Package Insert: Information for the Patient

Forxiga 5 mg Film-Coated Tablets

Forxiga 10 mg Film-Coated Tablets

dapagliflozina

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

What is Forxiga

Forxiga contains the active ingredient dapagliflozina. It belongs to a group of medicines called "inhibitors of the sodium-glucose cotransporter 2 (SGLT2)". They work by blocking the SGLT2 protein in the kidneys. By blocking this protein, sugar in the blood (glucose), salt (sodium), and water are eliminated from the body through urine.

What is Forxiga used for

Forxiga is used to treat:

• Type 2 diabetes

• in adults and children 10 years of age or older.
• if your type 2 diabetes cannot be controlled with diet and exercise.
• Forxiga can be used alone or in combination with other medicines to treat diabetes.
• it is essential that you continue following the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse.

• Heart failure

• in adults (18 years of age or older) when the heart does not pump blood as well as it should.

• Chronic kidney disease

• in adults with reduced renal function.

What is type 2 diabetes and how does Forxiga help?

• In type 2 diabetes, your body does not produce enough insulin or is unable to use insulin effectively. This leads to high blood sugar levels. This can cause serious problems such as heart disease or kidney disease, blindness, and poor circulation in arms and legs.
• Forxiga works by eliminating excess sugar from your body. It may also help prevent heart disease.

What is heart failure and how does Forxiga help?

• This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as well as it should. This can lead to serious medical problems and the need for hospital care.

• The most common symptoms of heart failure are shortness of breath, constant fatigue, and swelling of the ankles.
• Forxiga helps protect the heart so it does not worsen and improves your symptoms. It may reduce the need for hospitalization and can help some patients live longer.

What is chronic kidney disease and how does Forxiga help?

• When you have chronic kidney disease, your kidneys may lose their function gradually. This means they will not be able to clean and filter your blood as they should. The loss of renal function can lead to serious medical problems and the need for hospital care.
• Forxiga helps protect your kidneys in the loss of their functionality. This may help some patients live longer.

Do not take Forxiga

• if you are allergic to dapagliflozina or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Contact a doctor or the nearest hospital immediately

Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual fatigue, sweet-smelling breath, a sweet or metallic taste in your mouth, or a different odor in your urine or sweat or rapid weight loss.
• The above symptoms may be a sign of “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening condition that occurs with diabetes due to an increase in “ketone bodies” in your urine or blood, detected by analysis.
• The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a greater need for insulin due to major surgery or a serious illness.
• Diabetic ketoacidosis can occur while taking Forxiga, even when your blood glucose is normal.

If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital immediately and do not take this medication.

Fournier's gangrene:

• Consult a doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. These symptoms may be a sign of a rare but serious, potentially life-threatening infection called Fournier's gangrene or necrotizing fasciitis of the perineum, which destroys tissue under the skin. Fournier's gangrene must be treated immediately.

Contact a doctor, pharmacist or nurse before starting to take Forxiga

• if you have “type 1 diabetes” - the type that typically appears when young and your body does not produce any insulin. Forxiga should not be used to treat this condition.
• if you have diabetes and have any kidney problems - your doctor may ask you to take an additional or different medication to control blood sugar.
• if you have any liver problems – your doctor may start with a lower dose.
• if you are taking medications to lower your blood pressure (anti-hypertensives) or have a history of low blood pressure (hypotension). More information is provided later in Taking Forxiga with other medications.
• if you have very high blood sugar levels that may cause dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting to take Forxiga if you experience any of these signs.
• if you have nausea (feeling like vomiting), vomiting or fever or are unable to eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
• if you frequently have urinary tract infections.

If any of the above situations apply to you (or you are unsure), speak with your doctor, pharmacist or nurse before taking Forxiga.

Diabetes and foot care

If you have diabetes, it is essential to regularly inspect your feet and follow any other foot care advice provided by your healthcare professional.

Blood glucose in urine

Due to how Forxiga works, your urine will test positive for glucose while taking this medication.

Children and adolescents

Forxiga can be used in children aged 10 years or older for the treatment of type 2 diabetes. There are no available data in children under 10 years of age.

Forxiga is not recommended in children or adolescents under 18 years of age for the treatment of heart failure or for the treatment of chronic kidney disease, as it has not been studied in these patients.

Taking Forxiga with other medications

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medication.

Especially inform your doctor:

• if you are taking a medication used to remove fluid from the body (diuretic).
• if you are taking other medications that reduce the amount of sugar in the blood, such as insulin or a “sulfonilurea” type medication. Your doctor may decide to reduce the dose of these medications to avoid low blood sugar (hypoglycemia).
• if you are taking lithium, as Forxiga may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication. You should stop taking this medication if you become pregnant, as it is not recommended for use during the second and third trimesters of pregnancy. Consult your doctor about the best way to control blood glucose during pregnancy.

Consult your doctor if you want to breastfeed before taking this medication. Do not use Forxiga during breastfeeding. It is unknown whether this medication passes into human breast milk.

Driving and operating machinery

Forxiga has a negligible or insignificant effect on the ability to drive or operate machinery.

Taking this medication with other medications called sulfonilureas or with insulin may cause very low blood sugar (hypoglycemia), which may cause symptoms such as trembling, sweating and visual disturbances that may affect your ability to drive or operate machinery.

Do not drive or use tools or machinery if you feel dizzy while taking Forxiga.

Forxiga contains lactose

Forxiga contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

What dose should you take

• The recommended dose is one 10 mg tablet per day.
• Your doctor may start with a dose of 5 mg if you have liver problems.
• Your doctor will prescribe the appropriate dose for you.

How to take this medication

• Swallow the tablet whole with half a glass of water.
• You can take the tablet with or without food.
• You can take the tablet at any time of the day. However, try to take it at the same time every day. This will help you remember to take it.

Your doctor may prescribe Forxiga along with other medication(s). Remember to take these other medication(s) following your doctor's instructions. This will help you achieve the best results for your health.

A healthy diet and exercise can help your body use blood sugar better. If you have diabetes, it is essential that you follow any diet and exercise program recommended by your doctor while taking Forxiga.

If you take more Forxiga than you should

If you take more Forxiga tablets than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you.

If you forget to take Forxiga

What to do if you forget to take a tablet depends on how much time is left until your next dose.

• If there are 12 hours or more until your next dose, take a dose of Forxiga as soon as you remember. Then take the next dose at the usual time.
• If there are less than 12 hours until the next dose, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Forxiga to make up for the missed doses.

If you interrupt treatment with Forxiga

Do not stop taking Forxiga without consulting your doctor first. If you have diabetes, your blood sugar may increase without this medication.

If you have any other questions about using this product, ask your doctor, pharmacist, or nurse.

Like all medicines, Forxiga may cause side effects, although not everyone will experience them.

Contact a doctor or the nearest hospital immediately if you experience any of the following side effects:

• angioedema, which is very rare (may affect up to 1 in 10,000 people).

These are the signs of angioedema:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and breathing difficulties

• diabetic ketoacidosis, which is rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increased levels of "ketone bodies" in your urine or blood.
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness and fatigue
• sweet odor in your breath, a sweet or metallic taste in your mouth, or a different odor in your urine or sweat.
• rapid weight loss

This may occur regardless of your blood sugar levels. Your doctor will decide whether to temporarily or permanently stop your treatment with Forxiga.

• fasciitis necroticans of the perineumor Fournier's gangrene, a severe infection of the soft tissues of the genitals or the area between the genitals and the anus, which is very rare.

Stop taking Forxiga and consult a doctor immediately if you notice any of these severe side effects:

• urinary tract infection, which occurs frequently (may affect up to 1 in 10 people).

These are the signs of a severe urinary tract infection:

• fever and/or chills
• burning sensation while urinating
• back or side pain.

Although it is not very common, if you notice blood in your urine, inform your doctor immediately.

Contact your doctor as soon as possible if you experience any of the following side effects:

• low blood sugar levels(hypoglycemia), which is very common (may affect more than 1 in 10 people) in patients with diabetes who take this medicine with a sulfonylurea or insulin

These are the signs of low blood sugar levels:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• feeling of hunger, headache, vision changes
• change in mood or feeling of confusion.

Your doctor will explain how to treat low blood sugar levels and what to do if you experience any of the above symptoms.

Other side effects of treatment with Forxiga:

Frequent

• genital infections (candidiasis) of the penis or vagina (the signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• increased urine output or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in tests)
• increases in red blood cell count in the blood (observed in tests)
• decreases in renal clearance of creatinine (observed in tests) at the start of treatment
• dizziness
• eruption

Rare (may affect up to 1 in 100 people)

• excessive loss of body fluids (dehydration, the signs may be a very dry or sticky mouth, infrequent or no urination; or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings due to the need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the start of treatment
• increase in urea (observed in blood tests)

Very rare

• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack or container after EXP/CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Forxiga

• The active ingredient is dapagliflozina.

Each film-coated tablet of Forxiga 5 mg contains dapagliflozina propanodiol monohydrate equivalent to 5 mg of dapagliflozina.

Each film-coated tablet of Forxiga 10 mg contains dapagliflozina propanodiol monohydrate equivalent to 10 mg of dapagliflozina.

• The other components are:

• Tablet core: microcrystalline cellulose (E460i), lactose (see section 2 “Forxiga contains lactose”), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
• Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the pack

The film-coated tablets of Forxiga 5 mg are yellow and round with a diameter of 0.7 cm. They have “5” engraved on one side and “1427” on the other.

The film-coated tablets of Forxiga 10 mg are yellow and rhomboid with a diagonal of approximately 1.1 x 0.8 cm. They have “10” engraved on one side and “1428” on the other.

Forxiga 5 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-precortated calendar blisters and in pack sizes of 30x1 or 90x1 film-coated tablets in precortated single-dose blisters.

Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-precortated calendar blisters and in pack sizes of 10x1, 30x1 or 90x1 film-coated tablets in precortated single-dose blisters.

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

SK10 2NA

United Kingdom

For more information about this medicine, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.