Diamicron MR

(Gliclazide)

The active ingredient in Diamicron MR is gliclazide. Gliclazide helps lower blood glucose levels by increasing insulin release from the pancreas. Insulin allows sugar to move from the blood into the body’s cells for energy, helping reduce high blood sugar in people with type 2 diabetes.

Diamicron MR is not used for type 1 diabetes, diabetic ketoacidosis, or diabetes-related pre-coma.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Diamicron MR. However, the following is a synopsis of the general guidelines for the use of Diamicron MR:

• Take Diamicron MR exactly as prescribed by a healthcare professional. Swallow tablets whole with water. It is usually taken once daily. Your healthcare professional will know what daily dose of Diamicron MR is best for you.
• Do not crush or chew the modified-release tablets.
• Take Diamicron MR with meals to reduce the risk of hypoglycemia.
• Avoid skipping meals and monitor blood glucose levels as directed.
• Diamicron MR may cause drowsiness or dizziness. Use caution when driving or operating machinery.

Some mild or common side effects of Diamicron MR seen in clinical trials as compared to placebo include:

• Hypoglycemia (hypoglycaemia) or low blood sugar.
• Headache.
• Dizziness or drowsiness.
• Abdominal pain.
• Nausea or vomiting.
• Constipation or diarrhea.
• Weight gain or weight loss.

Some individuals may experience serious side effects while using Diamicron MR. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe hypoglycemia with confusion, seizures, or loss of consciousness.
• Hypersensitvity reactions such as rash, blistering, angioedema, or swelling of the face or throat.
• Chest pain or irregular heartbeat.
• Signs of liver problems, including jaundice or yellowing of the skin or eyes, dark urine, increased liver enzyme levels, or persistent abdominal pain.
• Decrease in blood cell counts (white blood cells, platelets, red blood cells).

These are not all of the possible side effects of Diamicron MR. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Diamicron MR, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney diseases or reduced kidney function.
• Liver impairment.
• G6PD-deficiency or red blood cell disorders.
• Thyroid disorders.
• A history of porphyria.
• Increased risk of hypoglycemia, including elderly patients.
• Acute illness, infection, fever, or planned surgery.

• Type 1 diabetes mellitus.
• Diabetic ketoacidosis or diabetic pre-coma.
• Severe kidney or liver impairment.
• Known hypersensitivity to gliclazide, sulfonylureas, or sulfonamides.

Blood glucose levels may begin to improve within days, and full stabilization may take several weeks.

When Diamicron MR is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Miconazole can cause severe hypoglycemia.
• Danazol may raise blood sugar levels.
• Chlorpromazine at high doses, which can increase blood glucose.
• Corticosteroids or glucocorticoids may cause hyperglycaemia.
• Beta-blockers may mask hypoglycemia symptoms.
• Warfarin or other anticoagulants may have altered effects.
• Phenylbutazone may increase hypoglycemic risk.
• Fluconazole or clarithromycin may increase low blood sugar.
• Salbutamol or terbutaline may raise blood glucose.
• St. John’s wort may reduce blood sugar control.
• Alcohol may increase the risk of hypoglycemia.

Diamicron MR is available as modified-release tablets of 30 mg and 60 mg. Dosing is individualized based on blood glucose response and patient factors. Your healthcare professional will know what dose of Diamicron MR is best for you.

It should be stored at room temperature, away from the reach of children or pets.

Diamicron MR is manufactured by Servier.

Diamicron MR is a brand-name product. Generic versions of Diamicron are available. The generic name is gliclazide modified release.

Do not stop Diamicron MR without medical advice. Stopping suddenly may cause high blood sugar. A healthcare professional will guide dose changes or discontinuation.

Diamicron MR is generally not recommended during pregnancy because very little is known about its safety in pregnancy. Insulin or metformin may be preferred. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Diamicron MR is not recommended during breastfeeding due to hypoglycemia risk in infants. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.