ALOGLIPTIN AND PIOGLITAZONE- alogliptin benzoate and pioglitazone hydrochloride tablet, film coated 
Padagis Israel Pharmaceuticals Ltd

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MEDICATION GUIDE

Alogliptin and Pioglitazone Tablets

Read this Medication Guide carefully before you start taking alogliptin and pioglitazone 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 your treatment. If you have any questions about alogliptin and pioglitazone tablets, ask your doctor or pharmacist.

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

Alogliptin and pioglitazone tablets can cause serious side effects, including:

1.
Heart failure: Alogliptin and pioglitazone tablets can cause heart failure and cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.

Before you start taking alogliptin and pioglitazone tablets:

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

Call your doctor right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • swelling or fluid retention, especially in the feet, ankles, or legs

These may be symptoms of heart failure.

2.
Inflammation of the pancreas (pancreatitis): Alogliptin, one of the medicines in alogliptin and pioglitazone tablets, may cause pancreatitis, which may be severe. Certain medical conditions make you more likely to get pancreatitis.

Before you start taking alogliptin and pioglitazone tablets:

Tell your doctor if you have ever had:

  • pancreatitis
  • kidney problems
  • liver problems

Stop taking alogliptin and pioglitazone 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.

What are alogliptin and pioglitazone tablets?

It is not known if alogliptin and pioglitazone tablets are safe and effective in children under the age of 18. Alogliptin and pioglitazone tablets are not recommended for use in children.

Who should not take alogliptin and pioglitazone tablets?

Do not take alogliptin and pioglitazone tablets if you:

If you have these symptoms, stop taking alogliptin and pioglitazone 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 and pioglitazone tablets?

Before you start taking alogliptin and pioglitazone tablets, tell your doctor if you:

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 a new medicine.

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

How should I take alogliptin and pioglitazone tablets?

What are the possible side effects of alogliptin and pioglitazone tablets?

Alogliptin and pioglitazone tablets can cause serious side effects, including:

The most common side effects of alogliptin and pioglitazone tablets include stuffy or runny nose and sore throat, back pain, 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 and pioglitazone 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 and pioglitazone tablets?

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

General information about the safe and effective use of alogliptin and pioglitazone tablets

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not take alogliptin and pioglitazone tablets for a condition for which it was not prescribed. Do not give alogliptin and pioglitazone 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 pioglitazone 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 pioglitazone 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 and pioglitazone tablets?

Active ingredients: alogliptin and pioglitazone.

Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and lactose monohydrate; the tablets are film-coated with hypromellose, polyethylene glycol, titanium dioxide, talc and ferric oxide (yellow and/or red) and are marked with red A1 or gray F1 printing ink.

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

All trademarks are the property of their respective owners

ALS333 R5

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

Revised: 12/2021
Padagis Israel Pharmaceuticals Ltd