DIVINUS (Dapagliflozin) 10 mg Film-Coated Tablets – 30 Tablets

What it is and what it is used for
DIVINUS is a prescription medicine containing dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This locally authorised product is used in adults aged 18 years and older with type 2 diabetes to improve blood-glucose control alongside diet and exercise. It may be used alone when metformin is unsuitable because of intolerance, or with other glucose-lowering medicines, including insulin, when additional control is needed. Dapagliflozin reduces glucose reabsorption in the kidneys so that more excess glucose leaves the body in urine. Urine tests are therefore expected to show glucose during treatment.

Important safety information
Dapagliflozin can rarely cause diabetic ketoacidosis, which may occur even when blood glucose is not very high. Rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast or deep breathing, confusion, unusual sleepiness or tiredness, or a sweet or metallic breath taste requires urgent medical assessment. Treatment is not intended for type 1 diabetes or diabetic ketoacidosis.

The medicine can increase urination and may cause dehydration, low blood pressure or kidney problems, especially during vomiting, fever, poor fluid intake, acute illness, fasting, in older adults, with kidney impairment or with diuretics. Kidney function and hydration status should be assessed before treatment and monitored as clinically needed. Urinary or genital infections may occur. Genital or perineal pain, redness or swelling with fever or feeling unwell may indicate the rare but life-threatening infection known as Fournier’s gangrene and requires emergency care.

Before treatment
Do not use DIVINUS if you are allergic to dapagliflozin or another ingredient. The prescriber must know about kidney or liver disease, low blood pressure, recurrent urinary or genital infections, foot problems, surgery or prolonged fasting, pregnancy, breastfeeding and all medicines being used. Insulin or sulfonylureas may need adjustment to reduce hypoglycaemia risk. Dapagliflozin is not recommended during the second and third trimesters of pregnancy and should not be used while breastfeeding. DIVINUS contains lactose.

Monitoring and storage
Continue the prescribed diet, exercise and glucose monitoring programme. Store below 30°C in the original package and keep out of the sight and reach of children.

Prescription medicine disclaimer
Use only for the patient and condition for which it was prescribed. This information supports safe product identification and general education; it does not diagnose diabetes, set individual glucose targets, select a dose for another condition or replace the directions of the prescriber or pharmacist. Do not start, stop or change treatment without medical supervision.