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 Medication, as it Contains Important Information for the Patient.

Keep this package leaflet. You may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed to you by a doctor. 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 those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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. Package Contents 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 medications called "sodium-glucose co-transporter-2 (SGLT2) inhibitors". Their mechanism of action involves blocking the SGLT2 protein in the kidneys. By blocking this protein, sugar (glucose), salt (sodium), and water are removed from the body through 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 diet and exercise alone do not provide adequate control of type 2 diabetes.
• Dapagliflozin Aurovitas can be used alone or with other anti-diabetic medications.
• It is essential 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 in its Treatment?

• In type 2 diabetes, the body does not produce enough insulin or cannot use the insulin it produces effectively. This leads to increased blood sugar levels. Such a condition can cause serious complications, such as heart disease, kidney disease, blindness, and poor blood circulation in the arms and legs.
• The action of Dapagliflozin Aurovitas involves removing excess sugar from the body. This medication can also help prevent heart disease.

What is Heart Failure and How Does Dapagliflozin Aurovitas Help in its Treatment?

• 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 condition 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 in its Treatment?

• In patients with chronic kidney disease, kidney function gradually decreases. This means that the kidneys 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 their function. This can help some patients live longer.

2. Important Information Before Taking Dapagliflozin Aurovitas

When Not to Take Dapagliflozin Aurovitas

• If you are allergic to dapagliflozin or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Seek Medical Attention Immediately

Diabetic Ketoacidosis:

• If you have diabetes and experience nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, 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 and potentially life-threatening complication of diabetes resulting from increased levels of "ketone bodies" in the urine or blood, as indicated 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 when blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, seek medical attention immediately and do not take this medication.
Fournier's Gangrene (necrotizing fasciitis of the genital area):

• If you experience 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, seek medical attention 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 you have "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 you have kidney disease and diabetes - your doctor may recommend additional or alternative medication to control your blood sugar levels.
• if you have liver disease - your doctor may start treatment with a lower dose.
• if you are taking blood pressure-lowering medications (antihypertensives) and have a history of low blood pressure (hypotension). More information is provided below, in the section "Dapagliflozin Aurovitas and Other Medications".
• 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 taking Dapagliflozin Aurovitas, inform 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 can cause dehydration. Your doctor may recommend stopping Dapagliflozin Aurovitas 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 Dapagliflozin Aurovitas.

Diabetes and Foot Care

For patients with diabetes, it is essential to regularly check the condition of your feet and follow any foot care recommendations provided by your 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 and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
In particular, inform your doctor:
if you are taking medications that help remove water from the body (diuretics).
if you are taking other medications that lower blood sugar levels, such as insulin or sulfonylurea derivatives. Your doctor may recommend reducing the dose of other medications to prevent hypoglycemia (low blood sugar levels).
if you are taking lithium, as Dapagliflozin Aurovitas may decrease lithium levels in the blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medication. If you become pregnant, stop taking this medication, as it is not recommended during the second and third trimesters of pregnancy. Consult your doctor to determine the best way to control your blood sugar levels during pregnancy.
If you are breastfeeding or wish to breastfeed, inform your doctor before taking this medication. Do not take Dapagliflozin Aurovitas while breastfeeding, as it is not known whether this medication 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 medication with other medications, such as sulfonylurea derivatives or insulin, may cause excessive lowering of blood sugar levels (hypoglycemia), resulting in muscle tremors, excessive sweating, and vision disturbances, which can affect your ability to drive and use machines.
Do not drive or operate any tools or machines if you feel dizzy or have dizziness after taking Dapagliflozin Aurovitas.

Dapagliflozin Aurovitas Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means Dapagliflozin Aurovitas is considered "sodium-free".

3. How to Take Dapagliflozin Aurovitas

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

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 Medication

• Swallow the tablet whole with half a glass of water.
• Tablets can be taken with or without food.
• Tablets can be taken at any time of day. However, try to take it at the same time every day. This will help you remember to take it.

Your doctor may recommend taking Dapagliflozin Aurovitas with other medications. Remember to take these medications as recommended by your doctor. This will help you achieve the best treatment results.
Diet and exercise can help your body use the sugar in your blood more effectively. For patients with diabetes, it is essential to follow any diet and exercise program recommended by your doctor while taking Dapagliflozin Aurovitas.

Taking More Than the Recommended Dose of Dapagliflozin Aurovitas

If you take more than the recommended dose of Dapagliflozin Aurovitas, contact your doctor or go to the hospital immediately.
Take the package leaflet with you.

Missing a Dose of Dapagliflozin Aurovitas

The action to take in case of a missed dose depends on the time left until the next dose.

• If there are 12 hours or more until the next dose, take the missed dose 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 of Dapagliflozin Aurovitas to make up for a missed dose.

Stopping Dapagliflozin Aurovitas

Do not stop taking Dapagliflozin Aurovitas without consulting your doctor. In patients with diabetes, blood sugar levels may increase after stopping this medication.
If you have any further questions on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

Seek Medical Attention Immediately if You Experience 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 (also see section 2 Warnings and Precautions):

• increased levels of "ketone bodies" in the urine or blood
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual sleepiness or fatigue
• 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. Your doctor may decide to stop or discontinue Dapagliflozin Aurovitas.

• 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 genital and anal areas, observed very rarely.

Stop Taking Dapagliflozin Aurovitas and Seek Medical Attention Immediately if You 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 severe urinary tract infection:
• fever and (or) chills
• burning sensation while urinating
• back or side pain. You may also experience blood in the urine, in which case you should inform your doctor immediately.

Seek Medical Attention if You 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 medication with sulfonylurea derivatives or insulin. Symptoms of low blood sugar:
• tremors, sweating, feeling anxious, rapid heartbeat
• feeling hungry, headache, vision disturbances
• mood changes or feeling disoriented.

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 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 frequently
• 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 dryness or stickiness of the mouth, passing little or no 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 you experience any side effects, including those not listed in this package leaflet, inform your 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 to gather more information on the safety of this medication.

5. How to Store Dapagliflozin Aurovitas

Keep this medication out of sight and reach of children.
Do not use this medication 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 medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package Contents 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, hydroxypropyl cellulose, croscarmellose sodium, silicon dioxide, and sodium stearyl fumarate
Tablet coating:Polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylate (type-1), sodium lauryl sulfate, and yellow iron oxide (E 172).

What Dapagliflozin Aurovitas Looks Like and Package Contents

Film-coated tablet
Dapagliflozin Aurovitas, 5 mg, film-coated tablets
Yellow, round, biconvex film-coated tablet with a diameter of approximately 7.2 mm, with "W" engraved on one side and "5" on the other.
Dapagliflozin Aurovitas, 10 mg, film-coated tablets
Yellow, round, biconvex film-coated tablet with a diameter of approximately 9.1 mm, 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 carton.

Package 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/Importer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

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 Medication 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 Package Leaflet: