ZEDILARF 5 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 the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this summary. See section 4.

Contents of the Summary

1. What is Zedilarf and what is it used for
2. What you need to know before taking Zedilarf
3. How to take Zedilarf
4. Possible side effects
5. Storage of Zedilarf
6. Package contents and additional 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 medications 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 eliminated from the body through urine.

What is Zedilarf used for

This medication is used to treat:

• Type 2 diabetes
• • in adults and children aged 10 years or older,
  • if your type 2 diabetes cannot be controlled with diet and exercise,
  • this medication can be used alone or with other medications to treat diabetes,
  • it is essential that you continue to follow 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 kidney function.

What is type 2 diabetes and how does Zedilarf help?

• In type 2 diabetes, your body does not produce enough insulin or cannot use the insulin it produces effectively. This leads to high blood sugar levels. This can cause serious problems such as heart or kidney disease, blindness, and poor circulation in arms and legs.
• This medication 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 hospitalization.
• The most common symptoms of heart failure are shortness of breath, feeling of constant fatigue, and swelling of the ankles.
• This medication helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalization and can 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 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 hospitalization.
• This medication helps protect your kidneys from losing their function. This may help some patients live longer.

2. What you need to know before taking Zedilarf

Do not take Zedilarf

• if you are allergic to dapagliflozin or 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, 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, 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 severe illness.
• When taking dapagliflozin, 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 medication.

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 malaise. 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 starting to take this medication

• if you have "type 1 diabetes" - the type that usually occurs 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 prescribe an additional medication or a different one to control blood sugar levels,
• if you have any liver problems - your doctor may start with 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 included later in "Other medications and Zedilarf",
• if you have very high blood sugar levels that can cause dehydration (loss of too much fluid from the body). Possible signs of dehydration are listed in section 4. Inform your doctor before starting dapagliflozin if you experience any of these signs,
• if you experience nausea (vomiting), vomiting, or fever, or are unable to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking dapagliflozin until you recover to prevent dehydration,
• if you frequently experience urinary tract infections.

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

Diabetes and foot care

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

Glucose in urine

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

Children and adolescents

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

This medication 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.

Other medications and Zedilarf

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

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 lower blood sugar levels, such as insulin or a "sulfonylurea" type medication. Your doctor may decide to reduce the dose of these medications to avoid low blood sugar levels (hypoglycemia),
• if you are taking lithium, as dapagliflozin may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should stop taking this medication if you become pregnant, as its use is not recommended during the second and third trimesters of pregnancy. Consult your doctor about the best way to control blood sugar levels during pregnancy.

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

Driving and using machines

This medication has a negligible influence on the ability to drive or use machines.

Taking this medication with other medications called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which can cause symptoms such as trembling, sweating, and vision changes 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 certain sugars, consult with them before taking this medication.

3. How to take Zedilarf

Follow the instructions for administration of this medication indicated by your doctor. In case of 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 a liver problem.
• 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 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 along with another medication(s). Remember to take these other medication(s) following your doctor's instructions. This will help you get the best results for your health.

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 dapagliflozin.

If you take more Zedilarf than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zedilarf

What you should 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 dapagliflozin 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 dapagliflozin to make up for missed doses.

If you stop taking Zedilarf

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Contact a doctor or the nearest hospital 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, 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 blood sugar levels. Your doctor should 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 while urinating
• back pain 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 side effects:

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

These are the signs of low blood sugar levels:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• hunger, headache, vision changes
• 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 urine production or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in laboratory tests)
• increases in the number of red blood cells in the blood (observed in laboratory tests)
• decreases in renal creatinine clearance (observed 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 absent urination, or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings to urinate
• dry mouth
• weight loss
• increased creatinine (observed in blood tests) at the start of treatment
• increased urea (observed in blood tests).

Rare

• kidney inflammation (tubulointerstitial nephritis).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this summary. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zedilarf

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

Do not use this medication after the expiration date stated on the blister or carton after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medication at 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/).