Daforbis

Package Leaflet: Information for the Patient

Daforbis, 5 mg, Film-Coated Tablets

Daforbis, 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Daforbis is and what it is used for
• 2. What you need to know before you take 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 Daforbis is and what it is used for

What Daforbis is

Daforbis 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), salt (sodium), and water are removed from the body in the urine.

What Daforbis is 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 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 is type 2 diabetes and how does Daforbis work?

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

What is heart failure and how does Daforbis work?

• 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 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 work?

• In patients with chronic kidney disease, the kidneys gradually lose their ability to clean and filter the blood. This means they cannot remove waste products and excess fluids from the body. Loss of kidney function can lead to serious medical consequences and the need for hospital treatment.
• Daforbis helps protect the kidneys from losing their function. This may help some patients live longer.

2. What you need to know before you take Daforbis

Do not 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, fast and deep breathing, confusion, unusual drowsiness or fatigue, 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 with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to serious surgery or 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(necrotizing fasciitis of the genital area):
• If you experience 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 and potentially life-threatening infection that can cause tissue damage.

Before taking Daforbis, talk to 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 is not for the treatment of 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 you on 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 experience 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), talk to your doctor, pharmacist, or nurse before taking Daforbis.

Diabetes and foot care

For patients with diabetes, it is important 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 glucose (sugar) 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 it has not been studied 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.

• tell your doctor if you are taking medicines that help remove water from the body (diuretics).
• tell your doctor if you are taking other medicines that lower blood sugar levels, such as insulin or sulfonylureas. Your doctor may recommend reducing the dose of these medicines to prevent low blood sugar levels (hypoglycemia).
• tell your doctor 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 plan to breastfeed, tell your doctor before taking Daforbis. 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 sulfonylureas or insulin, may cause low blood sugar levels (hypoglycemia), which can cause shakiness, sweating, and blurred vision, 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 Daforbis.

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 5 mg dose 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 important to follow the 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 be taken depends 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.

If you stop taking Daforbis

Do not stop taking Daforbis without talking to 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 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, 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
• fast and deep breathing
• confusion
• unusual drowsiness or fatigue
• 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 discontinue Daforbis.

• Fournier's gangrene(necrotizing fasciitis of the genital area), a serious and potentially life-threatening infection, which is very rare.

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
• blood in the urine (seek medical help immediately if this occurs)

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 sulfonylureas or insulin. Symptoms of low blood sugar:
• shakiness, sweating, feeling anxious, fast heartbeat
• hunger, headache, blurred vision
• mood changes or confusion

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)
• decreased 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 less urine than usual, or fast 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the "Contact" section below.

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 conditions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 silicon dioxide, 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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 Authorisation Holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 54 66 400

This medicine is authorised 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