Sandoz Saxagliptin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Saxagliptin is used to improve blood sugar levels in adult patients with type 2 diabetes, in combination with;

• metformin,
• sulfonylurea,
• metformin and a sulfonylurea or
• insulin (with or without metformin)

when diet and exercise and metformin, sulfonylurea, metformin and a sulfonylurea or insulin (with or without metformin) alone have failed to adequately control blood sugar levels.

What it does:

Sandoz Saxagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Sandoz Saxagliptin helps to improve blood sugar levels in response to a meal. Sandoz Saxagliptin also lowers blood sugar levels between meals, and helps to decrease the amount of sugar made by your body.

What is Type 2 Diabetes?

Insulin is a hormone that helps control the level of sugar (glucose) in your blood. Type 2 diabetes is a condition in which your body does not make enough insulin and/or the insulin that your body produces does not work as well as it should. When this happens, glucose can build up in the blood. This can lead to serious problems.

When it should not be used:

• Do not take Sandoz Saxagliptin if you are allergic to

  any of the ingredients in Sandoz Saxagliptin or if you are allergic to the other drugs belonging to DPP-4 class.

• Do not take Sandoz Saxagliptin if you have diabetic

  ketoacidosis (accumulation of ketones in the blood and urine), diabetic pre-coma or diabetic coma.

• Do not take Sandoz Saxagliptin if you have Type 1

  diabetes.

What the medicinal ingredient is:

Saxagliptin hydrochloride

What the nonmedicinal ingredients are:

Non-medicinal ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and (dilute) hydrochloric acid. In addition, the film coating contains the following inactive ingredients: hypromellose, macrogol, lactose anhydrous, titanium dioxide and yellow iron oxide (2.5 mg) or red iron oxide (5 mg).

What dosage forms it comes in:

Sandoz Saxagliptin is supplied in 2.5 mg and 5 mg (as saxagliptin hydrochloride) film-coated tablets.

WARNINGS AND PRECAUTIONS

BEFORE you use Sandoz Saxagliptin talk to your doctor or pharmacist if:

• you have had an allergic reaction to other DPP-4 inhibitors
• you have or have had any kidney problems
• you have or have had liver problems
• you have or have had heart failure

• you have been told you have a reduced immune system

  [e.g. you have had organ transplantation or have been diagnosed with human immunodeficiency syndrome (HIV/AIDS)]

• you are pregnant or planning to become pregnant

• you are breast-feeding or plan to breast-feed
• you have or have had pancreas problems such as inflammation of the pancreas (pancreatitis)

Heart Failure has been seen in patients treated with Sandoz Saxagliptin. Heart Failure is when your heart is unable to pump enough blood to meet the needs of the body. You are at greater risk of Heart Failure if you have or have had:

• heart or blood vessel disease including heart failure and heart attack
• kidney disease
• several risk factors of getting heart disease

Symptoms of heart failure include one or more of the following: tiredness, swollen ankles, a fast increase in weight and increased shortness of breath especially when lying down. This is serious. You must talk to your physician immediately or go to the hospital if this happens to you.

Sandoz Saxagliptin should not be used in patients with end-stage renal disease (ESRD) who require dialysis.

Lactose monohydrate is a non-medicinal ingredient in Sandoz Saxagliptin. Do not take Sandoz Saxagliptin if a doctor has told you that you have one of the following hereditary diseases: galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery, or trauma (stress conditions). In such

cases contact your doctor as your medication may need to be adjusted.

INTERACTIONS WITH THIS MEDICATION

Talk to your doctor or pharmacist about all the drugs you take. This includes prescription drugs, as well as those you buy yourself, and herbal supplements.

PROPER USE OF THIS MEDICATION

Follow the directions given to you by your doctor.

Usual Dose:

The usual recommended adult dose is 5 mg, once daily, taken with or without food.

You may need a lower dose of Sandoz Saxagliptin if your kidneys are not working well.

Sandoz Saxagliptin tablets must not be split or cut.

Overdose:

If you think you have taken too much Sandoz Saxagliptin, call your doctor or pharmacist right away, or contact your local poison control centre immediately.

Missed Dose:

If you miss a dose of Sandoz Saxagliptin, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The common side effects of Sandoz Saxagliptin include: upper respiratory tract infection, urinary tract infection and headache. Hypoglycemia may occur more frequently in people who already take a sulfonylurea or insulin. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache, and change in mood. Tell your physician or pharmacist if you develop any unusual side effects, or if any of the above side effects do not go away or get worse.

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

Store at room temperature (15-30°C). Store in the original packaging. Protect from moisture. Keep well out of reach and sight of children.

REPORTING SIDE EFFECTS

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 Sandoz Saxagliptin:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for

  healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer's website www.sandoz.com, or by calling 1-800-361-3062.

Or

by written request at:

110 Rue de Lauzon Boucherville, Québec, Canada, J4B 1E6

Or by e-mail at: medinfo@sandoz.com

Last revised: February 25, 2019