DAFORBIS 5 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Daforbis 5 mg film-coated tablets EFG

dapagliflozin

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Daforbis and what is it used for
2. What you need to know before taking Daforbis
3. How to take Daforbis
4. Possible side effects
5. Storage of Daforbis
6. Package contents and additional 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 medications called "sodium-glucose cotransporter 2 (SGLT2) inhibitors". They work by blocking the SGLT2 protein in the kidney. By blocking this protein, sugar in the blood (glucose), salt (sodium), and water are eliminated from the body through urine.

What Daforbis is used for

Dapagliflozin is used to treat:

• Type 2 diabetes

• in adults and children aged 10 years or older.
• if your type 2 diabetes cannot be controlled with diet and exercise.
• dapagliflozin can be used alone or in combination with other medications to treat diabetes.
• it is essential that you continue to follow the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse.

• Heart failure

• - in adults (18 years or older) with symptoms due to a weak heart pump.

• Chronic kidney disease

• - in adults with reduced kidney function.

What is type 2 diabetes and how does Daforbis help?

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

What is heart failure and how does Daforbis help?

• 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 problems and the need for hospital care.
• The most common symptoms of heart failure are shortness of breath and constant fatigue and swelling of the ankles.
• Dapagliflozin helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalization and may help some patients live longer.

What is chronic kidney disease and how does Daforbis help?

• When you have chronic kidney disease, your kidneys may gradually lose their function.

This means they will not be able to clean and filter your blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospital care.

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

2. What you need to know before taking Daforbis

Do not take Daforbis

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

Warnings and precautions

Contact a doctor or the nearest hospital immediately:

Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual fatigue, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, or rapid weight loss.
• The above symptoms may be a sign of "diabetic ketoacidosis" - a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in "ketone bodies" in your urine or blood, which is detected in tests.
• The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a greater need for insulin due to major surgery or severe illness.
• When you are being treated with dapagliflozin, diabetic ketoacidosis may occur even if your blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital immediately and do not take this medication.

Fournier's gangrene:

• Consult your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general malaise. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene requires immediate treatment.

Contact a doctor, pharmacist, or nurse before starting to take Daforbis:

• if you have "type 1 diabetes" - the type that usually occurs when you are young and your body does not produce any insulin. Dapagliflozin should not be used to treat this condition.
• if you have diabetes and have any kidney problems - your doctor may prescribe an additional medication or a different one to control blood sugar levels.
• if you have any liver problems – your doctor may start with a lower dose.
• if you are taking medications to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in Taking dapagliflozin with other medications.
• if you have very high blood sugar levels that may cause dehydration (loss of too much fluid from the body). Possible signs of dehydration are listed in section 4. Inform your doctor before starting to take Daforbis if you experience any of these signs.
• if you experience nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking dapagliflozin until you recover to prevent dehydration.
• if you frequently experience urinary tract infections.

If any of the above situations apply to you (or you are unsure), talk to your doctor, pharmacist, or nurse before taking dapagliflozin.

Diabetes and foot care

If you have diabetes, it is essential that you regularly check your feet and follow any other foot care advice provided by your healthcare professional.

Glucose in urine

• Due to how dapagliflozin works, your urine will test positive for glucose while you are taking this medication.

Children and adolescents

Dapagliflozin can be used in children aged 10 years or older to treat type 2 diabetes. There is no data available in children under 10 years of age.

Dapagliflozin is not recommended in children or adolescents under 18 years of age to treat heart failure or chronic kidney disease, as it has not been studied in these patients.

Taking dapagliflozin with other medications

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medications.

Especially tell your doctor:

• if you are taking a medication used to remove fluid from the body (diuretic).
• if you are taking other medications that lower blood sugar levels, such as insulin or a "sulfonylurea" type medication. Your doctor may decide to reduce the dose of these medications to avoid low blood sugar levels (hypoglycemia).
• if you are taking lithium, as dapagliflozin may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medication.

You should stop taking this medication if you become pregnant, as it is not recommended for use during the second and third trimesters of pregnancy. Consult your doctor about the best way to control blood sugar levels during pregnancy.

Consult your doctor if you want to breastfeed or are breastfeeding before taking this medication. Do not use dapagliflozin during breastfeeding. It is not known if this medication passes into human breast milk.

Driving and using machines

Dapagliflozin has no significant influence on the ability to drive or use machines. Taking this medication with other medications called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which can cause symptoms such as shaking, sweating, and changes in vision that may affect your ability to drive or use machines.

Do not drive or use tools or machines if you feel dizzy while taking dapagliflozin.

Daforbis contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

Daforbis contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Daforbis

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse again.

How much to take

• The recommended dose is one 10 mg tablet per day.
• Your doctor may start with a dose of 5 mg if you have a liver problem.
• Your doctor will prescribe the correct dose for you.

How to take this medication

• Swallow the tablet whole with a half glass of water.
• 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 each day. This will help you remember to take it.

Your doctor may prescribe dapagliflozin along with another medication(s). Remember to take these other medication(s) as instructed by your doctor. This will help you get the best results for your health. Diet and exercise can help your body use blood sugar better. If you have diabetes, it is essential that you follow any diet and exercise program recommended by your doctor while taking dapagliflozin.

If you take more Daforbis than you should

If you take more dapagliflozin tablets than you should, consult your doctor or go to the hospital immediately. Take the medication package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Daforbis

What you should do if you forget to take a tablet depends on how much time is left until your next dose.

• If there are 12 hours or more until your next dose, take a dose of dapagliflozin as soon as you remember. Then take the next dose at the usual time.
• If there are 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 dapagliflozin to make up for missed doses.

If you stop taking Daforbis

Do not stop taking dapagliflozin without consulting your doctor first. If you have diabetes, your blood sugar levels may increase without this medication.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, dapagliflozin can cause side effects, although not everyone will experience them.

Contact a doctor or the nearest hospital immediately if you experience any of the following side effects:

• angioedema,seen very rarely (may affect up to 1 in 10,000 people).

These are the signs of angioedema:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and breathing problems

• diabetic ketoacidosis,rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people).

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increase in "ketone bodies" in your urine or blood.

• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness and unusual fatigue
• sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat.
• rapid weight loss

This can occur regardless of blood sugar levels. Your doctor will decide whether to temporarily or permanently stop your treatment with dapagliflozin.

• Fournier's gangreneor necrotizing fasciitis of the perineum, a rare but serious infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely.

Stop taking Daforbis and consult a doctor immediately if you notice any of these serious side effects:

• urinary tract infection,common (may affect up to 1 in 10 people).

These are the signs of a serious urinary tract infection:

• fever and/or chills
• burning sensation while urinating
• back or side pain.

Although it is not common, if you notice blood in your urine, inform your doctor immediately.

Contact your doctor as soon as possible if you experience any of the following side effects:

• low blood sugar levels(hypoglycemia), very common (may affect more than 1 in 10 people) in patients with diabetes who take this medication along with a sulfonylurea or insulin

The signs of low blood sugar levels are:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• feeling hungry, headache, changes in vision
• change in mood or feeling of confusion.

Your doctor will explain how to treat low blood sugar levels and what to do if you experience any of the above signs.

Other side effects:

Common:

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• increased urine production or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in tests)
• increases in red blood cell count in the blood (observed in tests)
• decreases in renal creatinine clearance (observed in tests) at the start of treatment
• dizziness
• rash

Uncommon(may affect up to 1 in 100 people)

• excessive loss of fluids from the body (dehydration, signs may include a very dry or sticky mouth, reduced or no urination; or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings due to the need to urinate
• dry mouth
• weight loss
• increased creatinine (observed in blood tests) at the start of treatment
• increased urea (observed in blood tests)

Rare

• kidney inflammation (tubulointerstitial nephritis)

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this summary of product characteristics. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of 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 carton and blister after "CAD:". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Daforbis

• The active ingredient is dapagliflozin. Each film-coated tablet contains 5 mg of dapagliflozin
• The other ingredients are:

• tablet core: microcrystalline cellulose (E460), lactose monohydrate (E473), crospovidone (E1202), sodium lauryl sulfate (E487), anhydrous colloidal silica (E551), mannitol (E421), magnesium stearate (E572)
• tablet coating: polyvinyl alcohol (E1203), macrogol 6000 (E1521), talc (E553b), titanium dioxide (E 171), yellow iron oxide (E 172)

Appearance of the Product and Package Contents

Yellow, round, biconvex, film-coated tablets, engraved with "5" on one side and smooth on the other.

Size:7.24 mm ± 0.2 mm

Daforbis 5 mg is available in blister packs (cold-formed OPA/Aluminum/PVC laminate and aluminum foil). The available pack sizes are 28, 30, and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona,

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Date of the Last Revision of thisLeaflet:January 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)