Forxiga 5 mg

Forxiga 5 mg is used as part of an individually selected dapagliflozin treatment plan. The reason for choosing this lower strength should be established by the prescribing healthcare professional.

• Type 2 Diabetes - Dapagliflozin is used with diet and regular physical activity to improve blood-sugar control in people with type 2 diabetes. It can be used alone when metformin is unsuitable or combined with other diabetes medicines.

• Severe Liver Impairment - Dapagliflozin exposure can increase in people with severe liver impairment. A healthcare professional can therefore begin treatment with 5 mg once daily and increase the dose only when the lower strength is well tolerated.

• Heart Failure and Chronic Kidney Disease - Dapagliflozin is also used to treat symptomatic chronic heart failure and chronic kidney disease in adults. The usual recommended dose for these conditions is 10 mg once daily.

Forxiga 5 mg should not be presented as the routine heart-failure or chronic kidney disease dose. A lower strength should only be used when it forms part of a specific treatment plan. People receiving treatment for heart failure can explore related information about heart disease medicines.

The 5 mg strength allows dapagliflozin treatment to be introduced at a lower dose when individual circumstances require it. Its practical benefits include:

• Provides a lower-strength dapagliflozin option

• Supports cautious treatment initiation

• Allows tolerability to be assessed before an increase

• Helps remove excess glucose through urine

• Supports blood-sugar management in type 2 diabetes

• Works independently of insulin production

• Can be taken with or without food

• Fits into a once-daily treatment schedule

When dapagliflozin is prescribed at the appropriate dose for heart failure or chronic kidney disease, its effects on sodium, fluid and kidney-filter pressure support cardiovascular and renal treatment.

The dose should match the diagnosed condition. The presence of the same active ingredient does not mean that every Forxiga strength provides the same treatment plan.

The kidneys filter glucose from the blood. A protein called SGLT2 normally returns much of this glucose to the bloodstream before urine leaves the kidneys.

Dapagliflozin blocks SGLT2. This allows more filtered glucose to pass out of the body through urine. Removing excess glucose helps reduce blood-sugar levels in people with type 2 diabetes.

The same process also increases the removal of sodium and water. This can reduce excess fluid, lower pressure within the kidney filters and decrease some of the workload placed on the heart.

These actions explain the different uses of dapagliflozin:

• Glucose removal supports type 2 diabetes treatment.

• Sodium and fluid removal support heart-failure care.

• Reduced pressure in kidney filters supports kidney protection.

Because dapagliflozin causes glucose to enter the urine, urine tests will usually remain positive for glucose during treatment. This is an expected result of the medicine’s action.

Forxiga does not replace insulin when insulin is required. It should not be used to treat type 1 diabetes or diabetic ketoacidosis.

Forxiga 5 mg should be taken only when this lower strength has been selected by a qualified healthcare professional.

Under current Forxiga product information, the recommended dose for type 2 diabetes, chronic heart failure and chronic kidney disease is generally 10 mg once daily. For patients with severe liver impairment, treatment can begin with 5 mg once daily. The dose can then be increased if the medicine is well tolerated and the healthcare professional considers the higher dose appropriate.

In regions where 5 mg is used as an initial diabetes dose, any increase should follow the local product information and the individual treatment plan.

Take Forxiga 5 mg:

• Once daily

• At approximately the same time each day

• With or without food

• With a glass of water

• Swallowed whole

Do not crush or chew the tablet. Do not take two 5 mg tablets to create a 10 mg dose unless the healthcare professional has specifically instructed this. Product strength and dose should not be changed independently.

Kidney and liver function should be reviewed before treatment. Forxiga should not normally be started when the estimated glomerular filtration rate is below 15 mL/min/1.73 m².

When Forxiga is used with insulin or a sulfonylurea, the accompanying medicine can require adjustment to reduce the risk of low blood sugar. Never reduce or stop insulin independently.

If a dose is missed:

• Take it when remembered if the next dose is at least 12 hours away.

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

• Take the following dose at the usual time.

• Do not take two doses together.

Common Side Effects: Forxiga 5 mg can cause genital fungal infections, urinary tract infections, increased urination, dizziness, back pain and skin rash. Blood tests can show changes in cholesterol, red blood cell levels and kidney measurements. Increased urination can cause thirst or mild dehydration. Low blood sugar is more likely when dapagliflozin is combined with insulin or a sulfonylurea.

Serious Side Effects: Seek urgent medical attention for nausea, vomiting, stomach pain, excessive thirst, fast or deep breathing, confusion, unusual tiredness or sweet-smelling 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, difficulty breathing, fever with back or side pain, blood in the urine or signs of a severe urinary infection. Pain, redness or swelling around the genitals or the area between the genitals and anus with fever requires immediate assessment.

Do not start Forxiga 5 mg without a complete medical assessment if any of the following apply:

• Allergy to dapagliflozin

• Allergy to another tablet ingredient

• Type 1 diabetes

• Diabetic ketoacidosis

• Severe dehydration

• Very low blood pressure

• Pregnancy

• Breastfeeding

• Serious recurrent urinary infections

• Starting treatment with an eGFR below 15

• Rare hereditary galactose intolerance

• Total lactase deficiency

• Glucose-galactose malabsorption

People with severe liver impairment require a carefully selected dose and continued monitoring. Children should receive dapagliflozin only for an authorised condition and under specialist supervision.

Tell the healthcare professional about every medicine, supplement and herbal product being used. Important interactions include:

• Insulin

• Sulfonylureas

• Loop diuretics

• Thiazide diuretics

• Blood-pressure medicines

• Lithium

• Other glucose-lowering medicines

Combining Forxiga with insulin or a sulfonylurea can increase the risk of hypoglycaemia. The prescriber can reduce the accompanying medicine when necessary and recommend closer glucose monitoring.

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

Dapagliflozin can increase the amount of lithium removed through the kidneys. Lithium blood levels should be monitored after starting Forxiga or changing its dose.

Do not add another diabetes, heart or kidney medicine without checking the combination with a healthcare professional.

• Keep Forxiga in its original packaging.

• Protect the tablets from moisture.

• Store away from excessive heat and sunlight.

• Keep out of reach of children and pets.

• Do not use damaged tablets.

• Do not use tablets from an opened or damaged blister.

• Check the expiry date before use.

• Follow the storage directions on the supplied pack.

• Dispose of expired tablets responsibly.

Current Forxiga product information states that the tablets do not require special storage conditions. Keeping them in the original blister and carton helps preserve the product details and prevents accidental damage.