Daforbis

Package leaflet: Information for the patient

Daforbis, 5 mg, coated tablets
Daforbis, 10 mg, coated tablets
Dapagliflozin
Please 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Daforbis is and what it is used for
2. What you need to know 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 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". These medicines work by blocking
the SGLT2 protein in the kidneys. By blocking this protein, sugar in the blood (glucose), salt
(sodium), and water are removed from the body through 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 adequate control of type 2 diabetes cannot be achieved with diet and physical exercise alone.
• Daforbis may be used alone or together with other antidiabetic medicines.
• It is important to continue following the diet and physical exercise recommendations provided 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 impaired kidney function.

What is type 2 diabetes and how does Daforbis help in treating it?

• In type 2 diabetes, the body does not produce enough insulin or cannot properly use the insulin it produces. This leads to increased blood sugar levels. Such a condition may cause serious complications, such as heart or kidney disease, blindness, and poor circulation in 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 help in treating it?

• This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as effectively as it should. This condition may lead to serious medical consequences and may require hospital treatment.
• The most common symptoms of heart failure are breathlessness, feeling tired or very tired all the time, and swelling around the ankles.
• Daforbis helps protect the heart from worsening and reduces symptoms. It may reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Daforbis help in treating it?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are no longer able to properly clean and filter the blood. Loss of kidney function may lead to serious medical consequences and may require hospital treatment.
• Daforbis helps protect the kidneys from further loss of function. This may help some patients live longer.

2. Important information before using Daforbis

When not to use Daforbis

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

Warnings and precautions
Contact a doctor or the nearest hospital immediately
Diabetic ketoacidosis:

• If the patient with diabetes develops nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, change in the smell of urine or sweat, or rapid weight loss.
• The above symptoms may indicate "diabetic ketoacidosis" – a rare but serious, sometimes life-threatening complication of diabetes caused by increased levels of "ketone bodies" in urine or blood, which can be confirmed by laboratory tests.
• The risk of diabetic ketoacidosis may increase during prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or severe illness.
• Diabetic ketoacidosis may occur during treatment with Daforbis even when blood glucose levels are within the normal range.

If the patient suspects diabetic ketoacidosis, they should immediately
contact a doctor or the nearest hospital and must not take this medicine.
Necrotizing fasciitis of the perineum (Fournier's gangrene):

• If the patient experiences a combination of symptoms such as pain, tenderness, redness or swelling of the external genital organs or the area between the genitals and the anus, accompanied by fever or general malaise, medical attention must be sought immediately. These may be symptoms of a rare but serious or even life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which leads to damage of subcutaneous tissue. Immediate treatment for Fournier's gangrene is essential.

Before starting Daforbis, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has "type 1 diabetes" – a type of diabetes that usually begins in young people whose bodies produce no insulin. Daforbis should not be used to treat this condition.
• if the patient has kidney disease – the doctor may recommend additional or alternative medication to control blood glucose levels.
• if the patient has liver disease – the doctor may start treatment with a lower dose.
• if the patient is taking antihypertensive medicines (medicines to lower blood pressure) and has a history of low blood pressure (hypotension). More information is provided below in the section "Daforbis with other medicines".
• if the patient has very high blood glucose levels, leading to dehydration (excessive fluid loss). Possible symptoms of excessive fluid loss are listed in section 4. Inform the doctor if any of these symptoms have occurred before starting this medicine.
• if the patient experiences nausea, vomiting, fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily stopping Daforbis until the patient's condition improves, to prevent dehydration.
• if the patient frequently suffers from urinary tract infections.

If any of the above warnings apply to the patient (or if the patient is unsure), they should
consult a doctor, pharmacist, or nurse before using Daforbis.
Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of the feet and to follow all
foot care advice provided by the doctor.
Glucose in urine
Due to the mechanism of action of Daforbis, laboratory tests may detect the presence of sugar
(glucose) in the urine.
Children and adolescents
Daforbis may be used in children aged 10 years and older for the treatment of type 2 diabetes. There is
no data on use in children under 10 years of age.
Daforbis is not recommended for use in children and adolescents under 18 years of age for the treatment of
heart failure or chronic kidney disease, as studies have not been conducted in this age group.
Daforbis with other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.
In particular, inform the doctor:

• if the patient is taking medicines that help remove water from the body (diuretics).
• if the patient is taking other medicines that lower blood glucose levels, such as insulin or sulfonylurea derivatives. The doctor may recommend reducing the doses of other medicines to prevent low blood glucose levels (hypoglycaemia).
• if the patient is taking lithium, as Daforbis may reduce blood lithium levels.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
If the patient becomes pregnant, she should stop taking this medicine, as its use is not recommended during the second and third trimesters of pregnancy. Consult a doctor to determine the best way to manage glycaemic control during pregnancy.
If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting
this medicine. Daforbis should not be used during breastfeeding. It is unknown whether the medicine passes into human breast milk.
Driving and operating machinery
Daforbis has no effect or a negligible effect on the ability to drive and operate machinery.
However, using this medicine together with other medicines such as sulfonylurea derivatives or insulin may
cause excessively low blood glucose levels (hypoglycaemia), manifesting as muscle tremors, excessive sweating, and visual disturbances, which may affect the ability to drive and operate machinery.
Do not drive or operate machinery if the patient experiences dizziness after taking Daforbis.
Daforbis contains lactose
Daforbis contains lactose (a sugar found in milk). If the patient has previously been diagnosed with
intolerance to certain sugars, they should consult a doctor before taking this medicine.
Daforbis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Daforbis

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor, pharmacist, or nurse.
What dose to take

• The recommended dose is one 10 mg tablet once daily.
• Your doctor may prescribe an initial dose of 5 mg if you have liver disease.
• Your doctor will determine the appropriate dose for you.

How to take this medicine

• Swallow the tablet whole with half a glass of water. Tablets must not be divided into equal doses.
• The tablet may be taken during or regardless of meals.
• The tablet may be taken at any time of day. However, it is advisable to take it at approximately the same time each day. This will help you remember to take it.

Your doctor may prescribe Daforbis to be taken together with other medicines. Always take these
medicines exactly as directed by your doctor. This will help achieve the best treatment results.
Diet and physical exercise may help your body better utilize blood sugar. For patients with diabetes, it is important to follow all dietary and exercise recommendations provided by the treating doctor while taking Daforbis.
Taking more Daforbis than prescribed
If you take more Daforbis than prescribed, contact your doctor immediately or go to a hospital.
Bring the medicine package with you.
If you forget to take Daforbis
The action to take if you miss a dose depends on the time remaining until the next dose.

• If 12 hours or more remain before the next dose is due, take Daforbis as soon as you remember. Take the next dose at your usual time.
• If less than 12 hours remain before the next dose is due, skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose of Daforbis to make up for a missed 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 about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should consult a doctor or the nearest hospital immediately if the patient experiences
any of the following adverse reactions:

• Angioedema, observed very rarely (may occur in no more than 1 in 10,000 people). Symptoms of angioedema:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and breathing difficulties
• Diabetic ketoacidosis – this is rare in patients with type 2 diabetes (may occur in no more than 1 in 1,000 people). Symptoms of ketoacidosis (see also section 2 Warnings and precautions):
  • increased concentration of "ketone bodies" in urine or blood
  • nausea or vomiting
  • abdominal pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • unusual drowsiness or fatigue
  • sweet breath odour, sweet or metallic taste in the mouth, or change in the smell of urine or sweat
  • rapid weight loss

This may occur regardless of blood glucose levels. The doctor may decide to interrupt or
discontinue treatment with Daforbis.

• Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a serious infection of the soft tissues of the external genital organs or the area between the genitals and anus, observed very rarely.

The patient should stop taking Daforbis and consult a doctor immediately if any of the following
serious adverse reactions occur:

• Urinary tract infections, which occur frequently (may affect up to 1 in 10 people). Symptoms of serious urinary tract infection:
  • fever and (or) chills
  • burning sensation during urination
  • back or flank pain. Blood in the urine may also occur not infrequently; if this occurs, consult a doctor immediately.

Contact a doctor immediately if the patient experiences any of the following adverse reactions:

• Low blood sugar (hypoglycaemia), which occurs very frequently (may occur in more than 1 in 10 people) – in diabetic patients taking this medicine with a sulfonylurea derivative or insulin. Symptoms of low blood sugar:
  • trembling, sweating, feeling anxious, rapid heartbeat
  • feeling hungry, headache, vision disturbances
  • mood changes or feeling confused.

The doctor will inform the patient how to treat low blood sugar and what to do if any of the above adverse reactions occur.
Other adverse reactions during treatment with Daforbis:
Frequent (may affect up to 1 in 10 people)

• infections (fungal) of the penis or vagina (e.g. irritation, itching, unusual discharge or unpleasant odour)
• back pain
• excessive urination or increased need to urinate
• changes in blood cholesterol or fat levels (detected in laboratory tests)
• increase in red blood cell count (detected in laboratory tests)
• decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• excessive loss of body fluids (dehydration, symptoms of which may include extreme dryness or stickiness in the mouth, reduced or no urine output, or rapid heartbeat)
• thirst
• constipation
• getting up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected in blood laboratory tests) at the beginning of treatment
• increased urea levels (detected in blood laboratory tests)

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

• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie
181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 4921 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Daforbis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Daforbis contains
The active substance is dapagliflozin.
Each Daforbis coated tablet, 5 mg contains 5 mg of dapagliflozin.
Each Daforbis coated tablet, 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 coated tablets are yellow, round, biconvex, approximately 7 mm in diameter, with the number “5” embossed on one side and smooth on the other.
Daforbis 10 mg coated tablets are yellow, rhomboidal, biconvex, approximately 11 x 8 mm in size, with the number “10” embossed on one side and smooth on the other.
Daforbis 5 mg coated tablets are available in:
Aluminum/OPA/PVC/Aluminum foil blisters in packs containing 30 or 98 coated tablets, in a cardboard carton.
Daforbis 10 mg coated tablets are available in:
Aluminum/OPA/PVC/Aluminum foil blisters in packs containing 28, 30 or 98 coated tablets, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
{logo of the Marketing Authorisation Holder}

Manufacturer/Importer:
Mylan Hungary Kft
Mylan Utca 1
2900, Komárom
Hungary
Mylan Germany GmbH
Benzstrasse 1
61352, Bad Homburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

This medicinal product is authorised in the European Economic Area countries under the following names:
Cyprus: Daforbis
Croatia: Daforbis
Greece: Daforbis
Poland: Daforbis
Romania: Daforbis
Sweden: Daforbis