IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION Pr SANDOZ® GLICLAZIDE MR What dosage forms it comes in: Gliclazide Sandoz Gliclazide MR comes in modified-release tablets of 30 mg and modified-release breakable tablets of 60 mg. Modified-release tablets
30 mg WARNINGS AND PRECAUTIONS Modified-release breakable tablets
60 mg Sandoz Gliclazide MR may cause low blood sugar
(hypoglycemia). You should ask your doctor, pharmacist or This leaflet is part III of a three-part “Product Monograph" diabetes educator about symptoms of low blood sugar and what to published when Pr Sandoz Gliclazide MR was approved for sale do if you experience these symptoms. You should also test your in Canada and is designed specifically for Consumers. This blood sugar as instructed by your doctor. leaflet is a summary and will not tell you everything about
Pr Sandoz Gliclazide MR. Contact your doctor or pharmacist if you have any questions about the drug. BEFORE you use Sandoz Gliclazide MR talk to your doctor or pharmacist if: you have or have had liver problems, ABOUT THIS MEDICATION you have or have had kidney problems, you are pregnant or planning to get pregnant, What the medication is used for: you are breast-feeding, Sandoz Gliclazide MR is used to lower blood glucose level in adult you have a blood disease called G6PD-deficiency anemia, patients with type 2 diabetes mellitus in addition to proper diet, you have an intolerance to lactose (for Sandoz Gliclazide MR exercise and weight reduction. 60 mg). Your blood sugar may get too high (hyperglycaemia) if you take What it does: Saint John's Wort preparations or if you experience fever, infection, surgery or trauma (stress conditions). In such cases, Sandoz Gliclazide MR belongs to the family of hypoglycemic contact your doctor as your medication may need to be adjusted. (antidiabetic) drugs and part of a sub family of medicines called Serious Skin Reactions (DRESS, Stevens-Johnson Syndrome, sulfonylureas. It helps improve insulin secretion in the body. Toxic Epidermal Necrolysis, hypersensitivity Syndrome): any
combination of red itchy rash with blisters and peeling of the skin When it should not be used: and /or of the lips, eyes, mouth, nasal passages or genitals. It often Sandoz Gliclazide MR is contraindicated (must not be taken): goes with fever, chills, headache, cough, body aches or joint pain. if you are allergic or hypersensitive to gliclazide, other You may have less or dark urine, yellow skin or eyes. If you sulfonylureas, sulfonamides, or to any of the ingredients of suspect these, you should stop taking the drug and talk with your these products, doctor or pharmacist. if you have unstable and/or insulin-dependent diabetes mellitus, juvenile diabetes (type I diabetes), diabetic Low blood sugar and high blood sugar can occur when Sandoz ketoacidosis, diabetes pre-coma and coma, Gliclazide MR is prescribed at the same time as medicines if you have a serious infection, trauma or surgery, belonging to a class of antibiotics called fluoroquinolones, if you have severe liver problems, especially if you are elderly. If you are taking these medications if you have severe kidney problems, together, your doctor will remind you of the importance of if you receive treatment with miconazole, monitoring your blood glucose. if you are pregnant and/or breast-feeding. Sandoz Gliclazide MR is not recommended for use in children under 18 years of age. What the medicinal ingredient is: Driving and Operating Machinery: Gliclazide. Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially at beginning of the treatment. This What the nonmedicinal ingredients are: may affect your ability to drive or to operate machinery. Sandoz Gliclazide MR 30 mg tablets contain: anhydrous colloidal silica, calcium hydrogen phosphate dihydrate, hypromellose, INTERACTIONS WITH THIS MEDICATION magnesium stearate, maltodextrin. Sandoz Gliclazide MR 60 mg tablets contain: anhydrous colloidal Serious Drug Interactions silica, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin.
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MR. Sandoz Gliclazide MR (gliclazide) should not be taken if you are also taking miconazole (an antifungal drug). See “When it PROPER USE OF THIS MEDICATION should not be used” section of this leaflet.
Usual dose: Other drugs that may interact with Sandoz Gliclazide MR include: The recommended starting dose of Sandoz Gliclazide MR is - other antidiabetic agents 30 mg per day (a half tablet of Sandoz Gliclazide MR 60 mg or a - antibiotics (sulphonamides/sulfa drugs, clarithromycin, tablet of Sandoz Gliclazide MR 30 mg), even in elderly patients fluoroquinolones) (over 65 years old). The daily dose should not exceed 120 mg. - anti-tuberculosis drugs - anti fungal drugs (fluconazole) Take Sandoz Gliclazide MR once daily at breakfast. The 30 mg - nonsteroidal anti-inflammatory drugs (NSAIDs) including tablets cannot be split in half and should be swallowed whole with phenylbutazone (used to treat inflammation and pain) a glass of water. The 60 mg tablets can be halved. Do not crush - cortiscosteroids (used to treat inflammation) or chew the tablets of either strength. - salicylates ( e.g., acetylsalicylic acid) - angiotensin converting enzyme (ACE) inhibitors (used to You should test your sugar level as directed by your physician to treat high blood pressure and certain heart conditions) make sure that your blood sugar is being controlled. Your - beta blockers (used to treat high blood pressure and physician should check your progress at regular visits, especially certain heart conditions) during the first few weeks that you take this medicine. - anticoagulant therapy (blood thinners), including warfarin - diuretics (thiazides, furosemide) (used to treat high blood Overdose: pressure and certain heart conditions) Taking too much of any medicine can be dangerous. If you take - fibrates, nicotinic acid (used to treat high levels of fats in too many Sandoz Gliclazide MR tablets at once, call your doctor the blood) or your nearest poison control center, or go to the emergency - H -receptor antagonists (used to treat acid 2 room of your local hospital. reflux/heartburn) - monoamine oxidase inhibitors (used to treat depression) - chlorpromazine (used to treat certain psychiatric Missed Dose: conditions) If you miss a dose of this medicine, skip the missed dose. Take - probenecid (used to treat high levels of uric acid in the your next dose at the regular time. Do not double doses. blood and gout) - salbutamol, terbutaline (used to treat asthma) and SIDE EFFECTS AND WHAT TO DO ABOUT THEM ritodrine - barbiturates (sedatives, anti-seizure medications) Sandoz Gliclazide MR is associated with some side effects. It - oral contraceptives (estrogen plus progestogen, used for may, however, affect different people in different ways. birth control) - danazol (used to treat breast cysts and endometriosis) Common side effects reported during clinical trials with Sandoz - alcohol. Gliclazide MR included: - hypoglycemia (low blood sugar) Some of the drugs described above may lead to loss of blood sugar - hyperglycemia (high blood sugar) control (high blood sugar), including diuretics, corticosteroids, oral - viral infection contraceptives, chlorpromazine, ritodrine, salbutamol, terbutaline, - upper respiratory infection, runny nose, sore throat, cough danazol and nicotinic acid. - back, muscle and joint pain Some herbs such as Saint John's Wort preparations may lead to - headache high blood sugar and loss of blood sugar control. - high blood pressure - angina (chest pain) Avoid drinking alcoholic beverages and taking medicines - leg swelling containing alcohol while you are taking Sandoz Gliclazide MR as - diarrhea, constipation, abdominal pain, nausea this can lead to a drop in blood sugar (hypoglycaemia). - dizziness - skin rash/itching Tell your doctor if you have recently taken any of the medicines - depression listed above or any other medicines, including those obtained You should know that the usual signs of low blood sugar level without a prescription. Do not take other medicines unless (hypoglycemia) are: anxious feeling, drowsiness, dizziness, chills, prescribed or approved by your doctor. Tell any healthcare cold sweats, confusion, cool pale skin, difficulty in concentration, professionals that you see that you are taking Sandoz Gliclazide excessive hunger, fast heartbeat, headache, nausea, depression,
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nervousness, shakiness, unsteady walk, unusual tiredness or SERIOUS SIDE EFFECTS, HOW OFTEN THEY weakness. The following signs and symptoms may also occur: HAPPEN AND WHAT TO DO ABOUT THEM clammy skin, anxiety, irregular heart beat, high blood pressure, chest pain or pressure, and/or shortness of breath (angina pectoris). Serious Skin Reactions (DRESS, Stevens-Johnson Syndrome, Symptom / effect Talk with your Stop taking Toxic Epidermal Necrolysis, Hypersensitivity Syndrome): any doctor or the drug pharmacist and call combination of red itchy rash with blisters and peeling of the skin your doctor and /or of the lips, eyes, mouth, nasal passages or genitals. It often Only In all or goes with fever, chills, headache, cough, body aches or joint pain. if cases pharmacist You may have less or dark urine, yellow skin or eyes. If you severe suspect these, you should stop taking the drug and talk with your Uncommon Unexplained fever, doctor or pharmacist. chills or sore throat If you recognize some of these signs of the drop in blood sugar, immediately eat or drink something containing sugar and Yellowing of skin notify your doctor without delay. Good sources of sugar are: or eyes, dark- coloured urine orange juice, corn syrup, honey, or sugar cubes or table sugar or light-coloured (dissolved in water). bowel movements (e.g., jaundice) SERIOUS SIDE EFFECTS, HOW OFTEN THEY Skin rash, redness, HAPPEN AND WHAT TO DO ABOUT THEM itching or hives Symptom / effect Talk with your Stop taking doctor or the drug Oedema, swelling pharmacist and call of the legs or your doctor unexpected weight Only In all or gain if cases pharmacist severe Chest pain or Common Low blood sugar pressure, and/or level (hypoglycemia) shortness of breath The usual signs are: Blood abnormalities Very rare Anxious feeling, with symptoms of Drowsiness sore throat, fever, Chills mouth sore, unusual Cold sweats bleeding or bruising, low level Confusion of red blood cells Cool pale skin (anemia) Difficulty in concentration Allergic Excessive hunger inflammation of Fast heartbeat blood vessels Headache (vasculitis) Nausea Dizziness Low sodium level in blood combined Nervousness Shakiness with symptoms of tiredness, weakness Unsteady walk and confusion Unusual tiredness or (hyponatraemia) weakness Rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing
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SERIOUS SIDE EFFECTS, HOW OFTEN THEY Reporting Side Effects HAPPEN AND WHAT TO DO ABOUT THEM You can report any suspected side effects associated with Symptom / effect Talk with your Stop taking the use of health products to Health Canada by: doctor or the drug
pharmacist and call Visiting the Web page on Adverse Reaction your doctor Reporting (https://www.canada.ca/en/health- Only In all or canada/services/drugs-health-products/medeffect- if cases pharmacist canada/adverse-reaction-reporting.html) for severe information on how to report online, by mail or by difficulty fax; or (angioedema) Calling toll-free at 1-866-234-2345.
Serious Skin NOTE: Contact your health professional if you need Reactions (DRESS, information about how to manage your side effects. The Stevens-Johnson Syndrome, Toxic Canada Vigilance Program does not provide medical advice. Epidermal Necrolysis, Hypersensitivity MORE INFORMATION Syndrome): any combination of red itchy rash with Talk to your healthcare professional blisters and peeling Find the full product monograph, prepared for healthcare of the skin and /or professionals and includes this Patient Medication of the lips, eyes, Information by visiting the Health Canada website mouth, nasal passages or (https://www.canada.ca/en/health-canada.html); Sandoz genitals. It often Canada Inc. website www.sandoz.ca, or by calling at 1- goes with fever, 800-361-3062, chills, headache, cough, body aches or by written request at: or joint pain. You 145, Jules-Léger may have less Boucherville, (Quebec), Canada or dark urine, J4B 7K8 yellow skin or eyes This is not a complete list of side effects. For any unexpected or by email at : effects while taking Sandoz Gliclazide MR, contact your doctor [email protected] or pharmacist. This leaflet was prepared by Sandoz Canada Inc.
HOW TO STORE IT Last revised: March 20, 2018
Keep out of reach and sight of children and pets.
Sandoz Gliclazide MR should be stored at room temperature (15°C-30C).
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.
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