Patient Medication Information: uses, side effects, how to take - Mylan-Glybe
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-GLYBE (glyburide) is used as an adjunct to proper diet, exercise and weight reduction to lower blood glucose in adult patients with type 2 diabetes mellitus.
What it does:
MYLAN-GLYBE lowers blood sugar by stimulating the pancreas to secrete insulin. The pancreas must produce insulin for this medication to work.
People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies 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 and by doing so can prevent long term complications.
In addition to taking MYLAN-GLYBE, you should continue to exercise and follow the diet recommended for you by your doctor.
When it should not be used:
Do not take MYLAN-GLYBE
- If you have Type 1 diabetes.
- If you have known hypersensitivity or allergy to this drug, any sulfonylurea or sulfonamides, or to any ingredient in the formulation or component of the container.
- 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). This condition should be treated with insulin.
- Diabetic precoma or coma.
- During stress conditions such as severe infections, trauma or surgery.
- In the presence of liver disease or frank jaundice; or kidney disease.
If you are being treated with bosentan.
If you are pregnant or breastfeeding.
What the medicinal ingredient is:
The medicinal ingredient for MYLAN-GLYBE is glyburide.
What the important nonmedicinal ingredients are:
MYLAN-GLYBE tablets contain the following non-medicinal ingredients: colloidal anhydrous silica, lactose monohydrate, magnesium stearate, starch (corn starch and pre-gelatinized corn starch) and talc.
What dosage forms it comes in:
Tablets. Each tablet contains 2.5 mg or 5.0 mg glyburide.
WARNINGS AND PRECAUTIONS
Proper diet, exercise and weight reduction are important to help you control your diabetes.
Your blood glucose may change in some situations, for example if you are stressed or suffering from other illnesses (e.g. infections). At such times, your doctor may need to modify your dose.
MYLAN-GLYBE may cause low blood sugar (hypoglycemia). , especially if you miss a meal, exercise for a long time, drink alcohol or use another antidiabetic medication with MYLAN-GLYBE.
Elderly patients may be more likely to experience low blood sugar with MYLAN-GLYBE.
If your blood sugar gets too low, you may feel shaky, weak, drowsy, confused, or very hungry. You may sweat or have blurred vision, abnormal heartbeats, trouble concentrating, or a headache that doesn't go away. Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures.
You should ask your doctor, pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. Teach your friends, co-workers, or family members what they can do to help you if you have low blood sugar.
You should also test your blood sugar as instructed by your doctor.
Before you use MYLAN-GLYBE talk to your doctor or pharmacist if:
You have or have had liver, kidney, or heart
disease;
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- You are pregnant or planning to get pregnant;
- You are breast-feeding.
You have a blood disease called G6PD-deficiency
anemia.
- You have a heart disease.
MYLAN-GLYBE is not recommended for use in children under 18 years of age.
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 MYLAN-GLYBE is not taken regularly. This may affect your ability to drive or to operate machinery.
INTERACTIONS WITH THIS MEDICATION
Ask your doctor or pharmacist before taking any other medicine, including over-the-counter products.
Drugs that can interact with MYLAN-GLYBE 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.
Avoid drinking alcohol while you are taking MYLAN-GLYBE.
PROPER USE OF THIS MEDICATION
Usual dose:
Take MYLAN-GLYBE exactly as prescribed by your doctor.
The usual dose is 2.5 to 10 mg daily. Maximum daily dose is 20 mg.
A dose of more than 10 mg should be taken in two divided doses.
Tablets should be taken during or immediately after meals.
Overdose:
Overdosage with this medication may result in hypoglycemia.
| 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. |
Missed Dose:
If you forget to take MYLAN-GLYBE tablets, do not take a double dose to make up for forgotten individual doses.
Discuss with your healthcare for dealing with such mistakes (in particular forgetting a dose or skipping a meal) or in the event a dose cannot be taken at the prescribed time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects:
As with any type of medication, glyburide is associated with some side effects.
The most common side effect of glyburide is low blood sugar (hypoglycemia). Please see the WARNINGS and PRECAUTIONS section above.
The following side effects have been observed with glyburide use: nausea, heartburn, feeling “full”, vomiting, diarrhea and abdominal pain.
Allergic skin reactions (itchiness, rash, eruption) have been reported in a number of patients. An increased sensibility to light has been associated with the use of oral antidiabetic drugs.
Transient visual disturbances may occur at the beginning of the treatment due to variations in level of blood sugar.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
| Symptom/ Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||||
| Only if severe | In all cases | ||||||
| Common | Low blood sugar (hypoglycemia) | √ | |||||
| Uncommon | Skin reactions (itchiness, rash, eruption) | √ | |||||
| Rare | Blood disorders (unusual bruising or bleeding) | √ | |||||
| Very rare | Liver problem (yellowing of the eyes or skin) | √ | |||||
Allergic reaction (difficult breathing, decreased blood pressure) | √ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-GLYBE, contact your doctor or pharmacist.
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HOW TO STORE IT
MYLAN-GLYBE should be stored between 15-30°C, and not beyond the expiry date indicated on the package.
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:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffet. 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 can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Revised on: January 11, 2016
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca
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