Dapagliflozin Tecnigén 5 mg Film-Coated Tablets

Introduction

Package Leaflet:information for the patient

Dapagliflozin TecniGen 5 mg film-coated tablets EFG

Dapagliflozin TecniGen 10 mg film-coated tablets EFG

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dapagliflozin TecniGen and what is it used for
2. What you need to know before you take Dapagliflozin TecniGen
3. How to take Dapagliflozin TecniGen
4. Possible side effects

5 Conservation of Dapagliflozin TecniGen

1. Contents of the pack and further information

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

What isDapagliflozin TecniGen

This medicinal product contains the active substance dapagliflozin. It belongs to a group of

medicines called "sodium-glucose cotransporter 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 the urine.

What is Dapagliflozin TecniGen 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 diet and exercise recommendations given to you by your doctor, pharmacist, or nurse.

Heart failure

• In adults (18 years of age 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 doesDapagliflozin TecniGenhelp?

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 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 doesDapagliflozin TecniGenhelp?

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 doesDapagliflozin TecniGenhelp?

When you have chronic kidney disease, your kidneys may gradually lose their function.

This means they will 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 TecniGen

Do not take Dapagliflozin TecniGen

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

Warnings and precautions

Seek medical help immediately:

Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or 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 the tests.
• The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased 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, seek medical help immediately and do not take this medicine.

Necrotizing fasciitis of the perineum:

• Consult your doctor immediately if you have a combination of symptoms such as 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 your doctor, pharmacist, or nurse before you start taking Dapagliflozin TecniGen:

• If you have "type 1 diabetes" - the type that usually occurs when you are young and your body does not produce any insulin. Dapagliflozin should not be used to treat this condition.
• If you have diabetes and have any kidney problems - your doctor may prescribe 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 TecniGen"
• 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. Inform your doctor before you start taking dapagliflozin if you have any of these signs.
• If you have or develop nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking dapagliflozin until you recover to prevent dehydration.
• If you frequently get 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 TecniGen

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 blood sugar levels, such as insulin or a "sulfonylurea" type medicine. Your doctor may decide to reduce the dose of these medicines to avoid 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. Ask your doctor about the best way to control your blood sugar levels during pregnancy.

Ask your doctor if you want to breastfeed before taking this medicine. Do not take 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.

3. How to take Dapagliflozin TecniGen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

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(s). Remember to take these other medicine(s) as instructed by your doctor. This will help you get the best results for your health.

Diet and exercise can 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 TecniGen than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Dapagliflozin TecniGen

What you should do if you miss 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 of dapagliflozin to make up for missed doses.

If you stop taking Dapagliflozin TecniGen

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.

Seek medical help immediately if you get any of the following serious 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, 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 can occur 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 and consult a doctor immediately if you notice any of these serious side effects:

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

These are the signs of a serious urinary tract infection:

• fever and/or chills
• burning sensation while urinating
• back or side pain.

Although it is not common, if you see blood in your urine, inform your doctor immediately.

Tell your doctor as soon as possible if you get 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

The signs of low blood sugar levels are:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• feeling hungry, headache, changes in vision
• mood changes 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 symptoms.

Other side effects of treatment with dapagliflozin:

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• increased need to urinate or more frequent urination
• changes in cholesterol or lipid levels in the blood (seen in tests)
• increases in red blood cell count in the blood (seen in tests)
• decreases in renal clearance of creatinine (seen in tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• excessive loss of fluids from the body (dehydration, signs may include a very dry or sticky mouth, reduced or no urination; or rapid heartbeat)
• thirst
• constipation
• waking up at night to urinate
• dry mouth
• weight loss
• increased creatinine (seen in blood tests) at the start of treatment
• increased 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 leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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. Conservation of Dapagliflozin TecniGen

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 carton after EXP. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Dapagliflozina TecniGen

• The active ingredient is dapagliflozina.

Each film-coated tablet (tablet) of Dapagliflozina TecniGen 5 mg contains dapagliflozina propanediol monohydrate equivalent to 5 mg of dapagliflozina.

Each film-coated tablet (tablet) of Dapagliflozina TecniGen 10 mg contains dapagliflozina propanediol monohydrate equivalent to 10 mg of dapagliflozina.

• The other components are:

• tablet core: mannitol, silicified microcrystalline cellulose, crospovidone, talc, magnesium stearate.
• coating: Poly (vinyl alcohol), titanium dioxide (E171), polyethylene glycol/macrogol, talc, yellow iron oxide (E172).

Appearance of the Product and Container Content

The film-coated tablets of Dapagliflozina TecniGen 5 mg are yellow and round, with a diameter of 7.0 mm ± 0.2 mm, and are engraved with "5" on one side.

The film-coated tablets of Dapagliflozina TecniGen 10 mg are yellow and oval, with a length of 11.5 mm ± 0.2 mm and a width of 7.0 mm ± 0.2 mm.

Dapagliflozina TecniGen 5 mg film-coated tablets are available in OPA-Alu blisters in packs of 14 and 28 film-coated tablets.

Dapagliflozina TecniGen 10 mg film-coated tablets are available in OPA-Alu blisters in packs of 14 or 28 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma - Produções Farmacêuticas S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra

Portugal

Or

Tecnimede - Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Dapagliflozina Tecnigen

Italy: Dapagliflozin Tecnigen

Cyprus: Dapagliflozin Farmoz

Date of the last revision of this leaflet:April 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)