Patient Medication Information: uses, side effects, how to take - Apo-Repaglinide
ABOUT THIS MEDICATION
What is APO-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 repaglinide or rosiglitazone alone.
How does APO-REPAGLINIDE work?:
APO-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 APO-REPAGLINIDE:
Medicinal ingredient: Repaglinide
Nonmedicinal ingredients: Dibasic calcium phosphate dehydrate, Polacrilin potassium, Meglumine, Poloxamer, Magnesium stearate, Colloidal silicon dioxide, Yellow iron oxide (1 mg), Red ferric oxide-red shade (2 mg).
APO-REPAGLINIDE comes in the following dosage forms:
APO-REPAGLINIDE is available in three strengths in bottles of 100 tablets and blisters of 100 tablets:
- 0.5 mg (white to off-white tablets)
- 1 mg (yellow tablets)
- 2 mg (peach-coloured tablets)
Do not use APO-REPAGLINIDE if you:
- Have a known hypersensitivity to repaglinide tablets or any of the other ingredients in APO-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 APO-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:
APO-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 from the pancreas) in general has been associated with more heart-related deaths as compared to treatment with diet alone or diet plus insulin.
APO-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 APO-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 heartbeat
- 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 (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.
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 APO-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 APO-REPAGLINIDE with gemfibrozil (used to treat high blood fats). Do not use APO-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 APO-REPAGLINIDE dose.
Listed below are the most common medicines which may affect your treatment with APO-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 inflamation)
- 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 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 APO-REPAGLINIDE on lowering your blood sugar and therefore impair your ability to concentrate. Avoid drinking alcohol while you are taking APO-REPAGLINIDE.
Grapefruit juice may increase the effect of APO-REPAGLINIDE.
PROPER USE OF THIS MEDICATION
How to take APO-REPAGLINIDE
Your doctor will prescribe APO-REPAGLINIDE according to your needs. Take APO-REPAGLINIDE exactly as prescribed by your doctor.
Usual dose:
APO-REPAGLINIDE tablets should be taken with meals, usually 15 minutes before the meal.
However, APO-REPAGLINIDE tablets may be taken 30 minutes before a meal or right before a meal.
Overdose:
If you take more APO-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 heartbeat, 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 APO-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 APO-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 APO-REPAGLINIDE?
These are not all the possible side effects you may feel when taking APO-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 APO-REPAGLINIDE:
Common
- visual disturbance
- abdominal pain
- nausea
- constipation
Uncommon
- Liver dysfunction
- Itching
- Redness
- Vomiting
- Rash
- Hives
- Abnormal blood test results
| 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 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 Patient Side Effect Reporting Form are available at MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. 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:
Keep out of reach and sight of children.
Store at room temperature 15°C - 30°C (59°F - 86°F). Do not store APO-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 APO-REPAGLINIDE after the expiry date 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.
MORE INFORMATION
If you want more information about APO-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.hc-sc.gc.ca; or by contacting DISpedia, Apotex's Drug Information Service at: 1-800-667-4708.