emergency room right away.

What should I tell my doctor before and during treatment with 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 not take 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.

What are the possible side effects of alogliptin tablets?

Alogliptin tablets can cause serious side effects, including:

See "What is the most important information I should know about alogliptin tablets?"

• Allergic (hypersensitivity) reactions such as:

  swelling of your face, lips, throat and other areas on your skin raised, red areas on your skin (hives)

  difficulty swallowing or breathing skin rash, itching, flaking or peeling

  If you have these symptoms, stop taking alogliptin tablets and contact your doctor right away.

• Liver problems. Call your doctor right away if you have unexplained symptoms, such as:

  nausea or vomiting loss of appetite

  stomach pain dark urine

  unusual or unexplained tiredness yellowing of your skin or the whites of your eyes

• Low blood sugar (hypoglycemia). If you take alogliptin tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take alogliptin tablets. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor. Signs and symptoms of low blood sugar include:

  shaking or feeling jittery fast heartbeat

  sweating change in vision

  hunger confusion

  headache dizziness

  change in mood

• Joint pain. Some people who take medicines called DPP-4 inhibitors like alogliptin tablets may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
• Skin reaction. Some people who take medicines called DPP-4 inhibitors, like alogliptin tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking alogliptin tablets.

The most common side effects of alogliptin tablets include stuffy or runny nose and sore throat, headache, or cold-like symptoms (upper respiratory tract infection).

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of alogliptin tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store alogliptin tablets?

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).

What are the ingredients in alogliptin tablets?

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