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Details for: ACARBOSE TABLETS

Company: STRIDES PHARMA CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02493780ACARBOSE TABLETSACARBOSE50 MGTABLETORAL
02493799ACARBOSE TABLETSACARBOSE100 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Regulatory Decision Summary

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

Acarbose Tablets (acarbose) is used alone or in combination with a sulfonylurea (such as tolbutamide, chlorpropamide, or 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

Acarbose Tablets 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 Acarbose Tablets if you have or have had any of the following:

  • Allergic reaction to acarbose or any of the other ingredients in Acarbose Tablets
  • 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

Colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose

What dosage form it comes in

Tablets. Each tablet contains 50 mg or 100 mg acarbose.

Warnings and precautions

Serious Warnings and Precautions

Acarbose Tablets 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 Acarbose Tablets 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

Acarbose Tablets are 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 Acarbose Tablets 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 Acarbose Tablets.

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 Acarbose Tablets 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

If you think you have taken too much Acarbose Tablets, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

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 Acarbose Tablets. 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.

Acarbose Tablets, 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 Acarbose Tablets may also cause hypoglycemia. If you do experience hypoglycemia while you are taking Acarbose Tablets, 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).

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Uncommon
Nausea, vomiting, abdominal pain    
Rare
Edema (swelling)    
Jaundice (yellowing of the skin)    
Very Rare
Allergic reactions: rash, skin inflammation    

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

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 30°C.

Keep out of reach and sight of children. Do not use the tablets beyond the expiry date.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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

If you want more information about Acarbose Tablets:

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or by calling 905-881-4410.

This leaflet was prepared by Strides Pharma Canada Inc.

Last Approved: November 5, 2019

Date modified: