Carvedilol Sandoz 6.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carvedilol Sandoz 6.25 mg tablets EFG

Carvedilol Sandoz 25 mg tablets EFG

carvedilol

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

• Keep this leaflet, as 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 Sandoz is and what it is used for
2. What you need to know before taking Carvedilol Sandoz
3. How to take Carvedilol Sandoz
4. Possible side effects
5. How to store Carvedilol Sandoz
6. Contents of the pack and other information

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

Carvedilol Sandoz contains carvedilol as the active substance, which belongs to a group of medicines known as alpha and beta receptor blockers. Carvedilol has antioxidant, antihypertensive (blood pressure-lowering), vasodilatory, and antianginal properties. It also reduces cardiac output and has beneficial effects on blood circulation in the heart. Carvedilol is indicated in the treatment of:

• Symptomatic congestive heart failure (the heart has lost part of its ability to pump blood), of moderate to severe degree, whether of ischaemic or non-ischaemic origin, in addition to standard therapy (such as ACE inhibitors and diuretics with or without digitalis).
• Essential hypertension (high blood pressure).
• Ischaemic heart disease (reduced blood and oxygen supply to the heart).

Note on use in chronic heart failure:

• Treatment with carvedilol may only be initiated if the patient has been stabilised with conventional basic therapy for heart failure; that is, the dose of this existing standard treatment must have remained stable for at least four weeks before starting treatment with carvedilol.

2. What you need to know before taking Carvedilol Sandoz

Do not take Carvedilol Sandoz:

• If you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6).
• If you have decompensated heart failure of NYHA class IV (inability of the heart to pump blood adequately during physical activity and at rest).
• If you have chronic obstructive pulmonary disease (COPD), with obstructed airways (difficulty breathing).
• If your liver is not working properly (liver impairment).
• If you have bronchial asthma.
• If you have a heart condition known as second- or third-degree atrioventricular block (unless you have a permanent pacemaker implanted).
• If your heart beats too slowly (less than 50 beats per minute).
• If you are in cardiogenic shock (a condition in which the heart is so damaged that it cannot supply enough blood to the body's organs).
• If you have a heart condition known as sinoatrial block.
• If you have very low blood pressure (systolic pressure less than 85 mmHg).

Special caution is required when carvedilol is administered at the same time as certain medications such as adrenaline (also epinephrine) used to treat allergic (anaphylactic) reactions.

You may respond less effectively to these medications. Inform your doctor immediately if you have any of these conditions or associated circumstances, as they must be considered before or during treatment.

Withdrawal symptoms (withdrawal syndrome)

Treatment with carvedilol must not be stopped suddenly. This is especially important in patients with heart disease due to reduced blood flow to the coronary arteries. Instead, the dose should be gradually reduced over a period of 2 weeks.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Carvedilol Sandoz.

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

• Any lung disease.
• Diabetes (high blood sugar).
• A heart condition.
• If you are taking other heart medications, especially if you are taking any of the following medicines: digitalis (increases the strength of the heartbeat), diuretics (increase urine output), ACE inhibitors (antihypertensive medicines), calcium antagonists (antihypertensive medicines), or antiarrhythmics (medicines that affect heart rhythm).
• Any thyroid problems.
• If you are allergic and are receiving treatment for your allergy.
• 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 condition).
• If you have Prinzmetal's angina (chest pain occurring at rest without obvious cause).
• If you are undergoing surgery with anesthesia. You must inform your anesthesiologist.
• If you wear contact lenses. Carvedilol may reduce tear production.
• If you experience severe skin adverse reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medicines with beta-blocking activity, treatment with carvedilol must not be stopped abruptly. The dose must be gradually reduced as directed by your doctor.

Use in athletes

Athletes should be informed that this medicine contains a component that may lead to a positive analytical finding in doping controls.

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.

Elderly patients

Elderly patients may be more sensitive to carvedilol and should be monitored more carefully.

Other medicines and Carvedilol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

This is extremely important, as taking more than one medicine at the same time may increase or decrease their effects. Therefore, you should not take carvedilol with any other medicine unless instructed by your doctor. Note that these instructions may also apply to medicines you have taken previously or may take in the future.

Inform your doctor if you are taking any of the following medicines:

• Fluoxetine and paroxetine (medicines used to treat 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).
• Dihydropyridines (medicines used to treat high blood pressure or angina).
• 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 used to treat depression).
• β-agonist bronchodilators (medicines used to improve breathing, for example in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).
• Other antihypertensive medicines (e.g., reserpine, guanethidine, alpha-methyldopa, guanfacine, alpha-blockers, or nitrate preparations).

Taking Carvedilol Sandoz with food, drinks, and alcohol

You should avoid taking carvedilol at the same time as, or immediately after, consuming grapefruit or grapefruit juice. Grapefruit or grapefruit juice may increase carvedilol levels in the blood and cause unpredictable adverse effects. You should also avoid excessive and simultaneous or occasional consumption of alcohol, as alcohol may affect the action of carvedilol.

Your doctor or pharmacist will advise you about the meals with which it is recommended to take carvedilol.

Pregnancy and breastfeeding

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

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

Carvedilol may cause fetal death in utero and premature birth. In addition, adverse effects may occur in the fetus and newborn. After birth, the newborn has an increased risk of heart and lung problems.

Since carvedilol is excreted in breast milk, its use is not recommended during breastfeeding.

Driving and using machines

Carvedilol may occasionally impair your ability to drive or operate machinery. This is especially likely when starting or changing treatment and when taking alcohol at the same time.

Carvedilol Sandoz contains lactose

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

3. How to take Carvedilol Sandoz

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

The usual dose is:

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 gradually 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

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/day).

Elderly

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

Symptomatic congestive heart failure

Adults and elderly

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

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

In any case, the recommended starting dose of carvedilol for the treatment of symptomatic congestive heart failure is 3.12 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 later prescribe (after at least two weeks) higher doses of carvedilol.

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, carvedilol should be withdrawn gradually over several days, or the dose should be halved every three days.

Use in children and adolescents

Carvedilol is not recommended for use in children and adolescents under 18 years of age, as there is insufficient data on safety and efficacy.

Instructions for correct administration

The tablets should be swallowed with sufficient liquid, preferably with 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 accumulation), you should take carvedilol with food to help prevent dizziness upon standing.

Remember to take your medicine.

If you take more Carvedilol Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Carvedilol Sandoz

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

If you stop taking Carvedilol Sandoz

Treatment with carvedilol should not be stopped abruptly, especially if you have ischaemic heart disease, a condition that causes 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 can cause adverse effects, although not everyone will experience them.

The frequencies of adverse effects are listed below according to the following definitions:

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)
Frequency not known (cannot be estimated from available data)

The adverse effects observed are as follows:

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, nightmares, confusion, psychosis.

Cardiac disorders

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

Common: Bradycardia (slowing of the heart rate), fluid overload, increase in 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, 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, erythema multiforme, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Blood and lymphatic system disorders

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

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

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

Hepatobiliary disorders

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

Eye disorders

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

Renal and urinary disorders

Common: Acute renal failure (kidney 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 discontinuation of the medicine).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Pain in the limbs.

Reproductive system and breast disorders

Uncommon: Impotence.

Metabolism and nutrition disorders

Common: Worsening of blood sugar control in diabetic patients (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 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 Sandoz

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

Do not store above 30°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after CAD/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 containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carvedilol Sandoz 6.25 mg:

• The active substance is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, povidone K 30, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (E 172).

Composition of Carvedilol Sandoz 25 mg:

• The active substance is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, povidone K 30, colloidal anhydrous silica, magnesium stearate.

Appearance of the product and contents of the pack

Carvedilol Sandoz 6.25 mg are round, biconvex, yellow tablets, scored on both sides and marked with "C2" on one side.

Packaged in containers of 28 tablets.

Carvedilol Sandoz 25 mg are round, biconvex, white tablets, scored on both sides and marked with "C4" on one side.

Packaged in containers of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Salutas Pharma GmbH
Otto Von Guericke Allee 1
39179 Barleben
Germany

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

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