Glifo-M XR 10/1000 Tablet

Combination of an SGLT2 inhibitor and a biguanide for adults with type 2 diabetes, with diet and exercise:

• When metformin alone does not control blood sugar
• To replace separate empagliflozin and metformin tablets
• Empagliflozin also lowers the risk of cardiovascular death in diabetes with heart disease, and helps protect the kidneys and heart

Adults: one tablet twice daily with meals (5 mg/500 mg, 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/500 mg, 12.5 mg/850 mg or 12.5 mg/1,000 mg), chosen according to the current doses.

Maximum: empagliflozin 25 mg + metformin 2,000 mg per day.

• Extended-release forms are taken once daily in the morning with food.
• Increase gradually to limit stomach upset.
• Not for children under 18.

• Type 1 diabetes, diabetic ketoacidosis
• Kidney impairment with eGFR below 30 ml/min
• Conditions that cause acidosis or low oxygen: severe infection, dehydration, shock, recent heart attack, severe heart or lung failure
• Liver failure, heavy alcohol use
• Before iodinated contrast studies or major surgery (stop temporarily)
• Allergy to empagliflozin or metformin

Common: genital fungal infections (itching, discharge), urinary tract infections, passing more urine, thirst, nausea, diarrhoea, stomach pain, metallic taste.

Less common: dizziness or low blood pressure from dehydration, low blood sugar (with insulin or sulphonylureas).

Rare but serious: ketoacidosis even with normal blood sugar (nausea, vomiting, stomach pain, fast breathing — emergency), lactic acidosis, Fournier's gangrene (painful swelling of the genital area with fever), severe kidney infection, vitamin B12 deficiency with long-term use.

• Drink enough fluids; stop temporarily during vomiting, diarrhoea, fasting or serious illness, and before surgery.
• Keep the genital area clean.
• Check kidney function at least yearly.
• Elderly or on diuretics: watch for dehydration.

Not recommended in pregnancy (insulin is preferred) or while breastfeeding.

• Iodinated contrast media (stop before and for 48 hours after)
• Alcohol (lactic acidosis)
• Insulin, sulphonylureas (low blood sugar — lower their doses)
• Diuretics (dehydration, low blood pressure)
• Lithium (levels may fall)
• NSAIDs, ACE inhibitors (kidney effects)

Risk of lactic acidosis from metformin — emergency treatment; haemodialysis may be needed.

Store below 30°C, dry.