Patient Medication Information: uses, side effects, how to take - NTP-Glyburide
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
NTP-GLYBURIDE (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:
NTP-GLYBURIDE 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 NTP-GLYBURIDE, you should continue to exercise and follow the diet recommended for you by your doctor.
When it should not be used:
Do not take NTP-GLYBURIDE
- If you have Type 1 diabetes.
If you have known hypersensitivity or allergy to 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 NTP-GLYBURIDE is glyburide.
What the important nonmedicinal ingredients are:
NTP-GLYBURIDE tablets contain the following non-medicinal ingredients: colloidal anhydrous silica, lactose monohydrate, magnesium stearate, starch (corn starch and pre-geletanized 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
NTP-GLYBURIDE may cause low blood sugar (hypoglycemia).
You should ask your doctor, pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. You should also test your blood sugar as instructed by your doctor.
Before you use NTP-GLYBURIDE talk to your doctor or pharmacist if:
- You have or have had liver, kidney, or heart disease;
- You are pregnant or planning to get pregnant;
- You are breast-feeding.
- You have a blood disease called G6PD-deficiency anemia
NTP-GLYBURIDE 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 NTP-GLYBURIDE is not taken regularly. This may affect your ability to drive or to operate machinery.
IN
INTERACTIONS WITH THIS MEDICATION
TERACTIONS WITH THIS MEDICATION
Ask your doctor or pharmacist before taking any other medicine, including over-the-counter products.
Drugs that can interact with NTP-GLYBURIDE 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 NTP-GLYBURIDE.
IMPORTANT: PLEASE READP
PROPER USE OF THIS MEDICATION
OPER USE OF THIS MEDICATION Usual dose:
Take NTP-GLYBURIDE 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 ypoglycemia. If you took too many NTP-GLYBURIDE tablets at once, call your doctor or go to the emergency room of your local hospital.
Missed Dose:
If you forget to take NTP-GLYBURIDE 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.
S
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
IDE EFFECTS AND WHAT TO DO ABOUT Side effects:
As with any type of medication, NTP-GLYBURIDE is associated with some side effects.
The most common side effect of NTP-GLYBURIDE is 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, 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 may have low blood sugar while you are taking NTP-GLYBURIDE, especially if you miss a meal, exercise for a long time, drink alcohol or use another antidiabetic medication with NTP-GLYBURIDE. Make sure you know what to do if your blood sugar gets too low (ask your doctor, pharmacist or diabetes educator). Teach you friends, co-workers, or family members what they can do to help you if you have low blood sugar.
The following side effects have been observed with NTP-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
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom/ Effect | Talk with your doctor or pharmacist | Stop taking NTP- GLYBURIDE 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 NTP-GLYBURIDE, contact your doctor or pharmacist.
HOW TO STORE IT
NTP-GLYBURIDE should be stored between 15-30°C, and not beyond the expiry date indicated on the package.
IMPORTANT: PLEASE READ
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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.
at: 1-800-268-4127 ext. 5005
or druginfo@novopharm.com
TevaCanada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9