Package Insert: Information for the User

Carvedilol Alter 25 mg Tablets EFG

Read the entire package insert carefully before starting to take the medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given 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 not listed in this package insert. See section 4

Carvedilol Alter contains carvedilol as the active ingredient. It belongs to a group of medications known as alpha 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 Alter is indicated for the treatment of:

• Heart failure with symptoms (the heart has lost part of its ability to pump blood) of moderate to severe degree, of ischemic or non-ischemic origin.

• Essential hypertension (elevated blood pressure).

Ischemic cardiopathy (little blood and oxygen reaches the heart).

Do not take Carvedilol Alter if you have:

• If you are allergic to carvedilol or any of the excipients (listed in section 6).
• Severe heart failure (class IV) (heart's inability to pump blood during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• Impaired liver function.
• Asthma.
• Heart disease consisting of second- and 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 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 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 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 any heart disease.
• If you are taking other heart medications, especially if you are taking any of the following medications, inform your doctor: digitalis (increases the force of the heart's beat), diuretics (increases urine production), ACE inhibitors (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (act on the heart's 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 Alter may reduce tear production.
• If you have severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all beta-blocker medications, do not stop treatment with carvedilol 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

Carvedilol is not recommended for use in children and adolescents under 18 years due to insufficient safety and efficacy data.

Carvedilol Alter with other medications

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. Therefore, do not take carvedilol with any other medication unless your doctor has permitted it.

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

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

• Fluoxetine and paroxetine (depression medication).

• Ciclosporin and tacrolimus (medications used to prevent transplant rejection).
• Digoxin, verapamil, diltiazem, and anti-arrhythmics (medications used to treat heart and blood pressure problems).
• Amiodarone (medication used to treat certain heart problems).
• Certain analgesics, such as Aspirin and Ibuprofen (NSAIDs).
• Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Diabetes medications (including insulin and oral antidiabetic medications).
• Clonidine (medication used to control blood pressure or migraines).
• 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).
• MAO inhibitors (medications used to treat depression).
• β-agonist bronchodilators (medications used to improve respiratory function, such as in asthma).

Carvedilol Alter with food, drinks, and alcohol

Avoid taking carvedilol 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 may affect the carvedilol effect. Your doctor or pharmacist will inform you about the foods with which you should take the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

Carvedilol is not recommended during pregnancy and breastfeeding.

Carvedilol may cause fetal death in the womb, as well as premature birth. 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 may impair your ability to drive or operate machinery, especially when starting or changing treatment and when taken with alcohol.

Carvedilol Alter 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 indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Essential hypertension:

Adults:

Oral route. The recommended starting dose is 12.5 mg once a day for the first two days. Subsequently, 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.

Older patients:

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 cardiopathy:

Adults:

Oral route. The recommended starting dose is 12.5 mg twice a day (total 25 mg per day) for the first two days. Subsequently, 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 100 mg once a day or in two doses of 50 mg each.

Older patients:

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

Treatment of symptomatic congestive heart failure

Adults and elderly:

Oral route. 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 heart disease medications (digitalis) or blood pressure control medications (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 carvedilol treatment in symptomatic congestive heart failure is 3.125 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 (at least two weeks after).

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 greater than 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, carvedilol withdrawal should be done gradually over a few days, or reduce the dose by half every three days.

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 18 years 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 carvedilol while eating, to avoid the feeling of dizziness when getting up.

Remember to take your medication:

If you take more Carvedilol Alter than you should:

In case of overdose or accidental ingestion or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

The tablet can be divided into equal doses.

If you forgot to take Carvedilol Alter:

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

If you interrupt treatment with Carvedilol Alter

Treatment with carvedilol should not be interrupted abruptly, especially if you have ischemic cardiopathy, a disease that causes the 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 doubts about the use of this product, 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 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) and frequency not known (cannot be estimated from available data).

Infections and infestations

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

Nervous system disorders

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

Common: Lightheadedness, fainting, especially at the beginning of treatment.

Uncommon: Paresthesias (tingling sensation).

Mental disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Frequency not known: Hallucinations.

Cardiac disorders

Very common: Increased 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).

Frequency not known: 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), increased symptoms in patients with intermittent claudication (increased pain in the legs 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 breathing difficulties in predisposed patients, accumulation of fluid in the lungs.

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal disturbances 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 exanthema, dermatitis, urticaria, itching, psoriasis, flat-topped lesions).

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

Haematological and lymphatic system disorders

Common: Decreased red blood cell count in blood (anemia).

Rare: Decreased platelet count in blood (thrombocytopenia)

Very rare: Decreased white blood cell count in blood (leucopenia).

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 renal failure (kidney not functioning well) and kidney 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 medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Limb 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.

Frequency not known: 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 experience 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30 °C.

Store in the original packaging.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carvedilol Alter

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

Appearance of the product and contents of the packaging

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

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

SPAIN

Responsible for manufacturing:

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

Last review date of this leaflet:December2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/