Patient Medication Information: uses, side effects, how to take - Auro-Repaglinide
ABOUT THIS MEDICATION
What is AURO-REPAGLINIDE used for:
- To lower blood sugar in patients with type 2 diabetes mellitus whose blood sugar levels cannot be controlled by diet and exercise alone (monotherapy).
- In combination with metformin to lower blood sugar in patients whose blood sugar levels cannot be controlled by diet and exercise only plus metformin alone.
- In combination with rosiglitazone in patients who cannot take metformin and whose blood sugar levels cannot be controlled by diet and exercise plus AURO-REPAGLINIDE or rosiglitazone alone.
How does AURO-REPAGLINIDE work?
AURO-REPAGLINIDE is an oral anti-diabetic agent used for the treatment of diabetes mellitus. It helps your body release more insulin when your blood sugar is high. This helps improve your blood sugar control.
What are the ingredients in AURO-REPAGLINIDE?
Medicinal ingredient: Repaglinide
Nonmedicinal ingredients: Calcium hydrogen phosphate, Cellulose microcrystalline, Glycerol, Magnesium stearate, Maize starch, Meglumine, Poloxamer, Polacrillin Potassium, Povidone, Ferric oxide yellow (1mg tablet), Ferric oxide red (2 mg tablet).
AURO-REPAGLINIDE comes in the following dosage forms:
AURO-REPAGLINIDE is available in three strengths in blister of 10 x 10 tablets & bottles of 30, 100, 500 & 1000 tablets:
- 0.5 mg (white to off white tablets).
- 1 mg (yellow tablets).
- 2 mg (peach-coloured tablets).
Do not use AURO-REPAGLINIDE if you:
- Have a known hypersensitivity to repaglinide tablets or any of the other ingredients in AURO-REPAGLINIDE.
- Have diabetic ketoacidosis (accumulation of ketones in the blood and urine).
- Have type 1 diabetes.
- Have severe liver disease.
- Are taking gemfibrozil (a medicine used to lower increased fat levels in the blood).
- Are taking clopidogrel (a medicine used to prevent blood clots).
WARNINGS AND PRECAUTIONS
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AURO-REPAGLINIDE. Talk about any health conditions or problems you may have, including 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
Other warnings you should know about:
AURO-REPAGLINIDE is not recommended for use in children and adolescents less than 18 years of age.
The treatment with insulin secretagogues (drugs that stimulate insulin secretion form the pancreas) in general has been associated with more heart-related deaths as compared to treatment with diet alone or diet plus insulin.
AURO-REPAGLINIDE may cause low blood sugar (hypoglycemia), especially if you miss a meal, exercise for a long time, drink alcohol or use another anti-diabetic medication with AURO-REPAGLINIDE..
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 warnings 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.
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.
Driving and Operating Machinery:
Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially when beginning or after changing treatment or when AURO-REPAGLINIDE is not taken regularly. This may affect your ability to drive or to operate machinery.
INTERACTIONS WITH THIS MEDICATION
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
Do not use AURO-REPAGLINIDE with gemfibrozil (used to treat high blood fats).
Do not use AURO-REPAGLINIDE with clopidogrel (a medicine used to prevent blood clots).
Many medicines affect the way glucose works in your body and this may influence your AURO-REPAGLINIDE dose.
Listed below are the most common medicines which may affect your treatment with AURO-REPAGLINIDE:
- Other anti-diabetic agents (used to lower blood sugar)
- Monoamine oxidase inhibitors (used to treat depression)
- 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 levels 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 (used to suppress the immune system)
- Deferasirox (used to reduce chronic iron overload)
- Non-prescription and over the counter drugs such as drugs for appetite control, asthma, colds, cough, hay fever or sinus problems
Alcohol may increase the effect of AURO-REPAGLINIDE on lowering your blood sugar and therefore impair your ability to concentrate. Avoid drinking alcohol while you are taking AURO-REPAGLINIDE.
Grapefruit juice may increase the effect of AURO-REPAGLINIDE.
PROPER USE OF THIS MEDICATION
How to take AURO-REPAGLINIDE:
Your doctor will prescribe AURO-REPAGLINIDE according to your needs. Take AURO-REPAGLINIDE exactly as prescribed by your doctor.
Usual dose:
AURO-REPAGLINIDE tablets should be taken with meals, usually 15 minutes before the meal. However, AURO-REPAGLINIDE tablets may be taken 30 minutes before a meal or right before a meal.
Overdose:
If you take more AURO-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.
Discuss with your healthcare professional about how to treat low blood sugar.
| If you think you have taken too much AURO-REPAGLINIDE 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 of AURO-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
What are the possible side effects from using AURO-REPAGLINIDE?
These are not all the possible side effects you may feel when taking AURO-REPAGLINIDE. If you experience any side effects not listed here, contact you healthcare professional. Please also see WARNINGS AND PRECAUTIONS.
The following side effects may occur during your treatment with AURO-REPAGLINIDE
Common
- Visual disturbance
- Abdominal pain
- Nausea
- constipation
Uncommon
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| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Very Common | Low blood sugar (hypoglycemia) Symptoms include: cold sweat, cool pale skin, headache, rapid heartbeat, feeling sick and/or difficulty in concentrating. | √ | ||
| Common | High blood sugar (hyperglycemia) Symptoms include: increased urination, feeling thirsty, dry skin and dry mouth. | √ | ||
| Sudden severe headache or worsening of headache, dizziness, tremors, fatigue or increased sweating | √ | |||
| Diarrhea , constipation, gas, upset stomach, nausea or abdominal pain | √ | |||
| Sudden partial or complete loss of vision | √ | |||
| Uncommon | Chest pain or pressure, and/or shortness of breath | √ | ||
Allergy Symptoms include: swelling, difficulty breathing, rapid heartbeat, feeling dizzy and sweating | √ | |||
If you have troublesome symptom or side effects that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
Postage paid labels, and the consumer side effect Reporting Form are available at MedEffect at (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). 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 |
HOW TO STORE IT
Storage:
Store at room temperature (15°C to 25°C), Protect from moisture.
MORE INFORMATION
If you want more information about AURO-REPAGLINIDE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professional and includes this Patient Medication Information by visiting the Health Canada website at http:// www.auropharma.ca; or by calling Auro Pharma Inc. at 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: April 28, 2016