Dagrafors

Package leaflet: Information for the patient

Dagrafors, 5 mg, film-coated tablets
Dagrafors, 10 mg, film-coated tablets
Dapagliflozin
Please read carefully this leaflet before taking this medicine because it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What Dagrafors is and what it is used for

What Dagrafors is
Dagrafors contains the active substance dapagliflozin. It belongs to a group of medicines called
"sodium-glucose cotransporter 2 (SGLT2) inhibitors". These 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 Dagrafors is used for
Dagrafors is used in the treatment of:

• 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.
• Dagrafors may be used as monotherapy or in combination with other antidiabetic medicines.
• It is important to continue following the diet and physical exercise 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 Dagrafors 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. Such a condition may cause serious complications, such as heart or kidney disease, blindness, and poor blood circulation in arms and legs.

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

What is heart failure and how does Dagrafors 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 hospitalization.
• The most common symptoms of heart failure are shortness of breath, feeling tired or extremely fatigued all the time, and swelling around the ankles.
• Dagrafors 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 Dagrafors help in its treatment?

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

2. Important information before using Dagrafors

When not to use Dagrafors

• 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 urine or sweat odor, 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 ketoacid游戏副本

3. How to use Dagrafors

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

• 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 with half a glass of water. The 10 mg tablet may be divided into equal doses or split to facilitate swallowing.
• Tablets may be taken with or between meals.
• The tablet may be taken at any time of day. However, you should try to take it at the same time each day. This will help you remember to take it.

Your doctor may recommend using Dagrafors together with other medicines. Always use these medicines as directed by your doctor. This will help achieve the best treatment results.
Diet and physical exercise may help your body better utilize the sugar in the blood. For patients with diabetes, it is important to follow all dietary and exercise programs recommended by your treating doctor while taking Dagrafors.
Taking more Dagrafors than prescribed
If you take more Dagrafors than prescribed, contact your doctor immediately or go to the hospital. Take the medicine packaging with you.
Missing a dose of Dagrafors
What to do 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 Dagrafors 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 Dagrafors to make up for a missed dose.

Stopping Dagrafors
Do not stop using Dagrafors 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
• urticaria and breathing difficulties
• Diabetic ketoacidosis – 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-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 Dagrafors.
• 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.

You should stop taking Dagrafors and consult a doctor immediately 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 severe urinary tract infection:
• fever and/or chills
• burning sensation during urination
• back or flank pain. Blood in the urine may also occur not infrequently; in such a case, immediate consultation with a doctor is required.

You should 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 treated with this medicine in combination with a sulfonylurea derivative or insulin. Symptoms of low blood sugar:
• trembling, sweating, feeling anxious, rapid heartbeat
• feeling hungry, headache, visual disturbances
• 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 Dagrafors:
Frequent (may occur in no more than 1 in 10 people)

• fungal infections (e.g. candidiasis) 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 lipid levels (detected in laboratory tests)
• increased number of red blood cells (detected in laboratory tests)
• decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
• dizziness
• rash

Not frequent (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
• nocturia (waking 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 occur in no more than 1 in 10,000 people)

• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. 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 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 Dagrafors

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 the cardboard
container following the abbreviation "EXP". The expiry date refers to the last day of the
specified month.
There are no special storage instructions 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. Such measures help protect the
environment.

6. Contents of the package and other information

What Dagrafors contains

• The active substance is dapagliflozin. Dagrafors 5 mg, film-coated tablets: Each film-coated tablet contains 5 mg of dapagliflozin (as dapagliflozin propanediol monohydrate). Dagrafors 10 mg, film-coated tablets: Each film-coated tablet contains 10 mg of dapagliflozin (as dapagliflozin propanediol monohydrate).
• Other ingredients are:
• tablet core: microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, crospovidone (type A), microcrystalline cellulose (type 102), and sodium stearyl fumarate
• tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide yellow (E 172). See section 2 "Dagrafors contains lactose and sodium".

What Dagrafors looks like and contents of the pack
5 mg: Light brownish-yellow, round, biconvex, film-coated tablets, marked with the number "5" on one side. The tablet diameter is approximately 7 mm.
10 mg: Light brownish-yellow, oval, biconvex, film-coated tablets with a division line on one side. Marked with the number "1" on one side of the division line and the number "0" on the other side. The tablet can be divided into equal doses. The tablet dimensions are approximately 13 x 6.5 mm.
Dagrafors is available in packages containing:

• 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets in non-perforated blisters in a cardboard carton.
• 14, 28, 56 or 98 film-coated tablets in calendar blisters without perforation in a cardboard carton.
• 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 or 100 x 1 film-coated tablets in single-dose perforated blisters in a cardboard carton.
• 14 x 1, 28 x 1, 56 x 1 or 98 x 1 film-coated tablets in single-dose calendar blisters with perforation in a cardboard carton.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
tel. 22 57 37 500