Dagetia

Package leaflet: Information for the patient

Dagetia, 5 mg, film-coated tablets
Dagetia, 10 mg, film-coated tablets
Dapagliflozinum
Please read this leaflet carefully before using 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Dagetia is and what it is used for

What Dagetia is
Dagetia contains the active substance dapagliflozin. It belongs to a group of medicines called
sodium-glucose co-transporter 2 (SGLT2) inhibitors. These 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 in the urine.

What Dagetia is used for
Dagetia 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.
  • Dagetia may be used alone or together with other antidiabetic medicines.
  • It is important to continue following the diet and 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 Dagetia help in its treatment?

• In type 2 diabetes, the body either does not produce enough insulin or cannot use the insulin it produces effectively. This leads to high blood sugar levels. Such a condition may cause serious problems, such as heart or kidney disease, vision loss, and poor circulation in the arms and legs.
• Dagetia works by removing excess sugar from the body. Dagetia may also help prevent heart disease.

What is heart failure and how does Dagetia 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 may require hospital treatment.
• The most common symptoms of heart failure are breathlessness, feeling tired or extremely fatigued, and swelling around the ankles.
• Dagetia 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 Dagetia help in its treatment?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are unable to properly clean and filter the blood. Loss of kidney function may lead to serious medical consequences and may require hospital treatment.
• Dagetia helps protect the kidneys from losing function. This may help prolong life in some patients.

2. Important information before taking Dagetia

When not to use Dagetia

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

Warnings and precautions
Contact a doctor or the 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 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 Dagetia even when blood glucose levels are within normal range. If the patient suspects diabetic ketoacidosis, they should contact a doctor or the nearest hospital immediately and must not take this medicine.

Necrotizing fasciitis of the perineum:

• If the patient develops 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 of Fournier's gangrene is essential.

Before starting Dagetia, 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. Dagetia must not be used to treat this condition.
• if the patient has kidney disease – the doctor may recommend using an additional or alternative medicine to help 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 (medicines to lower blood pressure) and has a history of low blood pressure (hypotension). More information is provided below in the section "Dagetia 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 experiences nausea, vomiting, or fever, or is unable to eat or drink. These may lead to dehydration. The doctor may recommend temporarily stopping Dagetia until the patient's condition improves, to prevent dehydration.
• if the patient frequently suffers from 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 using Dagetia.
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 given by the doctor.
Glucose in urine
Due to the mechanism of action of Dagetia, laboratory tests may detect the presence of sugar (glucose) in the urine.
Children and adolescents
Dagetia 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.
Dagetia 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.
Dagetia with other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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 dose of these other medicines to prevent low blood glucose levels (hypoglycaemia).
• if the patient is taking lithium, as Dagetia may reduce lithium levels in the blood.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using 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 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. Dagetia must not be used during breastfeeding. It is not known whether the medicine passes into breast milk.
Driving and operating machinery
Dagetia has no effect or 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 (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 Dagetia, the patient feels dizzy or experiences dizziness.
Dagetia contains lactose
Dagetia contains lactose (a sugar found in milk). If the patient has been diagnosed with an intolerance to certain sugars, they should inform their doctor before taking this medicine.
3. How to take Dagetia
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the 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 may be taken with or between meals.
• 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 to take it.

The doctor may recommend taking Dagetia together with other medicines. Remember to take these medicines as directed by the doctor. This will help 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 program recommended by the treating doctor while taking Dagetia.
Taking more Dagetia than prescribed
If more Dagetia has been taken than prescribed, contact a doctor or go to a hospital immediately. Take the medicine packaging with you.
Missed dose of Dagetia
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 is due, take Dagetia as soon as the patient remembers. Take the next dose at the usual time.

• If less than 12 hours remain before the next dose is due, 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 Dagetia
Do not stop taking Dagetia without consulting your doctor. In patients with diabetes, blood glucose 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 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 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
  • hives 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 tiredness
  • 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 Dagetia.
• 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 Dagetia and consult a doctor immediately if the patient experiences any of the following severe adverse reactions:

• 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 during urination
  • back or flank pain
    Blood in the urine may occasionally occur; 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 (hypoglycemia), which occurs very frequently (may occur in 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
  • hunger, 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 Dagetia:
Frequent

• fungal infections (e.g. candidiasis) of the penis or vagina (e.g. irritation, itching, unusual discharge, or unpleasant odor)
• back pain
• excessive urination or increased need to urinate
• changes in blood cholesterol or 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, reduced or no urine output, or rapid heartbeat)
• thirst
• constipation
• nocturia (waking up at night to urinate)
• 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, 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
Fax: + 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 Dagetia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton after 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 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 Dagetia contains

• The active substance is dapagliflozin. One coated tablet (tablet) of Dagetia 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. One coated tablet (tablet) of Dagetia 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• Other ingredients are:
  • Tablet core: lactose monohydrate (see section 2 "Dagetia 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, iron oxide yellow (E172).

What Dagetia looks like and contents of the pack
Dagetia 5 mg coated tablets are yellow, biconvex, round coated tablets, with "5" embossed on one side and smooth on the other side, approximately 7.2 mm in diameter.
Dagetia 10 mg coated tablets are yellow, biconvex, oval coated tablets, with "10" embossed on one side and smooth on the other side, approximately 11.1 mm x 6.1 mm in size.
Dagetia is available in blisters made 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 blisters, and 10x1, 28x1, 30x1, 50x1, 90x1, 98x1 or 100x1 coated tablets in single-dose perforated 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 Member States of the European Economic Area under the following names:
Bulgaria Dagetia 5 mg & 10 mg film-coated tablets (Дагетия 5 mg & 10 mg филмирани таблетки)
Czech Republic Dagetia
Poland Dagetia
Romania Dagetia 5 mg & 10 mg comprimate filmate
Slovakia Dagetia 5 mg & 10 mg
Hungary Dagetia 5 mg & 10 mg filmtabletta