DIAFLIX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Diaflix, 5 mg, film-coated tablets
3. Diaflix, 10 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What Diaflix is and what it is used for
   1. What Diaflix is
   2. What Diaflix is used for
   3. What is type 2 diabetes and how does Diaflix work?
   4. What is heart failure and how does Diaflix work?
   5. What is chronic kidney disease and how does Diaflix work?
5. What you need to know before you take Diaflix
   1. Do not take Diaflix
   2. Warnings and precautions
   3. Seek medical help immediately
   4. Before taking Diaflix, talk to your doctor, pharmacist, or nurse:
   5. Diabetes and foot care
   6. Glucose in urine
   7. Children and adolescents
   8. Diaflix and other medicines
   9. Pregnancy and breastfeeding
   10. Driving and using machines
6. How to take Diaflix
   1. How much to take
   2. How to take this medicine
   3. If you take more Diaflix than you should
   4. If you forget to take Diaflix
   5. If you stop taking Diaflix
7. Possible side effects
   1. Seek medical help immediately if you experience any of the following side effects:
   2. Stop taking Diaflix and seek medical help immediately if you experience any of the following serious side effects:
   3. Seek medical help if you experience any of the following side effects:
   4. Other side effects when taking Diaflix:
   5. Reporting side effects
8. How to store Diaflix
9. Contents of the pack and other information
   1. What Diaflix contains
   2. What Diaflix looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Diaflix, 5 mg, film-coated tablets

Diaflix, 10 mg, film-coated tablets

Dapagliflozin

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 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 and other information

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

1. What Diaflix is and what it is used for

What Diaflix is

Diaflix 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, which absorbs glucose from the blood. By blocking this protein, glucose, sodium, and water are removed from the body through urine.

What Diaflix is used for

Diaflix 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.
• Diaflix can be used alone or with other anti-diabetic medicines.
• It is important to continue to follow the diet and exercise plan as advised by your doctor, pharmacist, or nurse.
• Heart failure
• in adults (aged 18 years and older) when the heart is not pumping blood as well as it should.
• Chronic kidney disease
• in adults with reduced kidney function.

What is type 2 diabetes and how does Diaflix work?

• In type 2 diabetes, the body does not produce enough insulin or cannot use the insulin it produces effectively. This can lead to serious complications, such as heart disease, kidney disease, blindness, and poor blood circulation in the arms and legs.
• Diaflix works by removing excess sugar from the body. If you have type 2 diabetes, Diaflix may also help prevent heart disease.

What is heart failure and how does Diaflix 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.
• Diaflix 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 Diaflix work?

• In patients with chronic kidney disease, the kidneys gradually lose their ability to clean and filter the blood. This can lead to serious medical consequences and the need for hospital treatment.
• Diaflix helps protect the kidneys from losing their function. This may help some patients live longer.

2. What you need to know before you take Diaflix

Do not take Diaflix

• 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, or rapid weight loss.
• These symptoms may indicate "diabetic ketoacidosis" - a rare but serious, potentially life-threatening complication of diabetes, resulting from increased levels of "ketone bodies" in the urine or blood, as shown in laboratory tests.
• The risk of diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to serious surgery or severe illness.
• During treatment with Diaflix, diabetic ketoacidosis may occur even if 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 life-threatening infection called Fournier's gangrene, which can cause tissue damage.

Before taking Diaflix, talk to your doctor, pharmacist, or nurse:

• if you have "type 1 diabetes" - a type of diabetes that usually starts in young people, whose body does not produce any insulin. Diaflix is not intended for the treatment of this condition.
• if you have kidney disease and diabetes - your doctor may recommend additional or alternative medication to control blood sugar levels.
• if you have liver disease - your doctor may start treatment with a lower dose.
• if you are taking blood pressure-lowering medicines (antihypertensives) and have a history of low blood pressure (hypotension). More information is provided below, in the section "Diaflix and other medicines".
• 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 starting treatment with this medicine, 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 may cause dehydration. Your doctor may recommend stopping Diaflix until your condition improves to prevent dehydration.
• if you frequently experience urinary tract infections. If any of the above warnings apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before taking Diaflix.

Diabetes and foot care

For patients with diabetes, it is essential to regularly check the condition of your feet and follow any foot care advice given by your doctor.

Glucose in urine

Due to the mechanism of action of Diaflix, laboratory tests may show the presence of sugar (glucose) in the urine.

Children and adolescents

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

Diaflix and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, including those obtained without a prescription.
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 hypoglycemia (too low blood sugar levels).
• if you are taking lithium, as Diaflix may decrease 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 this medicine, as it is not recommended for use in the second and third trimesters of pregnancy. Consult your doctor to determine the best way to control blood sugar levels during pregnancy.
If you are breastfeeding or wish to breastfeed, tell your doctor before taking this medicine. Do not take Diaflix while breastfeeding, as it is not known whether the medicine passes into human milk.

Driving and using machines

Diaflix 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 hypoglycemia (too low blood sugar levels), which can cause muscle tremors, sweating, anxiety, rapid heartbeat, hunger, headache, vision disturbances, mood changes, or confusion, and may affect your ability to drive and use machines.
Do not drive or operate machinery if you feel dizzy or have dizziness after taking Diaflix.

3. How to take Diaflix

Always take Diaflix exactly as your doctor has told you. If you are unsure, 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 treatment with a 5 mg dose if you have liver disease.
• Your doctor will prescribe the dose that is right for you.

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• Tablets can be taken with or without food.
• 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 recommend taking Diaflix with other medicines. Remember to take these medicines as advised by your doctor. This will help you get the best results from treatment. Diet and exercise can help your body use sugar in the blood more effectively. For patients with diabetes, it is essential to follow any diet and exercise program recommended by your doctor while taking Diaflix.

If you take more Diaflix than you should

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

If you forget to take Diaflix

What to do if you miss a dose, depending on the time remaining until the next dose.

• If there are 12 hours or more until the next dose, take Diaflix as soon as you remember. 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 to make up for a missed dose.

If you stop taking Diaflix

Do not stop taking Diaflix without talking to your doctor. If you have diabetes, your 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, observed very rarely (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, observed rarely 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 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. This may occur regardless of blood sugar levels. Your doctor may decide to stop or discontinue Diaflix.
• Fournier's gangreneor necrotizing fasciitis of the genital area, a serious infection of the soft tissues of the external genital area or the area between the genitals and anus, observed very rarely.

Stop taking Diaflix and seek medical help immediately if you experience any of the following serious side effects:

• Urinary tract infections, which occur frequently (may affect up to 1 in 10 people). Symptoms of acute urinary tract infection:
• fever and (or) chills
• burning sensation while urinating
• back or side pain. Less commonly, you may experience blood in the urine; in this case, seek medical help immediately.

Seek medical help if you experience any of the following side effects:

• Low blood sugar (hypoglycemia), which occurs very frequently (may affect more than 1 in 10 people) - in patients with diabetes taking this medicine with sulfonylurea or insulin. Symptoms of low blood sugar:
• tremors, sweating, anxiety, rapid heartbeat
• hunger, headache, vision disturbances
• mood changes or confusion. 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 when taking Diaflix:

Frequently (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. Less frequently (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 less urine or no 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). Very rarely (may affect up to 1 in 10,000 people)
• kidney inflammation (interstitial nephritis).

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diaflix

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
The packaging is labeled with the expiry date and batch number (Lot/LOT).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diaflix contains

• The active substance is dapagliflozin. Each film-coated tablet Diaflix 5 mg contains 5 mg of dapagliflozin. Each film-coated tablet Diaflix 10 mg contains 10 mg of dapagliflozin.
• The other ingredients are:
• Tablet core: microcrystalline cellulose (PH 101), mannitol, colloidal silicon dioxide, magnesium stearate
• Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172)

What Diaflix looks like and contents of the pack

Diaflix 5 mg film-coated tablets are yellow, round, biconvex, with the number "5" embossed on one side, with a diameter of 6.1 mm.
Diaflix 10 mg film-coated tablets are yellow, oval, biconvex, with the number "10" embossed on one side; dimensions: 11.1 mm x 6.4 mm.
The medicine is available in aluminum/PVC/PCTFE or aluminum/PVC/PVDC blisters in a cardboard box, in packs of 30, 60, or 90 film-coated tablets in non-perforated blisters, 28, 56, or 98 film-coated tablets with days of the week marked in non-perforated blisters, and 30x1 or 90x1 film-coated tablets in perforated single-dose blisters.
The medicine is available in HDPE bottles with a PP cap and a PE seal in a cardboard box, containing 30, 60, 90, or 98 film-coated tablets.
The medicine is available in HDPE containers with an LDPE lid in a cardboard box, containing 30, 60, 90, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: