Zedilarf

Package Leaflet: Information for the Patient

Zedilarf, 5 mg, film-coated tablets

Zedilarf, 10 mg, film-coated tablets

Dapagliflozin

Read all of this leaflet carefully before 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Zedilarf is and what it is used for
• 2. What you need to know before you take Zedilarf
• 3. How to take Zedilarf
• 4. Possible side effects
• 5. How to store Zedilarf
• 6. Contents of the pack and other information

1. What Zedilarf is and what it is used for

What Zedilarf is

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

What Zedilarf is used for

Zedilarf is used to treat:

• Type 2 diabetes
• in adults and children aged 10 years and older.
• when diet and exercise alone are not enough to control type 2 diabetes.
• Zedilarf can be used alone or with other medicines that lower blood sugar levels.
• It is important to continue to follow the diet and exercise plan as recommended by your doctor, pharmacist, or nurse.
• Heart failure
• in adults (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 type 2 diabetes is and how Zedilarf works

• In type 2 diabetes, the body does not make enough insulin or does not use the insulin it makes effectively. This leads to high blood sugar levels. This can cause serious problems, such as heart disease, kidney disease, blindness, and poor blood circulation in the arms and legs.
• Zedilarf works by removing excess sugar from the body. Zedilarf may also help prevent heart disease.

What heart failure is and how Zedilarf works

• 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 consequences and the need for hospital treatment.
• The most common symptoms of heart failure are shortness of breath, feeling tired or very tired all the time, and swelling around the ankles.
• Zedilarf helps protect the heart from getting worse and relieves symptoms. It may reduce the need for hospitalization and help some patients live longer.

What chronic kidney disease is and how Zedilarf works

• In patients with chronic kidney disease, the kidneys gradually lose their ability to filter and clean the blood. This can lead to serious medical consequences and the need for hospital treatment.
• Zedilarf helps protect the kidneys from losing their function. This may help some patients live longer.

2. What you need to know before you take Zedilarf

Do not take Zedilarf

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

Warnings and precautions

Seek medical help immediately

Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, abdominal pain, rapid heartbeat, or deep and rapid breathing, confusion, drowsiness, or excessive thirst, sweet smell of breath, sweet or metallic taste in the mouth, or change in the smell of urine or sweat, or rapid weight loss.
• These symptoms may indicate "diabetic ketoacidosis" - a rare but serious and potentially life-threatening complication of diabetes caused by high levels of "ketone bodies" in the urine or blood.
• The risk of diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to serious surgery or illness.
• During treatment with Zedilarf, diabetic ketoacidosis may occur even if your blood sugar levels are normal. If you suspect you have diabetic ketoacidosis, seek medical help immediately and do not take this medicine.

Fournier's gangrene:

• If you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the external genital area or the area between the genitals and anus, with fever or general feeling of being unwell, seek medical help immediately. These may be symptoms of a rare but serious or potentially life-threatening infection called Fournier's gangrene, which can cause damage to the tissue under the skin.

Before taking Zedilarf, talk to your doctor, pharmacist, or nurse

• if you have type 1 diabetes - a type of diabetes that usually affects young people and is caused by the body not producing insulin. Zedilarf is not for the treatment of this condition.
• if you have kidney disease and are taking insulin or certain other medicines that lower blood sugar - your doctor may recommend a different dose or a different medicine to control your blood sugar levels.
• if you have liver disease - your doctor may start you on a lower dose.
• if you are taking medicines that lower blood pressure and have low blood pressure - see also "Zedilarf with other medicines" below.
• if you have very high blood sugar levels, which can cause dehydration (loss of too much fluid). Possible symptoms of excessive fluid loss are listed in section 4. Before starting Zedilarf, tell your doctor if you experience any of these symptoms.
• if you experience nausea, vomiting, or fever, or if you are unable to eat or drink. This can cause dehydration. Your doctor may recommend stopping Zedilarf until your condition improves to prevent dehydration.
• if you frequently experience urinary tract infections.

If any of these warnings apply to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before taking Zedilarf.

Diabetes and foot care

For patients with diabetes, it is essential to regularly check the condition of your feet and follow any foot care recommendations given by your doctor.

Glucose in urine

Due to the mechanism of action of Zedilarf, laboratory tests may show the presence of glucose in the urine.

Children and adolescents

Zedilarf can be used in children aged 10 years and older to treat type 2 diabetes. There is no data on the use of Zedilarf in children under 10 years of age. Zedilarf is not recommended for use in children and adolescents under 18 years of age to treat heart failure or chronic kidney disease, as no studies have been conducted in this age group.

Zedilarf with other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, tell your doctor:

• if you are taking medicines that help remove water from the body (diuretics).
• if you are taking other medicines that lower blood sugar, such as insulin or sulfonylurea. Your doctor may recommend reducing the dose of other medicines to prevent low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Zedilarf may lower lithium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant, stop taking this medicine, as it is not recommended during the second and third trimesters of pregnancy. Consult your doctor to determine the best way to control your blood sugar levels during pregnancy. If you are breastfeeding or wish to breastfeed, tell your doctor before taking this medicine. Do not take Zedilarf while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Zedilarf has no or negligible influence on the ability to drive and use machines. Taking this medicine with other medicines, such as sulfonylurea or insulin, may cause low blood sugar levels (hypoglycemia), which can cause shakiness, sweating, and blurred vision, affecting your ability to drive or operate machinery. Do not drive or operate machinery if you feel dizzy or have dizziness after taking Zedilarf.

Zedilarf contains lactose

Zedilarf contains lactose (a sugar found in milk). If you have been told that you have an intolerance to some sugars, tell your doctor before taking this medicine.

3. How to take Zedilarf

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

How much to take

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

How to take Zedilarf

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

Your doctor may recommend taking Zedilarf with other medicines. Remember to take these medicines as recommended by your doctor. This will help you get the best results from your treatment. Diet and exercise can help your body use the sugar in your blood. For patients with diabetes, it is essential to follow the diet and exercise plan recommended by your doctor while taking Zedilarf.

If you take more Zedilarf than you should

If you take more Zedilarf than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you.

If you forget to take Zedilarf

What to do if you miss a dose depends on how much time is left before your next dose.

• If it is 12 hours or more before your next dose, take Zedilarf as soon as you remember. Take your next dose at the usual time.
• If it is less than 12 hours before your next dose, skip the missed dose. Take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zedilarf

Do not stop taking Zedilarf without talking to your doctor first. If you have diabetes, your blood sugar levels may increase after stopping Zedilarf. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Seek medical help immediately if you experience any of the following side effects:

• Angioedema, which is very rare (may affect up to 1 in 10,000 people). Symptoms of angioedema:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing
• Diabetic ketoacidosis, which is rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people). Symptoms of diabetic ketoacidosis (see also section 2 "Warnings and precautions"):
• high levels of "ketone bodies" in the urine or blood
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness or tiredness
• sweet smell of breath, sweet or metallic taste in the mouth, or change in the smell of urine or sweat
• rapid weight loss It may occur regardless of blood sugar levels. Your doctor may decide to stop or discontinue Zedilarf.
• Fournier's gangreneor necrotizing fasciitis of the genital area, a serious and potentially life-threatening infection of the soft tissues of the genital area, which is very rare.

Stop taking Zedilarf and seek medical help immediately if you experience any of the following serious side effects:

• Urinary tract infections, which are common (may affect up to 1 in 10 people). Symptoms of acute urinary tract infection:
• fever and/or chills
• burning sensation while urinating
• back or side pain

Seek medical help if you experience any of the following side effects:

• Low blood sugar (hypoglycemia), which is very common (may affect more than 1 in 10 people) - in patients with diabetes taking Zedilarf with sulfonylurea or insulin. Symptoms of low blood sugar:
• shakiness, sweating, feeling anxious
• fast heartbeat
• feeling hungry, headache, blurred vision
• mood changes or feeling confused

Other side effects of Zedilarf:

Common

• infections (thrush) of the penis or vagina (e.g., irritation, itching, unusual discharge, or unpleasant smell)
• back pain
• increased urination or need to urinate more often
• changes in cholesterol or fat levels in the blood (detected in laboratory tests)
• increased red blood cell count (detected in laboratory tests)
• decreased kidney function (detected in laboratory tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• loss of too much fluid from the body (dehydration, which can cause dryness or stickiness in the mouth, passing less urine than usual, or rapid heartbeat)
• thirst
• constipation
• getting up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected in blood tests) at the start of treatment
• increased urea levels (detected in blood tests)

Rare

• kidney infection (pyelonephritis)

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 the "Further information" section. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zedilarf

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. The expiry date refers to the last day of that month. There are no special storage conditions for this medicine. 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. Contents of the pack and other information

What Zedilarf contains

• The active substance is dapagliflozin. One film-coated tablet (tablet) of Zedilarf 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. One film-coated tablet (tablet) of Zedilarf 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
• The other ingredients are
• Tablet core: lactose monohydrate (see section 2 "Zedilarf contains lactose"), microcrystalline cellulose type 101, crospovidone type A, povidone K-30, colloidal anhydrous silica, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Zedilarf looks like and contents of the pack

Zedilarf 5 mg film-coated tablets are yellow, biconvex, round tablets with "5" engraved on one side and smooth on the other, approximately 7.2 mm in diameter. Zedilarf 10 mg film-coated tablets are yellow, biconvex, oval tablets with "10" engraved on one side and smooth on the other, approximately 11.1 mm x 6.1 mm in size. Zedilarf is available in OPA/Aluminum/PVC//Aluminum blisters in cartons containing 10, 28, 30, 60, 90, or 98 film-coated tablets in blisters; 14, 28, 56, or 98 film-coated tablets in calendar blisters, and 10x1, 28x1, 30x1, 50x1, 90x1, 98x1, or 100x1 film-coated tablets in perforated unit-dose blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PharmaPath S.A., 28is Oktovriou 1, Agia Varvara, 123 51, Greece, tel. +302105401500

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Zedilarf 5 mg & 10 mg comprimidos recubiertos con película EFG, Poland: Zedilarf, Hungary: Zedilarf 5 mg & 10 mg filmtabletta

Date of last revision of the leaflet: