CARVEDILOL AUROVITAS 6.25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Carvedilol Aurovitas 6.25mg 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.
• If you have any further questions, ask your doctor or pharmacist.
• 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 Package Leaflet

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

1. What is Carvedilol Aurovitas and what is it used for

Carvedilol Aurovitas contains carvedilol as the active ingredient. It belongs to a group of medicines known as alpha and beta blockers. Carvedilol has antioxidant, antihypertensive (reducing blood pressure), vasodilating, and anti-anginal properties. It also reduces cardiac output and has favorable effects on blood circulation at the heart level.

Carvedilol Aurovitas is indicated for the treatment of:

• Symptomatic congestive heart failure (the heart has lost some of its ability to pump blood) of moderate to severe degree, of ischemic or non-ischemic origin.
• Essential hypertension (high blood pressure).
• Ischemic heart disease (the heart receives little blood and oxygen).

2. What you need to know before you take Carvedilol Aurovitas

Do not take Carvedilol Aurovitas:

• If you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
• A type of decompensated heart failure called class IV (the heart is unable to perform its pumping function during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver is not functioning properly.
• Bronchial asthma.
• A heart condition that consists of atrioventricular (A-V) block of second and third degree (unless a permanent pacemaker has been implanted).
• If your heart beats slowly (less than 50 beats per minute).
• Heart failure (or shock, a condition in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• A heart condition that consists of sino-atrial node block.
• Very low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carvedilol Aurovitas.

Tell your doctor if you have any of the following diseases:

• If you have any lung disease.
• If you are diabetic.
• If you have a heart condition.
• If you are taking other heart medications, especially if you are taking any of the following medications, inform your doctor: digitalis (increases the strength of the heartbeat), diuretics (increases urine production), ACE inhibitors (antihypertensive medication), calcium antagonists (antihypertensive medication), and anti-arrhythmics (act on the heart rhythm).
• If you have any thyroid problems.
• If you are allergic and are receiving treatment for your allergy.
• If you have circulation problems or Raynaud's phenomenon.
• If you have a scheduled surgical intervention, inform your doctor that you are being treated with carvedilol.
• If you suffer from a disease called pheochromocytoma.
• If you have psoriasis (skin disease).
• If you have Prinzmetal's angina (chest pain that starts during rest without obvious causes).
• If you are going to undergo surgery with anesthesia. You should inform the anesthesiologist.
• If you use contact lenses. Carvedilol may reduce tear production.
• If you have severe adverse skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all beta-blocking medications, you should not stop treatment with Carvedilol Aurovitas abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

This medicine contains carvedilol, which may produce a positive result in doping tests.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age due to insufficient safety and efficacy data.

Other medicines and Carvedilol Aurovitas

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

This is very important because taking several medicines at the same time can increase or decrease their effect. Therefore, you should not take Carvedilol Aurovitas with any other medicine unless your doctor has allowed it.

Note that these instructions may also apply to medicines that have been used before or may be used after.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Fluoxetine and paroxetine (medicines for depression).
• Cyclosporine and tacrolimus (medicines used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medicines used to treat heart problems and high blood pressure).
• Amiodarone (a medicine used to treat certain heart problems).
• Certain pain relievers such as aspirin and ibuprofen (NSAIDs).
• Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Medicines for diabetes (including insulin and oral antidiabetics).
• Clonidine (a medicine used to control blood pressure or migraines).
• Rifampicin (a medicine used to treat infections).
• Cimetidine (a medicine used to treat stomach problems).
• Inducers or inhibitors of hepatic metabolism (medicines that modify the elimination of other medicines from the body).
• Monoamine oxidase inhibitors (medicines for depression).
• Beta-agonist bronchodilators (medicines used to improve respiratory capacity, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Carvedilol Aurovitas with food, drinks, and alcohol

Avoid taking Carvedilol Aurovitas at the same time or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in the active ingredient carvedilol in the blood and cause unpredictable side effects. Also, avoid excessive and simultaneous or occasional consumption of alcohol because alcohol influences the effect of this medicine. Your doctor or pharmacist will inform you about the meals with which you should take the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The use of carvedilol is not recommended during pregnancy and breastfeeding.

Carvedilol may cause fetal death in the womb, as well as premature births. Additionally, side effects may occur in the fetus and newborn. After birth, the newborn has a higher risk of suffering heart and lung problems.

Carvedilol passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

Occasionally, Carvedilol Aurovitas may impair your ability to drive or operate machines. This happens especially when starting or changing treatment and when taken together with alcohol.

Carvedilol Aurovitas contains sucrose and lactose

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

3. How to take Carvedilol Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Essential hypertension:

Adults:

Oral. The recommended dose to start treatment is 12.5 mg once a day for the first two days. Then, the recommended dose is 25 mg once a day. If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) up to 50 mg once a day or in two doses of 25 mg each.

Elderly patients:

Oral. The recommended dose to start therapy is 12.5 mg once a day, which has provided satisfactory control in some patients. If the response is not adequate, your doctor will adjust the dose (at intervals of at least two weeks).

Ischemic heart disease:

Adults:

Oral. The recommended dose to start treatment is 12.5 mg twice a day (a total of 25 mg per day) for the first two days. Then, the recommended dose is 25 mg twice a day (a total of 50 mg per day). If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) up to 50 mg twice a day (a total of 100 mg per day).

Elderly patients:

Oral. The maximum recommended dose for elderly patients is 50 mg administered in divided doses (twice a day).

Treatment of symptomatic congestive heart failure

Adults and elderly patients:

Oral. Your doctor will tell you individually the dose you should take, monitoring you closely during the adjustment to higher doses.

In case you are using heart medications (digitalis) or blood pressure medications (diuretics and/or ACE inhibitors) and before starting treatment with carvedilol, your doctor will adjust the amount of these medications you should take.

In any case, the recommended dose for starting treatment with this medicine in the treatment of symptomatic congestive heart failure is 3.125 mg twice a day (a total of 6.25 mg per day) for two weeks. If you tolerate this dose well, it can be increased later (at intervals of at least two weeks) up to 6.25 mg twice a day (a total of 12.5 mg per day).

Your doctor may prescribe higher doses of this medicine later (after at least two weeks).

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice a day (a total of 50 mg per day). If your weight is over 85 kg, the maximum recommended dose is 50 mg twice a day (100 mg per day).

Your doctor will indicate the duration of your treatment with carvedilol.

As a general rule, regardless of your disease, the withdrawal of this medicine should be done gradually over a few days, or the dose should be reduced by half every three days.

Use in children and adolescents

Carvedilol is not recommended for use in children and adolescents under 18 years of age due to insufficient safety and efficacy data.

Guidelines for correct administration

Take the tablets with a sufficient amount of liquid, a glass of water.

If you have congestive heart failure (your heart has lost some of its ability to pump blood and may cause difficulty breathing, weakness, and fluid accumulation), you should take this medicine while eating to avoid feeling dizzy when standing up.

Remember to take your medicine.

If you take more Carvedilol Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or go to the nearest hospital. Bring the medicine with you. You can also contact the Toxicology Information Service, phone 91 562.04.20.

If you forget to take Carvedilol Aurovitas

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Carvedilol Aurovitas

Treatment with this medicine should not be stopped abruptly, especially if you have ischemic heart disease, a condition that causes the heart to not pump blood well. Your doctor will gradually reduce the dose over a few days until you stop taking carvedilol completely.

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

4. Possible Adverse Effects

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

Effects are classified into: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and unknown frequency (cannot be estimated from available data).

Infections and Infestations

Frequent: Bronchitis, pneumonia, upper respiratory tract infections, urinary tract infections.

Disorders of the Nervous System

Very frequent: Headache, dizziness, and weakness that are usually mild and occur mainly at the beginning of treatment.

Frequent: Presyncope, syncope (fainting), especially at the start of treatment.

Infrequent: Paresthesias (tingling sensation).

Psychiatric Disorders

Frequent: Depressed mood, depression.

Infrequent: Sleep disorders.

Unknown frequency: Hallucinations.

Cardiac Disorders

Very frequent: Increased heart failure (the heart has lost some of its ability to pump blood).

Frequent: Bradycardia (decreased heart rate), fluid overload, increased blood volume in the body.

Infrequent: Atrioventricular (AV) block (heart problems), and angina pectoris (chest pain).

Unknown frequency: Sinus arrest (a condition that makes the heartbeats become very slow or stop), especially in elderly patients or patients with other heart rhythm problems.

Vascular Disorders:

Very frequent: Low blood pressure.

Frequent: Postural hypotension (dizziness when standing up or changing body position), peripheral circulation disorders (cold hands and feet), increased symptoms in patients with intermittent claudication (increased leg pain when walking) or Raynaud's phenomenon (decreased blood flow to fingers and toes, ears, and nose), hypertension.

Respiratory, Thoracic, and Mediastinal Disorders

Frequent: Asthma and difficulty breathing in predisposed patients, fluid accumulation in the lungs.

Rare: Nasal congestion.

Gastrointestinal Disorders

Frequent: Gastrointestinal disorders with symptoms such as nausea, diarrhea, and abdominal pain, indigestion, vomiting.

Infrequent: Constipation.

Rare: Dry mouth.

Disorders of the Skin and Subcutaneous Tissue

Infrequent: Skin reactions (e.g., allergic exanthema, dermatitis, urticaria, itching, psoriasis, skin lesions of lichen planus type).

Unknown frequency: Hair loss, severe skin adverse reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Disorders of the Blood and Lymphatic System

Frequent: Decreased red blood cell count (anemia).

Rare: Reduced platelet count (thrombocytopenia).

Very rare: Reduced white blood cell count (leukopenia).

Hepatobiliary Disorders

Very rare: Alterations in serum transaminases (changes in the amount of certain liver enzymes in the blood).

Ocular Disorders

Frequent: Decreased tear production (dry eye), eye irritation, vision changes.

Renal and Urinary Disorders

Frequent: Acute renal failure (the kidney does not function properly) and renal function disorders in patients with diffuse vascular disease and/or altered renal function.

Rare: Urination problems.

Unknown frequency: Urinary incontinence in women (disappears when stopping the medication).

Disorders of the Immune System

Very rare: Allergic reactions.

Musculoskeletal and Connective Tissue Disorders

Frequent: Pain in the limbs.

Disorders of the Reproductive System and Breast

Infrequent: Impotence.

Metabolic and Nutritional Disorders

Frequent: Worsening of blood sugar control in diabetic patients (hyperglycemia, hypoglycemia), weight gain, increased cholesterol in the blood.

Unknown frequency: It is possible that latent diabetes mellitus may manifest or that existing diabetes may worsen.

General Disorders and Administration Site Conditions

Very frequent: Fatigue.

Frequent: Pain, edema (fluid retention, swelling of the legs, ankles, and feet).

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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. Storage of Carvedilol Aurovitas

Keep out of sight and reach of children.

Do not store at a temperature above 30 °C.

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

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 of Carvedilol Aurovitas

• The active ingredient is carvedilol. Each film-coated tablet contains 6.25 mg of carvedilol.
• The other components (excipients) are: lactose monohydrate, anhydrous colloidal silica, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate, macrogol 400, polysorbate 80, titanium dioxide (E 171), and hypromellose.

Appearance of the Product and Package Contents

Film-coated tablet.

White to off-white, oval, film-coated tablets marked with "F 57" on one side of the tablet and with a score line on the other side. The tablet can be divided into equal doses.

PVC/PE/PVDC-Aluminum:

Package sizes: 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Orion Corporation

Orionintie 1,

FI-02200 Espoo,

Finland

Date of the Last Revision of this Prospectus:April 2025

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/).