Teva-Repaglinide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-REPAGLINIDE is used:

• to lower blood sugar in patients with type 2

  diabetes mellitus whose blood sugar levels cannot be satisfactorily controlled by diet and exercise alone (monotherapy).

• in combination therapy with metformin to lower

  blood sugar in patients whose blood sugar levels cannot be controlled by diet and exercise only plus metformin monotherapy.

• in combination with rosiglitazone in patients

  who cannot take metformin and whose blood sugar levels cannot be controlled by diet and exercise plus TEVA-REPAGLINIDE or rosiglitazone monotherapy.

What it does:

TEVA-REPAGLINIDE is an oral antidiabetic agent used for the treatment of diabetes mellitus that works by stimulating release of insulin from the pancreas and thereby reducing levels of sugar in the blood and urine.

When TEVA-REPAGLINIDE should not be used:

Do not take TEVA-REPAGLINIDE:

• If you have known hypersensitivity to

  repaglinide tablets or any of the other ingredients in TEVA-REPAGLINIDE

• If you have diabetic ketoacidosis (accumulation

  of ketones in the blood and urine)

• If you have type 1 diabetes
• If you have severe liver disease

• If you are taking gemfibrozil (a medicine used to

  lower increased fat levels in the blood)

What the medicinal ingredient is:

Repaglinide

What the non-medicinal ingredient is:

Each tablet contains the following inactive ingredients: Calcium phosphate dibasic, colloidal anhydrous silica, magnesium stearate, meglumine, microcrystalline cellulose, polacrilin potassium, poloxamer 188, povidone, pregelatinized starch and the following colorants:

0.5 mg tablets: FD&C Blue No. 2 (Indigo carmine) Aluminum lake

1 mg tablets: Yellow iron oxide

2 mg tablets: Red iron oxide

What dosage forms it comes in:

TEVA-REPAGLINIDE is available in three strengths in bottles of 100 tablets:

• 0.5 mg (Light blue to blue tablets)
• 1 mg (Yellow to light yellow tablets)
• 2 mg (Mottled peach tablets)

WARNINGS AND PRECAUTIONS

The treatment with insulin secretagogues (drugs that stimulate insulin secretion from the pancreas) in general has been reported to be associated with increased cardiovascular mortality (death) as compared to treatment with diet alone or diet plus insulin.

TEVA-REPAGLINIDE may cause low blood sugar (hypoglycemia).

You should ask your doctor or 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.

The warning signs of hypoglycemia may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; difficulty in concentrating.

Severe hypoglycemia can cause loss of

consciousness, seizure, brain damage and even death.

Before you use TEVA-REPAGLINIDE talk to your doctor or pharmacist if you:

• have a history of allergy or intolerance to any medications or other substances

• have a history of liver or kidney problems

• are or think you may be pregnant

• are breastfeeding
• are over 75 years of age

Your blood sugar may get too high (hyperglycaemia) if you have fever, infection, surgery, or trauma (stress conditions). In such cases contact your doctor as your medication may need to be adjusted.

Alcohol may increase the effect of TEVA-REPAGLINIDE on lowering your blood sugar and therefore impair your ability to concentrate. In this case, do not drive or operate machinery.

INTERACTIONS WITH THIS MEDICATION

Serious Drug Interactions

Use of TEVA-REPAGLINIDE (repaglinide) with gemfibrozil (used to treat high blood fats) is contraindicated

Many medicines affect the way glucose works in your body and this may influence your TEVA-REPAGLINIDE dose. Listed below are the most common medicines which may affect your treatment with TEVA-REPAGLINIDE:

• Monoamine oxidase inhibitors

• Beta-blocking agents (used to treat high blood

  pressure and certain heart conditions)

• Angiotensin converting enzyme (ACE) inhibitors

  (used to treat high blood pressure and certain heart conditions)

• Salicylates (e.g. acetylsalicylic acid)
• Octreotide

• Non-steroidal anti-inflammatory agents

  (NSAIDS) (a type of painkillers)

• Anabolic steroids and corticosteroids (used for

  anemia or to treat inflammation)

• Oral contraceptives (used for birth control)
• Thiazides (diuretics or ‘water pills’)

• Danazol (used to treat breast cysts and

  endometriosis)

• Thyroid hormones (used to treat patients with

  low production of thyroid hormones)

• Sympathomimetics (used to treat asthma)

• Clarithromycin, trimethoprim, rifampicin

  (antibiotics)

• Itraconazole, ketoconazole (anti-fungal drug)

• Phenytoin, carbamazepine, phenobarbital (used

  to treat epilepsy/seizures)

• Cyclosporine

  • Non-prescription and over the counter drugs such as drugs for appetite control, asthma, colds, cough, hay fever or sinus problems
  • Alcohol

Grapefruit juice may increase the effect of TEVA-REPAGLINIDE.

Tell your doctor if you have recently taken any of these medicines, or any medicines obtained without a prescription.

PROPER USE OF THIS MEDICATION

How to use TEVA-REPAGLINIDE

Your doctor will prescribe TEVA-REPAGLINIDE according to your needs. Take TEVA-

REPAGLINIDE exactly as prescribed by your doctor.

TEVA-REPAGLINIDE tablets should be taken with meals, usually within 15 minutes of the meal. However, TEVA-REPAGLINIDE tablets may be taken 30 minutes before a meal or right before a meal.

Overdose:

If you take more TEVA-REPAGLINIDE than you should your blood sugar may become too low leading to a hypoglycemic event. The symptoms of such an event include: headache, dizziness, tiredness, rapid heart beat, nervousness, shakiness, nausea and sweating.

If you experience any of these symptoms, you should take glucose tablets or sugar or have a sugary drink and then rest.

If you take more TEVA-REPAGLINIDE than you should, contact your doctor, or poison control centre or the nearest hospital emergency department immediately.

Missed Dose:

If you miss a dose of TEVA-REPAGLINIDE, do not take the missed dose. Wait and take your usual dose before your next meal.

SIDE EFFECTS AND

WHAT TO DO ABOUT THEM

The following side effects may occur during your treatment with TEVA-REPAGLINIDE:

Very common

• hypoglycemia (low blood sugar)

If you blood sugar is low or you experience any of the symptoms of hypoglycemia such as cold sweat, cool pale skin, headache, rapid heart beat, feeling sick and/or difficulty in concentrating eat a glucose tablet or a high sugar drink or snack, then rest.

Common

• hyperglycemia (high blood sugar).

If your blood sugar is high or you experience any of the symptoms of hyperglycemia such as increased urination; feeling thirsty; dry skin and dry mouth talk to your doctor

• visual disturbance
• abdominal pain
• nausea
• vomiting
• constipation

Uncommon

liver dysfunction

• allergy
• itching

This is not a complete list of side effects. For any unexpected effects while taking TEVA-

REPAGLINIDE, contact your doctor or pharmacist.

HOW TO STORE IT

How to store TEVA-REPAGLINIDE

Keep out of reach of children.

TEVA-REPAGLINIDE should be stored at 15ºC to 30ºC, protect from light and moisture. Do not store TEVA-REPAGLINIDE in moist areas, like the bathroom medication cabinet or other damp places. Always store it in the bottle it came in, with the lid on tight.

Do not use TEVA-REPAGLINIDE after the expiry date printed on the package.

Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

REPORTING SUSPECTED SIDE EFFECTS

REPORTING SUSPECTED SIDE EFFECTS

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 MedEffect™ 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: March 31, 2011