ZEDILARF 10 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Zedilarf 5mg film-coated tablets EFG

Zedilarf 10mg film-coated tablets EFG

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

1. What is Zedilarf and what is it used for

What is Zedilarf

Zedilarf 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 Zedilarf used for

This medicine 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,
  • this medicine can be used alone or with other medicines to treat diabetes,
  • it is important that you continue to follow the dietary and exercise recommendations given to you 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 kidney function.

What is type 2 diabetes and how does Zedilarf help?

• In type 2 diabetes, your body does not produce enough insulin or is not able to use the insulin it produces 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.
• This medicine works by removing excess sugar from your body. It may also help prevent heart disease.

What is heart failure and how does Zedilarf 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.
• This medicine 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 Zedilarf help?

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they may 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.
• This medicine helps protect your 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 attention 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 fatigue, 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 dapagliflozin, diabetic ketoacidosis may occur even if your blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, seek medical attention immediately and do not take this medicine.

Necrotizing fasciitis of the perineum:

• Consult your doctor immediately if you experience a combination of symptoms such as 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.

Consult your doctor, pharmacist, or nurse before you start taking this medicine

• if you have "type 1 diabetes" - the type that usually appears when you are young and your body does not produce any insulin. Dapagliflozin 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 "Other medicines and Zedilarf",
• 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. Inform your doctor before you start taking dapagliflozin 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 may cause dehydration. Your doctor may ask you to stop taking dapagliflozin until you recover to prevent dehydration,
• if you frequently get urinary tract infections.

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

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

Children and adolescents

Dapagliflozin 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.

This medicine 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.

Other medicines and Zedilarf

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 dapagliflozin may lower 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 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. Ask your doctor about the best way to control your blood sugar levels during pregnancy.

Ask your doctor if you want to breastfeed before taking this medicine. Do not take dapagliflozin during breastfeeding. It is not known if this medicine passes into human breast milk.

Driving and using machines

This medicine 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 dapagliflozin.

Zedilarf contains lactose

Zedilarf contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them 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.

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 a liver problem.
• 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 dapagliflozin 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 dapagliflozin.

If you take more Zedilarf than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Zedilarf

What you should do if you miss a dose 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 dapagliflozin as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take a double dose of dapagliflozin to make up for a missed dose.

If you stop taking Zedilarf

Do not stop taking dapagliflozin 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, this medicine can cause side effects, although not everybody gets them.

Seek medical attention immediately if you experience 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 fatigue
• 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 can occur regardless of your blood sugar levels. Your doctor will decide whether to temporarily or permanently stop your treatment with dapagliflozin.

• 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 Zedilarf and consult 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 pain or pain in the side.

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

Consult your doctor as soon as possible if you experience 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.

These are the signs of low blood sugar levels:

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

Other side effects of treatment with Zedilarf:

Common

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• increased urination or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (seen in laboratory tests)
• increases in red blood cell count 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 or no urination; 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

• kidney inflammation (tubulointerstitial nephritis).

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. In case of doubt, ask your pharmacist how to dispose of medicines no longer required through the SIGRE Point in the pharmacy. This will help protect the environment.

6. Container Content and Additional Information

Zedilarf Composition

• The active ingredient is dapagliflozin.

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

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

• The other components (excipients) are:
• • tablet core: lactose monohydrate (see section 2 "Zedilarf contains lactose"), microcrystalline cellulose PH 101, crospovidone Type A, povidone K-30, anhydrous colloidal silica, magnesium stearate.
  • coating material: poly(vinyl alcohol), titanium dioxide (E171), macrogol (type 3350), talc, yellow iron oxide (E172).

Product Appearance and Container Content

The film-coated tablets of Zedilarf 5 mg are yellow, biconvex, round tablets with a diameter of approximately 7.2 mm, film-coated, with "5" engraved on one side and flat on the other.

The film-coated tablets of Zedilarf 10 mg are yellow, biconvex, oval tablets with a size of approximately 11.1 mm x 6.1 mm, film-coated, with "10" engraved on one side and flat on the other.

Zedilarf tablets are available in OPA/Al/PVC//Al blisters in pack sizes of 10, 28, 30, 60, 90 or 98 film-coated tablets in non-perforated blisters; 14, 28, 56 or 98 film-coated tablets in non-perforated calendar blisters and in packs of 10x1, 28x1, 30x1, 50x1, 90x1, 98x1 or 100x1 film-coated tablets in perforated unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

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

Hungary Zedilarf 5 mg & 10 mg filmtabletta

Spain Zedilarf 5 mg film-coated tablets EFG

Zedilarf 10 mg film-coated tablets EFG

Poland Zedilarf

Date of the last revision of thisleaflet: August 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).