Dagrafors

Package Leaflet: Information for the Patient

Dagrafors, 5 mg, Film-Coated Tablets

Dagrafors, 10 mg, Film-Coated Tablets

Dapagliflozin

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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

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

1. What Dagrafors is and what it is used for

What Dagrafors is

Dagrafors 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 Dagrafors is used for

Dagrafors 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.
• Dagrafors 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 Dagrafors work?

• 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 or kidney disease, blindness, and poor circulation in the arms and legs.

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

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

What is heart failure and how does Dagrafors 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.
• Dagrafors helps protect the heart from worsening and relieves symptoms. It may reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Dagrafors work?

• In patients with chronic kidney disease, kidney function gradually decreases. This means that the kidneys will not be able to clean and filter the blood as they should. Loss of kidney function can lead to serious medical consequences and the need for hospital treatment.
• Dagrafors helps protect the kidneys from losing function. This may help some patients live longer.

2. What you need to know before you take Dagrafors

Do not take Dagrafors

• 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 urine or sweat smell.
• These symptoms may indicate "diabetic ketoacidosis" - a rare but serious and potentially life-threatening complication of diabetes caused by increased levels of "ketone bodies" in the urine or blood.
• 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 serious surgery or illness.
• During treatment with Dagrafors, 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 potentially life-threatening infection called Fournier's gangrene or necrotizing fasciitis of the genital area, which can cause tissue damage.

Before taking Dagrafors, 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. Dagrafors 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 you on a lower dose.
• if you are taking blood pressure-lowering medicines (antihypertensives) and have low blood pressure (hypotension). See also "Dagrafors 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 Dagrafors, 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 Dagrafors until you recover 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 Dagrafors.

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

Children and adolescents

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

Dagrafors with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as 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 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 Dagrafors 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 Dagrafors, 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 Dagrafors. Do not take Dagrafors while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Dagrafors 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 muscle tremors, excessive sweating, and vision disturbances, affecting your ability to drive and use machines. Do not drive or use machines if you feel dizzy or have dizziness after taking Dagrafors.

Dagrafors contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Dagrafors

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 with half a glass of water. The 10 mg tablet can be divided into equal doses or to facilitate swallowing.
• Tablets can be taken with or without food.
• Tablets can be taken at any time of day. However, try to take it at the same time each day. This will help you remember to take it.

Your doctor may recommend taking Dagrafors 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 in the blood better. For patients with diabetes, it is important to follow the diet and exercise program recommended by your doctor while taking Dagrafors.

If you take more Dagrafors than you should

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

If you forget to take Dagrafors

What to do if you miss a dose depends on how much time is left before your next dose.

• If it is 12 hours or more until your next dose, take Dagrafors as soon as you remember. Take your next dose at the usual time.
• If it is 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 of Dagrafors to make up for a missed dose.

If you stop taking Dagrafors

Do not stop taking Dagrafors 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):
• increased 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 urine or sweat smell
• rapid weight loss. It may occur regardless of blood sugar levels. Your doctor may decide to stop or discontinue Dagrafors.
• Fournier's gangreneor necrotizing fasciitis of the genital area, a serious and potentially life-threatening infection of the soft tissues of the genital area, which is very rare.

Stop taking Dagrafors 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 serious urinary tract infections:
• 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 is very common (may affect more than 1 in 10 people) - in patients with diabetes taking Dagrafors with sulfonylurea or insulin. Symptoms of low blood sugar:
• tremors, sweating, feeling anxious, rapid heartbeat
• feeling hungry, headache, vision disturbances
• 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 Dagrafors:

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 in laboratory tests)
• increased red blood cell count (detected in laboratory tests)
• decreased kidney function (detected in 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 in blood tests) at the start of treatment
• increased urea levels (detected in blood tests)

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

• kidney inflammation (interstitial nephritis)

Reporting of 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 below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dagrafors

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. These measures will help protect the environment.

6. Contents of the pack and other information

What Dagrafors contains

• The active substance is dapagliflozin. Dagrafors, 5 mg, film-coated tablets Each film-coated tablet contains 5 mg of dapagliflozin (as dapagliflozin propanediol monohydrate). Dagrafors, 10 mg, film-coated tablets Each film-coated tablet contains 10 mg of dapagliflozin (as dapagliflozin propanediol monohydrate).
• The other ingredients are:
• tablet core: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), microcrystalline cellulose (type 102), and sodium stearyl fumarate
• tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, yellow iron oxide (E 172). See section 2 "Dagrafors contains lactose and sodium".

What Dagrafors looks like and contents of the pack

5 mg: Yellowish-brown, round, biconvex, film-coated tablets, with "5" engraved on one side. The diameter of the tablet is approximately 7 mm. 10 mg: Yellowish-brown, oval, biconvex, film-coated tablets, with a break line on one side. Engraved with "1" on one side of the break line and "0" on the other side of the break line. The tablet can be divided into equal doses. The diameter of the tablet is approximately 13 x 6.5 mm. Dagrafors is available in packs containing:

• 14, 28, 30, 56, 60, 90, 98, or 100 film-coated tablets in non-perforated blisters in a cardboard box.
• 14, 28, 56, or 98 film-coated tablets in non-perforated calendar blisters in a cardboard box.
• 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1, or 100 x 1 film-coated tablets in perforated unit dose blisters in a cardboard box.
• 14 x 1, 28 x 1, 56 x 1, or 98 x 1 film-coated tablets in perforated calendar unit dose blisters in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For more information about this medicine, contact the local representative of the marketing authorisation holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warszawa tel. 22 57 37 500

Date of last revision of the leaflet