CARVEDILOL ALTER 25 mg TABLETS

2. What you need to know before you take Carvedilol Alter

Do not take Carvedilol Alter if you have:

• If you are allergic to carvedilol or any of the excipients (listed in section 6).
• A type of decompensated heart failure called class IV (the heart is unable 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.
• A heart condition 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).
• A heart condition consisting of sinoatrial node block.
• Very low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions:

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

• If you have any lung disease.
• If you are diabetic.
• If you have a heart condition.
• 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 urine production), 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 are receiving treatment for your allergy.
• 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 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 Alter may reduce tear production.
• If you have had severe adverse skin 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 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 tests.

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 medications

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

This is very important because taking several medications at the same time can increase or decrease their effect. Therefore, you should not take carvedilol with any other medication unless your doctor has allowed it.

Note that these instructions may also apply to medications that have been used before or may be used after.

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

• Fluoxetine and paroxetine (medication for depression).

• Cyclosporine and tacrolimus (medication 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 such as aspirin and ibuprofen (NSAIDs).
• Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Medications for diabetes (including insulin and oral antidiabetics).
• Clonidine (medication used to control blood pressure or migraines).
• Rifampicin (medication for treating infections).
• Cimetidine (medication for treating 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).

Taking Carvedilol Alter with food, drinks, and alcohol

Avoid taking carvedilol simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may lead to an increase in the active ingredient carvedilol in the blood and cause unpredictable side effects. Also, avoid excessive and simultaneous or occasional consumption of alcohol because alcohol influences the effect of carvedilol. Your doctor or pharmacist will inform you about the meals with which you should take the medication.

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 any medication.

The use of 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 suffering heart and lung problems.

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

Driving and using machines

Occasionally, carvedilol may impair your ability to drive or operate machines. This occurs especially when starting or changing treatment and when taking it in combination with alcohol.

Carvedilol Alter contains sucrose and lactose

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

3. How to take Carvedilol Alter

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

Essential hypertension:

Adults:

Oral. The recommended dose for starting treatment 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 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.

Elderly patients:

The recommended dose for starting therapy 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 dose for starting treatment is 12.5 mg twice a day (for a total of 25 mg per day) for the first two days. Then, the recommended dose is 25 mg twice a day (for a total of 50 mg per day). If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) up to 100 mg once a day or in two doses of 50 mg each.

Elderly patients:

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

Treatment of symptomatic congestive heart failure

Adults and elderly:

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

In case you are using medications for heart diseases (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 3.125 mg twice a day (for a total of 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 (for a total of 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 (for a total of 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 this medication.

As a general rule, regardless of your disease, the 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

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

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 some of its ability to pump blood and may cause difficulty breathing, weakness, and fluid accumulation), you should take carvedilol while eating to avoid feeling dizzy when standing up.

Remember to take your medication:

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, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

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

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 forgotten doses.

If you stop treatment with Carvedilol Alter

Treatment with carvedilol should not be stopped 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 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 all people suffer from them.

Effects are classified into: very frequent (may affect more than 1 in 10 patients), frequent (may affect up to 1 in 10 patients), infrequent (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

Infections and Infestations

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

Disorders of the Nervous System

Very frequent: Dizziness, headache, and weakness that are usually mild and occur mainly at the beginning of treatment,

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

Infrequent: Paresthesias (tingling sensation).

Psychiatric Disorders

Frequent: Depressed mood, depression.

Infrequent: Sleep disorders.

Unknown frequency: Hallucinations.

Cardiac Disorders

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

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

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

Unknown frequency: 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 frequent: Low blood pressure.

Frequent: 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 fingers and toes, ears, and nose), hypertension.

Respiratory, Thoracic, and Mediastinal Disorders

Frequent: Asthma and breathing difficulties in predisposed patients, fluid accumulation in the lungs.

Rare: Nasal congestion.

Gastrointestinal Disorders

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

Infrequent: Constipation.

Rare: Dry mouth.

Disorders of the Skin and Subcutaneous Tissue

Infrequent: Skin reactions (e.g., allergic exanthema, dermatitis, urticaria, itching, psoriasis, skin lesions of lichen planus type).

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

Disorders of the Blood and Lymphatic System

Frequent: 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).

Ocular Disorders

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

Renal and Urinary Disorders

Frequent: Acute renal failure (kidney does not function properly) and kidney function disorders in patients with diffuse vascular disease and/or altered renal function.

Rare: Urination problems.

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

Disorders of the Immune System

Very rare: Allergic reactions.

Musculoskeletal and Connective Tissue Disorders

Frequent: Limb pain.

Disorders of the Reproductive System and Breast

Infrequent: Impotence.

Metabolic and Nutritional Disorders:

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

Unknown frequency: It is possible that latent diabetes mellitus may manifest or that existing diabetes may worsen.

General Disorders and Administration Site Conditions

Very frequent: Fatigue.

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

If you consider that any of the adverse effects you are experiencing 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 Alter

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

Do not store above 30 °C.

Store in the original package.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages 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 packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Carvedilol Alter

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

Appearance of the Product and Package Contents

Carvedilol Alter 25 mg is presented in the form of white, round, and scored tablets on one of its faces.

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

SPAIN

Manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora.

PORTUGAL

or

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2,

Abrunheira, 2710-089 Sintra

PORTUGAL

Date of the Last Revision of this Prospectus:December 2023

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