Dapazine

Package leaflet: Information for the patient

Dapazyna, 5 mg, film-coated tablets
Dapazyna, 10 mg, film-coated tablets
Dapagliflozinum
Please read this leaflet carefully before taking 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Dapazyna is and what it is used for

What Dapazyna is
Dapazyna 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 the urine.

What Dapazyna is used for
Dapazyna 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.
  • Dapazyna 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 Dapazyna 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 levels of sugar in the blood. This condition may cause serious complications such as heart or kidney disease, blindness, and poor circulation in the arms and legs.

• Dapazyna works by removing excess sugar from the body. Dapazyna may also help prevent heart disease.

What is heart failure and how does Dapazyna help in its treatment?

• This type of heart failure occurs when the heart cannot 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 very tired all the time, and swelling around the ankles.
• Dapazyna 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 Dapazyna help in its treatment?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are no longer able to clean and filter blood as they should. Loss of kidney function may lead to serious medical consequences and the need for hospitalization.
• Dapazyna helps protect the kidneys from further loss of function. This may help some patients live longer.

2. Important information before taking Dapazyna

When not to use Dapazyna

• If the patient is allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
You should 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 tiredness, 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 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 requirements due to major surgery or severe illness.
• Diabetic ketoacidosis may occur during treatment with Dapazyna even when blood glucose levels are within normal range.

If the patient suspects they have diabetic ketoacidosis, they should immediately
contact their doctor or nearest hospital and must not take this medicine.
Necrotizing fasciitis of the perineum (Fournier's gangrene):

• 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 anus, accompanied by fever or general malaise, they should seek immediate medical attention. 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 of Fournier's gangrene is essential. 2/7

Before starting to take Dapazyna, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has "type 1 diabetes" – a type of diabetes that usually begins in young people whose bodies produce no insulin at all. Dapazyna should not be used to treat this condition;
• if the patient has kidney disease due to diabetes – the doctor may recommend using an additional or different medicine 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 medicines to lower blood pressure (antihypertensives) and has a history of low blood pressure (hypotension). More information is provided below in the section "Dapazyna with other medicines";
• if the patient has very high blood glucose levels, leading to dehydration (excessive loss of fluids). 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 experiences nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily stopping Dapazyna 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), they should
consult their doctor, pharmacist, or nurse before taking Dapazyna.
Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of the feet and follow all
foot care advice provided by the doctor.
Glucose in urine
Due to the mechanism of action of Dapazyna, laboratory tests may detect
the presence of sugar (glucose) in the urine.
Children and adolescents
Dapazyna 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.
Dapazyna 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.
Dapazyna with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 lower blood glucose levels, such as insulin or sulfonylurea derivatives. The doctor may recommend reducing the doses of these other medicines to prevent low blood glucose levels (hypoglycemia);
• if the patient is taking lithium, as Dapazyna may reduce blood lithium levels.

Pregnancy and breastfeeding
If the patient is pregnant or 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 Dapazyna, as it should not be used during the second and third
trimesters of pregnancy. Consult the doctor to determine the best way to control blood glucose levels
during pregnancy.
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If the patient is breastfeeding or wishes to breastfeed, she should inform her doctor before starting
Dapazyna. Dapazyna should not be used during breastfeeding. It is unknown whether this medicine passes into human milk.
Driving and operating machinery
Dapazyna has no effect or has a negligible effect on the ability to drive
and operate machinery.
However, using this medicine together with other medicines such as sulfonylurea derivatives or insulin
may cause excessively low blood glucose levels (hypoglycemia), manifesting as muscle tremors, excessive sweating, and visual disturbances, which may affect the ability to drive and operate machinery.
Do not drive or operate machinery if, after taking Dapazyna, the patient feels dizzy or experiences dizziness.
Dapazyna contains lactose
Dapazyna contains lactose (a sugar found in milk). If the patient has previously been diagnosed with
an intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
3. How to take Dapazyna
Dapazyna should always be taken exactly as prescribed by the doctor. If in doubt,
contact the doctor, pharmacist, or nurse again.
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 this medicine

• Swallow the tablet whole with half a glass of water.
• The tablet can be taken during or between meals.
• The tablet can 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 Dapazyna together with other medicines. Remember to take
these medicines as prescribed by the doctor. This will help achieve the best treatment outcomes.
Diet and physical exercise can help the patient's body better utilize glucose in the blood. For patients with diabetes, it is important to follow all dietary and exercise recommendations provided by the treating doctor while taking Dapazyna.
Taking more Dapazyna than recommended
If more Dapazyna has been taken than recommended, contact a doctor immediately or go to the hospital. Bring the medicine packaging with you.
Missing a dose of Dapazyna
What to do if a dose is missed, depending on the time remaining until the next dose.
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• If 12 hours or more remain until the next dose, take Dapazyna as soon as remembered. Take the next dose at the usual time.
• If less than 12 hours remain 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 missed dose.

Stopping Dapazyna
Do not stop taking Dapazyna without consulting your doctor. In patients with diabetes, blood glucose levels may rise after discontinuing this medicine.
If there are any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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 no more than 1 in 10,000 people). Symptoms of angioedema:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and breathing difficulties.
• Diabetic ketoacidosis – occurs rarely in patients with type 2 diabetes (may occur in no more than 1 in 1,000 people). Symptoms of diabetic 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 tiredness
  • sweet breath odour, sweet or metallic taste in the mouth, or change in the odour of urine or sweat
  • rapid weight loss. This may occur regardless of blood sugar levels. The doctor may decide to interrupt or discontinue treatment with Dapazyna.
• Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a severe 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 Dapazyna and consult a doctor immediately if the patient experiences any of the following serious adverse reactions:

• Urinary tract infections, which occur frequently (may affect 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 occurs very frequently (may affect more than 1 in 10 people) – in diabetic patients taking this medicine with a sulfonylurea derivative or insulin. Symptoms of low blood sugar:
  • trembling, sweating, feeling anxious, rapid heartbeat
  • feeling hungry, headache, vision disturbances
  • mood changes or feeling confused. The doctor will advise how to treat low blood sugar and what to do if any of the above adverse reactions occur.

Other adverse reactions during treatment with Dapazyna:
Frequent (may affect up to 1 in 10 people):

• genital infection (candidiasis) of the penis or vagina (symptoms may include irritation, itching, unusual discharge or unpleasant odour)
• back pain
• excessive urination or increased need to urinate
• changes in cholesterol or blood lipid levels (detected in laboratory tests)
• increased number of red blood cells (detected in laboratory tests)
• decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
• dizziness
• rash.

Uncommon (may affect up to 1 in 100 people):

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

Very rare (may affect fewer than 1 in 10,000 people):

• inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of adverse reactions
If any adverse reactions occur, including any 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 Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02 - 222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
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5. How to store the medicine Dapazyna

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or cardboard package following: Exp. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must 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 Dapazyna contains

• The active substance is dapagliflozin. Each Dapazyna 5 mg coated tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. Each Dapazyna 10 mg coated tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• Other ingredients are:
  • Tablet core: microcrystalline cellulose, lactose (see section 2 “Dapazyna contains lactose”), crospovidone (type B), colloidal anhydrous silica, magnesium stearate.
  • Coating: polyvinyl alcohol (E1203), calcium carbonate (E170), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172).

What Dapazyna looks like and contents of the pack
Dapazyna 5 mg, coated tablets
Pale yellow to yellow, biconvex, oval coated tablets measuring 11.1 x 5.5 mm, with a break line on one side.
Dapazyna 10 mg, coated tablets
Pale yellow to yellow, biconvex, round coated tablets with bevelled edges and cross-shaped lines on one side, 10.0 mm in diameter.
Dapazyna 5 mg is available in OPA/Aluminium/PVC/Aluminium blisters in pack sizes of 28, 30, 56, 60, 84, 90, 112 or 120 coated tablets.
Dapazyna 10 mg is available in OPA/Aluminium/PVC/Aluminium blisters in pack sizes of 28, 30, 56, 60, 84, 90, 112 or 120 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]
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