Carvedilol Aurovitas 6.25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carvedilol Aurovitas 6.25 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Carvedilol Aurovitas contains carvedilol as the active ingredient. It belongs to a group of medicines known as alpha and beta receptor blockers. Carvedilol has antioxidant, antihypertensive (reduction of blood pressure), vasodilatory, and antianginal properties. In addition, it reduces cardiac output and has beneficial effects on blood circulation in the heart.

Carvedilol Aurovitas is indicated for the treatment of:

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

2. What you need to know before taking Carvedilol Aurovitas

Do not take Carvedilol Aurovitas:

• If you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6).
• In cases of decompensated heart failure of the so-called class IV (inability of the heart 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.
• Heart disease involving second- or third-degree atrioventricular (A-V) block (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 is so damaged it cannot supply sufficient blood to the body's organs).
• Heart disease involving sino-auricular node block.
• Very low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions

Talk to your doctor or pharmacist before taking Carvedilol Aurovitas.

Inform your doctor if you have any of the following conditions:

• Any lung disease.
• Diabetes.
• Heart disease.
• If you are taking other medicines for the heart, especially if you are taking any of the following: digitalis (which increases the force of the heartbeat), diuretics (which increase urine output), ACE inhibitors (antihypertensive medicines), calcium channel blockers (antihypertensive medicines), or antiarrhythmics (medicines that affect heart rhythm).
• Thyroid problems.
• Allergies and if you are receiving treatment for them.
• Circulatory problems or Raynaud's phenomenon.
• If you are scheduled for surgery, inform your doctor that you are being treated with carvedilol.
• If you have a condition called phaeochromocytoma.
• If you have psoriasis (a skin disease).
• If you have Prinzmetal's angina (chest pain occurring at rest without obvious causes).
• If you are undergoing surgery with anaesthesia. Inform the doctor responsible for the anaesthesia.
• If you wear contact lenses. Carvedilol may reduce tear production.
• If you suffer from severe skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medicines with beta-blocking activity, you must 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 lead to a positive result in doping control 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is very important because taking several medicines at the same time may increase or decrease their effects. Therefore, you should not take Carvedilol Aurovitas with any other medicine unless approved by your doctor.

Please note that these instructions may also apply to medicines taken previously or that may be taken in the future.

It is important to 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 transplant rejection).
• Digoxin, verapamil, diltiazem, and antiarrhythmic medicines (used to treat heart and blood pressure problems).
• Amiodarone (a medicine used to treat certain heart problems).
• Certain painkillers such as aspirin and ibuprofen (NSAIDs).
• Other blood pressure medicines, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Medicines for diabetes (including insulin and oral antidiabetics).
• Clonidine (a medicine used to control blood pressure or migraine).
• Rifampicin (a medicine used to treat infections).
• Cimetidine (a medicine used to treat stomach problems).
• Inducers or inhibitors of hepatic metabolism (medicines that alter the elimination of other medicines from the body).
• Monoamine oxidase inhibitors (medicines for depression).
• β-agonist bronchodilators (medicines used to improve breathing, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Carvedilol Aurovitas with food, drinks, and alcohol

You should avoid taking Carvedilol Aurovitas at the same time as, or immediately after, consuming grapefruit or grapefruit juice. Grapefruit or grapefruit juice may increase blood levels of the active ingredient carvedilol and cause unpredictable adverse effects. Excessive and simultaneous or occasional consumption of alcohol should also be avoided, as alcohol affects the action of this medicine. Your doctor or pharmacist will advise you on which foods to take with 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 utero and premature births. In addition, adverse effects may occur in the fetus and newborn. After birth, the newborn has an increased risk of heart and lung problems.

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

Driving and using machines

Carvedilol Aurovitas may occasionally impair your ability to drive or operate machinery. This is especially likely when starting or changing treatment and when taken together with alcohol.

Carvedilol Aurovitas contains sucrose and lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Carvedilol Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Essential hypertension:

Adults:

Oral use. The recommended starting dose is 12.5 mg once daily for the first two days. Then, the recommended dose is 25 mg once daily. If necessary, your doctor may increase your dose (at intervals of at least two weeks) up to 50 mg once daily or in two divided doses of 25 mg each.

Elderly patients:

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

Ischaemic heart disease:

Adults:

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

Elderly patients:

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

Treatment of symptomatic congestive heart failure

Adults and elderly patients:

Oral use. Your doctor will individually determine the dose you should take, monitoring you closely during dose escalation to higher doses.

If you are already taking medications for heart conditions (digitalis) or for blood pressure control (diuretics and/or ACE inhibitors), your doctor will adjust the amount of these medications before starting carvedilol treatment.

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

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

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice daily (total 50 mg per day). If you weigh more than 85 kg, the maximum recommended dose is 50 mg twice daily (100 mg per day).

Your doctor will advise you on the duration of your carvedilol treatment.

As a general rule, regardless of your condition, discontinuation of this medicine should be done gradually over several days, by reducing the dose 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 data on safety and efficacy.

Instructions for correct administration

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

If you have congestive heart failure (your heart has lost some ability to pump blood and you may experience shortness of breath, weakness, and fluid retention), you should take this medicine with food to avoid dizziness upon standing.

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. Take the medicine with you. You may also contact the Toxicology Information Service at telephone number 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 taking Carvedilol Aurovitas

Treatment with this medicine should not be stopped abruptly, especially if you have ischaemic heart disease, a condition causing poor blood pumping by the heart. Your doctor will gradually reduce your dose over several days until you completely stop taking carvedilol.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects are classified as follows: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (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 frequency not known (cannot be estimated from the available data).

Infections and infestations

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

Disorders of the nervous system

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

Common: Presyncope, syncope (fainting), especially at the beginning of treatment.

Uncommon: Paresthesia (tingling sensation).

Psychiatric disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Frequency not known: Hallucinations.

Cardiac disorders

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

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

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

Frequency not known: Sinus arrest (a condition causing the heartbeat to become very slow or stop), especially in elderly patients or patients with other cardiac rhythm disorders.

Vascular disorders

Very common: Low blood pressure.

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

Respiratory, thoracic and mediastinal disorders

Common: Asthma and breathing difficulties in predisposed patients, pulmonary edema (fluid accumulation in the lungs).

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal discomfort with symptoms such as nausea, diarrhea, and abdominal pain, indigestion, vomiting.

Uncommon: Constipation.

Rare: Dry mouth.

Skin and subcutaneous tissue disorders

Uncommon: Skin reactions (e.g. allergic rash, dermatitis, urticaria, itching, psoriasis, lichen planus-type skin lesions).

Frequency not known: Hair loss, serious skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Blood and lymphatic system disorders

Common: Decreased number of red blood cells in the blood (anemia).

Rare: Reduced number of platelets in the blood (thrombocytopenia).

Very rare: Reduced number of white blood cells in the blood (leukopenia).

Hepatobiliary disorders

Very rare: Abnormalities in serum transaminases (changes in blood levels of certain liver enzymes).

Eye disorders

Common: Decreased tear production (dry eye), eye irritation, vision disturbances.

Renal and urinary disorders

Common: Acute renal failure (kidneys not functioning properly) and kidney function disorders in patients with diffuse vascular disease and/or impaired renal function.

Rare: Urination problems.

Frequency not known: Urinary incontinence in women (resolves upon discontinuation of the medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Limb pain.

Reproductive system and breast disorders

Uncommon: Impotence.

Metabolism and nutrition disorders

Common: Worsening of blood sugar control in patients with diabetes (hyperglycemia, hypoglycemia), weight gain, increased blood cholesterol.

Frequency not known: Latent diabetes mellitus may become apparent, or pre-existing diabetes may worsen.

General disorders and administration site conditions

Very common: Fatigue.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carvedilol Aurovitas

Keep out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carvedilol Aurovitas

• The active substance is carvedilol. Each film-coated tablet contains 6.25 mg of carvedilol.
• The other components (excipients) are: monohydrate lactose, 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 contents of the pack

Film-coated tablet.

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

PVC/PE/PVDC-Aluminum:

Pack size: 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Or

Orion Corporation

Orionintie 1,

FI-02200 Espoo,

Finland

Date of the most recent review of this leaflet: April 2025

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/).