Xigduo XR 10/1000 mg

Xigduo XR combines two established diabetes medicines in one extended-release tablet. Its main benefits include:

• Lowers elevated blood glucose

• Improves long-term HbA1c control

• Works through two different mechanisms

• Reduces glucose production by the liver

• Removes some excess glucose through urine

• Improves the body’s response to insulin

• Provides convenient once-daily administration

• Can support heart and kidney risk reduction in eligible adults

The risk of low blood sugar is generally limited when Xigduo XR is used without insulin or a sulfonylurea. However, hypoglycaemia becomes more likely when these medicines are taken together.

The treatment works best when it is supported by consistent meals, physical activity, blood-sugar monitoring and regular medical reviews.

Xigduo XR controls blood glucose through the combined actions of dapagliflozin and metformin.

Dapagliflozin blocks a kidney protein called sodium-glucose cotransporter 2, or SGLT2. This protein normally returns filtered glucose to the bloodstream. Blocking it allows more glucose to leave the body through urine, reducing the amount circulating in the blood.

Metformin reduces the amount of glucose produced and released by the liver. It also improves insulin sensitivity, allowing muscle and other tissues to use glucose more effectively. In addition, it reduces some glucose absorption from the digestive system.

These actions complement each other. Dapagliflozin removes excess glucose, while metformin reduces glucose production and improves its use by the body. Xigduo XR does not cure diabetes, but regular treatment helps maintain better glucose control and lowers the risk of complications caused by persistently high blood sugar.

Xigduo XR 10/1000 mg is generally taken once daily in the morning with food. Taking it with a meal helps reduce stomach-related effects from metformin.

Swallow the tablet whole with water. Do not crush, cut or chew it because doing so can interfere with its extended-release design.

The 10/1000 mg tablet provides the maximum recommended daily amount of dapagliflozin together with 1000 mg of extended-release metformin. It is not a universal starting dose. The appropriate strength is selected according to the medicines already being taken, blood-sugar results, kidney function and tolerance to metformin.

The maximum recommended daily dosage across all Xigduo XR strengths is 10 mg of dapagliflozin and 2000 mg of extended-release metformin. Any increase in the metformin dose is normally made gradually to limit nausea, diarrhoea and stomach discomfort.

Kidney function should be checked before treatment and periodically afterwards. Starting Xigduo XR is not recommended when the estimated glomerular filtration rate is below 45 mL/min/1.73 m², and it must not be used when this value is below 30 or when end-stage kidney disease is present.

If a dose is missed, take it when remembered unless the next scheduled dose is close. Do not take two doses together.

Common Side Effects: Xigduo XR can cause genital yeast infections, urinary tract infections, diarrhoea, nausea, headache, a stuffy or runny nose, sore throat and increased urination. Some people experience thirst, mild dizziness or stomach discomfort. These effects are often manageable, but continuing or troublesome symptoms should be discussed with a healthcare professional.

Serious Side Effects: Obtain urgent medical help for breathing difficulty, facial swelling, severe weakness, persistent vomiting, intense abdominal pain, unusual sleepiness, confusion or rapid breathing. These can indicate an allergic reaction, ketoacidosis or the rare but serious build-up of lactic acid. Medical attention is also required for fainting, severe dehydration, yellow skin or eyes, a serious urinary infection, or pain, redness and swelling around the genitals or the area between the genitals and anus.

Xigduo XR is not suitable for everyone. It should be avoided or replaced with another treatment in people with:

• Severe kidney impairment

• End-stage kidney disease

• Diabetic ketoacidosis

• Metabolic acidosis

• Allergy to dapagliflozin or metformin

• Type 1 diabetes

• Significant liver disease

• Mitochondrial disorders such as MELAS or MIDD

• Pregnancy, particularly during later pregnancy

• Breastfeeding

• Age below 10 years

People experiencing prolonged fasting, severe infection, dehydration, heavy alcohol intake or an upcoming operation require medical review before continuing treatment.

Tell the healthcare professional about every medicine, supplement and herbal product being used.

Important interactions include:

• Insulin

• Sulfonylureas

• Diuretics

• Corticosteroids

• Topiramate

• Acetazolamide

• Zonisamide

• Cimetidine

• Dolutegravir

• Ranolazine

• Vandetanib

• Lithium

• Iodinated contrast agents

• Excessive alcohol

Insulin and sulfonylureas can increase the risk of hypoglycaemia. Diuretics can add to fluid loss and low blood pressure. Certain medicines that reduce metformin clearance can increase metformin levels and raise the risk of lactic acidosis.

Xigduo XR can also affect some laboratory tests. Glucose will be present in the urine because this is part of how dapagliflozin works, so urine-glucose testing is not suitable for judging diabetes control while taking this medicine.

• Store at 20°C to 25°C.

• Keep the tablets in their original container.

• Protect them from excessive heat and moisture.

• Keep the container tightly closed.

• Store away from children and pets.

• Do not use broken, damaged or discoloured tablets.

• Check the expiry date before taking a tablet.

• Dispose of expired medicine according to local guidance.