Daforbis

Package Leaflet: Information for the Patient

Daforbis, 5 mg, Film-Coated Tablets

Daforbis, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Daforbis and what is it used for

What is Daforbis

Daforbis 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 in the urine.

What is Daforbis used for

Daforbis 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.
• Daforbis 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 Daforbis 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 complications, such as heart disease, kidney disease, blindness, and poor blood circulation in the arms and legs.
• Daforbis works by removing excess sugar from the body. Daforbis may also help to prevent heart disease.

What is heart failure and how does Daforbis 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.
• Daforbis 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 Daforbis help to treat it?

• In patients with chronic kidney disease, the kidneys gradually lose their ability to clean and filter the blood. This can lead to serious medical consequences and the need for hospital treatment.
• Daforbis helps to protect the kidneys from losing their function. This may help some patients live longer.

2. Important information before taking Daforbis

When not to take Daforbis

• 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

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 caused by high levels of "ketone bodies" in the urine or blood, as shown by laboratory tests.
• The risk of diabetic ketoacidosis may increase if you have a prolonged fast, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to a serious surgical procedure or severe illness.
• During treatment with Daforbis, 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 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 life-threatening infection called Fournier's gangrene, which can cause tissue damage. Immediate treatment is necessary.

Before taking Daforbis, discuss with your doctor, pharmacist, or nurse:

• if you have "type 1 diabetes" - a type of diabetes that usually starts in young people and is caused by the body not producing any insulin. Daforbis should not be used to treat this condition.
• if you have kidney disease and diabetes - your doctor may recommend additional or alternative treatments 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 (antihypertensives) and have low blood pressure (hypotension). See also "Daforbis 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 taking this medicine, tell your doctor if you have experienced any of these symptoms.
• if you experience nausea, vomiting, or fever, or if you are unable to eat or drink. This can cause dehydration. Your doctor may recommend stopping Daforbis 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), consult your doctor, pharmacist, or nurse before taking Daforbis.

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

Children and adolescents

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

Daforbis 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.

Daforbis with other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

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. Your doctor may recommend reducing the dose of other medicines to prevent low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Daforbis may reduce 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 Daforbis, 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 Daforbis while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Daforbis 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 levels (hypoglycemia), which can cause shakiness, sweating, and vision disturbances, affecting your ability to drive and use machines.

Do not drive or use machines if you experience dizziness after taking Daforbis.

Daforbis contains lactose

Daforbis contains lactose (a sugar found in milk). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Daforbis contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Daforbis

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. The tablets cannot be divided into equal doses.
• You can take the tablet 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 Daforbis 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 sugar from the blood more effectively. For patients with diabetes, it is essential to follow any diet and exercise program recommended by your doctor while taking Daforbis.

If you take more Daforbis than you should

If you take more Daforbis than you should, contact your doctor or go to the hospital immediately.

Take the medicine pack with you.

If you forget to take Daforbis

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 Daforbis 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 of Daforbis to make up for a forgotten dose.

Stopping Daforbis

Do not stop taking Daforbis without consulting your doctor. In patients with diabetes, blood sugar levels may increase after stopping the medicine.

If you have any further questions on the use of this medicine, 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, which is very rare (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, which is rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people). Symptoms of 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

This may occur regardless of your blood sugar levels. Your doctor may decide to stop or interrupt Daforbis treatment.

• Fournier's gangreneor necrotizing fasciitis of the genital area, a rare but serious or life-threatening infection of the soft tissues of the genital area, which can cause tissue damage.

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

• Urinary tract infections, which are common (may affect up to 1 in 10 people). Symptoms of severe urinary tract infections:
• fever and/or chills
• burning sensation while urinating
• back or side pain

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

• Low blood sugar (hypoglycemia), which is very common (may affect more than 1 in 10 people) - in patients with diabetes taking Daforbis with sulfonylurea or insulin. Symptoms of low blood sugar:
• shakiness, sweating, feeling anxious, fast heartbeat
• hunger, headache, vision disturbances
• mood changes or feeling confused

Your doctor will tell you how to treat low blood sugar and what to do if you experience any of these side effects.

Other side effects of Daforbis:

Common (may affect up to 1 in 10 people)

• infections (thrush) of the penis or vagina (e.g., irritation, itching, unusual discharge, or unpleasant smell)
• 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)
• reduced kidney function (detected by laboratory tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect 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 laboratory tests) at the start of treatment
• increased urea levels (detected by laboratory tests)

Rare (may affect up to 1 in 10,000 people)

• kidney inflammation (interstitial nephritis)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daforbis

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 and 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 Daforbis contains

The active substance is dapagliflozin.

Each film-coated tablet Daforbis 5 mg contains 5 mg of dapagliflozin.

Each film-coated tablet Daforbis 10 mg contains 10 mg of dapagliflozin.

The other ingredients are:

Tablet core: microcrystalline cellulose (M102), lactose monohydrate (see section 2 "Daforbis contains lactose"), crospovidone (type B), magnesium stearate, sodium lauryl sulfate (see section 2 "Daforbis contains sodium"), colloidal anhydrous silica, mannitol.

Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 6000, talc, yellow iron oxide (E 172).

What Daforbis looks like and contents of the pack

Daforbis 5 mg film-coated tablets are yellow, round, biconvex, approximately 7 mm in diameter, with "5" engraved on one side and smooth on the other.

Daforbis 10 mg film-coated tablets are yellow and rhomboid, biconvex, approximately 11 x 8 mm, with "10" engraved on one side and smooth on the other.

Daforbis 5 mg film-coated tablets are available in:

Blister packs of 30 or 98 film-coated tablets, in a carton.

Daforbis 10 mg film-coated tablets are available in:

Blister packs of 30 or 98 film-coated tablets, in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer:

Mylan Hungary Kft

Mylan Utca 1

2900, Komárom

Hungary

Mylan Germany GmbH

Benzstrasse 1

61352, Bad Homburg

Germany

For further information on this medicine, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 54 66 400

This medicine is authorized in the Member States of the European Economic Area under the following names:

Cyprus: Daforbis

Croatia: Daforbis

Greece: Daforbis

Poland: Daforbis

Romania: Daforbis

Sweden: Daforbis

Date of last revision of the leaflet:03/2025