Carvedilol Alter 25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Carvedilol Alter 25 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Carvedilol Alter 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. It also reduces cardiac output and has beneficial effects on blood circulation in the heart.

Carvedilol Alter is indicated for the treatment of:

• Symptomatic congestive heart failure (the heart has lost part 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 Alter

Do not take Carvedilol Alter if you have:

• Hypersensitivity to carvedilol or to any of the excipients (listed in section 6).
• 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).
• Impaired liver function.
• Bronchial asthma.
• Heart disease involving second- or third-degree atrioventricular (A-V) block (unless a permanent pacemaker has been implanted).
• Slow heart rate (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).
• Sino-auricular node block (a heart condition).
• Very low blood pressure (systolic pressure below 85 mmHg).

Warnings and precautions:

Consult your doctor or pharmacist before starting Carvedilol Alter. Inform your doctor if you have any of the following conditions:

• Any lung disease.
• Diabetes.
• Any heart disease.
• If you are taking other heart medications, especially if you are taking any of the following: digitalis (increases the force of heart contractions), diuretics (increase urine output), ACE inhibitors (antihypertensive drugs), calcium channel blockers (antihypertensive drugs), or antiarrhythmics (affect heart rhythm).
• Any thyroid disorder.
• Allergies and undergoing allergy treatment.
• Circulatory problems or Raynaud's phenomenon.
• If you have a surgical procedure scheduled, inform your doctor that you are being treated with carvedilol.
• If you have a condition called phaeochromocytoma.
• Psoriasis (a skin disease).
• Prinzmetal's angina (chest pain occurring at rest without obvious cause).
• If you are undergoing surgery with anesthesia. Inform the anesthesiologist that you are taking carvedilol.
• If you wear contact lenses. Carvedilol Alter may reduce tear production.
• If you suffer from severe cutaneous adverse reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medications with beta-blocking activity, treatment with carvedilol should not be stopped abruptly. The dose must be gradually reduced according to your doctor's instructions.

Use in athletes

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

Children and adolescents

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

Taking Carvedilol Alter with other medicines

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 simultaneously may increase or decrease their effects. Therefore, you should not take carvedilol with any other medicine unless authorized by your doctor.

Note that these instructions may also apply to medicines taken previously or those that may be used 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 conditions).
• Certain analgesics 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 gastric 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).

Taking Carvedilol Alter with food, drinks, and alcohol

You should avoid taking carvedilol simultaneously 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 alcohol consumption should also be avoided, as alcohol affects the action of carvedilol. Your doctor or pharmacist will advise you on which meals to take the medicine with.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

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

Carvedilol may cause fetal death in utero and premature delivery. 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; therefore, its use is not recommended during breastfeeding.

Driving and use of machines

Carvedilol 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 Alter contains sucrose and lactose

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

3. How to take Carvedilol Alter

Follow exactly the instructions for use of this medicine as given by your doctor. If 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:

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).

Ischemic heart disease:

Adults:

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

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:

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

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 carvedilol for the treatment of symptomatic congestive heart failure is 3.125 mg twice daily (total 6.25 mg daily) for two weeks. If this dose is well tolerated, it may subsequently be increased (at intervals of at least two weeks) to 6.25 mg twice daily (total 12.5 mg daily). Your doctor may then prescribe higher doses of carvedilol (after at least two weeks).

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

Your doctor will inform you about the duration of your treatment with this medicine.

As a general rule, regardless of your condition, carvedilol should be withdrawn gradually over several days, reducing the dose by half every three days.

Use in children and adolescents

This medicine 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 of its ability to pump blood and you may experience shortness of breath, weakness, and fluid retention), you should take carvedilol with food to avoid dizziness upon standing.

Remember to take your medicine:

If you take more Carvedilol Alter than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

For administration of 3.125 mg or 6.25 mg doses, other commercial presentations containing this amount of active ingredient are available.

The tablet can be divided into equal doses.

If you forget to take Carvedilol Alter:

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

If you stop taking Carvedilol Alter:

Treatment with carvedilol must not be stopped abruptly, especially if you have ischemic 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 doubts about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

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

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 frequency not known (cannot be estimated from available data).

Infections and infestations

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

Disorders of the nervous system

Very common: Dizziness, headache, 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), disorders of peripheral circulation (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, fluid accumulation in the lungs.

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal discomfort with symptoms such as nausea, diarrhea, 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, lichenoid skin lesions).

Frequency not known: Hair loss, severe skin adverse 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 (leucopenia).

Hepatobiliary disorders

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

Eye disorders

Common: Reduced 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 kidney function.

Rare: Problems with urination.

Frequency not known: Urinary incontinence in women (resolves upon stopping 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 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 via 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 Alter

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carvedilol Alter

• The active substance is carvedilol. Each tablet contains 25 mg.
• The other components are: Sucrose, lactose monohydrate, corn starch, povidone, anhydrous colloidal silica, crospovidone and magnesium stearate.

Appearance of the product and contents of the pack

Carvedilol Alter 25 mg is presented as white, round, scored tablets on one side.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2,

Abrunheira, 2710-089 Sintra

Portugal

Date of the most recent review of this leaflet: December 2023

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