Details for: MYLAN-GLICLAZIDE MR
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02438658 | MYLAN-GLICLAZIDE MR | GLICLAZIDE | 30 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Mylan-Gliclazide MR is used to lower blood glucose level in adult patients with type 2 diabetes mellitus in addition to proper diet, exercise and weight reduction.
What it does
Mylan-Gliclazide MR belongs to the family of hypoglycemic (antidiabetic) drugs and part of a sub family of medicines called sulfonylureas. It helps improve insulin secretion in the body.
When it should not be used
Mylan-Gliclazide MR is contraindicated (must not be taken):
- if you are allergic or hypersensitive to gliclazide, other sulfonylureas, sulfonamides, or to any of the ingredients of these products,
- if you have unstable and/or insulin-dependent diabetes mellitus, juvenile diabetes (type I diabetes), diabetic ketoacidosis, diabetes pre-coma and coma,
- if you have a serious infection, trauma or surgery,
- if you have severe liver problems,
- if you have severe kidney problems,
- if you receive treatment with miconazole,
- if you are pregnant and/or breast-feeding.
What the medicinal ingredient is
Gliclazide.
What the non-medicinal ingredients are
Mylan-Gliclazide MR 30 mg and 60 mg tablets contain: Hypromellose, magnesium stearate and microcrystalline cellulose.
What dosage form it comes in
Mylan-Gliclazide MR comes in modified-release tablets of 30 mg and modified-release breakable tablets of 60 mg.
Warnings and precautions
Mylan-Gliclazide MR may cause low blood sugar (hypoglycemia). You should ask your doctor, 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.
BEFORE you use Mylan-Gliclazide MR talk to your doctor or pharmacist if:
- you have or have had liver problems,
- you have or have had kidney problems,
- you are pregnant or planning to get pregnant,
- you are breast-feeding,
- you have a blood disease called G6PD-deficiency anemia,
Your blood sugar may get too high (hyperglycaemia) if you take St. John’s Wort preparations or if you experience fever, infection, surgery or trauma (stress conditions). In such cases, contact your doctor as your medication may need to be adjusted.Serious Skin Reactions (DRESS, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, hypersensitivity Syndrome): any combination of red itchy rash with blisters and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. If you suspect these, you should stop taking the drug and talk with your doctor or pharmacist.
Low blood sugar and high blood sugar can occur when Mylan-Gliclazide MR is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, especially if you are elderly. If you are taking these medications together, your doctor will remind you of the importance of monitoring your blood glucose.
Mylan-Gliclazide MR is not recommended for use in children under 18 years of age.
Driving and Operating Machinery:
Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially at beginning of the treatment. This may affect your ability to drive or to operate machinery.
Interactions with this medication
Mylan-Gliclazide MR should not be taken if you are also taking miconazole (an anti-fungal drug). See “When it should not be used” section of this leaflet.
Other drugs that may interact with Mylan-Gliclazide MR include:
- other antidiabetic agents
- antibiotics (sulphonamides/sulfa drugs, clarithromycin, fluoriquinolones)
- anti-tuberculosis drugs
- anti-fungal drugs (fluconazole)
- non-steroidal anti-inflammatory drugs (NSAIDs) including phenylbutazone (used to treat inflammation and pain)
- corticosteroids (used to treat inflammation)
- salicylates ( e.g. acetylsalicylic acid)
- angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and certain heart conditions)
- beta blockers (used to treat high blood pressure and certain heart conditions)
- anticoagulant therapy (blood thinners), including warfarin
- diuretics (thiazides, furosemide) (used to treat high blood pressure and certain heart conditions)
- fibrates, nicotinic acid (used to treat high levels of fats in the blood)
- H2-receptor antagonists (used to treat acid reflux/heartburn)
- monoamine oxidase inhibitors (used to treat depression)
- chlorpromazine (used to treat certain psychiatric conditions)
- probenecid (used to treat high levels of uric acid in the blood and gout)
- salbutamol, terbutaline (used to treat asthma) and ritodrine
- barbiturates (sedatives, anti-seizure medications)
- oral contraceptives (estrogen plus progestogen, used for birth control)
- danazol (used to treat breast cysts and endometriosis)
- alcohol.
Some of the drugs described above may lead to loss of blood sugar control (high blood sugar), including diuretics, corticosteroids, oral contraceptives, chlorpromazine, ritodrine, salbutamol, terbutaline, danazol and nicotinic acid.
Some herbs such as St. John’s Wort preparations may lead to high blood sugar and loss of blood sugar control.
Avoid drinking alcoholic beverages and taking medicines containing alcohol while you are taking Mylan-Gliclazide MR as this can lead to a drop in blood sugar (hypoglycaemia).
Tell your doctor if you have recently taken any of the medicines listed above or any other medicines, including those obtained without a prescription. Do not take other medicines unless prescribed or approved by your doctor. Tell any health care professionals that you see that you are taking Mylan-Gliclazide MR.
Proper use of this medication
Usual dose
The recommended starting dose of Mylan-Gliclazide MR is 30 mg per day (a half tablet of Mylan-Gliclazide MR 60 mg or a tablet of Mylan-Gliclazide MR 30 mg), even in elderly patients (over 65 years old). The daily dose should not exceed 120 mg.
Take Mylan-Gliclazide MR once daily at breakfast. The 30 mg tablets cannot be split in half and should be swallowed whole with a glass of water. The 60 mg tablets can be halved. Do not crush or chew the tablets of either strength.
You should test your sugar level as directed by your physician to make sure that your blood sugar is being controlled. Your physician should check your progress at regular visits, especially during the first few weeks that you take this medicine.
Overdose
Missed Dose
If you miss a dose of this medicine, skip the missed dose. Take your next dose at the regular time. Do not double doses
Side effects and what to do about them
Mylan-Gliclazide MR is associated with some side effects. It may, however, affect different people in different ways.
Common side effects reported during clinical trials with
gliclazide modified-release tablets included:
- hypoglycemia (low blood sugar)
- hyperglycemia (high blood sugar)
- viral infection
- upper respiratory infection, runny nose, sore throat, cough
- back, muscle and joint pain
- headache
- high blood pressure
- angina (chest pain)
- leg swelling
- diarrhea, constipation, abdominal pain, nausea
- dizziness
- skin rash/itching
- depression
You should know that the usual signs of low blood sugar level (hypoglycemia) are: anxious feeling, drowsiness, dizziness, chills, cold sweats, confusion, cool pale skin, difficulty in concentration, excessive hunger, fast heartbeat, headache, nausea, depression, nervousness, shakiness, unsteady walk, unusual tiredness or weakness. The following signs and symptoms may also occur: 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, Toxic Epidermal Necrolysis, hypersensitivity Syndrome): any combination of red itchy rash with blisters and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. If you suspect these, you should stop taking the drug and talk with your doctor or pharmacist.
If you recognize some of these signs of the drop in blood sugar, immediately eat or drink something containing sugar and notify your doctor without delay. Good sources of sugar are: orange juice, corn syrup, honey, or sugar cubes or table sugar (dissolved in water).
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Low blood sugar level (hypoglycemia) | ✔ | ||
| The usual signs are: | |||
| Anxious feeling | ✔ | ||
| Drowsiness | ✔ | ||
| Chills | ✔ | ||
| Cold sweats | ✔ | ||
| Confusion | ✔ | ||
| Cool pale skin | ✔ | ||
| Difficult in concentration | ✔ | ||
| Excessive hunger | ✔ | ||
| Fast heartbeat | ✔ | ||
| Headache | ✔ | ||
| Nausea | ✔ | ||
| Dizziness | ✔ | ||
| Nervousness | ✔ | ||
| Shakiness | ✔ | ||
| Unsteady walk | ✔ | ||
| Unusual tiredness or weakness | ✔ | ||
| Uncommon | |||
| Unexplained fever, chills, or sore throat | ✔ | ||
| Yellowing of skin or eyes, dark coloured urine or light colored bowel movements (i.e. jaundice) | ✔ | ||
| Skin rash, redness, itching or hives | ✔ | ||
| Oedema, swelling of the legs or unexpected weight gain | ✔ | ||
| Chest pain or pressure, and/or shortness of breath | ✔ | ||
| Very Rare | |||
| Blood abnormalities with symptoms of sore throat, fever, mouth sore, unusual bleeding or bruising, low level of red blood cells (anemia) | ✔ | ||
| Allergic inflammation of blood vessels (vasculitis) | ✔ | ||
| Low sodium level in blood combined with symptoms of tiredness, weakness and confusion (hyponatraemia) | ✔ | ||
| Rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty (angioedema) | ✔ | ||
| Serious Skin Reactions (DRESS, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, hypersensitivity Syndrome): any combination of red itchy rash with blisters and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Mylan-Gliclazide MR, contact your doctor or pharmacist.
How to store
Store Mylan-Gliclazide MR at controlled room temperature between 15ºC to 30ºC, protected from moisture. Keep out of reach or 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free 1-866-234-2345
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.
More information
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6
Revised on: November 4, 2019
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca