Zedilarf

Package leaflet: Information for the patient

Zedilarf, 5 mg, film-coated tablets
Zedilarf, 10 mg, film-coated tablets
Dapagliflozin
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

1. What Zedilarf is and what it is used for
2. Important information before taking 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. These medicines work by blocking the
SGLT2 protein in the kidneys. By blocking this protein, sugar (glucose) in the blood, salt (sodium), and water are removed from the body through urine.

What Zedilarf is used for
Zedilarf is used to treat:

• Type 2 diabetes
  • in adults and children aged 10 years and older.
  • when adequate control of type 2 diabetes cannot be achieved with diet and physical exercise alone.
  • Zedilarf may be used alone or together with other antidiabetic medicines.
  • It is important to continue following the diet and physical exercise regimen recommended 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 impaired kidney function.

What is type 2 diabetes and how does Zedilarf help in its treatment?

• In type 2 diabetes, the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high blood sugar levels. Such a condition can cause serious problems, such as heart or kidney disease, vision loss, 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 is heart failure and how does Zedilarf help in its treatment?

• This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as effectively as it should. This condition may lead to serious medical consequences and the need for hospitalization.
• The most common symptoms of heart failure are shortness of breath, feeling tired or extremely fatigued all the time, and swelling around the ankles.
• Zedilarf helps protect the heart from worsening and alleviates symptoms. It may reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Zedilarf help in its treatment?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are no longer able to properly clean and filter the blood. Loss of kidney function may lead to serious medical consequences and the need for hospital treatment.
• Zedilarf helps protect the kidneys from further loss of function. This may help extend life in some patients.

2. Important information before taking Zedilarf

When not to take Zedilarf

• if the patient has a known allergy (hypersensitivity) to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Contact your doctor or nearest hospital immediately
Diabetic ketoacidosis:

• If the patient with diabetes develops nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, change in the smell of urine or sweat, or rapid weight loss.
• The above symptoms may indicate "diabetic ketoacidosis" – a rare but serious, sometimes life-threatening complication of diabetes caused by increased levels of "ketone bodies" in blood or urine, which is confirmed by laboratory tests.
• The risk of diabetic ketoacidosis may increase during prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or severe illness.
• Diabetic ketoacidosis may occur during treatment with Zedilarf even when blood sugar levels are within normal range. If the patient suspects diabetic ketoacidosis, they should contact their doctor or the nearest hospital immediately and must not take this medicine.

Necrotizing fasciitis of the perineum:

• If the patient experiences a combination of symptoms such as pain, tenderness, redness or swelling of the external genital organs or the area between the genitals and the anus, accompanied by fever or general malaise, they should seek immediate medical attention. These may be signs of a rare but serious or even life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which leads to damage of subcutaneous tissue. Immediate treatment for Fournier's gangrene is essential.

Before starting Zedilarf, discuss this with your doctor, pharmacist, or nurse

• if the patient has "type 1 diabetes" – a type of diabetes which usually affects younger individuals whose bodies do not produce insulin. Zedilarf must not be used to treat this condition.
• if the patient has kidney disease – the doctor may recommend additional or alternative medication to control blood sugar levels.
• if the patient has liver disease – the doctor may start treatment with a lower dose.
• if the patient is taking antihypertensive medicines (medicines that lower blood pressure) and has a history of low blood pressure (hypotension). More information is provided below under the section "Zedilarf with other medicines".
• if the patient has very high blood sugar levels leading to dehydration (excessive fluid loss). Possible symptoms of excessive fluid loss are listed in section 4. Inform the doctor if any of these symptoms have occurred before starting the medicine.
• if the patient experiences nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily stopping Zedilarf until the patient's condition improves, to prevent dehydration.
• if the patient frequently suffers from urinary tract infections.

If any of the above warnings apply to the patient (or if the patient is unsure), consult a doctor, pharmacist, or nurse before taking Zedilarf.
Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of the feet and to follow all foot care advice provided by the doctor.
Glucose in urine
Due to the mechanism of action of Zedilarf, laboratory tests may detect the presence of sugar (glucose) in the urine.
Children and adolescents
Zedilarf may be used in children aged 10 years and older for the treatment of type 2 diabetes.
There is no data on use in children under 10 years of age.
Zedilarf is not recommended for use in children and adolescents under 18 years of age for the treatment of heart failure or chronic kidney disease, as studies have not been conducted in this age group.
Zedilarf with other medicines
Inform your doctor, pharmacist, or nurse about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor:

• if the patient is taking medicines that help remove water from the body (diuretics).
• if the patient is taking other medicines that reduce blood sugar levels, such as insulin or sulfonylurea derivatives. The doctor may recommend reducing the dose of these medicines to prevent low blood sugar (hypoglycaemia).
• if the patient is taking lithium, as Zedilarf may reduce blood lithium levels.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine. If the patient becomes pregnant, she should stop taking this medicine, as its use is not recommended during the second and third trimesters of pregnancy. Consult your doctor to determine the best way to control glycaemia during pregnancy.
If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting this medicine. Zedilarf must not be used during breastfeeding. It is unknown whether the medicine passes into breast milk.
Driving and using machines
Zedilarf has no effect or has a negligible effect on the ability to drive and use machines.
However, using this medicine together with other medicines such as sulfonylurea derivatives or insulin may cause excessively low blood sugar levels (hypoglycaemia), manifesting as muscle tremors, excessive sweating, and visual disturbances, which may affect the ability to drive and use machines.
Do not drive or operate machinery if, after taking Zedilarf, the patient feels dizzy or experiences dizziness.
Zedilarf contains lactose
Zedilarf contains lactose (a sugar found in milk). If the patient has been diagnosed with intolerance to certain sugars, inform the doctor before taking this medicine.
3. How to take Zedilarf
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.
What dose to take

• The recommended dose is one 10 mg tablet once daily.
• The doctor may recommend starting treatment with a 5 mg dose if the patient has liver disease.
• The doctor will prescribe the dose appropriate for the patient.

How to take the medicine

• Swallow the tablet whole with half a glass of water.
• The tablets can be taken during or between meals.
• The tablet can be taken at any time of day. However, try to take it at the same time each day. This will help you remember to take it.

The doctor may recommend taking Zedilarf together with other medicines. Remember to take these medicines exactly as prescribed by your doctor. This will help achieve the best treatment outcome.
Diet and physical exercise can help the patient's body use the sugar present in the blood. For patients with diabetes, it is important to follow the diet and exercise program recommended by the treating doctor while taking Zedilarf.
Taking more Zedilarf than prescribed
If you take more Zedilarf than prescribed, contact your doctor or go to hospital immediately. Take the medicine packaging with you.
If you forget to take Zedilarf
The action to take if a dose is missed depends on the time remaining until the next dose.

• If 12 hours or more remain before the next dose, take Zedilarf as soon as you remember. Take the next dose at the usual time.

• If less than 12 hours remain before the next dose, skip the missed dose. Take the next dose at the usual time.

• Do not take a double dose to make up for a missed dose.

Stopping Zedilarf
Do not stop taking Zedilarf without consulting your doctor. In patients with diabetes, blood sugar levels may rise after stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
You should consult a doctor or the nearest hospital immediately if the patient
experiences any of the following adverse reactions:

• Angioedema, observed very rarely (may occur in up to 1 in 10,000 people). Symptoms of angioedema:
  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • urticaria and breathing difficulties
• Diabetic ketoacidosis – this is rare in patients with type 2 diabetes (may occur in 1 in 1,000 people). Symptoms of ketoacidosis (see also section 2 Warnings and precautions):
  • increased concentration of "ketone bodies" in urine or blood
  • nausea or vomiting
  • abdominal pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • unusual drowsiness or fatigue
  • sweet breath odor, sweet or metallic taste in the mouth, or change in the smell of urine or sweat
  • rapid weight loss. This may occur regardless of blood glucose levels. The doctor may decide to suspend or discontinue treatment with Zedilarf.
• Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a serious infection of the soft tissues of the external genital organs or the area between the genitals and the anus, observed very rarely.

You should stop using Zedilarf and consult a doctor immediately if the patient
experiences any of the following severe adverse reactions:

• Urinary tract infections, which are common (may occur in up to 1 in 10 people). Symptoms of acute urinary tract infection:
  • fever and (or) chills
  • burning sensation during urination
  • back or flank pain. Blood in the urine may occasionally appear; if so, consult a doctor immediately.

You should contact a doctor immediately if the patient experiences any of the
following adverse reactions:

• Low blood sugar (hypoglycaemia), which is very common (may occur in more than 1 in 10 people) – in patients with diabetes taking this medicine together with a sulfonylurea or insulin. Symptoms of low blood sugar:
  • trembling, sweating, feeling anxious, rapid heartbeat
  • feeling hungry, headache, visual disturbances
  • mood changes or feeling confused. The doctor will advise on how to treat low blood sugar and what to do if any of the above adverse reactions occur.

Other adverse reactions during treatment with Zedilarf:
Common

• infections (fungal) of the penis or vagina (e.g. irritation, itching, unusual discharge, or unpleasant odour)
• back pain
• excessive urination or increased need to urinate
• changes in cholesterol or blood fat levels (detected in laboratory tests)
• increase in red blood cell count (detected in laboratory tests)
• decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
• dizziness
• rash

Uncommon (may occur in up to 1 in 100 people)

• excessive loss of body fluids (dehydration, symptoms of which may include extreme dryness or stickiness in the mouth, passing only a small amount of urine or no urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to pass urine
• dry mouth
• weight loss
• increased creatinine levels (detected in blood laboratory tests) at the beginning of treatment
• increased urea levels (detected in blood laboratory tests)

Very rare

• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zedilarf

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton following EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 of dapagliflozin. One film-coated tablet (tablet) of Zedilarf 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• Other ingredients of the medicine 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 film-coated tablets,
with "5" embossed on one side and smooth on the other side, with a diameter of approximately 7.2 mm.
Zedilarf 10 mg film-coated tablets are yellow, biconvex, oval film-coated tablets,
with "10" embossed on one side and smooth on the other side, with dimensions of approximately 11.1 mm x 6.1 mm.
Zedilarf is available in blisters made of OPA/Aluminium/PVC//Aluminium in cardboard boxes
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 Authorisation Holder and Manufacturer
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece
tel. +302105401500

This medicinal product is authorised in the European Economic Area member states under the following names:
Spain Zedilarf 5 mg & 10 mg film-coated tablets EFG
Poland Zedilarf
Hungary Zedilarf 5 mg & 10 mg film tablets