Patient Medication Information: uses, side effects, how to take - Pro-Saxagliptin
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
PRO-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:
PRO-SAXAGLIPTIN belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). PRO-SAXAGLIPTIN helps to improve blood sugar levels in response to a meal. PRO-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 PRO-SAXAGLIPTIN if you are allergic to any of the ingredients in PRO-SAXAGLIPTIN or if you are allergic to the other drugs belonging to DPP-4 class.
- Do not take PRO-SAXAGLIPTIN if you have diabetic ketoacidosis (accumulation of ketones in the blood and urine), diabetic pre-coma or diabetic coma.
Do not take PRO-SAXAGLIPTIN if you have
WHAT THE MEDICINAL INGREDIENT IS:
PRO-SAXAGLIPTIN contains saxagliptin (as saxagliptin hydrochloride) the active ingredient.
WHAT THE NONMEDICINAL INGREDIENTS ARE:
PRO-SAXAGLIPTIN tablets contain the following non-medicinal ingredients: Hydroxypropyl methylcellulose, hydroxypropyl cellulose, mannitol, polyethylene glycol, red ferric oxide (5 mg), sodium hydroxide, stearic acid, tartaric acid, titanium dioxide and yellow ferric oxide (2.5 mg).
WHAT DOSAGE FORMS IT COMES IN:
PRO-SAXAGLIPTIN is supplied in 2.5 mg and 5 mg saxagliptin (as saxagliptin hydrochloride) tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use PRO-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 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.
PRO-SAXAGLIPTIN should not be used in patients with end-stage renal disease (ESRD) who require dialysis.
IMPORTANT: PLEASE READ
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.
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.
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 PRO-SAXAGLIPTIN if your kidneys are not working well.
PRO-SAXAGLIPTIN tablets must not be split or cut.
OVERDOSE:
| If you think you, or a person you are caring for, have taken too much PRO-SAXAGLIPTIN , contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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MISSED DOSE:
If you miss a dose of PRO-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 PRO-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 PRO-SAXAGLIPTIN ,
contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15°C to 30°C).
Keep PRO-SAXAGLIPTIN out of the reach and sight of children and pets.
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 to protect the environment.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
Only if severe | In all cases | |||||
| Uncommon | ||||||
Pancreatitis (inflammation of the pancreas): prolonged severe abdominal pain which may be accompanied by vomiting | X | X | ||||
| Severe disabling joint pain | X | |||||
| Very rare | ||||||
| Allergic (hypersensitivity) reactions: rash, hives, swelling of the face, lips, and throat that may cause difficulty in breathing or swallowing | X | X | ||||
| Bullous pemphigoid (serious skin reaction): blistering of the skin, redness, peeling skin | X | |||||
Rhabdomyolysis (breakdown of damaged muscle): muscle spams, weakness, red brown (tea-coloured) urine. | X | |||||
| Unknown | ||||||
| Heart failure (a weakness of the heart): tiredness, swollen ankles, increasing shortness of breath especially when lying down and a fast increase in weight | X | |||||
PROPER USE OF THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
IMPORTANT: PLEASE READ
by mail or by fax; or
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. |
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MORE INFORMATION
If you want more information about
PRO- SAXAGLIPTIN :
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or medinfo@prodoc.qc.ca
Pro Doc Ltée, Laval, Quebec, H7L 3W9