Gliclazide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, circulation problems, and decreased sexual ability.

Gliclazide belongs to the class of drugs known as sulfonylureas. It works by causing the release of your body's natural insulin.

Read the Patient Information Leaflet if available from your pharmacist before you start using gliclazide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication comes in an immediate-release form and a modified-release form. The dosing is not the same. Do not use one form of this medication in place of the other.

If you are using the immediate-release form, take it by mouth with a meal as directed by your doctor, usually 1 to 3 times a day.

If you are using the modified-release form, take it as directed by your doctor, usually once daily with breakfast. Do not crush or chew the modified-release form of this drug. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split modified-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet with a glass of cool water, without crushing or chewing.

The dosage is based on your medical condition and response to treatment. Your doctor will adjust your dose based on your blood sugar to find the best dose for you. Follow your doctor's directions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition lasts or gets worse (such as if blood sugar readings are too high or too low).

Nausea, stomach upset, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as sore throat that doesn't go away, fever)
• easy bleeding/bruising
• unusual/sudden weight gain
• mental/mood changes
• swelling of the hands/ankles/feet
• severe stomach/abdominal pain
• dark urine
• unusual tiredness/weakness
• yellowing eyes/skin

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction right away. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking gliclazide, tell your doctor or pharmacist if you are allergic to it; or to other sulfonylureas such as glipizide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• use/abuse of alcohol
• bleeding problems
• liver problems
• kidney problems
• certain metabolic problem (porphyria)
• certain hormonal conditions (adrenal/pituitary insufficiency, thyroid disease)

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar. Rarely, alcohol can interact with gliclazide and cause a serious reaction with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. If you notice any of these effects, tell your doctor right away.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Older adults may be more sensitive to the side effects of the drug, especially low blood sugar.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using gliclazide. Gliclazide may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Beta blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Lab and/or medical tests (such as kidney/liver function, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments. Check your blood sugar regularly as directed and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).