Raskal

Package Leaflet: Information for the Patient

RASKAL, 5 mg + 850 mg, film-coated tablets

RASKAL, 5 mg + 1000 mg, film-coated tablets

Dapagliflozin + Metformin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Raskal and what is it used for

This medicine contains two different active substances: dapagliflozin and metformin. Both belong to a group of medicines called oral antidiabetic medicines. They are taken orally for diabetes.
Raskal is used to treat a type of diabetes called type 2 diabetes in adults (aged 18 years and older) and usually occurs in older patients. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to respond properly to insulin produced in the right amount. This leads to high blood sugar levels.
Dapagliflozin works by removing excess sugar from the body with urine and lowering blood sugar levels. It may also help prevent heart disease.
Metformin works mainly by inhibiting glucose production in the liver.
In the treatment of diabetes:
This medicine should be used in combination with the prescribed diet and exercise program.
This medicine is used when it is not possible to achieve proper control of diabetes with other antidiabetic medicines.
The doctor may recommend using this medicine alone or in combination with other medicines used to treat diabetes. These may be other oral medicines and/or injectable medicines such as insulin, or a GLP-1 receptor agonist (helps the body increase insulin production when blood sugar levels are high).
If the patient is currently taking both dapagliflozin and metformin in separate tablets, the doctor may recommend switching to this medicine. To avoid overdose, do not continue taking dapagliflozin and metformin in separate tablets when taking Raskal.
It is essential to continue following the dietary and exercise recommendations given to the patient by the doctor, pharmacist, or nurse.

2. Important information before taking Raskal

When not to take Raskal

• if the patient is allergic (hypersensitive) to dapagliflozin, metformin, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had diabetic coma;
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor;
• if the patient has significantly reduced kidney function;
• if the patient has a severe infection;
• if the patient has lost a significant amount of water from the body (is dehydrated), e.g., due to prolonged or severe diarrhea, or due to repeated vomiting in a short period;
• if the patient has recently had a heart attack or if the patient has heart failure/circulatory failure, or severe circulatory disorders or breathing difficulties;
• if the patient has liver disease or liver function disorders;
• if the patient consumes large amounts of alcohol, daily or from time to time (see "Raskal with alcohol"). Do not take this medicine if any of the above points apply to the patient.

Warnings and precautions

Risk of lactic acidosis
Raskal may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver function disorders, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above circumstances apply to the patient, the patient should consult the doctor for more detailed instructions.
The patient should temporarily stop taking Raskal if they have a medical condition that may lead to dehydration (significant water loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult the doctor for more detailed instructions.
The patient should stop taking Raskal and immediately contact the doctor or the nearest hospital if they experience any symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include vomiting, abdominal pain, muscle cramps, general malaise with severe fatigue, breathing difficulties, decreased body temperature, and slowed heart rate.
Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
The patient should immediately contact the doctor to receive further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient has experienced any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before starting and during treatment with Raskal, the patient should tell the doctor, pharmacist, or nurse:

• if the patient has type 1 diabetes - a type of diabetes that usually starts in young people, whose body does not produce insulin. Raskal should not be used to treat this disease.
• if the patient experiences rapid weight loss, nausea, or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet breath odor, sweet or metallic taste in the mouth, or a change in the smell of urine or sweat, the patient should immediately contact the doctor or the nearest hospital. These symptoms may indicate diabetic ketoacidosis - a rare but serious complication of diabetes resulting from increased levels of "ketone bodies" in the urine or blood, which is detected in tests. The risk of diabetic ketoacidosis may increase in case of prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction of insulin dose, or increased insulin requirements due to major surgery or severe illness.
• if the patient has kidney disease; the doctor will check the patient's kidney function.
• if the patient has very high blood sugar levels, which may lead to dehydration (loss of too much fluid). Possible symptoms of dehydration are listed at the beginning of section 4. Before starting treatment with this medicine, the patient should inform the doctor if they experience any of these symptoms.
• if the patient is taking blood pressure-lowering medicines (antihypertensive medicines) and has a history of low blood pressure (hypotension). More information is provided below in the "Raskal with other medicines" section.
• if the patient frequently experiences urinary tract infections; this medicine may contribute to the development of urinary tract infections, and therefore the doctor may prescribe more frequent check-ups to closely monitor the patient's health; in case of a severe infection, the doctor may consider temporarily changing the treatment.
• if the patient is to undergo major surgery, they should not take Raskal during surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Raskal.

Regular foot care and following the recommendations of medical staff regarding foot care are essential.
If any of the above warnings apply to the patient (or if the patient is unsure), they should consult the doctor, pharmacist, or nurse before taking this medicine.
If the patient experiences a combination of symptoms such as pain, tenderness, redness, or swelling of the external genital area or the area between the genitals and anus, along with fever or general malaise, they should immediately contact the doctor. These may be symptoms of a rare but serious or life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, leading to tissue damage.
Immediate treatment of Fournier's gangrene is necessary.
Kidney function
During treatment with Raskal, the doctor will check the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has worsening kidney function.
Glucose in urine
Due to the mechanism of action of this medicine, laboratory tests will show the presence of sugar (glucose) in the urine during treatment.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as it has not been studied in this group of patients.

Raskal with other medicines

If the patient is to receive an iodine-containing contrast agent intravenously, e.g., for an X-ray examination or computed tomography, they should stop taking Raskal before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Raskal.
The patient should tell the doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Raskal by the doctor. It is particularly important to inform about the following medicines:

• diuretics (medicines that increase urine production);
• other medicines that lower blood sugar, such as insulin or sulfonylurea derivatives; the doctor may recommend reducing the doses of these other medicines to prevent the patient from experiencing too low blood sugar levels (hypoglycemia);
• cimetidine, a medicine used to treat stomach diseases and disorders;
• bronchodilators (beta-2 adrenergic receptor agonists) used to treat asthma;
• corticosteroids (used to treat inflammatory conditions such as asthma and arthritis), taken orally, by injection, or inhaled;
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Raskal with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Raskal, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult the doctor or pharmacist before taking this medicine.
If the patient becomes pregnant, they should stop taking Raskal, as it is not recommended for use in the second and third trimesters (the last six months) of pregnancy. The patient should consult the doctor to determine the best way to control blood sugar levels during pregnancy.
If the patient is breastfeeding or wants to breastfeed, they should tell the doctor before taking Raskal. Raskal should not be used during breastfeeding. Metformin passes into breast milk in small amounts. It is not known whether dapagliflozin passes into breast milk.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. Using this medicine with other medicines that lower blood sugar, such as insulin or sulfonylurea derivatives, may cause too low blood sugar levels (hypoglycemia), characterized by weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, which may affect the ability to drive and use machines. The patient should not drive or use machines if they start to experience these symptoms.

3. How to take Raskal

Raskal should always be taken as directed by the doctor. If the patient is unsure, they should ask the doctor or pharmacist.

What dose to take

The amount of this medicine the patient will take varies depending on the patient's condition and the current doses of metformin and/or separately taken dapagliflozin and metformin tablets. The doctor will inform the patient exactly which strength of Raskal tablet to take.
The recommended dose is one tablet twice a day.

How to take the medicine

The tablet should be swallowed whole with half a glass of water.
The tablet should be taken during a meal. This is to reduce the risk of stomach side effects.
The tablets should be taken twice a day, one in the morning (during breakfast) and one in the evening (during dinner).
The doctor may recommend taking this medicine with other medicines to lower blood sugar levels. These may be oral medicines and/or injectable medicines such as insulin, or a GLP-1 receptor agonist. The patient should remember to take these other medicines as directed by the doctor. This will help achieve the best treatment results.

Diet and exercise

To properly control diabetes, the patient should continue to follow a proper diet and exercise, even if they are taking this medicine. It is essential to continue following the dietary and exercise recommendations given by the doctor, pharmacist, or nurse; in particular, if the patient is following a diabetic diet to maintain a proper weight, they should continue this diet while taking this medicine.

Overdose of Raskal

In case of overdose, the patient may experience lactic acidosis. Symptoms of lactic acidosis include severe nausea or vomiting, abdominal pain, muscle cramps, severe fatigue, or breathing difficulties. If the patient experiences lactic acidosis, they may require immediate hospitalization, as lactic acidosis can lead to coma. In such a case, the patient should stop taking this medicine and immediately contact the doctor or the nearest hospital (see section 2). The patient should take the medicine packaging with them.

Missed dose of Raskal

If the patient misses a dose, they should take it as soon as they remember. If the patient does not remember until it is time for the next dose, they should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine to make up for the missed dose.

Stopping treatment with Raskal

The patient should not stop taking Raskal without consulting the doctor. If the patient has diabetes, their blood sugar levels may increase after stopping the medicine.
If the patient has any further questions about taking this medicine, they should ask the doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should stop taking Raskal and immediately consult the doctor if they experience any of the following serious or potentially serious side effects:

• Lactic acidosis, observed very rarely (may occur in less than 1 in 10,000 patients) Raskal may very rarely cause a very serious side effect called lactic acidosis (see section 2 "Warnings and precautions"). If this occurs, the patient must stop taking Raskal and immediately contact the doctor or the nearest hospital, as lactic acidosis can lead to coma.

The patient should immediately consult the doctor or the nearest hospital if they experience any of the following side effects:

• Diabetic ketoacidosis, observed rarely (may occur in less than 1 in 1,000 patients). Symptoms of ketoacidosis (see also section 2 "Warnings and precautions"): increased levels of "ketone bodies" in the urine or blood, rapid weight loss, nausea, or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet breath odor, sweet or metallic taste in the mouth, or a change in the smell of urine or sweat. It may occur regardless of blood sugar levels. The doctor may decide to discontinue or stop treatment with Raskal.

Necrotizing fasciitis of the perineum or Fournier's gangrene, a severe infection of the soft tissues of the external genital area or the area between the genitals and anus, observed very rarely.
The patient should stop taking Raskal and immediately consult the doctor if they experience any of the following serious or potentially serious side effects:
Urinary tract infections, observed frequently (may occur in less than 1 in 10 patients). Signs and symptoms of severe urinary tract infection:

• fever and/or chills, burning sensation while urinating, back or side pain. The patient may also experience blood in the urine; in this case, they should immediately consult the doctor.

The patient should immediately contact the doctor if they experience any of the following side effects:
Low blood sugar (hypoglycemia) observed very frequently (may occur in more than 1 in 10 patients) when taking this medicine with sulfonylurea derivatives or other medicines that lower blood sugar, such as 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 proceed in case of low blood sugar and what to do if they experience any of these symptoms. If the patient experiences symptoms of low blood sugar, they should eat glucose tablets, a snack high in sugar, or drink fruit juice. They should measure their blood sugar levels and rest.

Other side effects include:
Very frequently: nausea, vomiting, diarrhea, or abdominal pain, loss of appetite.
Frequently: genital infections (thrush) of the penis or vagina (e.g., irritation, itching, unusual discharge, or unpleasant odor), back pain, discomfort while urinating, increased 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 in the blood (detected in laboratory tests), decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment, taste disturbances, dizziness, rash.
Not very frequently (may occur in less than 1 in 100 patients): excessive fluid loss from the body (dehydration, which may include severe dryness or stickiness in the mouth, passing small amounts of urine or not passing urine, or rapid heartbeat), thirst, constipation, nocturia, 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).
Rarely: decreased vitamin B12 levels in the blood, abnormal liver test results, hepatitis, skin redness (erythema), itching, or itchy rash (urticaria).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Raskal

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the EXP abbreviation indicates the expiry date, and after the Lot/LOT abbreviation, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask the pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Raskal contains

Raskal, 5 mg + 850 mg, film-coated tablets

• The active substances of this medicine are dapagliflozin and metformin hydrochloride. Each film-coated tablet contains 5 mg of dapagliflozin and 850 mg of metformin hydrochloride.
• Other ingredients are:
• tablet core: microcrystalline cellulose (PH102); microcrystalline cellulose (PH101); mannitol; copovidone K28; colloidal silicon dioxide; magnesium stearate;
• tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Raskal, 5 mg + 1000 mg, film-coated tablets

• The active substances of this medicine are dapagliflozin and metformin hydrochloride. Each film-coated tablet contains 5 mg of dapagliflozin and 1000 mg of metformin hydrochloride.
• Other ingredients are:
• tablet core: microcrystalline cellulose (PH102); microcrystalline cellulose (PH101); mannitol; copovidone K28; colloidal silicon dioxide; magnesium stearate;
• tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Raskal looks like and contents of the pack

Raskal, 5 mg + 850 mg, film-coated tablets
Oval, biconvex orange film-coated tablets with "850" embossed on one side. Tablet dimensions: length 20.2 mm ± 0.2 mm, width 10.0 mm ± 0.2 mm.
Raskal, 5 mg + 1000 mg, film-coated tablets
Oval, biconvex yellow film-coated tablets with "1000" embossed on one side.
Tablet dimensions: length 21.5 mm ± 0.2 mm, width 10.6 mm ± 0.2 mm.
Raskal, 5 mg + 850 mg, film-coated tablets, and Raskal, 5 mg + 1000 mg, film-coated tablets are available in Aluminum/PVC/PCTFE blisters in a carton.
Pack sizes: 10, 14, 28, 30, 56, 60, 90, 120, 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:March 2025