Details for: GLUCOBAY
Company: BAYER INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02190885 | GLUCOBAY | ACARBOSE | 50 MG | TABLET | ORAL |
| 02190893 | GLUCOBAY | ACARBOSE | 100 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
GLUCOBAY (acarbose) is used alone or in combination with a sulfonylurea (such as tolbutamide, chlorpropamide, or DiaBeta®/glyburide), metformin, or insulin to lower blood glucose in adult patients with type 2 diabetes mellitus in addition to proper diet, exercise and weight reduction.
What it does
GLUCOBAY will slow the absorption of glucose from your gut to reduce the high blood glucose levels that occur after each meal.
When it should not be used
Do not take GLUCOBAY if you have or have had any of the following:
- Allergic reaction to acarbose or any of the other ingredients in GLUCOBAY
- Inflammation or ulceration of the bowel (eg, ulcerative colitis or Crohn’s disease)
- Diabetic ketoacidosis
- Bowel obstruction
- Chronic intestinal diseases that affect digestion or absorption of food, or a large hernia
What the medicinal ingredient is
Acarbose
What the non-medicinal ingredients are
corn starch, magnesium stearate, microcrystalline cellulose, silicon dioxide
What dosage form it comes in
Tablets. Each tablet contains 50 mg or 100 mg acarbose.
Warnings and precautions
GLUCOBAY in combination with a sulfonylurea or insulin
may cause low blood sugar (hypoglycemia). You should ask
your doctor, pharmacist or diabetes educator about the
symptoms of low blood sugar and what to do if you experience
these symptoms. You should also test your blood sugar
according to instructions given to you by your doctor, nurse, or
pharmacist.
Before you use GLUCOBAY talk to your doctor or pharmacist
if:
- you have or have had kidney or liver disease
- you are pregnant or planning to get pregnant
- you are breast-feeding
GLUCOBAY is not recommended for use in children under 18 years of age.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including the medicine you
can buy without a prescription, and natural health products.
Drugs that interact with GLUCOBAY include digestive
enzyme preparations, cholestyramine, diuretics (water pills),
corticosteroids (such as prednisone), digoxin, thyroid
medications, estrogen, oral contraceptives, phenytoin, nicotinic
acid, sympathominetics, and isoniazid.
Avoid drinking alcohol while taking GLUCOBAY.
Proper use of this medication
Take the tablets as prescribed by your doctor. Tablets should be
taken orally with the first bite of a main meal. Do not take
GLUCOBAY between meals.
You should continue to monitor your blood glucose levels
according to the instructions given to you by your healthcare
professional.
Usual Dose
The usual starting dose is 50 mg once daily. The usual maintenance dose is 50 mg or 100 mg three times daily. The maximum dose is 100 mg three times daily.
Overdose
Missed Dose
If you miss a dose, take your next dose as usual. Do not double dose to make up for the missed dose.
Side effects and what to do about them
You may experience some side effects while taking
GLUCOBAY. The most common are gastrointestinal in nature,
such as flatulence (gas) and abdominal discomfort. It is also
possible that you may pass softer stools or even experience
diarrhea, particularly after a meal containing foods with sucrose
(ordinary sugar). Normally, these symptoms will diminish with
continued treatment. You should not take antacid preparations
for treating these symptoms, as they are unlikely to have any
beneficial effects. If your symptoms persist, or if you have any
other undesirable effects, consult your doctor.
GLUCOBAY, when given alone, should not cause
hypoglycemia (low blood sugar). However, since sulfonylureas
(oral antidiabetic drugs) or insulin may cause hypoglycemia,
the combination of a sulfonylurea or insulin and GLUCOBAY
may also cause hypoglycemia. If you do experience
hypoglycemia while you are taking GLUCOBAY, either alone
or with a sulfonylurea, metformin or insulin, do not treat it with
ordinary sugar (sucrose); instead, take glucose tablets (also
known as dextrose).
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Nausea, vomiting, abdominal pain | ✔ | ||
| Rare | |||
| Edema (swelling) | ✔ | ||
| Jaundice (yellowing of the skin) | ✔ | ||
| Very rare | |||
| Allergic reactions: rash, skin inflammation | ✔ | ||
How to store
It is best if you keep your tablets in their original carton. The
tablets should be kept in a dry place at a temperature between
15°C and 25°C.
Keep out of the reach of children.
Do not use the tablets beyond the expiry date.
Reporting side effects
Canada Vigilance Program
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
Bayer Inc
You can report any suspected adverse reactions associated with the use of health products to Bayer Inc. by:
- Toll-free telephone: 1-800-265-7382
- Email: canada.medinfo@bayer.com
- Regular Mail:
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
NOTE: Should you require information related to the management of the side effect, please contact your health professional. Bayer Inc. does not provide medical advice.
More information
For more information, please contact your health professional
or pharmacist first, or Bayer Medical Information at 1-800-265-
7382 or canada.medinfo@bayer.com.
This document plus the full product monograph, prepared for
health professionals can be found at: www.bayer.ca
or by contacting the sponsor at the above mentioned phone
number and email address.
This leaflet was prepared by:
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
Last revised: June 10, 2010
© 2010, Bayer Inc.
™ GLUCOBAY is a registered trademark of Bayer AG, used
under license by Bayer Inc.