CARVEDILOL SANDOZ 6.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Carvedilol Sandoz 6.25 mg Tablets EFG

Carvedilol Sandoz 25 mg Tablets EFG

carvedilol

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.

• 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 pack and other information

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

1. What is Carvedilol Sandoz and what is it 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 (reducing blood pressure), vasodilating, and anti-anginal properties. It also reduces cardiac output and has beneficial effects on blood circulation at the heart level. Carvedilol 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, in addition to standard treatment (such as ACE inhibitors and diuretics with or without digitalis).
• Essential hypertension (high blood pressure).
• Ischemic heart disease (little blood and oxygen reach the heart)

Note on use in chronic heart failure:

• Treatment with carvedilol can only be initiated if the patient has been stabilized with conventional basic treatment for heart failure, i.e., 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 you take Carvedilol Sandoz

Do not take Carvedilol Sandoz:

• If you are allergic to carvedilol or any of the other components of this medicine (listed in section 6).
• If you have decompensated heart failure of class IV (NYHA) (the heart is unable to perform its pumping function during physical activity and at rest).
• If you have chronic obstructive pulmonary disease (COPD), with obstructed bronchi (difficulty breathing).
• If your liver is not functioning properly (liver disorders).
• If you have bronchial asthma.
• If you have a heart disease that consists of a second- or third-degree atrioventricular block (unless you have a permanent pacemaker implanted).
• If your heart beats slowly (less than 50 heartbeats per minute).
• In case of 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).
• In case of heart disease that consists of sinoatrial node block.
• In case of very low blood pressure (systolic pressure less than 85 mmHg).

When carvedilol is administered at the same time as certain medications, such as adrenaline (also epinephrine) to treat allergic reactions (anaphylactic), special caution is required. It is possible that they may respond less to these. Inform your doctor immediately if you have these diseases or circumstances that accompany them, as they must be taken into account before or during treatment.

Withdrawal symptoms (withdrawal syndrome)

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

Warnings and precautions

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

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

• If you have any lung disease.
• If you have diabetes (high blood sugar).
• If you have heart disease.
• If you are taking other heart medications, especially if you are taking any of the following medications, you should inform your doctor: digitalis (increases the strength of the heartbeat), diuretics (increases the amount of urine), ACE inhibitors (antihypertensive medication), calcium antagonists (antihypertensive medication), and antiarrhythmics (act on the heart rhythm).
• If you have any thyroid problems.
• If you are allergic and receive any treatment for your allergy.
• If you have circulation problems or Raynaud's phenomenon.
• If you have scheduled 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 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 skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

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

Use in athletes

Athletes are informed that this medication contains a component that 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.

Older adults

Older adults may be more sensitive to carvedilol and should be monitored more closely.

Other medications and Carvedilol Sandoz

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

This is extremely important, as taking more than one medication at the same time can increase or decrease its effect. Therefore, you should not take carvedilol with any other medication unless your doctor indicates it. Note that these instructions may also apply to medications that have been used before or may be used after.

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

• Fluoxetine and paroxetine (medications for depression).
• Cyclosporine and tacrolimus (medications used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and antiarrhythmic medications (medications used to treat heart problems and high blood pressure).
• Amiodarone (medication used to treat certain heart problems).
• Certain pain relievers of the aspirin and ibuprofen type (NSAIDs).
• Other medications for high blood pressure, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Medications for diabetes (including insulin and oral antidiabetics).
• Clonidine (medication used to control high blood pressure or migraines).
• Dihydropyridines (medications used to treat high blood pressure or angina pectoris).
• Rifampicin (medication used to treat infections).
• Cimetidine (medication used to treat stomach problems).
• Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).
• Monoamine oxidase inhibitors (medications for depression).
• Beta-agonist bronchodilators (medications used to improve respiratory capacity, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).
• Other antihypertensive medications (e.g., reserpine, guanethidine, alpha-methyldopa, guanfacine, alpha blockers, or nitro preparations).

Taking Carvedilol Sandoz with food, drinks, and alcohol

It is recommended to avoid taking carvedilol simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in carvedilol in the blood and lead to unpredictable side effects. Excessive and simultaneous or occasional consumption of alcohol should also be avoided, as alcohol influences the effect of carvedilol.

Your doctor or pharmacist will inform 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

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

Driving and using machines

Occasionally, carvedilol may impair the ability to drive or operate machines. This occurs especially when starting or changing treatment and when taken together with alcohol.

Carvedilol Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

3. How to take Carvedilol Sandoz

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

The normal dose is:

Essential hypertension

Adults

Oral. The recommended starting dose 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 gradually 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.

Older adults

Oral. The recommended starting dose 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 starting dose is 12.5 mg twice a day (total 25 mg per day) for the first two days. Then, the recommended dose is 25 mg twice a day (total 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 (total 100 mg/day).

Older adults

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

Symptomatic congestive heart failure

Adults and older adults

Oral. Your doctor will indicate the individual dose you should take, monitoring you during the adjustment to higher doses.

In case you are taking other 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 medications you should take.

In any case, the recommended dose for starting treatment with carvedilol in the treatment of symptomatic congestive heart failure is 3.12 mg twice a day (total 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 (total 12.5 mg per day).

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

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice a day (total 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, withdrawal of carvedilol should be done gradually over a few days, or the dose should be reduced by half every three days.

Use in children and adolescents

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

Guidelines 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 may cause difficulty breathing, weakness, and fluid accumulation), you should take carvedilol while eating to avoid dizziness when standing up.

Remember to take your medication.

If you take more Carvedilol Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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 interrupted abruptly, especially if you have ischemic heart disease, a disease 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 medication, 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.

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

Very common (may affect more than 1 in 10 patients)

Common (may affect up to 1 in 10 patients)

Uncommon (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 patients)

Very rare (may affect up to 1 in 10,000 patients)

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

The adverse effects that have been observed are the following:

Infections and Infestations

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

Disorders of the Nervous System

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

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

Uncommon: Paresthesias (tingling sensation).

Psychiatric Disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Frequency not known: Hallucinations, nightmares, confusion, psychosis.

Cardiac Disorders

Very common: Increased heart failure (the heart has lost part 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).

Frequency not known: 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 common: Low blood pressure.

Common: 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 the fingers and toes, ears, and nose), hypertension.

Respiratory, Thoracic, and Mediastinal Disorders

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

Rare: Nasal congestion.

Gastrointestinal Disorders

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

Uncommon: Constipation.

Rare: Dry mouth.

Disorders of the Skin and Subcutaneous Tissue

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

Frequency not known: Hair loss, severe cutaneous adverse reactions (e.g., toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Disorders of the Blood and Lymphatic System

Common: Decreased red blood cell count (anemia).

Rare: Decreased platelet count (thrombocytopenia)

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

Hepatobiliary Disorders

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

Eye Disorders

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

Renal and Urinary Disorders

Common: 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.

Frequency not known: Urinary incontinence in women (disappears when stopping the medication).

Disorders of the Immune System

Very rare: Allergic reactions.

Musculoskeletal and Connective Tissue Disorders

Common: Pain in the limbs.

Disorders of the Reproductive System and Breast

Uncommon: Impotence.

Metabolic and Nutritional Disorders

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

Frequency not known: It is possible that latent diabetes mellitus may manifest or that existing diabetes may worsen.

General Disorders and Administration Site Conditions

Very common: Fatigue.

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

If you consider that any of the adverse effects you are suffering from 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 Sandoz

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after CAD/EXP. 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 Sandoz 6.25 mg:

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

Composition of Carvedilol Sandoz 25 mg:

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

Appearance of the Product and Package Contents

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

They are available in packages of 28 tablets.

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

They are available in packages 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 Last Revision of this Prospectus:January 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/.