Figozap

Package leaflet: Information for the patient

Figozap, 5 mg, film-coated tablets
Figozap, 10 mg, film-coated tablets
Dapagliflozin
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Figozap is and what it is used for

What Figozap is
Figozap contains the active substance dapagliflozin. It belongs to a group of medicines called
"sodium-glucose co-transporter 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 urine.

What Figozap is used for
Figozap 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 activity alone.
• Figozap may be used alone or together with other antidiabetic medicines.
• It is important to continue following the diet and physical activity regimen 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 impaired kidney function.

What is type 2 diabetes and how does Figozap help in its treatment?

• 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 may cause serious complications, such as heart or kidney disease, blindness, and poor blood circulation in the arms and legs.

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

What is heart failure and how does Figozap help in its treatment?

• 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 the need for hospital treatment.
• The most common symptoms of heart failure are shortness of breath, feeling tired or extremely fatigued all the time, and swelling around the ankles.
• Figozap helps protect the heart from worsening and alleviates symptoms. It may reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Figozap help in its treatment?

• 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 the need for hospital treatment.
• Figozap helps protect the kidneys from further loss of function. This may help some patients live longer.

2. Important information before taking Figozap

When not to take Figozap:

• 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 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 Figozap even when blood glucose levels are within the normal range. If the patient suspects diabetic ketoacidosis, they should contact a 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, they should seek immediate medical attention. These may be symptoms of a rare but serious or even life-threatening infection called necrotizing fasciitis of the perineum, also known as Fournier's gangrene, which leads to damage of subcutaneous tissue. Immediate treatment of Fournier's gangrene is essential.

Before starting to take Figozap, 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 do not produce insulin. Figozap should not be used in the treatment of this condition.
• if the patient has kidney disease due to diabetes – the doctor may recommend using an additional or different medicine 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 that lower blood pressure) and has a history of low blood pressure (hypotension). More information is provided below under "Figozap and other medicines".
• if the patient has very high blood glucose levels leading to dehydration (excessive loss of body fluids). Possible symptoms of excessive fluid loss are listed in section 4. The doctor should be informed if any of these symptoms have occurred before starting Figozap.
• if the patient has nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily stopping Figozap 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 a doctor, pharmacist, or nurse before taking Figozap.
Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of the feet and follow all
foot care recommendations provided by the doctor.
Glucose in urine
Due to the mechanism of action of Figozap, laboratory tests may detect the presence of
sugar (glucose) in the urine.
Children and adolescents
Figozap 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.
Figozap 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.
Figozap and other medicines
Inform your doctor, pharmacist, or nurse 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 doses of these other medicines to prevent low blood glucose levels (hypoglycemia).
• if the patient is taking lithium, as Figozap may reduce blood lithium levels.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before taking this medicine. If the patient becomes pregnant, she should stop taking Figozap, as its use is not recommended during the second and third trimesters of pregnancy. Consult a doctor to determine the best way to control blood glucose levels during pregnancy.
If the patient is breastfeeding or intends to breastfeed, she should inform the doctor before starting Figozap. Figozap should not be used during breastfeeding. It is unknown whether this medicine passes into human breast milk.
Driving and operating machinery
Figozap has no effect or has 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 (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 the patient experiences dizziness after taking Figozap.
Figozap contains lactose
Figozap contains lactose (a sugar found in milk). If the patient has been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to take Figozap

Figozap must always be taken exactly as directed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

How much medicine to take

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

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• Tablets may be taken during or between 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 recommend taking Figozap together with other medicines. Always follow your doctor's instructions regarding these medicines to achieve the best treatment results.
Diet and physical exercise may help your body use blood sugar more effectively. For patients with diabetes, it is important to follow all dietary and exercise recommendations provided by your treating physician while taking Figozap.

Taking more Figozap than you should
If you take more Figozap than prescribed, contact your doctor immediately or go to the hospital. Take the medicine packaging with you.

If you forget to take Figozap
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, take Figozap as soon as you remember. Take the next dose at your usual time.
• If less than 12 hours remain before the next dose, skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Figozap
Do not stop taking Figozap without consulting your doctor. In patients with diabetes, blood sugar levels may increase after stopping this 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 go to 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 – 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 tiredness
• sweet-smelling 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 blood sugar levels. The doctor may decide to interrupt or discontinue treatment with Figozap.

• 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 the anus, observed very rarely.

Treatment with Figozap should be discontinued and immediate medical advice sought if the patient
experiences any of the following serious adverse reactions:

• Urinary tract infections, which occur frequently (may occur in no more than 1 in 10 people). Symptoms of serious urinary tract infection:
• fever and/or chills
• burning sensation during urination
• back or flank pain. If blood in the urine occurs, which is not uncommon, the patient should 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 patients with diabetes who are 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 on how to treat low blood sugar and what to do if any of the above adverse reactions occur.
Other adverse reactions during treatment with Figozap:
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 need to urinate
• changes in cholesterol or blood 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 extreme dryness or stickiness in the mouth, passing small amounts of urine or no urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to pass urine
• dry mouth
• weight loss
• increased creatinine levels (detected in laboratory blood tests) at the beginning of treatment
• increased urea levels (detected in laboratory blood tests)

Very rare

• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: 22 49 21 301, fax: 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 Figozap

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box following the abbreviation EXP.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Figozap contains

• The active substance is dapagliflozin. Each Figozap 5 mg coated tablet contains 5 mg of dapagliflozin as dapagliflozin propanediol monohydrate. Each Figozap 10 mg coated tablet contains 10 mg of dapagliflozin as dapagliflozin propanediol monohydrate.
• Other ingredients are:
• tablet core: microcrystalline cellulose (E460i), crospovidone (E1202), lactose (see section 2 “Figozap contains lactose”), colloidal anhydrous silica (E551), sodium stearyl fumarate.
• tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc, yellow iron oxide (E172).

What Figozap looks like and contents of the pack
Figozap 5 mg coated tablets are yellow, biconvex, round coated tablets with a diameter of 7 mm, smooth on both sides.
Figozap 10 mg coated tablets are yellow, biconvex, diamond-shaped coated tablets, approximately 11 mm x 8 mm in size.
Figozap is available in the following pack:
Laminated cold-form blister packs (structure: oriented polyamide/aluminium foil/PVC) with a backing composed of rigid, tempered aluminium foil coated on the inner side with a heat-seal lacquer, in cardboard boxes containing 10, 14, 28, 30, 60 or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Ludwika Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87,
2132 JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca,
Romania

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Sweden Figozap 5 mg filmdragerade tabletter
Figozap 10 mg filmdragerade tabletter
Germany FIGOZAP 5 mg Filmtabletten
FIGOZAP 10 mg Filmtabletten
Denmark Figozap
Spain FIGOZAP 5 mg comprimidos recubiertos con película EFG
FIGOZAP 10 mg comprimidos recubiertos con película EFG
Finland FIGOZAP 5 mg kalvopäällysteiset tabletit
FIGOZAP 10 mg kalvopäällysteiset tabletit
France Figozap 5 mg, comprimé pelliculé
Figozap 10 mg, comprimé pelliculé
Italy FIGOZAP
Netherlands Figozap 5mg filmomhulde tabletten
Figozap 10mg filmomhulde tabletten
Norway Figozap
Romania Figozap 5 mg comprimate filmate
Figozap 10 mg comprimate filmate