Odelniqva

Package Leaflet: Information for the Patient

Odelniqva, 5 mg, film-coated tablets

Odelniqva, 10 mg, film-coated tablets

Dapagliflozin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Odelniqva and what is it used for

What is Odelniqva

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

What is Odelniqva used for

Odelniqva is used to treat:

• Type 2 diabetes
• in adults and children aged 10 years and older.
• when diet and exercise alone do not provide adequate control of type 2 diabetes.
• Odelniqva can be used alone or with other anti-diabetic medicines.
• It is important to continue with the diet and exercise as 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 reduced kidney function.

What is type 2 diabetes and how does Odelniqva help to treat it?

• In type 2 diabetes, the body does not produce enough insulin or does not 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 blood circulation in the hands and feet.
• Odelniqva works by removing excess sugar from the body. Odelniqva may also help to prevent heart disease.

What is heart failure and how does Odelniqva help to treat it?

• 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.
• Odelniqva helps to protect the heart from getting worse and relieves symptoms. It may reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Odelniqva help to treat it?

• 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.
• Odelniqva helps to protect the kidneys from losing their function. This may help some patients live longer.

2. Important information before taking Odelniqva

When not to take Odelniqva

• if you are allergic (hypersensitive) 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, excessive thirst, rapid and deep breathing, confusion, unusual sleepiness or tiredness, 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 resulting from high levels of "ketone bodies" in the urine or blood, as shown by laboratory tests.
• The risk of diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirements due to serious surgery or illness.
• During treatment with Odelniqva, 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.

Necrotizing fasciitis of the perineum:

• 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 necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause tissue damage. Immediate treatment of Fournier's gangrene is necessary.

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

• if you have "type 1 diabetes" - a type of diabetes that usually affects young people and whose body does not produce insulin. Odelniqva should not be used to treat this condition.
• if you have kidney disease and diabetes - your doctor may recommend additional or alternative medication to control your blood sugar levels.
• if you have liver disease - your doctor may start with a lower dose.
• if you are taking blood pressure-lowering medicines (antihypertensive medicines) and have a history of low blood pressure (hypotension). More information is provided below, in the section "Odelniqva and other medicines".
• 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 treatment, 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 may cause dehydration. Your doctor may recommend stopping Odelniqva until your condition improves to prevent dehydration.
• if you frequently experience urinary tract infections.

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

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 Odelniqva, laboratory tests may show the presence of sugar (glucose) in the urine.

Children and adolescents

Odelniqva can be used in children aged 10 years and older to treat type 2 diabetes. There is no data on the use of Odelniqva in children under 10 years of age. Odelniqva 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.

Odelniqva and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking now 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 levels, such as insulin or sulfonylurea derivatives. Your doctor may recommend reducing the dose of other medicines to prevent hypoglycemia (low blood sugar levels).
• if you are taking lithium, as Odelniqva may decrease 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 Odelniqva while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Odelniqva has no or negligible influence on the ability to drive and use machines. Taking this medicine with other medicines, such as sulfonylurea derivatives or insulin, may cause excessive lowering of blood sugar levels (hypoglycemia), which can cause muscle tremors, excessive sweating, and vision disturbances, affecting the ability to drive and use machines. Do not drive or operate machinery if you feel dizzy or have dizziness after taking Odelniqva.

Odelniqva contains lactose

Odelniqva 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 Odelniqva

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

What dose to take

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

How to take Odelniqva

• Swallow the tablet whole with half a glass of water.
• You can take Odelniqva with or without food.
• You can take Odelniqva at any time of the 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 Odelniqva 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 program recommended by your doctor while taking Odelniqva.

What to do if you take more Odelniqva than you should

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

What to do if you miss a dose of Odelniqva

The action to take will depend on the time remaining until the next dose.

• If it is 12 hours or more until the next dose, take Odelniqva as soon as you remember. Take the next dose at the usual time.
• If it is 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 to make up for a forgotten dose.

What to do if you stop taking Odelniqva

Do not stop taking Odelniqva without talking to your doctor. For patients with diabetes, blood sugar levels may increase after stopping the 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 help immediately if you experience any of the following side effects:

• 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
• hives and difficulty breathing
• Diabetic ketoacidosis- a rare side effect in patients with type 2 diabetes (may occur in up to 1 in 1,000 people). Symptoms of ketoacidosis (see also section 2 Warnings and precautions):
• increased levels of "ketone bodies" in the urine or blood
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual sleepiness 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 withdraw Odelniqva.
• Necrotizing fasciitis of the perineumor Fournier's gangrene, a serious infection of the soft tissues of the external genital area or the area between the genitals and anus, observed very rarely.

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

• Urinary tract infections, which occur frequently (may occur in up to 1 in 10 people). Symptoms of acute urinary tract infection:
• fever and/or chills
• burning sensation while urinating
• back or side pain. You may also experience blood in the urine, in which case you should seek medical help immediately.

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

• Low blood sugar (hypoglycemia), which occurs very frequently (may occur in more than 1 in 10 people) - in patients with diabetes taking this medicine with sulfonylurea derivatives or insulin. Symptoms of low blood sugar:
• tremors, sweating, feeling anxious, rapid heartbeat
• feeling hungry, headache, vision disturbances
• mood changes or feeling confused. Your doctor will inform you how to treat low blood sugar and what to do if you experience any of these side effects.

Other side effects of Odelniqva:

Frequently

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

Less frequently (may occur in up to 1 in 100 people)

• loss of too much fluid from the body (dehydration, which may cause dryness or stickiness in the mouth, passing small amounts of urine or not passing urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected by blood tests) at the start of treatment
• increased urea levels (detected by blood tests)

Very rarely

• kidney inflammation (interstitial nephritis)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Odelniqva

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. This will help protect the environment.

6. Contents of the pack and other information

What Odelniqva contains

• The active substance is dapagliflozin. One film-coated tablet (tablet) of Odelniqva 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. One film-coated tablet (tablet) of Odelniqva 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• The other ingredients are
• Tablet core: lactose monohydrate (see section 2 "Odelniqva 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 Odelniqva looks like and contents of the pack

Odelniqva 5 mg film-coated tablets are yellow, biconvex, round tablets with "5" embossed on one side and smooth on the other, approximately 7.2 mm in diameter. Odelniqva 10 mg film-coated tablets are yellow, biconvex, oval tablets with "10" embossed on one side and smooth on the other, approximately 11.1 mm x 6.1 mm in size. Odelniqva is available in OPA/Aluminum/PVC//Aluminum blisters 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 single-dose perforated 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:

Austria: Odelniqva 5 mg & 10 mg Filmtabletten, Czech Republic: Odelniqva, Poland: Odelniqva, Hungary: Odelniqva 5 mg & 10 mg filmtabletta

Date of last revision of the package leaflet: