Dapagliflozin Aurobindo

Package leaflet: Information for the user

Dapagliflozin Aurobindo 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Dapagliflozin Aurobindo is
Dapagliflozin Aurobindo contains the active substance dapagliflozin. It belongs to a group of
medicines called “sodium-glucose co-transporter 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 the urine.

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

Type 2 diabetes

• In adults and children from 10 years of age and older.
• When type 2 diabetes cannot be controlled by diet and exercise.
• Dapagliflozin Aurobindo may be used alone or together with other medicines to treat diabetes.
• It is important to continue following your doctor’s or pharmacist’s advice regarding diet and exercise.

Heart failure

• In adults (from 18 years of age and older) when the heart does not pump blood as it should.

Chronic kidney disease

• In adults with reduced kidney function.

What is diabetes and how can Dapagliflozin Aurobindo help?

• In type 2 diabetes, the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high levels of sugar in the blood. This can result in serious problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
• Dapagliflozin Aurobindo works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Dapagliflozin Aurobindo help?

• This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as it should. This can lead to serious medical problems 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 in the ankles.
• Dapagliflozin Aurobindo helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalisation and may help some patients live longer.

What is chronic kidney disease and how can Dapagliflozin Aurobindo help?

• When you have chronic kidney disease, your kidneys may gradually lose their ability to function. This means they are unable to clean and filter the blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospital treatment.
• Dapagliflozin Aurobindo helps protect the kidneys from losing their function. This may help some patients live longer.

2. What you need to know before taking Dapagliflozin Aurobindo

Do not take Dapagliflozin Aurobindo

• if you are allergic to dapagliflozin or to 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 you have diabetes and experience nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, a different odour of urine or sweat, or rapid weight loss.
• These symptoms listed above may be signs of diabetic ketoacidosis, a rare but serious condition that can sometimes be life-threatening, caused by diabetes due to increased levels of “ketone bodies” in the urine or blood, detectable by laboratory tests.
• The risk of developing diabetic ketoacidosis may be increased by prolonged fasting, excessive alcohol intake, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or serious illness.
• When treated with Dapagliflozin Aurobindo, diabetic ketoacidosis can occur even if blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, contact your doctor or nearest hospital immediately
and do not take this medicine.
Necrotizing fasciitis of the perineum:

• Seek immediate medical attention if you notice a combination of symptoms such as pain, tenderness, redness, or swelling in the genital area or the area between the genitals and the anus, accompanied by fever or general malaise. These symptoms may indicate a rare but serious and potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys subcutaneous tissue. Fournier’s gangrene requires immediate treatment.

Talk to your doctor or pharmacist before taking Dapagliflozin Aurobindo:

• if you have "type 1 diabetes" – the type of diabetes that usually develops at a young age and in which the body produces no insulin. Dapagliflozin Aurobindo must not be used to treat this condition.
• if you have diabetes and have kidney problems – your doctor may advise you to take an additional or different medicine
  to control blood sugar levels.
• if you have liver problems – your doctor may start you on a lower dose.
• if you are taking medicines to lower blood pressure (antihypertensives) and have previously experienced low blood pressure (hypotension). Further information is provided in section “Other medicines and Dapagliflozin Aurobindo” below.
• if you have very high blood sugar levels that may dehydrate you (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Dapagliflozin Aurobindo if you have any of these signs.
• if you have or develop nausea (feeling unwell), vomiting, or fever, or if you are unable to eat or drink. These conditions can lead to dehydration. Your doctor may ask you to stop taking Dapagliflozin Aurobindo until you recover to prevent dehydration.
• if you frequently have urinary tract infections.

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse
before taking Dapagliflozin Aurobindo.
Diabetes and foot care
If you have diabetes, it is important to regularly check your feet and follow any other foot care advice
provided by healthcare professionals.
Glucose in urine
Due to the mechanism of action of Dapagliflozin Aurobindo, urine tests will show the presence of sugar
during treatment with this medicine.
Children and adolescents
Dapagliflozin Aurobindo may be used in children aged 10 years and older for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
Dapagliflozin Aurobindo is not recommended for children and adolescents under 18 years of age for the treatment of heart failure or chronic kidney disease, as it has not been studied in these patients.
Other medicines and Dapagliflozin Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor:

• if you are taking a medicine to remove water from the body (diuretics).
• if you are taking other medicines that lower blood sugar levels, such as insulin or a medicine containing “sulphonylurea”. Your doctor may consider reducing the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).
• if you are taking lithium, because Dapagliflozin Aurobindo may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must stop taking this medicine if pregnancy occurs, as Dapagliflozin Aurobindo is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to control blood sugar during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Dapagliflozin Aurobindo if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Dapagliflozin Aurobindo has negligible or no effect on the ability to drive or use machines.
Taking this medicine together with other medicines called sulphonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which can cause symptoms such as trembling, sweating, and vision disturbances, and may impair your ability to drive or use machines.
Do not drive or operate tools or machinery if you feel dizzy while taking Dapagliflozin Aurobindo.
Dapagliflozin Aurobindo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., Dapagliflozin Aurobindo is essentially “sodium-free”.

3. How to take Dapagliflozin Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

How much to take

• The recommended dose is one 10 mg tablet once daily.
• Your doctor may start you on 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.
• You may take the tablet with or without food.
• You may take the tablet at any time of day. However, try to take it at the same time each day. This will help you remember to take it.

Your doctor may prescribe Dapagliflozin Aurobindo together with other medicines. Remember to take these other medicines as directed by your doctor. This will help you achieve the best health outcomes.

Diet and exercise can help your body use blood sugar more effectively. If you have diabetes, it is important to follow the diet and physical activity plan recommended by your doctor while taking Dapagliflozin Aurobindo.

If you take more Dapagliflozin Aurobindo than you should
If you take more Dapagliflozin Aurobindo tablets than prescribed, contact your doctor immediately or go to hospital straight away.
Take the medicine with you.

If you forget to take Dapagliflozin Aurobindo
If you forget to take a tablet, the action you should take depends on how long it is until your next dose.

• If there are 12 hours or more until your next dose, take the missed dose as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
• Do not take a double dose of Dapagliflozin Aurobindo to make up for a missed dose.

If you stop taking Dapagliflozin Aurobindo
Do not stop taking Dapagliflozin Aurobindo without first talking to your doctor. If you have diabetes, your blood sugar levels may increase without this medicine.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or the nearest hospital immediately if you experience any of the following
side effects:

• Angioedema, very rarely observed (may occur in up to 1 person in 10,000). These are symptoms of angioedema:
  • swelling of the face, tongue, or throat;
  • difficulty swallowing;
  • hives and breathing problems.
• Diabetic ketoacidosis – this is rare in patients with type 2 diabetes (may occur in up to 1 person in 1,000). These are symptoms of diabetic ketoacidosis (see also section 2 “Warnings and precautions”):
  • increased levels of “ketone bodies” in the urine or blood;
  • feeling unwell or generally unwell;
  • stomach pain;
  • excessive thirst;
  • rapid and deep breathing;
  • confusion;
  • unusual drowsiness or tiredness;
  • sweet-smelling breath, sweet or metallic taste in the mouth, or a different smell of urine or sweat;
  • rapid weight loss.

This may occur regardless of blood sugar levels. Your doctor may decide to temporarily or permanently discontinue treatment with Dapagliflozin Aurobindo.

• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genital area or the area between the genitals and the anus, very rarely observed.

Stop taking Dapagliflozin Aurobindo and consult a doctor as soon as possible if you notice any of the
following serious side effects:

• Urinary tract infections, commonly observed (may occur in up to 1 person in 10). These are symptoms of a severe urinary tract infection:
  • fever and/or chills;
  • burning sensation when urinating;
  • back or side pain. Although uncommon, if you see blood in your urine, contact your doctor immediately.

Contact your doctor as soon as possible if you experience any of the following side effects:

• Low blood sugar levels (hypoglycaemia), very commonly observed (may occur in more than 1 person in 10) in patients with diabetes who take this medicine with a sulphonylurea or insulin. These are symptoms of low blood sugar:
  • trembling, sweating, feeling very anxious, rapid heartbeat;
  • feeling hungry, headache, changes in vision;
  • mood changes or feeling confused. Your doctor will advise you on how to treat low blood sugar levels and what to do if any of the symptoms listed above occur.

Other side effects when taking Dapagliflozin Aurobindo:
Common (may affect up to 1 in 10 people)

• genital infection (candidiasis) of the penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• increased amount of urine or increased urge to urinate more frequently
• changes in cholesterol or fat levels in the blood (observed in blood tests)
• increase in red blood cells (observed in blood tests)
• decrease in creatinine renal clearance (observed in blood tests) at the beginning of treatment
• dizziness
• rash.

Uncommon (may affect up to 1 in 100 people)

• fungal infection
• genital itching
• excessive loss of body fluids (dehydration, signs may include very dry or sticky mouth, reduced or no urine output, or rapid heartbeat)
• thirst
• constipation
• waking up during the night to urinate
• dry mouth
• weight loss
• increased creatinine (observed in blood tests) at the beginning of treatment
• increased urea (observed in blood tests).

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dapagliflozin Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.

6. Contents of the Pack and Other Information

What Dapagliflozin Aurobindo 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 stearoyl fumarate.
Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate
(type 1), sodium lauryl sulfate, yellow iron oxide (E172).

Description of the Appearance of Dapagliflozin Aurobindo and Pack Contents
Film-coated tablet.
Dapagliflozin Aurobindo 5 mg film-coated tablets
Film-coated, yellow, round tablet, approximately 7.2 mm in diameter, biconvex, with "W" engraved on one side and "5" on the other side.
Dapagliflozin Aurobindo 10 mg film-coated tablets
Film-coated, yellow, round tablet, approximately 9.1 mm in diameter, biconvex, with "W" engraved on one side and "10" on the other side.
Dapagliflozin Aurobindo 5 mg and 10 mg film-coated tablets are available in blister packs.
Pack sizes:
In blisters: 10, 14, 28, 30, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Dapagliflozin PUREN Pharma 5 mg/10 mg Filmtabletten
Italy: Dapagliflozin Aurobindo
Malta: Dapagliflozin Aurobindo Pharma 5 mg/10 mg film-coated tablets