Sinjard M 500 

Presentation:Sinjard M 500 is a tablet formulation containing two active pharmaceutical ingredients: Empagliflozin and Metformin Hydrochloride.Each tablet contains Empagliflozin 5 mg and Metformin Hydrochloride 500 mg.It is supplied in blister packs.

Indications:Sinjard M 500 is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise in the following situations:  

• In patients insufficiently controlled on their maximally tolerated dose of Metformin alone. 
• In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products. 
• In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.  

Dosageand Administration: The dosage of Sinjard M 500 should be individualized based on the patient's current regimen, glycemic control, and tolerability. It is generally taken twice daily with meals to reduce the gastrointestinal side effects associated with Metformin.  

• For patients on Metformin, the starting dose may be one tablet of Sinjard M 500 twice daily, providing Empagliflozin 5 mg and a similar total daily dose of Metformin.
• For patients on Empagliflozin, the starting dose may be one tablet of Sinjard M 500 twice daily, providing Metformin Hydrochloride 500 mg and a similar total daily dose of Empagliflozin.
• For patients switching from separate tablets of Empagliflozin and Metformin, the switch can be made to Sinjard M 500 containing the same total daily doses of each component.  

The maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and for Empagliflozin is 25 mg. Renal function should be assessed prior to initiation and periodically thereafter. Sinjard M 500 is contraindicated in patients with an eGFR below 45 mL/min/1.73 m².

Side Effects:Common side effects associated with Sinjard M 500 may include nausea, vomiting, diarrhea, headache, dizziness, fatigue, abdominal pain, increased urination, and weight loss.⁷As it contains Metformin, gastrointestinal disturbances are common, particularly during treatment initiation.Empagliflozin may increase the risk of urinary tract and genital infections.Hypoglycemia may occur when used in combination with insulin or sulfonylureas.Lactic acidosis is a rare but serious potential side effect associated with Metformin.  

Precautions: Sinjard M 500 is contraindicated in patients with severe renal impairment (eGFR < 45 mL/min/1.73 m²), metabolic acidosis (including diabetic ketoacidosis), or known hypersensitivity to Empagliflozin or Metformin. It is not recommended for use in patients with type 1 diabetes. Caution should be exercised in patients with risk factors for lactic acidosis, such as severe hepatic impairment, alcohol abuse, and conditions of hypoperfusion. Assess renal function before initiating and regularly during treatment. Temporary discontinuation may be necessary for surgical procedures or iodinated contrast imaging.  

Storage: Store Sinjard M 500 tablets at a temperature not exceeding 30°C. Protect from light and moisture. Keep out of the reach of children. Do not use after the expiry date.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.