DAPAGLIFLOZIN TEVA

Package leaflet: Information for the patient

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

Generic medicine
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Dapagliflozin Teva is
Dapagliflozin Teva contains the active substance dapagliflozin. It belongs to a class 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 Teva is used for
Dapagliflozin Teva is used to treat:

• Type 2 diabetes
• in adults and children aged 10 years and older.
• when type 2 diabetes cannot be controlled by diet and exercise alone.
• Dapagliflozin Teva can be used alone or together with other medicines to treat diabetes.
• it is important to continue following your doctor’s, pharmacist’s or nurse’s advice on diet and exercise.
• Heart failure
• in adults (aged 18 years and older) who have symptoms due to reduced pumping function of the heart.
• Chronic kidney disease
• in adults with reduced kidney function.

What is type 2 diabetes and how can Dapagliflozin Teva 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, which can result in serious problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
• Dapagliflozin Teva works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Dapagliflozin Teva help?

• This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body, which can lead to serious medical problems and the need for hospital treatment.
• The most common symptoms of heart failure are shortness of breath, persistent or marked tiredness, and swollen ankles.
• Dapagliflozin Teva helps protect the heart from further weakening and improves symptoms. It may reduce the need for hospitalisation and help some patients live longer.

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

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they are no longer able 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 Teva helps protect the kidneys from further loss of function. This may help some patients live longer.

2. What you need to know before taking Dapagliflozin Teva

Do not take Dapagliflozin Teva:

• 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 feel unwell or are ill, with stomach pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, unusual odour of urine or sweat, or rapid weight loss.
• These symptoms could be signs of “diabetic ketoacidosis”, a rare but serious condition, sometimes potentially life-threatening, which can be 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 increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or serious illness.
• When treated with Dapagliflozin Teva, diabetic ketoacidosis can occur even if blood sugar levels are within the normal range. If you suspect you have developed 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 develop a combination of symptoms such as pain, tenderness, redness or swelling of the genitals or the area between the genitals and the anus, accompanied by fever or a general feeling of being unwell. These symptoms could indicate a rare but serious, 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, pharmacist, or nurse before taking Dapagliflozin Teva:

• 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.
• if you have diabetes and have kidney problems – your doctor may advise you to take an additional or different medicine to control your 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). For further information, see section “Other medicines and Dapagliflozin Teva”.
• if you have very high blood sugar levels that could lead to dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Dapagliflozin Teva if you experience any of these signs.
• if you have or develop nausea (feeling sick), vomiting, or fever, or if you are unable to eat or drink. These conditions may cause dehydration. Your doctor may advise you to stop treatment with Dapagliflozin Teva until you recover to prevent dehydration.
• if you frequently get urinary tract infections. If any of the above conditions apply to you (or you are unsure), inform your doctor, pharmacist, or nurse before taking Dapagliflozin Teva.

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 Teva, urine tests will show the presence of sugar during treatment with this medicine.
Children and adolescents
Dapagliflozin Teva can be used in children aged 10 years and older for the treatment of type 2 diabetes. There are no data available for children under 10 years of age.
Dapagliflozin Teva 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 it has not been studied in these patient groups.
Other medicines and Dapagliflozin Teva
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor:

• if you are taking a medicine used to remove water from the body (a diuretic).
• if you are taking other medicines that lower blood sugar levels, such as insulin or a “sulfonylurea”. Your doctor may consider reducing the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).

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. If you become pregnant, you must stop treatment with this medicine, as Dapagliflozin Teva is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to control your blood sugar levels during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Dapagliflozin Teva if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Dapagliflozin Teva has no effect or has a negligible effect on the ability to drive and use machines.
However, taking this medicine together with other medicines called sulfonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which could lead to 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 experience dizziness during treatment with Dapagliflozin Teva.
Dapagliflozin Teva contains lactose and sodium
Dapagliflozin Teva contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per 5 mg film-coated tablet, i.e., essentially “sodium-free”.

3. How to take Dapagliflozin Teva

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor, pharmacist, or nurse.
Dosage

• The recommended dose is one 10 mg tablet once daily.
• Your doctor may start your treatment with a 5 mg dose if you have a liver problem.
• Your doctor will prescribe the dose appropriate 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 Teva together with another medicine or other medicines. Remember to take these other medicines as instructed by your doctor. This will help you achieve the best health outcomes.

Diet and physical exercise can help your body use blood sugar more effectively. If you have diabetes, it is important to follow the diet and physical activity regimen recommended by your doctor while being treated with Dapagliflozin Teva.
If you take more Dapagliflozin Teva than you should
If you take more Dapagliflozin Teva than you should, contact your doctor or go to hospital immediately. Take the medicine pack with you.
If you forget to take Dapagliflozin Teva
If you forget to take a tablet, the action you should take depends on how much time is left before your next dose.

• If there are 12 hours or more until your next dose, take a dose of Dapagliflozin Teva 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 Teva to make up for a forgotten dose.

If you stop taking Dapagliflozin Teva
Do not stop taking Dapagliflozin Teva without first talking to your doctor. If you have diabetes, your blood sugar levels may rise 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 everybody gets them.
Contact your doctor or the nearest hospital immediately if you experience any of the
following side effects:

• Angioedema, very rare (may affect up to 1 in 10,000 people). Signs of angioedema include:
• swelling of the face, tongue or throat
• difficulty swallowing
• hives and breathing problems.
• Diabetic ketoacidosis, rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people). Signs of diabetic ketoacidosis are (see also section 2 “Warnings and precautions”):
• increased levels of “ketone bodies” in the urine or blood
• feeling unwell
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness or unusual tiredness
• sweet smell of breath, sweet or metallic taste in the mouth, or 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 Teva.
• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, very rarely observed.

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

• Urinary tract infection, commonly observed (may affect up to 1 in 10 people). Signs of a severe urinary tract infection include:
• fever and/or chills
• burning sensation when urinating
• back or side pain. Although uncommon, if you notice blood in your urine, inform your doctor immediately.

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

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

Other side effects during treatment with Dapagliflozin Teva:
Common

• genital infection (candidiasis) of the penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• increased amount of urine compared to normal or increased urge to urinate
• changes in cholesterol or blood fat levels (observed in blood tests)
• increases in red blood cell count (observed in blood tests)
• reduction in creatinine renal clearance (observed in blood tests) at the beginning of treatment
• dizziness
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• excessive fluid loss from the body (dehydration; signs may include very dry or sticky mouth, reduced or absent urination, or rapid heartbeat)
• thirst
• constipation
• waking up during the night to urinate
• dry mouth
• weight loss
• increases in creatinine (observed in blood tests) at the beginning of treatment
• increases in urea (observed in blood tests).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at
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 Teva

Keep this medicine out of the sight and reach of children.
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 that month.
This medicine does not require any special storage temperature. Store in the original packaging, protected from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dapagliflozin Teva contains

• The active substance is dapagliflozin. Each 5 mg film-coated tablet contains 5 mg of dapagliflozin. Each 10 mg film-coated tablet contains 10 mg of dapagliflozin.
• The other components are microcrystalline cellulose, lactose, crospovidone, anhydrous colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), and sodium lauryl sulfate.

Description of the appearance of Dapagliflozin Teva and contents of the pack
The 5 mg film-coated tablets are yellow, round, film-coated tablets, 6.8 mm in diameter, marked with “TV” on one side and “5D” on the other side.
The 10 mg film-coated tablets are yellow, oval, film-coated tablets, measuring 11.3 mm x 6.9 mm, marked with “TV” on one side and “1D” on the other side.
Dapagliflozin Teva is available in calendarized blisters containing 14, 28, and 98 tablets, and in divisible unit-dose blisters containing 28x1, 30x1, 50x1, 90x1, 98x1, and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands

Manufacturer:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa, 2600
Bulgaria