Dapagliflozin farmak

Patient Information Leaflet

Dapagliflozin Farmak, 5 mg, film-coated tablets
Dapagliflozin Farmak, 10 mg, film-coated tablets
Dapagliflozinum
Please read 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it 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, please tell your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Dapagliflozin Farmak is and what it is used for

What Dapagliflozin Farmak is
Dapagliflozin Farmak 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 (glucose) in the blood, salt (sodium), and water are removed from the body through the urine.

What Dapagliflozin Farmak is used for
Dapagliflozin Farmak 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.
  • Dapagliflozin Farmak may be used alone or in combination with other antidiabetic medicines.
  • It is important to continue following the diet and exercise advice given 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 Dapagliflozin Farmak help in treating it?

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

What is heart failure and how does Dapagliflozin Farmak help in treating it?

• This type of heart failure occurs when the heart cannot 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 hospitalization.
• The most common symptoms of heart failure are shortness of breath, feeling tired or very fatigued all the time, and swelling around the ankles.
• Dapagliflozin Farmak 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 Dapagliflozin Farmak help in treating it?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are unable to clean and filter blood as they should. Loss of kidney function may lead to serious medical consequences and hospitalization.
• Dapagliflozin Farmak helps protect the kidneys from losing function. This may help some patients live longer.

2. Important information before taking Dapagliflozin Farmak

When not to use Dapagliflozin Farmak

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

Warnings and precautions
Contact your doctor or 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 the blood or urine, 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 Dapagliflozin Farmak even when blood glucose levels are within the normal range.

If the patient suspects diabetic ketoacidosis, they should contact their doctor or the nearest hospital immediately and must not take this medicine.
Necrotizing fasciitis of the perineum:

• 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, immediate medical attention is required. 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 necessary.
  Before starting treatment with Dapagliflozin Farmak, 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 at all. Dapagliflozin Farmak 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 under "Dapagliflozin Farmak and 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 before starting Dapagliflozin Farmak if any of these symptoms have occurred.

• if the patient experiences nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily stopping Dapagliflozin Farmak until the patient's condition improves to prevent dehydration.

• if the patient frequently experiences urinary tract infections.

If any of the above warnings apply to the patient (or if the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Dapagliflozin Farmak.
Diabetes and foot care
For patients with diabetes, regular foot examination and adherence to all foot care recommendations provided by the doctor are important.
Glucose in urine
Due to the mechanism of action of Dapagliflozin Farmak, laboratory tests may detect the presence of sugar (glucose) in the urine.
Children and adolescents
Dapagliflozin Farmak 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.
Dapagliflozin Farmak 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.
Dapagliflozin Farmak and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
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 dose of these other medicines to prevent low blood glucose (hypoglycemia).
• if the patient is taking lithium, as Dapagliflozin Farmak may reduce blood lithium levels.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking 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 the doctor to determine the best way to manage blood glucose control during pregnancy.
If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting Dapagliflozin Farmak. Dapagliflozin Farmak should not be used during breastfeeding. It is not known whether this medicine passes into human milk.
Driving and operating machinery
Dapagliflozin Farmak has no effect or 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 (hypoglycemia), manifesting as muscle tremors, excessive sweating, and visual disturbances, which may affect the ability to drive and operate machinery.
Do not drive or operate tools or machinery if, after taking Dapagliflozin Farmak, the patient feels dizzy or experiences dizziness.
Dapagliflozin Farmak contains lactose and sodium
Dapagliflozin Farmak contains lactose (a sugar found in milk). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".
3. How to take Dapagliflozin Farmak
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
What dose to take

• The recommended dose is one 10 mg tablet once daily.
• The doctor may recommend starting treatment with a 5 mg dose if the patient has liver disease.
• The doctor will prescribe the dose appropriate for the patient.

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• The tablets can be taken during or between meals.
• The tablet can be taken at any time of day. However, it is advisable to take it at the same time each day to help remember the dose.

The doctor may prescribe Dapagliflozin Farmak to be taken together with other medicines. It is important to take these medicines as directed by the doctor to achieve the best treatment outcomes.
Diet and physical exercise may help the patient's body use blood glucose more effectively. For patients with diabetes, it is important to follow all dietary and exercise recommendations provided by the treating doctor while taking Dapagliflozin Farmak.
Taking more than the recommended dose of Dapagliflozin Farmak
If more than the recommended dose of Dapagliflozin Farmak is taken, contact a doctor or go to hospital immediately. Bring the medicine packaging with you.
Missing a dose of Dapagliflozin Farmak
What to do if a dose is missed, depending on the time remaining until the next dose.

• If 12 hours or more remain before the next dose is due, take Dapagliflozin Farmak as soon as remembered. Take the next dose at the usual time.
• If less than 12 hours remain before the next dose is due, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Dapagliflozin Farmak to make up for a missed dose.

Stopping Dapagliflozin Farmak
Do not stop taking Dapagliflozin Farmak without consulting the doctor. In patients with diabetes, blood glucose levels may rise after discontinuing this medicine.
If there are any further questions about the use of this medicine, consult the 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 seek immediate medical advice from a doctor or the nearest hospital 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 – occurs rarely in patients with type 2 diabetes (may occur in no more than 1 in 1,000 people). Symptoms of diabetic 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 Dapagliflozin Farmak.
• 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.

You should stop taking Dapagliflozin Farmak and seek immediate medical advice if the patient
experiences any of the following serious adverse reactions:

• Urinary tract infections, commonly observed (may occur in no more than 1 in 10 people). Symptoms of severe urinary tract infection:
  • fever and (or) chills,
  • burning sensation during urination,
  • back or flank pain. Blood in the urine may occasionally occur; if so, immediate medical advice should be sought.

You should contact a doctor immediately if the patient experiences any of the following
adverse reactions:

• Low blood sugar (hypoglycaemia), very commonly observed (may occur in more than 1 in 10 people) – in patients with diabetes taking this medicine with a sulfonylurea derivative or insulin. Symptoms of low blood sugar:
  • trembling, sweating, feeling anxious, rapid heartbeat,
  • feeling hungry, headache, blurred vision,
  • mood changes or feeling confused. The doctor will advise how to treat low blood sugar and what to do if any of the above adverse reactions occur.

Other adverse reactions during treatment with Dapagliflozin Farmak:
Common

• genital infections (fungal infections) of the penis or vagina (symptoms may include irritation, itching, unusual discharge or unpleasant odour),
• back pain,
• excessive urination or increased frequency of urination,
• 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 occur in no more than 1 in 100 people)

• excessive loss of body fluids (dehydration, symptoms of which may include marked dryness or stickiness in the mouth, reduced or no urine output, or rapid heartbeat),
• thirst,
• constipation,
• getting up at night to pass urine,
• 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

• kidney inflammation (tubulointerstitial nephritis).

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

5. How to store Dapagliflozin Farmak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must 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 package and other information

What Dapagliflozin Farmak contains

• The active substance is dapagliflozin. Each 5 mg film-coated tablet contains 5 mg of dapagliflozin. Each 10 mg film-coated tablet contains 10 mg of dapagliflozin.
• Other ingredients are: microcrystalline cellulose, lactose, crospovidone, colloidal anhydrous silica, magnesium stearate.

Depending on the strength, the tablet coating contains:
5 mg tablet: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).
10 mg tablet: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Dapagliflozin Farmak looks like and contents of the pack
Dapagliflozin Farmak 5 mg are light yellow to light orange, round, biconvex film-coated tablets without a break line. Tablet dimensions: diameter (7.2 ± 0.2) mm, height (3.1 ± 0.4) mm.
Dapagliflozin Farmak 10 mg are yellow-brown, oval, biconvex film-coated tablets without a break line. Tablet dimensions: length (12.2 ± 0.3) mm, width (6.2 ± 0.2) mm, height (3.9 ± 0.4) mm.

Dapagliflozin Farmak is available in blisters made of laminated polyvinyl chloride (PVC/PA/Aluminium) and polyamide with coated aluminium foil, containing 10 film-coated tablets per blister.
Cardboard cartons containing 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Manufacturer/Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Dapagliflozin FMK
Poland: Dapagliflozin Farmak
Portugal: Dapagliflozina Farmak