Ratio-Glimepiride: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-GLIMEPIRIDE is a medication that is used to treat type 2 diabetes. The chemical name for ratio-GLIMEPIRIDE is “glimepiride”; it belongs to a class of drugs called sulfonylureas.

To properly control your diabetes, it is essential that you follow the diet, exercise and weight loss program recommended by your doctor. It is also important that you test your blood for sugar according to your doctor’s recommendations.

What it does:

ratio-GLIMEPIRIDE is indicated as an addition to proper dietary management, exercise and weight reduction to lower the blood glucose in patients with type 2 diabetes whose high blood sugar levels cannot be controlled by diet and exercise alone.

ratio-GLIMEPIRIDE may be used in combination with metformin when diet and exercise, and ratio-GLIMEPIRIDE or metformin alone do not result in adequate control of blood sugar levels.

ratio-GLIMEPIRIDE is also indicated for use in combination with insulin to lower blood glucose in patients with type 2 diabetes whose high blood sugar levels cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic (a drug used to lower blood sugar levels) agent alone.

When it should not be used:

ratio-GLIMEPIRIDE should not be used

• If you have Type 1 diabetes

• If you have known hypersensitivity or allergy to ratio-

  GLIMEPIRIDE, any sulfonylurea or sulfonamides or any other component of the formulation. See “What the important nonmedicinal ingredients are”.

• If you have diabetic ketoacidosis (an emergency condition

  with high blood glucose levels, a lack of insulin and an accumulation of ketones (chemicals) in the blood and urine), with or without coma. This condition should be treated with insulin.

• If you are pregnant or breast-feeding.

What the medicinal ingredient is:

The medicinal ingredient for ratio-GLIMEPIRIDE is

“glimepiride”.

What the important nonmedicinal ingredients are:

ratio-GLIMEPIRIDE tablets contain the following non-medicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. In addition: ratio-GLIMEPIRIDE 1 mg tablets contain Ferric Oxide, ratio-GLIMEPIRIDE 2 mg tablets contain Ferric Oxide and FD&C Blue #2 Aluminum Lake, and ratio-GLIMEPIRIDE 4 mg tablets contain FD&C Blue #2 Aluminum Lake.

What dosage forms it comes in:

ratio-GLIMEPIRIDE is formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration.

WARNINGS AND PRECAUTIONS

BEFORE you use ratio-GLIMEPIRIDE talk to your doctor or pharmacist if you have kidney, liver, heart or a blood disease called G6PD-deficiency anemia.

• Do not take this medicine if you have had an allergic reaction to ratio-GLIMEPIRIDE or other sulfonylurea drugs or sulfonamides.
• This medicine has been prescribed for you alone because of your medical condition. This or any other prescription medicine should be used only by the person for whom it was prescribed. It should not be shared.
• Wear a medical identification (I.D.) bracelet or neck chain at all times. Also, carry an I.D. card in your wallet or purse that says that you have diabetes and a list of your medicines.

Low blood sugar (hypoglycemia):

• If your blood sugar gets too low, you may feel shaky, weak, drowsy, confused, or very hungry. You may sweat or have blurred vision, a fast heartbeat, trouble concentrating, or a headache that doesn't go away. Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures.

• You may have low blood sugar while you are taking ratio-

  GLIMEPIRIDE, especially if you miss a meal, exercise for a long time, drink alcohol or use another antidiabetic medication or other drugs which can cause low blood sugar when taken with ratio-GLIMEPIRIDE (for examples of such drugs please see the INTERACTIONS WITH THIS MEDICATION section below).

Make sure you know what to do if your blood sugar gets too low (ask your doctor, pharmacist or diabetes educator). Teach your friends, co-workers, or family members what they can do to help you if you have low blood sugar.

Pregnancy and breastfeeding:

ratio-GLIMEPIRIDE should not be used during pregnancy or if you are breastfeeding. Make sure your doctor knows if you are breastfeeding, pregnant, or think you might be pregnant. Your doctor may want you to use insulin during this time.

Driving and Operating Machinery:

Alertness and reactions may be impaired due to low or high blood sugar (hypo- or hyperglycemia), especially when beginning or after changing treatment or when ratio-GLIMEPIRIDE is not taken regularly. This may affect your ability to drive or to operate machinery.

INTERACTIONS WITH THIS MEDICATION

Drugs and foods to avoid:

Ask your doctor or pharmacist before taking any other medicine, including over-the-counter products.

• Avoid drinking alcohol while you are taking this medicine.

• There are various drugs that can interact with ratio-

  GLIMEPIRIDE and cause hypoglycemia, which can be severe. Some of these drugs are acetylsalicylic acid such as Aspirin, “sulfa” drugs (e.g. sulfonamides), warfarin, non-steroidal anti-inflammatory drugs (NSAID), some antibiotics (e.g. clarithromycin, tetracycline) and beta-blockers.

• Some medicines can make it harder for you to control your

  diabetes. These include diuretics (water pills), corticosteroids (such as prednisone), ACE inhibitors (a drug used to treat high blood pressure (hypertension)), birth control pills, and some kinds of cold and allergy drugs.

• If taken at the same time, colesevelam (bile acid binder to

  lower cholesterol) reduces glimepiride absorption which may result in high blood sugar. ratio-GLIMEPIRIDE should be taken at least 4 hours before colesevelam.

• Make sure your doctor and pharmacist knows if you are taking

  these or any other medicines.

PROPER USE OF THIS MEDICATION

Usual dose:

ratio-GLIMEPIRIDE is usually taken once daily, with breakfast or the first main meal of the day. ratio-GLIMEPIRIDE tablets must be swallowed with sufficient amount of liquid (approximately ½ glass), without chewing. Your doctor will prescribe for you how much to take and how often. It is important that you follow your doctor’s instructions carefully.

Missed Dose:

Take the missed dose as soon as possible, unless it is almost time for your next dose.

Do not take two doses at the same time.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects:

As with any type of medication, ratio-GLIMEPIRIDE is associated with some side effects. It may, however, affect different people in different ways. Just because side effects have occurred in other people does not mean you will get them.

If you have problems with these side effects, talk with your doctor or pharmacist:

• Mild nausea or vomiting
• Dizziness
• Low blood sugar (hypoglycemia), see above.
• This medicine may make your skin sensitive to sunlight and could cause a rash or sunburn. Use a sunscreen when outdoors. Avoid using sunlamps or tanning beds.

Call your doctor right away if you have any of these side effects:

• Unexplained fever, chills or sore throat
• Unusual bleeding or bruising
• Yellowing of skin or eyes, dark-colored urine or light-colored bowel movements
• Skin rash or hives
• Oedema, swelling of the legs or unexpected weight gain.

Stop taking the drug and seek medical help immediately if you have:

• Severe allergic reactions (severe skin reaction, swelling of the throat, lips, tongue, difficulty breathing or swallowing)

This is not a complete list of side effects. For any unexpected effects while taking ratio-GLIMEPIRIDE, contact your doctor or pharmacist.

HOW TO STORE IT

How to store these medicine tablets:

• Store the tablets at room temperature (15-30°C), away from heat, moisture, and direct light.
• As with all medicines, keep this product out of the reach of children.
• Do not keep outdated medicine or medicine no longer needed.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available

at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document, plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Teva Canada Limited:

1-800-268-4127 ext 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Toronto, Ontario

Canada, M1B 2K9.

Last revised: November 6, 2014.