Dapagliflozin/Metformin TecniGen 5 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dapagliflozin/Metformin Tecnigen 5 mg/1000 mg film-coated tablets EFG

dapagliflozin/metformin hydrochloride

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 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 Dapagliflozin/Metformina Tecnigen is and what it is used for
2. What you need to know before you take Dapagliflozin/Metformina Tecnigen
3. How to take Dapagliflozin/Metformina Tecnigen
4. Possible side effects
5. Storage of Dapagliflozin/Metformina Tecnigen
6. Contents of the pack and other information

1. What Dapagliflozin/Metformina Tecnigen is and what it is used for

This medicine contains two different active substances called dapagliflozin and metformin. Both belong to a group of medicines called oral antidiabetics. These are medicines that you take by mouth to treat diabetes.

Dapagliflozin/Metformin Tecnigen is used to treat a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years or older) and that normally appears when you are older. If you have type 2 diabetes, your pancreas does not produce enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar (glucose) in your blood.

• Dapagliflozin works by removing excess sugar from your body through urine and decreasing the amount of sugar in your blood. It may also help prevent heart disease.
• Metformin works mainly by inhibiting glucose production in the liver.

To treat diabetes:

• This medicine is taken in combination with diet and exercise.
• This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes.
• Your doctor may ask you to take this medicine alone or with other medicines to treat diabetes. It may be another oral medicine and/or an injectable medicine, such as insulin or a GLP-1 receptor agonist (helps your body increase insulin production when your blood sugar is high).
• If you are already taking dapagliflozin and metformin in individual tablets, your doctor may ask you to switch to this medicine. To avoid overdose, do not continue taking the dapagliflozin and metformin tablets if you are taking this medicine.

It is essential that you continue to follow the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse.

2. What you need to know before you take Dapagliflozin/Metformina Tecnigen

Do not take Dapagliflozin/Metformina Tecnigen

• if you are allergic to dapagliflozin, metformin, or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a diabetic coma.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• if you have severe kidney function impairment.
• if you have a severe infection.
• if you have lost a large amount of body water (dehydration), for example, due to prolonged or severe diarrhea or if you have vomited several times in a row.
• if you have recently had a heart attack or if you have heart failure or any severe blood circulation problems or difficulty breathing.
• if you have liver problems.
• if you consume large amounts of alcohol, every day or only occasionally (see section “Taking Dapagliflozina/Metformina Tecnigen with alcohol”).

Do not take this medicine if any of the above situations apply to you.

Warnings and precautions

Risk of lactic acidosis

Dapagliflozin/Metformin may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Dapagliflozina/Metformina Tecnigen for a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking Dapagliflozina/Metformina Tecnigen and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis,as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction of body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor, pharmacist, or nurse before starting to take Dapagliflozina/Metformina Tecnigen, and during treatment:

• if you have “type 1 diabetes” - the type that usually appears when you are young and your body does not produce any insulin. Dapagliflozina/Metformina should not be used to treat this disease.
• if you experience rapid weight loss, have nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual fatigue, sweet smell in your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may be a sign of “diabetic ketoacidosis” - a rare but serious problem, sometimes life-threatening, 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 a greater need for insulin due to major surgery or severe illness.
• if you have any kidney problems. Your doctor will check your kidney function.
• if you have very high blood sugar levels that can cause dehydration (lose too much body fluid). Possible signs of dehydration are included in section 4. Inform your doctor before starting to take this medicine if you have any of these signs.
• 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 Dapagliflozina/Metformina Tecnigen”.
• if you frequently have urinary tract infections. This medicine may cause urinary tract infections, and your doctor may want to monitor you more closely. Your doctor may consider temporarily changing your treatment if you develop a severe infection.

If you need to undergo major surgery, you should stop taking Dapagliflozina/Metformina while the procedure is being performed and for a period after it. Your doctor will decide when you should stop treatment with Dapagliflozina/Metformina and when to restart it.

It is essential that you regularly check your feet and follow any other foot care advice provided by your healthcare professional.

If any of the above situations apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.

Consult your doctor immediately if you have a combination of symptoms of pain, pain on palpation, redness, or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. 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 should be treated immediately.

Kidney function

During treatment with Dapagliflozina/Metformina, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is worsening.

Glucose in urine

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

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as it has not been studied in these patients.

Other medicines and Dapagliflozina/Metformina Tecnigen

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Dapagliflozina/Metformina before the injection or at the time of the injection. Your doctor will decide when you should stop treatment with Dapagliflozina/Metformina and when to restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Dapagliflozina/Metformina. It is especially important to mention the following:

• 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 the blood, such as insulin or a “sulfonylurea” type medicine. Your doctor may decide to reduce the dose of these medicines to avoid having too low blood sugar levels (hypoglycemia).
• if you are taking cimetidine, a medicine used to treat stomach problems.
• if you are using bronchodilators (beta-2 agonists) used to treat asthma.
• if you are using corticosteroids (used to treat inflammation in diseases such as asthma and arthritis) given orally, injected, or inhaled.
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Taking Dapagliflozina/Metformina Tecnigen with alcohol

Avoid excessive alcohol consumption while taking Dapagliflozina/Metformina, as this can increase the risk of lactic acidosis (see section “Warnings and precautions”).

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 (the last six months). Consult your doctor about the best way to control your blood sugar during pregnancy.

Consult your doctor if you want to breastfeed or are breastfeeding before taking this medicine. You should not use this medicine during breastfeeding. Metformin passes into breast milk in small amounts. It is not known if dapagliflozin passes into breast milk.

Driving and using machines

This medicine has a negligible influence on the ability to drive and use machines. Taking it with other medicines that lower the amount of sugar in the blood, such as insulin or a “sulfonylurea” type medicine, can cause very low blood sugar levels (hypoglycemia), which can cause symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, vision changes, or difficulty concentrating, which can affect your ability to drive or use machines. Do not drive or use tools or machines if you start to feel these symptoms.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Dapagliflozina/Metformina Tecnigen

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The amount of this medicine you take varies depending on your condition and the doses you are currently taking of metformin and/or individual tablets of dapagliflozin and metformin. Your doctor will tell you exactly which concentration of this medicine to take.
• The recommended dose is one tablet twice a day.

How to take this medicine

• Swallow the tablet whole with a half glass of water.
• Take the tablet with food. This is to reduce the risk of stomach side effects.
• Take your tablet twice a day, one in the morning (breakfast) and one in the evening (dinner).

Your doctor may prescribe this medicine along with other medicine(s) to lower the amount of sugar in your blood. These may be oral medicine(s) and/or injectable medicine(s), such as insulin or a GLP-1 receptor agonist. Remember to take these other medicines following your doctor's instructions. This will help you get the best results for your health.

Diet and exercise

To control your diabetes, you should continue with diet and exercise, even when taking this medicine. Therefore, it is essential that you continue to follow the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse. In particular, if you are following a weight control diet for diabetics, continue with it while taking this medicine.

If you take more Dapagliflozina/Metformina Tecnigen than you should

If you take more tablets of Dapagliflozina/Metformina than you should, you may experience lactic acidosis. The symptoms of lactic acidosis include having a lot of nausea or vomiting, stomach pain, muscle cramps, intense fatigue, or difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to a coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital right away (see section 2). Bring the medicine pack with you.

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

If you forget to take Dapagliflozina/Metformina Tecnigen

If you forget a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and follow your regular schedule. Do not take a double dose of this medicine to make up for missed doses.

If you stop taking Dapagliflozina/Metformina Tecnigen

Do not stop taking this medicine without first talking to your doctor. Your blood sugar may increase without this medicine.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Dapagliflozina/Metformina Tecnigen and consult a doctor immediately if you notice any of these serious or potentially serious adverse effects:

• Lactic acidosis,occurs rarely (may affect up to 1 in 10,000 people)

Dapagliflozina/Metformina may cause a very rare but very serious adverse effect called lactic acidosis (see section "Warnings and Precautions"), If this happens to you, you must stop takingDapagliflozina/Metforminaand contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Contact a doctor or the nearest hospital immediately if you experience any of the following adverse effects:

• Diabetic ketoacidosis, has been observed rarely (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
• rapid weight loss
• you have nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness and fatigue
• sweet smell in your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat.

This can occur despite blood glucose levels. Your doctor should decide whether to temporarily or permanently interrupt your treatment with Dapagliflozina/Metformina.

• 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 Dapagliflozina/Metformina Tecnigen and consult a doctor as soon as possible if you notice any of the following serious or potentially serious adverse 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
• feeling of burning when urinating (peeing)
• back pain or side pain.

Although it is infrequent, if you notice blood in your urine, inform your doctor immediately.

Contact a doctor as soon as possible if you experience any of the following adverse effects:

• Decrease in blood sugar levels (hypoglycemia), is observed very frequently (may affect more than 1 in 10 people) – when taking this medicine with a sulfonylurea or other medicines that reduce blood sugar levels, such as insulin.

The signs of low blood sugar are:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• feeling of hunger, headache, vision changes
• change in mood or feeling of confusion.

Your doctor will explain how to treat low blood sugar and what to do if you experience any of the above signs. If you have symptoms of low blood sugar, take glucose tablets, a sugary snack, or drink a fruit juice. Measure your blood sugar level, if possible, and rest.

Other adverse effects include:

Very frequent

• nausea, vomiting
• diarrhea or stomach pain
• loss of appetite

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• trouble urinating, increased urine production, or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in analyses)
• increase in the number of red blood cells in the blood (observed in analyses)
• decrease in renal clearance of creatinine (observed in analyses) at the start of treatment
• changes in taste
• dizziness
• rash
• low levels of vitamin B12in the blood or decreased (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may request some tests to discover the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

Uncommon(may affect up to 1 in 100 people)

• excessive fluid loss from the body (dehydration, signs may include very dry or sticky mouth, scant or no urination, or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings due to need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood analyses) at the start of treatment
• increase in urea (observed in blood analyses)

Very rare

• abnormal results in liver function tests, liver inflammation (hepatitis)
• redness of the skin (erythema), itching, or pruritus (hives)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dapagliflozina/Metformina Tecnigen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister or packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofDapagliflozina/Metformina Tecnigen

• The active ingredients are dapagliflozina and metformina hydrochloride (HCl of metformina).

Each film-coated tablet (tablet) contains dapagliflozina propanediol monohydrate equivalent to 5 mg of dapagliflozina and 1000 mg of metformina hydrochloride.

• The other components are:
• • Core of the tablet: silicified microcrystalline cellulose, sodium croscarmellose, hypromellose, stearic acid fumarate, and sodium.
  • Coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol/PEG type 3350, talc, and yellow iron oxide.

Appearance of the Product and Package Contents

• The film-coated tablets are yellow, biconvex, oval-shaped, 21.3 mm ± 0.4 mm, and 10.4 mm ± 0.4 mm.

They are available in PCTFE/PVC/Alu blisters with 56 tablets.

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 De Tapada Grande 2

Abrunheira, 2710-228 Sintra

Portugal

Date of the Last Revision of this Prospectus: October 2024

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