Leaflet: information for the user

Carvedilol Aurovitas 6.25mg film-coated tablets EFG

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

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

1. What isCarvedilol Aurovitasand for what it is used

2. What you need to know before starting totake Carvedilol Aurovitas

3. How to takeCarvedilol Aurovitas

4. Possible side effects

5. Storage ofCarvedilol Aurovitas

6. Contents of the pack and additional information

Carvedilol Aurovitas contains carvedilol as the active ingredient. It belongs to a group of medications known asalpha and beta receptor blockers. Carvedilol has antioxidant, antihypertensive (blood pressure reduction), vasodilatory, and antianginal 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 (elevated blood pressure).
• Ischemic cardiopathy (insufficient blood and oxygen supply to the heart).

Do not take Carvedilol Aurovitas:

• If you are allergic to carvedilol or any of the other components of this medication (listed in section 6).
• Class IV heart failure (heart inability to pump blood during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver does not function properly.
• Asthma.
• Heart disease consisting of second- and 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 state in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• Heart disease consisting of sino-atrial node block.
• Very low blood pressure (systolic pressure of less than 85 mmHg).

Warnings and precautions

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

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

• If you have any lung disease.
• If you are diabetic.
• If you have heart disease.
• If you are taking other heart medications, especially if you are taking any of the following medications, inform your doctor: digitalis (increases heart rate), diuretics (increases urine production), ACE inhibitors (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (act on heart rhythm).
• If you have any thyroid problems.
• If you are allergic and receiving allergy treatment.
• If you have circulation 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 disease called pheochromocytoma.
• If you have psoriasis (skin disease).
• If you have Prinzmetal's angina (chest pain that begins during rest without obvious causes).
• If you are undergoing anesthesia. Inform your responsible anesthesiologist.
• If you wear contact lenses. Carvedilol may reduce tear production.
• If you have severe skin adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

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

Use in athletes

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

Children and adolescents

This medication is not recommended for children and adolescents under 18 years of age due to insufficient safety and efficacy data.

Other medications and Carvedilol Aurovitas

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

This is very important, as taking multiple medications at the same time may increase or decrease their effect.

Do not take Carvedilol Aurovitas with any other medication unless your doctor has allowed it.

These instructions may also apply to medications that have been used before or may be used later.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

- Fluoxetine and paroxetine (depression medications).

- Ciclosporin and tacrolimus (medications used to prevent transplant rejection).

- Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medications used to treat heart problems and hypertension).

- Amiodarone (medication used to treat certain heart problems).

- Certain analgesics such as aspirin and ibuprofen (NSAIDs).

- Other medications for hypertension, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.

- Diabetes medications (including insulin and oral antidiabetic medications).

- Clonidine (medication used to control hypertension or migraine).

- Rifampicin (medication used to treat infections).

- Cimetidine (medication used to treat gastrointestinal problems).

- Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).

- Monoamine oxidase inhibitors (medications used to treat depression).

- Beta-agonist bronchodilators (medications used to improve respiratory function, such as in asthma).

- Adrenaline/epinephrine (used to treat severe allergic reactions).

Carvedilol Aurovitas with food, drinks, and alcohol

Avoid taking Carvedilol Aurovitas simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in carvedilol levels in the blood and lead to unpredictable adverse effects. Also, avoid excessive and simultaneous or occasional consumption of alcohol, as alcohol affects the medication's effect.

Pregnancy and breastfeeding

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

Carvedilol is not recommended during pregnancy and breastfeeding.

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

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

Driving and operating machinery

In some cases, Carvedilol Aurovitas may impair your ability to drive or operate machinery, especially when starting or changing treatment and when taken with alcohol.

Carvedilol Aurovitas contains saccharose and lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Essential hypertension:

Adults:

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

Older patients:

Oral route. The recommended starting dose is 12.5mg once a day, whichhas provided satisfactory control in some patients. If the response is not adequate, your doctor will adjust the dose (at intervals of at least twoweeks).

Ischemic cardiopathy:

Adults:

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

Older patients:

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

Chronic heart failure treatment:

Adults and older patients:

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

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

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

Your doctor may prescribe you higher doses of this medication (at least two weeks after) subsequently.

If you weigh less than 85kg, the maximum recommended dose is 25mg twice a day (total 50mg per day). If your weight is greater than 85kg, the maximum recommended dose is 50mg twice a day (100mg 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 medication should be done gradually over a few days, or reduce the dose by half every three days.

Use in children and adolescents:

Carvedilol is not recommended for use in children and adolescents under 18years due to the lack of sufficient data on safety and efficacy.

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 a little of its ability to pump blood and may produce difficulty breathing, weakness, and fluid accumulation), you should take this medication while eating, to avoid the feeling of dizziness when getting up.

Remember to take your medication.

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 medication with you. You can also consult the Toxicological Information Service, phone 91 562.04.20.

If you forgot to take Carvedilol Aurovitas:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Carvedilol Aurovitas:Aurovitas

The treatment with this medication should not be interrupted abruptly, especially if you suffer from ischemic cardiopathy, a disease that causes your heart not to 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Side effects are classified as: 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 unknown frequency (cannot be estimated from available data).

Infections and infestations

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

Nervous system disorders

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:Paresthesias (tingling sensation).

Mental and behavioural disorders

Common:Depressed mood, depression.

Uncommon:Mood disorders.

Unknown frequency: Hallucinations.

Cardiac disorders

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

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

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

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

Vascular disorders

Very common:Low blood pressure.

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

Respiratory, thoracic and mediastinal disorders

Common:Asthma and breathing difficulties in predisposed patients, 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:Cutaneous reactions (e.g. allergic exanthema, dermatitis, urticaria, pruritus, psoriasis, lichen planus-like skin lesions).

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

Haematological and lymphatic system disorders

Common:Anemia (decreased red blood cell count).

Rare:Thrombocytopenia (decreased platelet count).

Very rare:Leucopenia (decreased white blood cell count).

Hepatobiliary disorders

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

Ocular disorders

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

Renal and urinary disorders

Common:Acute kidney injury (kidney not functioning properly) and kidney function disorders in patients with diffuse vascular disease and/or altered kidney function.

Rare:Urination problems.

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

Immune system disorders

Very rare:Allergic reactions.

Musculoskeletal and connective tissue disorders

Common:Arm and leg pain.

Reproductive 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.

Unknown frequency: Possible manifestation of latent diabetes, or worsening of existing diabetes.

General disorders and administration site conditions

Very common:Fatigue.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

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, saccharose, magnesium stearate, macrogol 400, polisorbate 80, titanium dioxide (E 171), and hypromellose.

Appearance of the product and contents of the packaging

Film-coated tablet.

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

PVC/PE/PVDC-Aluminium:

Packaging size: 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: April 2025

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