October 24, 2014
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Gliclazide MR by AA Pharma Inc.

(gliclazide MR)

DIN (Drug Identification Number)

02297795 GLICLAZIDE MR 30MG EXTENDED RELEASE TABLET

What side effects are possible with Gliclazide MR by AA Pharma Inc.?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • back, muscle, or joint pain
  • constipation
  • diarrhea
  • dizziness
  • headache
  • nausea
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • high blood pressure
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash or hives
  • swelling of the legs or unexpected weight gain
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heart beat, weakness, shakiness, feeling drunk, headache, slurred speech)
  • unusual or more frequent infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest pain or pressure and/or shortness of breath
  • seizures
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Gliclazide MR by AA Pharma Inc.?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Alcohol use: Gliclazide MR can cause an unpleasant "intolerance reaction" to alcohol. People taking gliclazide MR may experience flushing, warmth, nausea, giddiness, and possibly increased heart rate when they use alcohol. To prevent this reaction, avoid drinking alcohol.

Diabetes complications: Similar to other medications for diabetes, the use of gliclazide MR will not prevent the development of diabetes complications.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency: If you have G6PD-deficiency, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypoglycemia (low blood sugar): Gliclazide MR, like other sulfonylurea drugs, can cause symptoms of hypoglycemia (low blood sugar) including dizziness, lack of energy, drowsiness, headache, and sweating. Weakness, nervousness, shakiness, and numbness or tingling have also been reported. Seniors, those with reduced liver or kidney function, and those who are fragile or malnourished are more likely to have low blood sugar when they take these medications. Low blood sugar is more likely to occur when food intake is inadequate or after strenuous or prolonged physical exercise. Blood glucose should be monitored regularly and emergency glucose (and glucagon kit) kept available in case the need arises to increase blood sugar levels.

Illness/stress: People on gliclazide MR therapy may experience loss of blood sugar control during illness or stressful situations, such as trauma or surgery. Under these conditions, the doctor may consider stopping the medication and prescribing insulin until the situation improves.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Proper diet: The use of gliclazide MR must be considered as treatment in addition to proper diet and not as a substitute for diet.

Worsening of condition: Over a period of time, gliclazide MR may become less effective because of the worsening of diabetes. If gliclazide MR no longer controls blood glucose to target levels, it should be stopped and another medication added.

Pregnancy: This medication should not be used during pregnancy as it may cause harm to the developing baby. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if gliclazide MR passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding women should not take gliclazide MR.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may be more likely to experience side effects with this medication.

What other drugs could interact with Gliclazide MR by AA Pharma Inc.?

There may be an interaction between gliclazide MR and any of the following:

  • alcohol
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • American ginseng
  • amiodarone
  • androgens
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • anticoagulants (e.g., warfarin, heparin)
  • "azole" antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole)
  • aprepitant
  • barbiturates (e.g., phenobarbital, thiopental)
  • beta-blockers (e.g., metoprolol, propranolol)
  • bosentan
  • buserelin
  • carbamazepine
  • clarithromycin
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • danazol
  • delaviridine
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • fenofibric acid
  • H2 receptor antagonists (e.g., ranitidine, famotidine, cimetidine)
  • fluvastatin
  • garlic
  • gemfibrozil
  • ginger
  • GLP-1 agonists (e.g., albiglutide, exenatide, liraglutide)
  • goserelin
  • leflunomide
  • leuprolide
  • mifepristone
  • milk thistle
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • nicotinic acid
  • nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen)
  • omeprazole
  • oral contraceptives (birth control pills)
  • other antidiabetic drugs (e.g., insulin, metformin)
  • peginterferon Alfa-2b
  • phenobarbital
  • phenylbutazone
  • phenytoin
  • primidone
  • porfimer
  • probenecid
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • ranitidine
  • rifampin
  • salbutamol
  • salicylates (e.g., acetylsalicylic acid [ASA])
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • sitaxentan
  • somatropin
  • sulfonamides (e.g., sulfadiazine, sulfamethoxazole)
  • tegafur
  • terbutaline
  • ticagrelor
  • tuberculosis medications (e.g., isoniazid, ethambutol)
  • tolbutamide
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • warfarin
  • zafirlukast

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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