METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, extended release 
Epic Pharma, LLC

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PATIENT INFORMATION

Metformin Hydrochloride [met-FORE-min HYE-droe-KLOR-ide]
Extended-Release Tablets, USP

Read the Patient Information that comes with metformin hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about metformin hydrochloride extended-release tablets?

Serious side effects can happen in people taking metformin hydrochloride extended-release tablets, including:

Lactic Acidosis. Metformin hydrochloride, the medicine in metformin hydrochloride extended-release tablets, can cause a rare, but serious, side effect 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 metformin hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

You have a higher chance of getting lactic acidosis if you:

Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets have the same active ingredient. However, metformin hydrochloride extended-release tablets work longer in your body. Both of these medicines help control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride extended-release tablets do not cause your body to make more insulin.

Who should not take metformin hydrochloride extended-release tablets?

Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis.

Do not take metformin hydrochloride extended-release tablets if you:

What should I tell my healthcare provider before taking metformin hydrochloride extended-release tablets?

Before taking metformin hydrochloride extended-release tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Can metformin hydrochloride extended-release tablets be used in children?

Metformin hydrochloride extended-release tablets have not been studied in children.

How should I take metformin hydrochloride extended-release tablets?

What should I avoid while taking metformin hydrochloride extended-release tablets?

Do not drink a lot of alcoholic drinks while taking metformin hydrochloride extended-release tablets. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.

What are the side effects of metformin hydrochloride extended-release tablets?

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 the 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 metformin hydrochloride extended-release tablets if you:

Common side effects of metformin hydrochloride extended-release tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they’ve gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.

About 3 out of every 100 people who take metformin hydrochloride extended-release tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

Metformin hydrochloride extended-release tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

How should I store metformin hydrochloride extended-release tablets?

Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Dispense in light-resistant containers.

Keep metformin hydrochloride extended-release tablets and all medicines out of the reach of children.

General information about the use of metformin hydrochloride extended-release tablets

If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about metformin hydrochloride extended-release tablets that is written for healthcare professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use metformin hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not share your medicine with other people.

What are the ingredients of metformin hydrochloride extended-release tablets?

Active ingredients of metformin hydrochloride extended-release tablets: metformin hydrochloride.

Inactive ingredients in each tablet of metformin hydrochloride extended-release tablets 500 mg: carboxymethylcellulose sodium, hypromellose, microcrystalline cellulose, and magnesium stearate.

Inactive ingredients in each tablet of metformin hydrochloride extended-release tablets 750 mg: carboxymethylcellulose sodium, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, and magnesium stearate.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

Talk to your healthcare provider about how to prevent, recognize, and take care of low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.

Manufactured by:
Yichang Humanwell Oral Solid Dosage Plant
Yichang, Hubei, China 443112

Distributed by:
Epic Pharma, LLC
Laurelton, NY 11413

Revised: 06/2020

Revised: 5/2022
Epic Pharma, LLC