Patient Medication Information: uses, side effects, how to take - Novo-Glimepiride
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-GLIMEPIRIDE (glimepiride) is a medication that is used to treat Type 2 Diabetes. The chemical name for NOVO-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:
NOVO-GLIMEPIRIDE (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.
NOVO-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 agent (a drug used to lower blood sugar levels) alone.
When it should not be used:
NOVO-GLIMEPIRIDE should not be used:
- If you have Type 1 Diabetes.
If you have known hypersensitivity or allergy to
any sulfonylurea 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 NOVO-GLIMEPIRIDE is “glimepiride”.
What the nonmedicinal ingredients are:
NOVO-GLIMEPIRIDE tablets contain the following non medicinal ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, and sodium starch glycolate. In addition: NOVO-GLIMEPIRIDE 1 mg tablets contain Ferric Oxide, NOVO-GLIMEPIRIDE 2 mg tablets contain FD&C Blue #2 Aluminum Lake and Ferric Oxide, and NOVO-GLIMEPIRIDE 4 mg tablets contain FD&C Blue #2 Aluminum Lake.
What dosage forms it comes in:
NOVO-GLIMEPIRIDE (glimepiride) is formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration.
WARNINGS AND PRECAUTIONS
BEFORE you use NOVO-GLIMEPIRIDE talk to your doctor or pharmacist if you have kidney, liver, or heart disease.
- Do not take this medicine if you have had an allergic reaction to NOVO-GLIMEPIRIDE or other sulfonylurea drugs.
- 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 include disorientation, loss of consciousness and seizures.
You may have low blood sugar while you are taking NOVO-GLIMEPIRIDE, especially if you miss a meal, exercise for a long time, drink alcohol or use another antidiabetic medication with NOVO-GLIMEPIRIDE. 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:
NOVO-GLIMEPIRIDE should not be used during pregnancy or if you are breast feeding. Make sure your doctor knows if you are breast feeding, pregnant, or think you might be pregnant. Your doctor may want you to use insulin during this time.
Driving a vehicle or operating machinery: Low or high blood sugar levels may impair alertness and reactions, especially when beginning or after altering treatment or when NOVO-GLIMEPIRIDE is not taken regularly. This may affect the 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
NOVO-GLIMEPIRIDE and change the way the medicine works. Some of these drugs are acetylsalicylic acid such as Aspirin, “sulfa” drugs, warfarin and beta-blockers.
Some medicines can make it harder for you to
control your diabetes. These include ACE inhibitors (i.e. drugs used to treat high blood pressure – hypertension), diuretics (water pills), corticosteroids (such as prednisone), birth control pills, and some kinds of cold and allergy drugs.
Make sure your doctor and pharmacist knows if
you are taking these or any other medicines.
PROPER USE OF THIS MEDICATION
Usual dose:
NOVO-GLIMEPIRIDE is usually taken once daily, with breakfast or the first main meal of the day. NOVO-GLIMEPIRIDE tablets must be swallowed 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with any type of medication, NOVO-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- coloured bowel movements
- Skin rash or hives
- Oedema, swelling of the legs or unexpected weight gain.
This is not a complete list of side effects. For any unexpected effects while taking NOVO-GLIMEPIRIDE, tell your doctor or pharmacist.
HOW TO STORE IT
- Store the tablets at room temperature (15 - 300C), 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 SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Novopharm Limited. at: at: 1-800-268-4127 ext. 5005
or druginfo@novopharm.com
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9