Dapagliflozin Aurovitas

Package Leaflet: Information for the Patient

Dapagliflozin Aurovitas, 5 mg, Film-Coated Tablets

Dapagliflozin Aurovitas, 10 mg, Film-Coated Tablets

Dapagliflozin

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

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

What is Dapagliflozin Aurovitas

Dapagliflozin Aurovitas contains the active substance dapagliflozin. It belongs to a group of medicines called “sodium-glucose co-transporter-2 (SGLT2) inhibitors”. Their action involves 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 with urine.

What is Dapagliflozin Aurovitas used for

Dapagliflozin Aurovitas is used to treat:

Type 2 Diabetes

• in adults and children aged 10 years and older.
• when type 2 diabetes cannot be controlled with diet and exercise alone.
• Dapagliflozin Aurovitas can be used alone or with other anti-diabetic medicines.
• It is important to continue with the diet and exercise recommended by your doctor or pharmacist.

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 reduced kidney function.

What is type 2 diabetes and how does Dapagliflozin Aurovitas help to treat it?

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

What is heart failure and how does Dapagliflozin Aurovitas help to treat it?

• 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.
• Dapagliflozin Aurovitas helps protect the heart from worsening and alleviates symptoms. It can reduce the need for hospitalization and help some patients live longer.

What is chronic kidney disease and how does Dapagliflozin Aurovitas help to treat it?

• In patients with chronic kidney disease, kidney function gradually decreases. This means they will not be able to clean and filter the blood as they should. Loss of kidney function can lead to serious medical consequences and the need for hospital treatment.
• Dapagliflozin Aurovitas helps protect the kidneys from losing function. This can help some patients live longer.

2. Important information before taking Dapagliflozin Aurovitas

When not to take Dapagliflozin Aurovitas

• If the patient is 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 the patient with diabetes experiences nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual sleepiness or tiredness, sweet breath odor, sweet or metallic taste in the mouth, or changed urine or sweat odor, or rapid weight loss.
• These symptoms may indicate “diabetic ketoacidosis” - a rare but serious, potentially life-threatening complication of diabetes resulting from high levels of “ketone bodies” in the urine or blood, as shown by laboratory tests.
• The risk of diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to serious surgery or severe illness.
• During treatment with Dapagliflozin Aurovitas, diabetic ketoacidosis may occur even if blood sugar levels are normal.

If the patient suspects they have diabetic ketoacidosis, they should contact their doctor or the nearest hospital immediately and not take this medicine.
Fournier's gangrene:

• 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 genital and anal areas, with fever or general feeling of being unwell, they should seek medical help immediately. These may be symptoms of a rare but serious or life-threatening infection called Fournier's gangrene, leading to tissue damage. Immediate treatment of Fournier's gangrene is necessary.

Before taking Dapagliflozin Aurovitas, discuss with your doctor or pharmacist:

• if the patient has “type 1 diabetes” - a type of diabetes that usually starts in young people, whose body does not produce any insulin. Dapagliflozin Aurovitas should not be used to treat this condition.
• if the patient with diabetes has kidney disease - the doctor may recommend using an additional or different medicine to control blood sugar levels.
• if the patient has liver disease - the doctor may start treatment with a lower dose.
• 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 section “Dapagliflozin Aurovitas with other medicines”.
• if the patient has very high blood sugar levels, leading to dehydration (loss of too much fluid). Possible symptoms of excessive fluid loss are listed in section 4. Before taking Dapagliflozin Aurovitas, the patient should inform their doctor if they experience any of these symptoms.
• if the patient experiences nausea, vomiting, or fever, or if they are unable to eat or drink. This may lead to dehydration. The doctor may recommend stopping Dapagliflozin Aurovitas 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 Aurovitas.

Diabetes and foot care

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

Glucose in urine

Due to the mechanism of action of Dapagliflozin Aurovitas, laboratory tests may show the presence of sugar in the urine.

Children and adolescents

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

Dapagliflozin Aurovitas with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor:

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. If the patient becomes pregnant, they should stop taking this medicine, as it is not recommended during the second and third trimesters of pregnancy. The patient should consult their doctor to determine the best way to control blood sugar during pregnancy.
If the patient is breastfeeding or wishes to breastfeed, they should inform their doctor before taking this medicine. Dapagliflozin Aurovitas should not be used during breastfeeding. It is not known whether this medicine passes into breast milk.

Driving and using machines

Dapagliflozin Aurovitas 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 low blood sugar (hypoglycemia), which can cause muscle tremors, excessive sweating, and vision disturbances, affecting the ability to drive and use machines.
The patient should not drive or operate any tools or machines if they feel dizzy or have dizziness after taking Dapagliflozin Aurovitas.

Dapagliflozin Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means Dapagliflozin Aurovitas is essentially “sodium-free”

3. How to take Dapagliflozin Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

What dose to take

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

How to take this medicine

• The tablet should be swallowed whole, with half a glass of water.
• The tablets can be taken with or without food.
• The tablet can be taken at any time of the day. However, the patient should try to take it at the same time every day. This will help them remember to take it.

The doctor may recommend taking Dapagliflozin Aurovitas with other medicines. The patient should remember to take these medicines as recommended by their doctor. This will help achieve the best treatment results.
Diet and exercise can help the patient's body use the sugar in the blood better. For patients with diabetes, it is essential to follow any diet and exercise program recommended by their doctor while taking Dapagliflozin Aurovitas.

Taking a higher dose of Dapagliflozin Aurovitas than recommended

In case of taking a higher dose of Dapagliflozin Aurovitas than recommended, the patient should contact their doctor or go to the hospital immediately.
The patient should take the medicine packaging with them.

Missing a dose of Dapagliflozin Aurovitas

The course of action in case of missing a tablet depends on the time left until the next dose.

• If there are 12 hours or more until the next dose, the patient should take the missed dose as soon as they remember. The next dose should be taken at the usual time.
• If there are less than 12 hours until the next dose, the patient should skip the missed dose. The next dose should be taken at the usual time.
• The patient should not take a double dose of Dapagliflozin Aurovitas to make up for a missed dose.

Stopping treatment with Dapagliflozin Aurovitas

The patient should not stop taking Dapagliflozin Aurovitas without consulting their doctor. In patients with diabetes, blood sugar levels may increase after stopping this medicine.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dapagliflozin Aurovitas can cause side effects, although not everybody gets them.

Seek medical help immediately if the patient experiences any of the following side effects:

• Angioedema, observed very rarely (may occur in less than 1 in 10,000 people). Symptoms of angioedema:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing
• Diabetic ketoacidosis, which occurs rarely in patients with type 2 diabetes (may occur in less than 1 in 1,000 people).

Symptoms of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• high levels of “ketone bodies” in the urine or blood
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual sleepiness or tiredness
• sweet breath odor, sweet or metallic taste in the mouth, or changed urine or sweat odor
• rapid weight loss.

This may occur regardless of blood sugar levels. The doctor may decide to stop or discontinue Dapagliflozin Aurovitas.

• Fournier's gangreneor necrotizing fasciitis of the genital area, a rare but serious or life-threatening infection of the soft tissues of the external genital area or the area between the genital and anal areas, observed very rarely.

The patient should stop taking Dapagliflozin Aurovitas and seek medical help immediately if they experience any of the following serious side effects:

• Urinary tract infection, observed frequently (may occur in less than 1 in 10 people). Symptoms of a serious 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 which case they should inform their doctor immediately.

The patient should seek medical help if they experience any of the following side effects:

• Low blood sugar (hypoglycemia), observed very frequently (may occur in more than 1 in 10 people) in patients with diabetes taking this medicine with sulfonylurea or insulin. Symptoms of low blood sugar:
• tremors, sweating, feeling anxious, rapid heartbeat
• feeling hungry, headache, vision disturbances
• mood changes or feeling disoriented.

The doctor will inform the patient how to treat low blood sugar and what to do if any of the above side effects occur.

Other side effects of Dapagliflozin Aurovitas:

Frequently (may occur in less than 1 in 10 people)

• genital infections (thrush) of the penis or vagina (symptoms may include irritation, itching, unusual discharge, or unpleasant odor)
• back pain
• increased urination or need to urinate more often
• changes in cholesterol or fat levels in the blood (detected by laboratory tests)
• increased red blood cell count (detected by laboratory tests)
• decreased kidney function (detected by laboratory tests) at the start of treatment
• dizziness
• rash

Less frequently (may occur in less than 1 in 100 people)

• fungal infections
• genital itching
• loss of too much fluid from the body (dehydration, which may include symptoms such as dryness or stickiness in the mouth, passing little urine or not passing urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected by blood tests) at the start of treatment
• increased urea levels (detected by blood tests)

Very rarely (may occur in less than 1 in 10,000 people)

• kidney inflammation (interstitial nephritis)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. 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, tel.: +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 Dapagliflozin Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Dapagliflozin Aurovitas contains

• The active substance is dapagliflozin.

Each film-coated tablet contains 5 mg of dapagliflozin.
Each film-coated tablet contains 10 mg of dapagliflozin.
Tablet core:Microcrystalline cellulose (type-112), mannitol, hydroxypropylcellulose, croscarmellose sodium, silicon dioxide, and sodium stearyl fumarate
Tablet coating:Polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprate (type-1), sodium lauryl sulfate, and yellow iron oxide (E 172).

What Dapagliflozin Aurovitas looks like and contents of the pack

Film-coated tablet
Dapagliflozin Aurovitas, 5 mg, film-coated tablets
Yellow, round, biconvex film-coated tablet, approximately 7.2 mm in diameter, with “W” engraved on one side and “5” on the other.
Dapagliflozin Aurovitas, 10 mg, film-coated tablets
Yellow, round, biconvex film-coated tablet, approximately 9.1 mm in diameter, with “W” engraved on one side and “10” on the other.
Dapagliflozin Aurovitas 5 mg and 10 mg film-coated tablets are available in blisters and HDPE containers, in a cardboard box.

Pack sizes:

Blister:10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 90, 98, 100, and 120 film-coated tablets.
Each HDPE container contains a desiccant/sachet with silica gel, which should not be swallowed.

HDPE container:

For 5 mg:30 and 98 film-coated tablets
For 10 mg:30, 98, and 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Dapagliflozin AB 5 mg/10 mg film-coated tablets/comprimés pelliculés/ Filmtabletten
France:
Dapagliflozine Arrow 10 mg, comprimé pelliculé
Germany:
Dapagliflozin PUREN 5 mg/10 mg Filmtabletten
Malta:
Dapagliflozin Aurobindo 5mg/10 mg film-coated tablets
Netherlands:
Dapagliflozine Aurobindo 5mg/10 mg, filmomhulde tabletten
Poland:
Dapagliflozin Aurovitas
Spain:
Dapagliflozina Aurovitas 10 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: