Empaglif-M 25/1000 XR Tablet

✔️ Dosage and Administration

The dose should be individualized according to the patient's current treatment, kidney function, blood glucose levels, and tolerability.

• Take the extended-release tablet with a meal, following the prescribed schedule.
• Swallow the tablet whole; do not crush, chew, or split it unless the product instructions specifically permit this.
• Patients switching from separate empagliflozin and metformin tablets may be prescribed a combination containing equivalent total daily doses, when appropriate.
• Dose adjustments should be made gradually as directed by the physician to help reduce gastrointestinal side effects.
• The maximum recommended daily doses for the relevant formulations are generally empagliflozin 25 mg and metformin 2,000 mg, but the appropriate dose depends on the specific product and the patient's clinical condition.

Renal impairment: Kidney function must be assessed before treatment and monitored periodically. This combination may be unsuitable for patients with significantly reduced kidney function. The exact eGFR threshold depends on the product labeling and applicable prescribing guidance.

Children: Safety and effectiveness in patients under 18 years of age have not been established for this combination.

✔️ Interaction

Inform the physician about all medicines and supplements being taken. Important interactions include:

• Diuretics: May increase urination and the risk of dehydration or low blood pressure.
• Insulin and sulfonylureas: Increase the risk of hypoglycemia.
• Medicines that reduce metformin clearance: Certain medicines, including cimetidine, dolutegravir, ranolazine and vandetanib, may increase metformin exposure.
• Carbonic anhydrase inhibitors: May increase the risk of metabolic acidosis.
• Medicines affecting blood glucose: Corticosteroids, some diuretics, thyroid medicines and other agents may alter glucose control.
• Alcohol: Excessive alcohol intake increases the risk of metformin-associated lactic acidosis.

Urine glucose tests are not reliable for monitoring blood glucose control during treatment with empagliflozin. Blood glucose testing or other clinician-recommended methods should be used instead.

✔️ Empaglif-M XR should not be used in patients with:

• Known hypersensitivity to empagliflozin, metformin or any component of the formulation.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis or lactic acidosis.
• Severe renal impairment or other conditions in which metformin is contraindicated.
• Acute conditions associated with substantial dehydration, shock or severe infection.
• Conditions associated with significant tissue hypoxia, such as certain cases of acute or decompensated heart or respiratory failure.
• Acute alcohol intoxication or alcoholism, where use of metformin is contraindicated.

✔️ Side Effects:

Possible side effects include:

• Gastrointestinal: Diarrhea, nausea, vomiting, flatulence, abdominal discomfort and indigestion.
• Genital infections: Vaginal yeast infections, vulvovaginitis, balanitis and other genital fungal infections.
• Urinary symptoms: Urinary tract infections and increased frequency of urination.
• Other effects: Thirst, itching, rash, headache and changes in blood lipid levels.
• Less common but important effects: Dehydration, low blood pressure, changes in kidney function and increased hematocrit.

Serious but uncommon risks include diabetic ketoacidosis and metformin-associated lactic acidosis. Seek urgent medical attention for severe abdominal pain, persistent nausea or vomiting, unusual breathing difficulty, marked weakness, confusion or other symptoms suggesting a serious reaction.

Low blood glucose is more likely when this medicine is used with insulin or insulin-releasing medicines such as sulfonylureas.

✔️ Precautions and Warnings

• Lactic acidosis: Metformin can rarely cause lactic acidosis, a medical emergency. Risk may increase with severe kidney impairment, dehydration, serious infection, tissue hypoxia or excessive alcohol consumption.
• Diabetic ketoacidosis: Empagliflozin may cause ketoacidosis even when blood glucose is not markedly elevated. Seek urgent assessment if symptoms occur.
• Dehydration and low blood pressure: Extra caution is required in older adults, people with kidney impairment, those with low blood pressure and patients taking diuretics.
• Kidney problems: Treatment may need to be temporarily interrupted during severe illness, dehydration, prolonged fasting or situations involving substantially reduced food and fluid intake.
• Urinary and genital infections: Report painful urination, fever, genital itching or swelling, or unusual genital pain promptly. Rarely, severe genital or perineal infections can occur.
• Hypoglycemia: A reduction in insulin or sulfonylurea dosage may be necessary when treatment is started.
• Vitamin B12 deficiency: Long-term metformin use can reduce vitamin B12 levels. Periodic assessment may be appropriate, particularly if anemia or nerve-related symptoms develop.
• Blood lipids: LDL cholesterol may increase; monitor as clinically indicated.
• Surgery and procedures: Inform the healthcare team before surgery or procedures involving prolonged fasting, as temporary interruption may be required.

✔️ Pregnancy & Lactation

Empagliflozin is generally not recommended during pregnancy, particularly during the second and third trimesters, because of potential risks to fetal kidney development. If pregnancy occurs or is planned, consult the treating physician promptly to review diabetes management.

This combination is not recommended during breastfeeding. A healthcare professional should select an appropriate treatment for blood glucose control during pregnancy or lactation.

✔️ Storage:

Store below 30°C, protected from light and moisture. Keep out of the reach of children.