FORXIGA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Forxiga 5 mg film-coated tablets

Forxiga 10 mg film-coated tablets

dapagliflozin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Forxiga and what is it used for
2. Before you take Forxiga
3. How to take Forxiga
4. Possible side effects
5. Storage of Forxiga
6. Further information

1. What is Forxiga and what is it used for

What is Forxiga

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

What is Forxiga used for

Forxiga is used to treat:

• Type 2 diabetes

• in adults and children aged 10 years and older.
• if your type 2 diabetes cannot be controlled with diet and exercise.
• Forxiga can be used alone or with other medicines to treat diabetes.
• it is important that you continue to follow the advice on diet and exercise given to you by your doctor, pharmacist, or nurse.

• Heart failure

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

• Chronic kidney disease

• in adults with reduced kidney function.

What is type 2 diabetes and how does Forxiga help?

• In type 2 diabetes, your body does not produce enough insulin or is not able to use the insulin it produces properly. This leads to high blood sugar levels. This can cause serious problems like heart disease or kidney disease, blindness, and poor circulation in arms and legs.
• Forxiga works by removing 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, feeling tired all the time, and swelling of the ankles.
• Forxiga helps protect the heart from getting worse and improves your symptoms. It may reduce the need to go to the hospital and may help some patients live longer.

What is chronic kidney disease and how does Forxiga help?

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

2. What you need to know before you start taking Forxiga

Do not take Forxiga

• if you are allergic to dapagliflozin or any of the other ingredients of this medicine (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, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual tiredness, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, or rapid weight loss.
• The above symptoms may be a sign of "diabetic ketoacidosis" - a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in "ketone bodies" in your urine or blood, which is detected in laboratory tests.
• 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 serious illness.
• When you are taking Forxiga, diabetic ketoacidosis may occur even if your blood sugar levels are normal.

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

Necrotizing fasciitis of the perineum:

• Consult your doctor immediately if you have a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene requires immediate treatment.

Contact a doctor, pharmacist, or nurse before you start taking Forxiga

• if you have "type 1 diabetes" - the type that usually appears when you are 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 medicine or a different one to control your blood sugar levels.
• if you have any liver problems - your doctor may start with a lower dose.
• if you are taking medicines to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in the section "Taking Forxiga with other medicines".
• if you have very high blood sugar levels that may cause dehydration (loss of too much fluid from the body). Possible signs of dehydration are listed in section 4. Tell your doctor before you start taking Forxiga if you have any of these signs.
• if you have nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
• if you get frequent urinary tract infections.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking Forxiga.

Diabetes and foot care

If you have diabetes, it is important that you regularly check your feet and follow any other foot care advice given to you by your healthcare professional.

Glucose in urine

Due to the way Forxiga works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

Forxiga can be used in children aged 10 years and older to treat type 2 diabetes. There is no data available in children under 10 years of age.

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

Taking Forxiga with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Especially tell your doctor:

• if you are taking a medicine used to remove fluid from the body (diuretic).
• if you are taking other medicines that lower your blood sugar levels, such as insulin or a "sulfonylurea" type medicine. Your doctor may decide to reduce the dose of these medicines to avoid you getting low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Forxiga may reduce the amount of lithium in your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should stop taking this medicine if you become pregnant, as it is not recommended during the second and third trimesters of pregnancy. Consult your doctor about the best way to control your blood sugar levels during pregnancy.

Consult your doctor if you want to breast-feed or are breast-feeding before taking this medicine. Do not take Forxiga during breast-feeding. It is not known if this medicine passes into human breast milk.

Driving and using machines

Forxiga has no or negligible influence on the ability to drive and use machines.

Taking this medicine with other medicines called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which can cause symptoms such as shaking, sweating, and changes in vision that can affect your ability to drive or use machines.

Do not drive or use tools or machines 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 some sugars, consult your doctor before taking this medicine.

3. How to take Forxiga

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor, pharmacist, or nurse.

What dose should you take

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

How to take this medicine

• 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 each day. This will help you remember to take it.

Your doctor may prescribe Forxiga with another medicine. Remember to take these other medicines as instructed by your doctor. This will help you get the best results for your health.

Diet and exercise may help your body use blood sugar better. If you have diabetes, it is important 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, talk to a doctor or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Forxiga

What you should do if you forget 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 a forgotten dose.

If you stop taking Forxiga

Do not stop taking Forxiga without first talking to your doctor. If you have diabetes, your blood sugar levels may increase without this medicine.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Forxiga can cause side effects, although not everybody gets them.

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

• angioedema, seen very rarely (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 problems

• diabetic ketoacidosis, this 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):

• increase in "ketone bodies" in your urine or blood.
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness and unusual tiredness
• sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat.
• rapid weight loss

This may happen even if your blood sugar levels are normal. Your doctor will decide whether to stop your treatment with Forxiga temporarily or permanently.

• necrotizing fasciitis of the perineumor Fournier's gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely.

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

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

These are the signs of a serious urinary tract infection:

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

Although not common, if you see blood in your urine, tell your doctor immediately.

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

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

The signs of low blood sugar levels are:

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

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

Other side effects of Forxiga treatment:

Common

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and unusual discharge or odor)
• back pain
• increased amount of urine or need to urinate more often
• changes in cholesterol or lipid levels in the blood (seen in laboratory tests)
• increases in the number of red blood cells in the blood (seen in laboratory tests)
• decreases in renal clearance of creatinine (seen in laboratory tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• excessive loss of fluids from the body (dehydration, signs may include a very dry or sticky mouth, reduced urine output, or rapid heartbeat)
• thirst
• constipation
• waking up at night to urinate
• dry mouth
• weight loss
• increase in creatinine (seen in blood tests) at the start of treatment
• increase in urea (seen in blood tests)

Rare

• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Forxiga

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

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP/CAD. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Forxiga Composition

• The active ingredient is dapagliflozin.

Each film-coated tablet (tablet) of Forxiga 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin.

Each film-coated tablet (tablet) of Forxiga 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.

• The other ingredients are:

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

Product Appearance and Package Contents

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

The film-coated tablets of Forxiga 10 mg are yellow and diamond-shaped with a diagonal of approximately 1.1 x 0.8 cm. They are marked with "10" on one side and "1428" on the other.

Forxiga 5 mg tablets are available in aluminum blisters in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and in packs of 30x1 or 90x1 film-coated tablets in perforated unit-dose blisters.

Forxiga 10 mg tablets are available in aluminum blisters in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and in packs of 10x1, 30x1, or 90x1 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

SK10 2NA

United Kingdom

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.