Dapagliflozin Teva 10 mg Film-Coated Tablets

Introduction

Package Leaflet: Information for the Patient

Dapagliflozin Teva 5 mg film-coated tablets EFG

Dapagliflozin Teva 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dapagliflozin Teva and what is it used for
2. What you need to know before you take Dapagliflozin Teva
3. How to take Dapagliflozin Teva
4. Possible side effects
5. Storage of Dapagliflozin Teva
6. Package contents and further information

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

What is Dapagliflozin Teva

Dapagliflozin Teva contains the active substance dapagliflozin. It belongs to a group of medicines called "sodium-glucose co-transporter 2 (SGLT2) inhibitors". They work by blocking the SGLT2 protein in the kidney. By blocking this protein, sugar in the blood (glucose), salt (sodium), and water are removed from the body through urine.

What is Dapagliflozin Teva used for

Dapagliflozin is used to treat:

• Type 2 diabetes
• • in adults and children aged 10 years and older.
  • if your type 2 diabetes cannot be controlled by diet and exercise.
  • Dapagliflozin can be used alone or with other medicines to treat diabetes.
  • it is important that you continue to follow the advice on diet and exercise given to you by your doctor, pharmacist, or nurse.

• Heart failure
• • in adults (18 years or 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 Teva help?

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

What is heart failure and how does Dapagliflozin Teva help?

• 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 problems and the need for hospital care.
• The most common symptoms of heart failure are shortness of breath, feeling tired all the time, and swelling of the ankles.
• Dapagliflozin helps protect the heart from getting worse and improves your symptoms. It may reduce the need to go to the hospital and may help some patients live longer.

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

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they may not be able to clean and filter your blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospital care.

Dapagliflozin helps protect your kidneys from losing their function. This may help some patients live longer.

2. What you need to know before you take Dapagliflozin Teva

Do not take Dapagliflozin Teva

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

Warnings and precautions

Consult a doctor or the nearest hospital immediately

Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual tiredness, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, or rapid weight loss.
• The above symptoms may be a sign of "diabetic ketoacidosis" - a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in "ketone bodies" in your urine or blood, which is detected in laboratory tests.
• The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a greater need for insulin due to major surgery or serious illness.
• When you are being treated with dapagliflozin, diabetic ketoacidosis may occur even if your blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital immediately and do not take this medicine.

Necrotizing fasciitis of the perineum:

• Consult your doctor immediately if you have a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene needs to be treated immediately.

Consult a doctor, pharmacist, or nurse before you start taking Dapagliflozin Teva

• if you have "type 1 diabetes" - the type that usually occurs when you are young and your body does not produce any insulin. Dapagliflozin Teva should not be used to treat this condition.
• if you have diabetes and have any kidney problems - your doctor may ask you to take an additional medicine or a different one to control your blood sugar levels.
• if you have any liver problems - your doctor may start with a lower dose.
• if you are taking medicines to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in "Other medicines and Dapagliflozin Teva".
• if you have very high blood sugar levels that may cause dehydration (loss of too much fluid from the body). Possible signs of dehydration are listed in section 4. Tell your doctor before you start taking dapagliflozin if you have any of these signs.
• if you have nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking dapagliflozin until you recover to prevent dehydration.
• if you get frequent urinary tract infections.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking dapagliflozin.

Diabetes and foot care

If you have diabetes, it is important that you regularly check your feet and follow any other foot care advice given to you by your healthcare professional.

Glucose in urine

Due to the way dapagliflozin works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

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

Dapagliflozin is not recommended in children and adolescents under 18 years of age to treat heart failure or to treat chronic kidney disease, as it has not been studied in these patients.

Other medicines and Dapagliflozin Teva

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Especially tell your doctor:

• if you are taking a medicine used to remove fluid from the body (diuretic).
• if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or a medicine of the "sulfonylurea" type. Your doctor may decide to reduce the dose of these medicines to avoid you getting low blood sugar levels (hypoglycemia).
• If you are taking lithium, as dapagliflozin may lower the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should stop taking this medicine if you become pregnant, as it is not recommended during the second and third trimesters of pregnancy. Consult your doctor about the best way to control your blood sugar levels during pregnancy.

Consult your doctor if you want to breastfeed before taking this medicine. Do not use dapagliflozin during breastfeeding. It is not known if this medicine passes into human breast milk.

Driving and using machines

Dapagliflozin has no or negligible influence on the ability to drive and use machines.

Taking this medicine with other medicines called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which can cause symptoms such as shaking, sweating, and changes in vision that can affect your ability to drive or use machines.

Do not drive or use tools or machines if you feel dizzy while taking dapagliflozin.

Dapagliflozin Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Dapagliflozin Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Dapagliflozin Teva

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor, pharmacist, or nurse again.

How much to take

• The recommended dose is one 10 mg tablet a day.
• Your doctor may start with a dose of 5 mg if you have a liver problem.
• Your doctor will prescribe the right dose for you.

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• You can take the tablet with or without food.
• You can take the tablet at any time of the 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 with another medicine. Remember to take these other medicines as instructed by your doctor. This will help you get the best results for your health.

Diet and exercise may help your body use blood sugar better. If you have diabetes, it is important that you follow any diet and exercise program recommended by your doctor while taking dapagliflozin.

If you take more Dapagliflozin Teva than you should

If you take more dapagliflozin tablets than you should, talk to a doctor or go to a hospital immediately. Take the medicine package with you.

If you forget to take Dapagliflozin Teva

What you should do if you forget to take a tablet depends on how much time is left until your next dose.

• If there are 12 hours or more until your next dose, take a dose of dapagliflozin as soon as you remember. Then 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 to make up for a forgotten dose.

If you stop taking Dapagliflozin Teva

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

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult a doctor or the nearest hospital immediately if you experience any of the following side effects:

• angioedema,seen very rarely (may affect up to 1 in 10,000 people).

These are the signs 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 affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increase in "ketone bodies" in your urine or blood
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness and unusual tiredness
• sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat
• rapid weight loss

This may happen regardless of your blood sugar levels. Your doctor will decide whether to temporarily or permanently stop your treatment with dapagliflozin.

• necrotizing fasciitis of the perineumor Fournier's gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely.

Stop taking Dapagliflozin Teva and consult a doctor immediately if you notice any of these serious side effects:

• severe urinary tract infection, occurs frequently (may affect up to 1 in 10 people).

These are the signs of a severe urinary tract infection:

• fever and/or chills
• burning sensation when urinating
• back pain or pain in the side.

Although not common, if you see blood in your urine, tell your doctor immediately.

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

• low blood sugar levels(hypoglycemia), very common (may affect more than 1 in 10 people) in patients with diabetes who take this medicine with a sulfonylurea or insulin.

These are the signs of low blood sugar levels:

• chills, sweating, feeling of great anxiety, fast heartbeat
• feeling hungry, headache, changes in vision
• change in mood or feeling confused

Your doctor will explain how to treat low blood sugar levels and what to do if you experience any of the above signs.

Other side effects of treatment with Dapagliflozin Teva:

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and unusual discharge or odor)
• back pain
• difficulty urinating, increased amount of urine, or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (seen in laboratory tests)
• increases in the number of red blood cells in the blood (seen in laboratory tests)
• decreases in renal clearance of creatinine (seen in laboratory tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• fungal infection
• genital itching
• excessive loss of fluids from the body (dehydration, signs may include a very dry or sticky mouth, reduced or no urination, or fast heartbeat)
• thirst
• constipation
• waking up at night to urinate
• dry mouth
• weight loss
• increase in creatinine (seen in blood tests) at the start of treatment
• increase in urea (seen in blood tests)

Rare

• kidney inflammation (tubulointerstitial nephritis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dapagliflozin Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP/CAD. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Keep the medicine in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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6. Container Content and Additional Information

Composition of Dapagliflozina Teva

• The active ingredient is dapagliflozina.

Each 5 mg film-coated tablet contains 5 mg of dapagliflozina.

Each 10 mg film-coated tablet contains 10 mg of dapagliflozina.

• The other components are: microcrystalline cellulose, lactose, crospovidone, anhydrous colloidal silica, stearic acid fumarate, and sodium. The coating contains: poly (vinyl alcohol), macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), and sodium lauryl sulfate.

Appearance of the Product and Container Content

The 5 mg film-coated tablets are yellow, film-coated, round with a diameter of 6.8 mm, engraved on one side with "TV" and "5D" on the other.

The 10 mg film-coated tablets are yellow, film-coated, oval-shaped with dimensions of 11.3 mm x 6.9 mm, engraved on one side with "TV" and "1D" on the other.

Dapagliflozina Teva is available in calendar blisters of 14, 28, and 98 film-coated tablets and in single-dose blisters of 28x1, 30x1, 50x1, 90x1, 98x1, and 100x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Balkanpharma Dupnitza AD

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Actavis Group PTC ehf.

Dalshraun 1, 220

Hafnarfjörður

Iceland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edficio Albatros B, 1ª planta

28018 Alcobendas, Madrid (Spain)

Date of the Last Revision of thisProspectus: October 2023

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es