Odelniqva

Package leaflet: Information for the patient

Odelniqva, 5 mg, film-coated tablets
Odelniqva, 10 mg, film-coated tablets
Dapagliflozin
Please read 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, please 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Odelniqva is and what it is used for
2. What you need to know 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 Odelniqva is and what it is used for

What Odelniqva is
Odelniqva 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 in the blood (glucose), salt (sodium), and water are removed from the body through urine.

What Odelniqva is used for
Odelniqva 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 exercise alone.
  • Odelniqva may be used alone or together with other antidiabetic medicines.
  • It is important to continue following the diet and exercise advice given 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 in treating it?

• 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. This condition can cause serious problems such as heart or kidney disease, vision loss, and poor blood circulation in the arms and legs.
• Odelniqva works by removing excess sugar from the body. Odelniqva may also help prevent heart disease.

What is heart failure and how does Odelniqva help in treating it?

• 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 can lead to serious medical consequences and may require hospital treatment.
• The most common symptoms of heart failure are shortness of breath, feeling tired or extremely fatigued all the time, and swelling around the ankles.
• Odelniqva helps protect the heart from worsening and relieves symptoms. It may reduce the need for hospitalisation and may help some patients live longer.

What is chronic kidney disease and how does Odelniqva help in treating it?

• In patients with chronic kidney disease, kidney function gradually decreases. This means the kidneys are no longer able to properly clean and filter the blood. Loss of kidney function can lead to serious medical consequences and may require hospital treatment.
• Odelniqva helps protect the kidneys from losing function. This may help some patients live longer.

2. Information before taking Odelniqva

When not to take Odelniqva

• if the patient has a known allergy (hypersensitivity) to dapagliflozin or to 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 the blood or urine, which can be 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 Odelniqva even when blood glucose levels are within the normal range. If the patient suspects diabetic ketoacidosis, they should contact their doctor or 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, medical attention must be sought immediately. These may be symptoms 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 required.

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

• if the patient has "type 1 diabetes" – a type of diabetes that usually affects young people whose bodies do not produce insulin. Odelniqva should not be used to treat this condition.
• if the patient has kidney disease – the doctor may recommend additional or alternative medication to control blood glucose levels.
• if the patient has liver disease – the doctor may start treatment with a lower dose.
• if the patient is taking antihypertensive medicines (blood pressure-lowering drugs) and has a history of low blood pressure (hypotension). More information is provided below under "Odelniqva with other medicines".
• if the patient has very high blood glucose 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 occur before starting the medicine.
• if the patient has nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may recommend temporarily stopping Odelniqva until the patient's condition improves to prevent dehydration.
• if the patient frequently experiences urinary tract infections.

If any of these warnings apply to the patient (or if the patient is unsure), they should consult their
doctor, pharmacist, or nurse before taking Odelniqva.
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 given by the doctor.
Glucose in urine
Due to the mechanism of action of Odelniqva, laboratory tests may detect the presence of
sugar (glucose) in the urine.
Children and adolescents
Odelniqva 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.
Odelniqva 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.
Odelniqva with other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
Specifically, 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 lower blood glucose levels, such as insulin or sulfonylurea derivatives. The doctor may recommend reducing the dose of these other medicines to prevent low blood glucose levels (hypoglycaemia).
• if the patient is taking lithium, as Odelniqva may reduce lithium levels in the blood.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she might 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 it is not recommended during the
second and third trimesters of pregnancy. Consult the doctor to determine the best way to manage
glycaemic control during pregnancy.
If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting
this medicine. Odelniqva must not be used during breastfeeding. It is unknown whether the medicine
is excreted in human breast milk.
Driving and using machines
Odelniqva has no effect or has a negligible effect on the ability to drive and operate machinery.
However, taking this medicine together with other medicines such as sulfonylurea derivatives or insulin may cause excessively low blood glucose levels (hypoglycaemia), which may manifest as muscle tremors, excessive sweating, and visual disturbances, potentially affecting the ability to drive and operate machinery.
Do not drive or operate machinery if, after taking Odelniqva, the patient feels dizzy or experiences dizziness.
Odelniqva contains lactose
Odelniqva contains lactose (a sugar found in milk). If the patient has been diagnosed with an intolerance to certain sugars, inform the doctor before taking this medicine.
3. How to take Odelniqva
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the
doctor, pharmacist, or nurse.
How much medicine 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 may be taken with or without food.
• The tablet may be taken at any time of day. However, it is advisable to take it at the same time each day to help remember the dose.

The doctor may recommend taking Odelniqva together with other medicines. It is important to
take these medicines as directed by the doctor to achieve the best treatment outcomes.
Diet and physical exercise can help the patient's body use the glucose in the blood.
For patients with diabetes, it is important to follow the diet and exercise plan recommended by the
attending doctor while taking Odelniqva.
Taking more Odelniqva than prescribed
If more Odelniqva is taken than prescribed, contact a doctor or go to a hospital immediately. Bring the medicine packaging with you.
Missed dose of Odelniqva
What to do if a dose is missed, depending on the time remaining until the next dose.

• If 12 hours or more remain before the next dose, take Odelniqva as soon as remembered. 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 Odelniqva
Do not stop taking Odelniqva without consulting the doctor. In patients with diabetes, blood glucose levels may rise after stopping the medicine.
If there are any further doubts about using this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, 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 symptoms:

• 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 – 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 sugar levels. The doctor may decide to suspend or discontinue treatment with Odelniqva.
• 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.

Treatment with Odelniqva should be discontinued and immediate medical advice sought if the patient experiences any of the following serious adverse symptoms:

• 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 occur; in such a case, immediate medical consultation is required.

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

• 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 sulphonylurea derivative 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 symptoms occur.

Other adverse reactions during treatment with Odelniqva:
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 marked dryness or stickiness in the mouth, passing small amounts 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 not listed in this leaflet, 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 Warszawa
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 Odelniqva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines should not be disposed of via the sewage system 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 Odelniqva contains

• The active substance is dapagliflozin. One coated tablet (tablet) of Odelniqva 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. One coated tablet (tablet) of Odelniqva 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• 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 coated tablets are yellow, biconvex, round coated tablets,
embossed with "5" on one side and smooth on the other, with a diameter of approximately 7.2 mm.
Odelniqva 10 mg coated tablets are yellow, biconvex, oval coated tablets,
embossed with "10" on one side and smooth on the other, measuring approximately 11.1 mm x 6.1 mm.
Odelniqva is available in blisters of OPA/Aluminium/PVC//Aluminium in cardboard boxes
containing 10, 28, 30, 60, 90 or 98 coated tablets in blisters; 14, 28, 56 or
98 coated tablets in calendar blister packs; and 10x1, 28x1, 30x1, 50x1, 90x1, 98x1 or 100x1
coated tablets in single-dose perforated blister packs.
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:
Austria Odelniqva 5 mg & 10 mg Filmtabletten
Czech Republic Odelniqva
Poland Odelniqva
Hungary Odelniqva 5 mg & 10 mg filmtabletta