Edistride 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Edistride 5 mg film-coated tablets

Edistride 10 mg film-coated tablets

dapagliflozin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Edistride is and what it is used for

What Edistride is

Edistride contains the active substance dapagliflozin. It belongs to a group of medicines called "sodium-glucose cotransporter 2 (SGLT2) inhibitors". These 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 the urine.

What Edistride is used for

Edistride is used to treat:

• Type 2 diabetes

  • in adults and children aged 10 years and older.
  • if your type 2 diabetes cannot be controlled by diet and exercise alone.
  • Edistride may be used alone or together with other medicines for diabetes.
  • it is important that you continue to follow the dietary and exercise advice provided by your doctor, pharmacist, or nurse.

• Heart failure

  • in adults (aged 18 years and 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 Edistride help?

• In type 2 diabetes, your body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high levels of sugar in the blood. This can cause serious problems such as heart or kidney disease, blindness, and poor circulation in arms and legs.
• Edistride works by removing excess sugar from your body. It may also help prevent heart disease.

What is heart failure and how does Edistride help?

• This type of heart failure occurs when the heart cannot pump blood to the lungs and the rest of the body as effectively as it should. This can lead to serious medical problems and the need for hospitalization.
• The most common symptoms of heart failure are shortness of breath, constant tiredness, and swelling of the ankles.
• Edistride helps protect the heart from worsening and improves your symptoms. It may reduce the need for hospitalization and may help some patients live longer.

What is chronic kidney disease and how does Edistride help?

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they are no longer able to clean and filter your blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospitalization.
• Edistride helps protect your kidneys from further loss of function. This may help some patients live longer.

2. What you need to know before taking Edistride

Do not take Edistride

• if you are allergic to dapagliflozin or to 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, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or unusual tiredness, sweet-smelling breath, a sweet or metallic taste in your mouth, a different smell in your urine or sweat, or rapid weight loss.
• The symptoms above may be signs of "diabetic ketoacidosis" – a rare but serious condition, sometimes potentially life-threatening, that occurs in diabetes due to increased "ketone bodies" in your blood or urine, which are detected in laboratory tests.
• The risk of developing diabetic ketoacidosis may be increased by prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or a serious illness.
• Diabetic ketoacidosis may occur even when your blood glucose levels are within the normal range while being treated with Edistride.

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:

• Contact your doctor immediately if you develop a combination of symptoms including pain, tenderness, redness, or swelling in the genital area or the area between your genitals and anus, accompanied by fever or general malaise. These symptoms could be signs 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 starting Edistride

• if you have "type 1 diabetes" – the type that usually develops at a young age when your body produces no insulin. Edistride should not be used to treat this condition.
• if you have diabetes and have kidney problems – your doctor may prescribe an additional or different medication to control your blood sugar.
• if you have liver problems – your doctor may start you on a lower dose.
• if you are taking medications to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is provided later in "Taking Edistride with other medicines".
• if you have very high blood sugar levels that could lead to dehydration (loss of too much fluid from your body). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Edistride if you have any of these signs.
• if you have or develop nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions may lead to dehydration. Your doctor may ask you to stop taking Edistride until you recover to prevent dehydration.
• if you frequently get urinary tract infections. This medicine may cause urinary tract infections, and your doctor may want to monitor you more closely. Your doctor may consider temporarily changing your treatment if you develop a serious infection.

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

Diabetes and foot care

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

Glucose in urine

Because of how Edistride works, your urine will test positive for glucose while you are taking this medicine.

Advanced age (≥ 65 years or older)

If you are elderly, there may be an increased risk of reduced kidney function and you may be taking other medications (see also "Kidney function" above and "Taking Edistride with other medicines" below).

Children and adolescents

Edistride can be used in children aged 10 years and older for the treatment of type 2 diabetes. No data are available in children under 10 years of age.

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

Taking Edistride with other medicines

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

In particular, inform your doctor:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You should stop taking this medicine if you become pregnant, as its use is not recommended during the second and third trimesters of pregnancy. Discuss with your doctor the best way to manage your blood glucose during pregnancy.

Consult your doctor if you are breastfeeding or intend to breastfeed before taking this medicine. Do not use Edistride while breastfeeding. It is unknown whether this medicine passes into human breast milk.

Driving and using machines

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

However, taking this medicine with other medicines called sulfonylureas or with insulin may cause very low blood sugar levels (hypoglycemia), which can lead to symptoms such as trembling, sweating, and vision disturbances that may affect your ability to drive or use machines.

Do not drive or operate tools or machinery if you feel dizzy while taking Edistride.

Edistride contains lactose

Edistride contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Edistride

Follow exactly the administration instructions for this medicine as indicated by your doctor.

If in doubt, consult your doctor, pharmacist, or nurse again.

How much to take

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

How to take this medicine

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

Your doctor may prescribe Edistride together with another medicine(s). Remember to take these other medicine(s) according to your doctor's instructions. This will help achieve the best results for your health.

Diet and exercise may help your body use blood sugar more effectively. If you have diabetes, it is important to follow any diet and exercise program recommended by your doctor while taking Edistride.

If you take more Edistride than you should

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

If you forget to take Edistride

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

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

If you stop taking Edistride

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

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

4. Possible adverse effects

Like all medicines, Edistride may cause adverse effects, although not everybody gets them.

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

• Angioedema, 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 problems

• 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
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness and fatigue
• sweet smell on your breath, a sweet or metallic taste in your mouth, or a different odour in your urine or sweat
• rapid weight loss

This may occur regardless of blood sugar levels. Your doctor must decide whether to temporarily or permanently discontinue your treatment with Edistride.

• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, very rare.

Stop taking Edistride and consult a doctor immediately if you notice any of these serious adverse effects:

• Urinary tract infection, which 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 (urination)
• back or side pain.

Although 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 adverse effects:

• Reduction in blood sugar levels (hypoglycaemia), very common (may affect more than 1 in 10 people) in patients with diabetes who take this medicine together with a sulphonylurea or insulin.

The signs of low blood sugar are:

• chills, sweating, feeling very anxious, rapid heartbeat
• feeling hungry, headache, vision disturbances
• mood changes or feeling confused.

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

Other adverse effects of treatment with Edistride:

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odour)
• back pain
• discomfort when urinating, increased amount of urine than normal, or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in blood tests)
• increases in the number of red blood cells in the blood (observed in blood tests)
• decreases in renal creatinine clearance (observed in blood tests) at the beginning of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• fungal infection
• excessive loss of body fluids (dehydration, signs may include a very dry or sticky mouth, little or no urination, or rapid heartbeat)
• thirst
• constipation
• waking up at night due to need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the beginning of treatment
• increase in urea (observed in blood tests)

Very rare

• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Edistride

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

Do not use this medicine after the expiry date stated on the blister or packaging following EXP/EXP. The expiry date refers to the last day of the month indicated.

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 and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Edistride

• The active substance is dapagliflozin.

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

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

• The other components are:

• tablet core: microcrystalline cellulose (E460i), lactose (see section 2 “Edistride 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

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

Edistride 10 mg film-coated tablets are yellow, diamond-shaped, approximately 1.1 x 0.8 cm diagonally. They are engraved with “10” on one side and “1428” on the other.

Edistride 5 mg tablets and Edistride 10 mg tablets are available in aluminium 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.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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