Dagetia

Package Leaflet: Information for the Patient

Dagetia, 5 mg, film-coated tablets

Dagetia, 10 mg, film-coated tablets

Dapagliflozin

Read all of 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Dagetia is and what it is used for
• 2. What you need to know before you take 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 cotransporter 2 (SGLT2) inhibitors. They work by blocking a protein in the kidneys called SGLT2. By blocking this protein, sugar (glucose), 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 diet and exercise alone are not enough to control type 2 diabetes.
• Dagetia can be used alone or with other medicines that lower blood sugar levels.
• It is important to continue to follow the diet and exercise 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 type 2 diabetes is and how Dagetia works

• In type 2 diabetes, the body does not make enough insulin or does not use the insulin it makes effectively. This leads to high blood sugar levels. This can cause serious problems, such as heart disease, kidney disease, blindness, and poor blood circulation in the arms and legs.
• Dagetia works by removing excess sugar from the body. Dagetia may also help prevent heart disease.

What heart failure is and how Dagetia works

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

What chronic kidney disease is and how Dagetia works

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

2. What you need to know before you take Dagetia

Do not take Dagetia

• if you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Seek medical help immediately if you experience any of the following symptoms:

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 Dagetia, 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.

Fournier's gangrene:

• If you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the external genital area or the area between the genital and anal areas, 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 Fournier's gangrene, which can cause tissue damage.

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

• if you have type 1 diabetes - a type of diabetes that usually affects young people and is caused by the body not producing insulin. Dagetia should not be used to treat this condition.
• if you have kidney disease and are taking insulin or certain other medicines that lower blood sugar - your doctor may recommend a different dose or a different medicine to control your blood sugar levels.
• if you have liver disease - your doctor may start you on a lower dose.
• if you are taking medicines that lower blood pressure and have low blood pressure - see also "Dagetia with other medicines" below.
• 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 have nausea, vomiting, or fever, or if you are unable to eat or drink. This can cause dehydration. Your doctor may recommend stopping Dagetia until your condition improves to prevent dehydration.
• if you frequently experience urinary tract infections.

If any of the above warnings apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking Dagetia.

Diabetes and foot care

For patients with diabetes, it is important to regularly check the condition of your feet and follow any foot care advice given by your doctor.

Glucose in urine

Due to the way Dagetia works, laboratory tests may show the presence of sugar (glucose) in the urine.

Children and adolescents

Dagetia can be used in children aged 10 years and older to treat type 2 diabetes. There is no data on the use of Dagetia in children under 10 years of age.
Dagetia is not recommended for use in children and adolescents under 18 years of age to treat heart failure or chronic kidney disease, as it has not been studied in this age group.

Dagetia with other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, and 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, such as insulin or sulfonylurea. Your doctor may recommend reducing the dose of these medicines to prevent low blood sugar (hypoglycemia).
• if you are taking lithium, as Dagetia may lower 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 want to breastfeed, tell your doctor before taking this medicine. Do not take Dagetia while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Dagetia has no or negligible influence on the ability to drive and use machines.
Taking this medicine with other medicines, such as sulfonylurea or insulin, may cause low blood sugar (hypoglycemia), which can cause shakiness, sweating, and blurred vision, affecting your ability to drive or operate machinery.
Do not drive or operate machinery if you feel dizzy or have dizziness after taking Dagetia.

Dagetia contains lactose

Dagetia 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 Dagetia

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

How much to take

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

How to take it

• Swallow the tablet whole with half a glass of water.
• You can take the tablets with or without food.
• You can take the tablet at any time of 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 Dagetia with other medicines. Remember to take these medicines as directed 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 important to follow the diet and exercise program recommended by your doctor while taking Dagetia.

If you take more Dagetia than you should

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

If you forget to take Dagetia

What to do if you miss a dose, depending on the time left until your next dose.

• If there are 12 hours or more until your next dose, take Dagetia as soon as you remember. Take your next dose at the usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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

If you stop taking Dagetia

Do not stop taking Dagetia 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 affect 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 affect up to 1 in 1,000 people). Symptoms of diabetic ketoacidosis (see also section 2 "Warnings and precautions"):
• high 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 interrupt Dagetia treatment.
• Fournier's gangreneor necrotizing fasciitis of the genital area, a rare but serious or potentially life-threatening infection of the soft tissues of the external genital area or the area between the genital and anal areas.

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

• 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 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 affect more than 1 in 10 people) - in patients with diabetes taking this medicine with sulfonylurea or insulin. Symptoms of low blood sugar:
• shakiness, sweating, and feeling anxious
• fast heartbeat
• feeling hungry, headache, and blurred vision
• 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 Dagetia:

Frequently

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

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

• loss of too much fluid from the body (dehydration, which can cause dryness or stickiness in the mouth, passing little or no urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected by laboratory tests) at the start of treatment
• increased urea levels (detected by laboratory tests)

Rarely

• kidney inflammation (interstitial nephritis)

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the national reporting system via the contact details listed below.
Department for Monitoring of Adverse Reactions to Medicinal Products
Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Dagetia

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 instructions 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 Dagetia contains

• The active substance is dapagliflozin. One film-coated tablet (tablet) of Dagetia 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. One film-coated tablet (tablet) of Dagetia 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
• The other ingredients are
• Tablet core: lactose monohydrate (see section 2 "Dagetia contains lactose"), microcrystalline cellulose type 101, crospovidone type A, povidone K-30, colloidal silicon dioxide, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Dagetia looks like and contents of the pack

Dagetia 5 mg film-coated tablets are yellow, biconvex, round film-coated tablets, with "5" engraved on one side and smooth on the other, approximately 7.2 mm in diameter.
Dagetia 10 mg film-coated tablets are yellow, biconvex, oval film-coated tablets, with "10" engraved on one side and smooth on the other, approximately 11.1 mm x 6.1 mm in size.
Dagetia 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:

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 film-coated tablets (Dagetia 5 mg & 10 mg comprimate filmate)
Slovakia
Dagetia 5 mg & 10 mg
Hungary
Dagetia 5 mg & 10 mg filmtabletta

Date of last revision of the leaflet: