LINAGLIPTIN AND METFORMIN HYDROCHLORIDE - linagliptin and metformin hydrochloride tablet, film coated 
Novadoz Pharmaceuticals LLC

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MEDICATION GUIDE



Linagliptin and metformin hydrochloride Tablets
(LIN-a-GLIP-tin and met-FOR-min HYE-droe-KLOR-ide) 
for oral use 

 What is the most important information I should know about linagliptin and metformin hydrochloride tablets?
Linagliptin and metformin hydrochloride tablets  can cause serious side effects, including:
1. Lactic acidosis. Metformin hydrochloride (HCl), one of the medicines in linagliptin and metformin hydrochloride tablets, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
Stop taking linagliptin and metformin hydrochloride tablets and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis:
  •  feel very weak and tired                                              
  •  have unusual sleepiness or sleep longer than usual
  •  have unusual (not normal) muscle pain                     
  •  feel cold, especially in your arms and legs
  •  have trouble breathing                                               
  •  feel dizzy or lightheaded
  •  have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea 
  •  have a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis with linagliptin and metformin hydrochloride tablets if you:
  •  have severe kidney problems. 
  •  have liver problems.
  •  drink a lot of alcohol (very often or 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 certain x-ray tests with injectable dyes or contrast agents. 
   •   have surgery or other procedures for which you need to restrict the amount of food and liquid you eat and drink. 
   •   have congestive heart failure.
   •   have a heart attack, severe infection, or stroke.
   •   are 65 years of age or older.
Tell your healthcare provider if you have any of the problems in the list above. Tell your healthcare provider that you are taking linagliptin and metformin hydrochloride before you have surgery or x-ray tests. Your healthcare provider may decide to stop your linagliptin and metformin hydrochloride tablets for a while if you have surgery or certain x-ray tests. Linagliptin and metformin hydrochloride tablets can have other serious side effects. See “What are the possible side effects of linagliptin and metformin hydrochloride tablets?”
2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking linagliptin and metformin hydrochloride tablets, tell your healthcare provider if you have ever had:
   • inflammation of your pancreas (pancreatitis)       •   stones in your gallbladder (gallstones)
   • a history of alcoholism                                       •    high blood triglyceride levels
Stop taking linagliptin and metformin hydrochloride tablets and call your healthcare provider 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 to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
What are linagliptin and metformin hydrochloride tablets?
  • Linagliptin and metformin hydrochloride tablets are a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin HCl. Linagliptin and metformin hydrochloride tablets can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus.
  •  Linagliptin and metformin hydrochloride tablets are not for people with type 1 diabetes mellitus.
  • If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take linagliptin and  metformin hydrochloride tablets.
  • It is not known if linagliptin and metformin hydrochloride tablets are safe and effective in children.

Who should not take linagliptin and metformin hydrochloride tablets?
 Do not take linagliptin and metformin hydrochloride tablets if you:
   • have severe kidney problems.
   • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
   • are allergic to linagliptin metformin, or any of the ingredients in linagliptin and metformin hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in linagliptin and metformin hydrochloride tablets.
Symptoms of a serious allergic reaction to linagliptin and metformin hydrochloride tablets may include:
      o  skin rash, itching, flaking or peeling
      o   raised red patches on your skin (hives)
      o   swelling of your face, lips, tongue and throat that may cause difficulty in breathing or swallowing
      o    difficulty with swallowing or breathing
If you have any of these symptoms, stop taking linagliptin and metformin hydrochloride tablets and call your healthcare provider right away or go to the nearest hospital emergency room.

What should I tell my healthcare provider before taking linagliptin and metformin hydrochloride tablets? 
Before taking linagliptin and metformin hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you:
   • have or have had inflammation of your pancreas (pancreatitis).
   • have kidney problems.
   • have liver problems.
   • have heart problems, including congestive heart failure.
   • are 65 years of age or older.
  • drink alcohol very often, or drink a lot of alcohol in short term (“binge” drinking).
  • are going to get an injection of dye or contrast agents for an x-ray procedure. Linagliptin and metformin hydrochloride tablets may need to be stopped for a short time. Talk to your healthcare provider about when you should stop linagliptin and metformin hydrochloride tablets and when you should start linagliptin and metformin hydrochloride tablets again. See “What is the most important information I should know about linagliptin and metformin hydrochloride tablets?”
  • have type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets should not be used to treat people with type 1 diabetes mellitus.
  • have low levels of vitamin B12 in your blood. 
  • are pregnant or plan to become pregnant. It is not known if linagliptin and metformin hydrochloride tablets will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
  •  are breastfeeding or plan to breastfeed. Linagliptin and metformin hydrochloride may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take linagliptin and metformin hydrochloride tablets.
  • are a person who has not gone through menopause (premenopausal) who does not have periods regularly or at all. Linagliptin and metformin hydrochloride tablets can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant. Tell your healthcare provider right away if you become pregnant while taking linagliptin and metformin hydrochloride tablets.
    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Linagliptin and metformin hydrochloride tablets may affect the way other medicines work, and other medicines may affect how linagliptin and metformin hydrochloride tablets works.
    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take linagliptin and metformin hydrochloride tablets?
   •  Take linagliptin and metformin hydrochloride tablets exactly as your healthcare provider tells you to take it.
  •  Take linagliptin and metformin hydrochloride tablets 2 times each day with meals. Taking linagliptin and metformin hydrochloride tablets with  meals may lower your chance of having an upset stomach.
  • If you miss a dose, take it with food as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of linagliptin and metformin hydrochloride tablets at the same time.
  • If you take too much linagliptin and metformin hydrochloride tablets, call your healthcare provider or local poison control center or go to the nearest hospital emergency room right away.
  • Your healthcare provider may tell you to take linagliptin and metformin hydrochloride tablets along with other diabetes medicines. Low blood sugar can happen more often when linagliptin and metformin hydrochloride tablets are taken with certain other diabetes medicines. See “What are the possible side effects of linagliptin and metformin hydrochloride tablets?”
  • Your healthcare provider will do blood tests to check how well your kidneys are working before and during your treatment with linagliptin and metformin hydrochloride tablets.

What should I avoid while taking linagliptin and metformin hydrochloride tablets? 
Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

What are the possible side effects of linagliptin and metformin hydrochloride tablets? 
Linagliptin and metformin hydrochloride tablets may cause serious side effects, including:
 • See “What is the most important information I should know about linagliptin and metformin hydrochloride tablets?”
Low blood sugar (hypoglycemia). If you take linagliptin and metformin hydrochloride 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 linagliptin and metformin hydrochloride tablets. Signs and symptoms of low blood sugar may include:
  o headache o irritability  o drowsiness  o hunger        o weakness 
  o fast heartbeat o dizziness  o sweating  o confusion  o shaking or feeling jittery 
• Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking linagliptin and metformin hydrochloride tablets. Symptoms may include:
     o swelling of your face, lips, tongue, throat, and other areas on your skin o difficulty with swallowing or breathing
     o raised, red areas on your skin (hives) o    skin rash, itching, flaking, or peeling
If you have any of these symptoms, stop taking linagliptin and metformin hydrochloride tablets and call your healthcare provider right away or go to the nearest hospital emergency room.
    • Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.
   • Joint pain. Some people who take linagliptin, one of the medicines in linagliptin and metformin hydrochloride tablets, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
   • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in linagliptin and metformin hydrochloride tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking linagliptin and metformin hydrochloride tablets.
   • Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking linagliptin and metformin hydrochloride 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 you lie down
    •  swelling or fluid retention, especially in the feet, ankles or legs
    •  an unusually fast increase in weight 
    • unusual tiredness
These may be symptoms of heart failure.
The most common side effects of linagliptin and metformin hydrochloride tablets include:     
    • stuffy or runny nose and sore throat 
    • diarrhea
Tell your healthcare provider if you have any side effects that bother you or that do not go away.
These are not all the possible side effects of linagliptin and metformin hydrochloride tablets. For more information, ask your healthcare provider 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 linagliptin and metformin hydrochloride tablets?
  •  Store linagliptin and metformin hydrochloride tablets at room temperature between 68°F and 77°F (20°C and 25°C).
  •  Keep tablets dry.
  •  Keep linagliptin and metformin hydrochloride tablets and all medicines out of the reach of children. 

General information about the safe and effective use of linagliptin and metformin hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use linagliptin and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give linagliptin and metformin hydrochloride tablets to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about linagliptin and metformin hydrochloride tablets that is written for health professionals.

What are the ingredients in linagliptin and metformin hydrochloride tablets?
Active Ingredients: linagliptin and metformin hydrochloride 
Inactive Ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, magnesium stearate, meglumine, povidone, propylene glycol, titanium dioxide, talc.
2.5 mg/500 mg and 2.5 mg/850 mg tablets also contain yellow iron oxide.
2.5 mg/850 mg and 2.5 mg/1,000 mg tablets also contain red iron oxide. 

Manufactured by:
MSN Laboratories Private Limited
Telangana - 509 228,
INDIA 

Distributed by:
Novadoz Pharmaceuticals LLC.
Piscataway, NJ 08854 -3714 

The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse Novadoz Pharmaceuticals LLC.. 

For more information about linagliptin and metformin hydrochloride tablets, including current prescribing information and Medication Guide, go to www.novadozpharma.com or call 1-855-668-2369.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                      Issued: 11/2025


Revised: 11/2025
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Version: 1
Effective Time: 20251104
Novadoz Pharmaceuticals LLC