GLIPIZIDE AND METFORMIN HYDROCHLORIDE Tablet, Film Coated [Teva Pharmaceuticals USA Inc]

Glipizide (GLIP-i-zide) and Metformin Hydrochloride (met-FOR-min hye-dro-KLOR-ide) Tablets USP

Rx only

Q1. Why do I need to take glipizide and metformin hydrochloride tablets?

Your doctor has prescribed glipizide and metformin hydrochloride tablets to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.

Q2. What is type 2 diabetes?

People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.

Q3. Why is it important to control type 2 diabetes?

The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications, such as heart disease, kidney disease, or blindness.

Q4. How is type 2 diabetes usually controlled?

High blood sugar can be lowered by diet and exercise, a number of oral medications, and insulin injections. Before taking glipizide and metformin hydrochloride tablets you should first try to control your diabetes by exercise and weight loss. Even if you are taking glipizide and metformin hydrochloride tablets, you should still exercise and follow the diet recommended for your diabetes.

Q5. Does glipizide and metformin hydrochloride tablets work differently from other glucose-control medications?

Yes, it does. Glipizide and metformin hydrochloride tablets combine 2 glucose-lowering drugs, glipizide and metformin. These 2 drugs work together to improve the different metabolic defects found in type 2 diabetes. Glipizide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you to achieve better glucose control.

Q6. What happens if my blood sugar is still too high?

When blood sugar cannot be lowered enough by glipizide and metformin hydrochloride tablets, your doctor may prescribe injectable insulin or take other measures to control your diabetes.

Q7. Can glipizide and metformin hydrochloride tablets cause side effects?

Glipizide and metformin hydrochloride tablets, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to glipizide and metformin hydrochloride tablets (see Question Nos. 9 to 13).

Q8. What are the most common side effects of glipizide and metformin hydrochloride tablets?

The most common side effects of glipizide and metformin hydrochloride tablets are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your glipizide and metformin hydrochloride tablets with meals can help reduce these side effects.

Symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.

Q9. Are there any serious side effects that glipizide and metformin hydrochloride tablets can cause?

People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take glipizide and metformin hydrochloride tablets may develop hemolytic anemia (fast breakdown of red blood cells). G6PD deficiency usually runs in families. Tell your doctor if you or any members of your family have been diagnosed with G6PD deficiency before you start taking glipizide and metformin hydrochloride tablets.

Glipizide and metformin hydrochloride tablets rarely cause serious side effects. The most serious side effect that glipizide and metformin hydrochloride tablets can cause is called lactic acidosis.

Q10. What is lactic acidosis and can it happen to me?

Lactic acidosis is caused by a buildup of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about 1 in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.

It’s also important for your liver to be working normally when you take glipizide and metformin hydrochloride tablets. Your liver helps remove lactic acid from your bloodstream.

Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.

There is no evidence that glipizide and metformin hydrochloride tablets cause harm to the kidneys or liver.

Q11. Are there other risk factors for lactic acidosis?

Your risk of developing lactic acidosis from taking glipizide and metformin hydrochloride tablets is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your doctor.

You should not take glipizide and metformin hydrochloride tablets if:

•

You have chronic kidney or liver problems

•

You have congestive heart failure which is treated with medications, e.g., digoxin (Lanoxin ®) or furosemide (Lasix ®)

•

You drink alcohol excessively (all the time or short-term “binge” drinking)

•

You are seriously dehydrated (have lost a large amount of body fluids)

•

You are going to have certain x-ray procedures with injectable contrast agents

•

You are going to have surgery

•

You develop a serious condition, such as a heart attack, severe infection, or stroke

•

You are ≥ 80 years of age and have NOT had your kidney function tested

Q12. What are the symptoms of lactic acidosis?

Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain; trouble breathing; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or lightheaded; or suddenly developing a slow or irregular heartbeat.

If you notice these symptoms, or if your medical condition has suddenly changed, stop taking glipizide and metformin hydrochloride tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.

Q13. What does my doctor need to know to decrease my risk of lactic acidosis?

Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking glipizide and metformin hydrochloride tablets temporarily.

You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Glipizide and metformin hydrochloride tablet therapy will need to be stopped temporarily in such instances.

Q14. Can I take glipizide and metformin hydrochloride tablets with other medications?

Remind your doctor that you are taking glipizide and metformin hydrochloride tablets when any new drug is prescribed or a change is made in how you take a drug already prescribed.

Glipizide and metformin hydrochloride tablets may interfere with the way some drugs work and some drugs may interfere with the action of glipizide and metformin hydrochloride tablets.

Q15. What if I become pregnant while taking glipizide and metformin hydrochloride tablets?

Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take glipizide and metformin hydrochloride tablets during pregnancy.

Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of glipizide and metformin hydrochloride tablets if you are nursing a child.

Q16. How do I take glipizide and metformin hydrochloride tablets?

Your doctor will tell you how many glipizide and metformin hydrochloride tablets to take and how often.

This should also be printed on the label of your prescription. You will probably be started on a low dose of glipizide and metformin hydrochloride tablets and your dosage will be increased gradually until your blood sugar is controlled.

Q17. Where can I get more information about glipizide and metformin hydrochloride tablets?

This leaflet is a summary of the most important information about glipizide and metformin hydrochloride tablets.

If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as glipizide and metformin hydrochloride tablets and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 9777402, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. D 12/2015

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GLIPIZIDE AND METFORMIN HYDROCHLORIDE Tablet, Film Coated [Teva Pharmaceuticals USA Inc]