ALOGLIPTIN AND METFORMIN HYDROCHLORIDE- alogliptin and metformin hydrochloride tablet, film coated 
Padagis Israel Pharmaceuticals Ltd

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MEDICATION GUIDE

Alogliptin and Metformin HCl Tablets

Read this Medication Guide carefully before you start taking alogliptin and metformin HCl 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 and metformin HCl tablets, ask your doctor or pharmacist.

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

Alogliptin and metformin HCl tablets can cause serious side effects, including:

1.
Lactic Acidosis. Metformin, one of the medicines in alogliptin and metformin HCl tablets, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

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:

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

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

Before you start taking alogliptin and metformin HCl tablets:

Tell your doctor if you have ever had:

  • pancreatitis
  • kidney problems
  • liver problems

Stop taking alogliptin and metformin HCl 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.

3.
Heart failure:

Before you start taking alogliptin and metformin HCl 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 are alogliptin and metformin HCl tablets?

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

Who should not take alogliptin and metformin HCl tablets?

Do not take alogliptin and metformin HCl tablets if you:

Symptoms of a serious allergic reaction to alogliptin and metformin HCl 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 and metformin HCl 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 metformin HCl tablets?

Before you take alogliptin and metformin HCl 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 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?

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

Alogliptin and metformin HCl tablets can cause serious side effects, including:

The most common side effects of alogliptin and metformin HCl tablets include:

  • cold-like symptoms (upper respiratory tract infection)
  • increase in blood pressure
  • urinary tract infection
  • stuffy or runny nose and sore throat
  • headache
  • diarrhea
  • back pain

Taking alogliptin and metformin HCl tablets with food can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment, may be a sign of something more serious.

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 metformin HCl 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 metformin HCl tablets?

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).

What are the ingredients in alogliptin and metformin HCl tablets?

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

ALK334 R6

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

Revised: 12/2021
Padagis Israel Pharmaceuticals Ltd