Forxiga 10 mg

The benefits of Forxiga depend on the condition being treated.

For type 2 diabetes, it:

• Removes excess glucose through urine

• Helps lower fasting blood sugar

• Supports improvement in HbA1c

• Works independently of insulin production

• Can complement other diabetes medicines

• Has a low risk of hypoglycaemia when used alone

For chronic heart failure, it:

• Helps remove excess sodium and fluid

• Reduces pressure on the heart

• Supports heart-failure symptom management

• Reduces the risk of worsening heart failure

• Supports continued cardiovascular treatment

For chronic kidney disease, it:

• Reduces pressure inside the kidney filters

• Helps slow the decline in kidney function

• Supports long-term kidney protection

• Reduces the risk of serious kidney-related outcomes

• Can be prescribed to suitable adults with or without diabetes

Forxiga does not replace diet, exercise, blood-pressure control or other prescribed treatment. It works as one part of an individual diabetes, heart or kidney care plan.

The kidneys filter glucose from the blood throughout the day. A protein called SGLT2 normally returns most of this filtered glucose to the bloodstream.

Dapagliflozin blocks the SGLT2 protein. As a result, the kidneys return less glucose to the blood and allow more of it to leave the body through urine. This lowers blood-glucose levels in people with type 2 diabetes.

Forxiga also increases the removal of sodium and water. This action reduces excess fluid and changes pressure within the blood vessels and kidney filters.

These effects explain why dapagliflozin is used for more than blood-sugar control. Reduced sodium and fluid retention can decrease strain on the heart, while reduced pressure inside the kidneys helps protect their filtering function.

Because glucose passes into the urine, urine-glucose tests will normally show a positive result during treatment. This is an expected effect of the medicine and does not by itself mean that diabetes has become worse.

The recommended dose for type 2 diabetes, chronic heart failure and chronic kidney disease is generally one Forxiga 10 mg tablet once daily.

Swallow the tablet whole with water. It can be taken with or without food and at any time of day. Taking it at approximately the same time each day helps maintain a consistent routine.

Do not crush, chew or split the tablet unless the supplied instructions specifically state that the tablet can be divided. Do not take more than one dose per day.

When Forxiga is combined with insulin or a sulfonylurea, the accompanying medicine can require adjustment to reduce the risk of low blood sugar. Do not reduce insulin independently because a sudden or excessive insulin reduction can increase the risk of diabetic ketoacidosis.

Kidney function should be checked before and during treatment. Forxiga should not normally be started when the estimated glomerular filtration rate is below 15 mL/min/1.73 m². Its blood-sugar-lowering effect also becomes weaker when kidney function is significantly reduced, although its heart and kidney uses are assessed separately.

People with severe liver impairment can require a lower starting dose before progressing to 10 mg.

If a dose is missed:

• Take it when remembered if the next dose is 12 hours or more away.

• Skip it if the next dose is less than 12 hours away.

• Continue with the next dose at the usual time.

• Do not take two doses together.

Do not stop Forxiga solely because blood-sugar readings or symptoms improve. The condition can worsen after treatment is stopped.

Common Side Effects: Forxiga 10 mg can cause genital fungal infections, urinary tract infections, increased urination, dizziness, back pain and skin rash. Changes in cholesterol, red blood cell levels and kidney blood-test results can also occur. Low blood sugar is more likely when Forxiga is combined with insulin or a sulfonylurea. Increased urination can contribute to thirst or mild dehydration, particularly during hot weather or illness.

Serious Side Effects: Seek urgent medical attention for nausea, vomiting, stomach pain, excessive thirst, fast or deep breathing, confusion, unusual tiredness or a sweet smell on the breath because these can indicate diabetic ketoacidosis even when blood sugar is not extremely high. Medical help is also required for severe dehydration, fainting, facial or throat swelling, breathing difficulty, fever with back or side pain, blood in the urine or a severe urinary infection. Pain, redness or swelling around the genitals or the area between the genitals and anus with fever requires immediate treatment because it can indicate a rare but serious infection called Fournier’s gangrene.

Do not start Forxiga 10 mg without a complete medical assessment if any of the following apply:

• Allergy to dapagliflozin

• Allergy to another tablet ingredient

• Type 1 diabetes

• Current or suspected diabetic ketoacidosis

• Severe dehydration

• Very low blood pressure

• Pregnancy

• Breastfeeding

• Severe liver impairment

• Recurrent serious urinary infections

• Starting treatment with an eGFR below 15

• Rare hereditary galactose intolerance

• Total lactase deficiency

• Glucose-galactose malabsorption

Forxiga should not be used for heart failure or chronic kidney disease in patients under 18 because these uses have not been established for this age group.

Tell the healthcare professional about all medicines, supplements and herbal products being used.

Important interactions include:

• Insulin

• Sulfonylureas

• Loop diuretics

• Thiazide diuretics

• Blood-pressure medicines

• Lithium

• Other glucose-lowering medicines

Insulin and sulfonylureas can increase the risk of low blood sugar when combined with Forxiga. The healthcare professional can adjust the accompanying diabetes medicine and recommend additional glucose monitoring.

Diuretics increase urine production. Combining them with Forxiga can increase the risk of dehydration, low blood pressure and dizziness.

Forxiga can increase lithium removal through the kidneys and lower lithium levels in the blood. People taking lithium require closer blood-level monitoring after starting or changing dapagliflozin treatment.

Do not start another diabetes, heart or kidney medicine without discussing the combination with the treating healthcare professional.

• Keep Forxiga in its original packaging.

• Protect the tablets from moisture.

• Store away from direct heat and sunlight.

• Keep out of reach of children and pets.

• Do not use tablets from damaged packaging.

• Check the expiry date before use.

• Do not use discoloured or damaged tablets.

• Follow the storage directions printed on the pack.

• Dispose of unwanted tablets according to local requirements.

Forxiga tablets do not require special storage conditions under the current product information. Keeping them in their original blister and carton helps protect the tablets and preserves the product details.