Dapagliflozin aurovitas

Package leaflet: Information for the patient

Dapagliflozin Aurovitas, 5 mg, film-coated tablets
Dapagliflozin Aurovitas, 10 mg, film-coated tablets
Dapagliflozinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
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. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Dapagliflozin Aurovitas is and what it is used for
2. What you need to know 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 Dapagliflozin Aurovitas is and what it is used for

What Dapagliflozin Aurovitas is
Dapagliflozin Aurovitas contains the active substance dapagliflozin. It belongs to a group of medicines called "sodium-glucose co-transporter 2 (SGLT2) inhibitors". These medicines 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 the urine.

What Dapagliflozin Aurovitas is used for
Dapagliflozin Aurovitas is used to treat:

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.
• Dapagliflozin Aurovitas may be used alone or together with other antidiabetic medicines.
• It is important to continue following the diet and exercise regimen 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 impaired kidney function.

What is type 2 diabetes and how does Dapagliflozin Aurovitas help in its treatment?

• In type 2 diabetes, the body either does not produce enough insulin or cannot use the insulin it produces effectively. 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 the arms and legs.
• Dapagliflozin Aurovitas works by removing excess sugar from the body. This medicine may 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 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.
• Dapagliflozin Aurovitas 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 Dapagliflozin Aurovitas help in its treatment?

• In patients with chronic kidney disease, kidney function gradually declines. This means the kidneys are unable to clean and filter blood as they should. Loss of kidney function may lead to serious medical consequences and the need for hospital treatment.
• Dapagliflozin Aurovitas helps protect the kidneys from losing function. This may help some patients live longer.

2. Important information before using Dapagliflozin Aurovitas

When not to use 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
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 tiredness, sweet-smelling breath, sweet or metallic taste in the mouth, or a change in the smell of urine or sweat, 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 ketoacidosis may increase during prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or severe illness.
• Diabetic ketoacidosis may occur during treatment with Dapagliflozin Aurovitas even when blood glucose levels are within the normal range.

If the patient suspects they have diabetic ketoacidosis, they should immediately
contact their doctor or nearest hospital and must not take this medicine.
Necrotizing fasciitis of the perineum:

• If the patient experiences a combination of symptoms such as pain, tenderness, redness, or swelling of the external genital organs or the area between the genitals and the anus, accompanied by fever or general malaise, they should seek immediate medical attention. These may be symptoms of a rare but serious or even life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which leads to damage of subcutaneous tissue. Immediate treatment for Fournier's gangrene is essential.

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

• if the patient has "type 1 diabetes" – a type of diabetes that usually begins in young people whose bodies produce no insulin. Dapagliflozin Aurovitas should not be used to treat this condition.
• if the patient has kidney disease – the doctor may recommend using an additional or different medicine to control blood glucose levels.
• if the patient has liver disease – the doctor may start treatment with a lower dose.
• if the patient is taking antihypertensive medicines (blood pressure-lowering medicines) and has a history of low blood pressure (hypotension). More information is provided below in section "Dapagliflozin Aurovitas and other medicines".
• if the patient has very high blood glucose levels, leading to dehydration (excessive fluid loss). Possible symptoms of excessive fluid loss are listed in section 4. The patient should inform their doctor if any of these symptoms have occurred before starting Dapagliflozin Aurovitas.
• if the patient experiences nausea, vomiting, or fever, or is unable to eat or drink. This may lead to dehydration. The doctor may advise temporarily 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 using Dapagliflozin Aurovitas.
Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of their feet and follow all
foot care advice given by their doctor.
Glucose in urine
Due to the mechanism of action of Dapagliflozin Aurovitas, laboratory tests may detect glucose in the urine.
Children and adolescents
Dapagliflozin Aurovitas may be used in children aged 10 years and older for the treatment of type 2 diabetes. There is no data on use in children under 10 years of age.
Dapagliflozin Aurovitas is not recommended for use in children and adolescents under 18 years of age for the treatment of heart failure or chronic kidney disease, as studies have not been conducted in this age group.
Dapagliflozin Aurovitas and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Specifically, inform the doctor:

• if the patient is taking medicines that help remove water from the body (diuretics).
• if the patient is taking other medicines that reduce blood glucose levels, such as insulin or sulfonylurea derivatives. The doctor may recommend reducing the doses of these other medicines to prevent low blood glucose levels (hypoglycaemia).
• if the patient is taking lithium, as Dapagliflozin Aurovitas may reduce blood lithium levels.
  Pregnancy and breastfeeding
  If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. If she becomes pregnant, she should stop taking this medicine, as its use is not recommended during the second and third trimesters of pregnancy. She should consult her doctor to determine the best way to manage blood glucose control during pregnancy.
  If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before starting this medicine. Dapagliflozin Aurovitas should not be used during breastfeeding. It is unknown whether this medicine passes into human breast milk.
  Driving and using machines
  Dapagliflozin Aurovitas has no effect or a negligible effect on the ability to drive and use machines.
  However, using this medicine together with other medicines such as sulfonylurea derivatives or insulin may cause excessively low blood glucose levels (hypoglycaemia), which may cause muscle tremors, excessive sweating, and visual disturbances, potentially affecting the ability to drive and use machines.
  Do not drive or operate any tools or machinery if, after taking Dapagliflozin Aurovitas, the patient feels dizzy or experiences dizziness.
  Dapagliflozin Aurovitas contains sodium
  This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning Dapagliflozin Aurovitas is considered "sodium-free".

3. How to take Dapagliflozin Aurovitas

This medicine should always be taken as prescribed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.

What dose to take

• 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 problems.
• Your doctor will prescribe the appropriate dose for you.

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• The tablets may be taken during or between meals.
• The tablet can be taken at any time of day. However, it is advisable to take it at the same time each day. This will help you remember to take it.

Your doctor may recommend taking Dapagliflozin Aurovitas together with other medicines. It is important
to follow your doctor's instructions regarding these medicines to achieve the best treatment results.
Diet and physical exercise may help your body use blood sugar more effectively. For patients with
diabetes, it is important to follow all dietary recommendations and exercise programs advised by your
doctor while taking Dapagliflozin Aurovitas.

Taking more Dapagliflozin Aurovitas than prescribed
If you take more Dapagliflozin Aurovitas than prescribed, contact your doctor immediately or go to a hospital.
Take the medicine packaging with you.

If you miss a dose of Dapagliflozin Aurovitas
What to do if you miss a dose depends on how much time remains until the next dose.

• If 12 hours or more remain before the next dose, take the missed dose of Dapagliflozin Aurovitas as soon as you remember. Take the next dose at your usual time.
• If less than 12 hours remain before the next dose, skip the missed dose. Take the next dose at your 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 medicine.
If you have any further questions about the use of this medicine, please 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 contact a doctor or the nearest hospital immediately if the patient experiences any of the
following adverse reactions after taking this medicine:

• 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
  • hives and breathing difficulties
• Diabetic ketoacidosis – occurs rarely in patients with type 2 diabetes (may occur in no more than 1 in 1,000 people).

Symptoms of diabetic 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 tiredness
• 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 Dapagliflozin Aurovitas.

• 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.

Treatment with Dapagliflozin Aurovitas should be discontinued and medical advice sought immediately if the
patient experiences any of the following serious adverse reactions:

• Urinary tract infection, observed 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 side pain. Blood in the urine may occasionally occur; if so, inform the doctor immediately.

Contact a doctor immediately if the patient experiences any of the following adverse reactions:

• Low blood sugar (hypoglycaemia), observed very frequently (may occur in more than 1 in 10 people) in diabetic patients taking this medicine with a sulphonylurea 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 how to treat low blood sugar and what to do if any of the above adverse reactions occur.
Other adverse reactions during treatment with Dapagliflozin Aurovitas:
Common (may occur in no more than 1 in 10 people)

• genital infection (candidiasis) of the penis or vagina (symptoms may include irritation, itching, unusual discharge or unpleasant odour)
• back pain
• excessive urination or increased need to urinate
• changes in cholesterol or blood fat levels (detected in laboratory tests)
• increase in red blood cell count (detected in laboratory tests)
• decreased renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
• dizziness
• rash

Uncommon (may occur in no more than 1 in 100 people)

• fungal infection
• genital itching
• excessive loss of fluid from the body (dehydration, symptoms of which may include extreme dryness or stickiness in the mouth, passing small amounts of urine or no urine, or rapid heartbeat)
• thirst
• constipation
• getting up at night to pass urine
• 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 reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store Dapagliflozin Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, container label, and blister pack following: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required 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 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, sodium croscarmellose,
anhydrous colloidal silica, sodium stearyl fumarate
Tablet coating: Polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprin (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 with a diameter of approximately 7.2 mm, engraved with "W" 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, engraved with "W" 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, packed in cardboard boxes.
Pack sizes:
Blisters: 10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 90, 98, 100 and 120 film-coated tablets.
Each HDPE container includes a desiccant sachet/container containing silica gel, which must not be swallowed.
HDPE containers:
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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Dapagliflozin AB 5 mg/10 mg filmomhulde tabletten/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