Package Leaflet: Information for the User

Carvedilol Sandoz 6.25 mg film-coated tablets EFG

Carvedilol Sandoz 25 mg film-coated tablets EFG

carvedilol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Carvedilol Sandoz contains carvedilol as the active ingredient, which belongs to a group of medications known as alpha and beta receptor blockers. Carvedilol has antioxidant properties, anti-hypertensive effects (reduction of blood pressure), vasodilatory effects, and anti-anginal effects. It also reduces cardiac output, and has favorable effects on blood circulation at the heart level.Carvedilol is indicated for the treatment of:

• Chronic 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, in addition to standard treatment (such as ACE inhibitors and diuretics with or without digitalis).
• Essential hypertension (elevated blood pressure).
• Ischemic cardiopathy (little blood and oxygen reaches the heart)

Note on the 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, that is, the dose of this existing standard treatment must have remained stable for at least four weeks before initiating treatment with carvedilol.

Do not take Carvedilol Sandoz:

• If you are allergic to carvedilol or any of the other components of this medication (listed in section 6).
• If you have decompensated heart failure class IV (NYHA) (heart inability to perform its pumping function with physical activity and at rest).
• If you have chronic obstructive pulmonary disease (COPD), with obstructed bronchi (difficulty breathing).
• If your liver does not function properly (liver alterations).
• If you have bronchial asthma.
• If you have a heart disease consisting of a second- and 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 consisting of sino-auricular block.
• In case of very low blood pressure (systolic pressure of less than 85 mmHg).

When carvedilol is administered at the same time as certain medications such as adrenaline (also epinephrine) for treating allergic reactions (anaphylactic) requires special caution.

You may respond less to these. Inform your doctor immediately if you have these diseases or circumstances that accompany them, as they should be taken into account before or during treatment.

Withdrawal symptoms (abstinence syndrome)

The 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 reduced gradually 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 (elevated blood sugar).
• If you have a 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 heartbeat), diuretics (increases the amount of urine), ACE inhibitors (anti-hypertensive medication), calcium antagonists (anti-hypertensive medication), and anti-arrhythmics (act on the heart rhythm).
• If you have any thyroid problems.
• If you are allergic and receive any allergy treatment.
• If you have circulation problems or Raynaud's phenomenon.
• If you have a scheduled surgical intervention, 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 going to undergo an operation with anesthesia. You must inform your responsible 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, you should not interrupt treatment with carvedilol abruptly. The dose should be reduced gradually according to your doctor's instructions.

Use in athletes

Inform athletes that this medication contains a component that may establish a positive analytical result in doping control.

Children and adolescents

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

Advanced age

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

Other medications and Carvedilol Sandoz

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

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

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

• Fluoxetine and paroxetine (depression medications).
• Ciclosporin and tacrolimus (medications used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medications used to treat heart problems and high blood pressure).
• Amiodarone (medication used to treat certain heart problems).
• Certain analgesics of the type of aspirin and ibuprofen (NSAIDs).
• Other medications for high blood pressure, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Diabetes medications (including insulin and oral antidiabetic medications).
• Clonidine (medication used to control high blood pressure or migraine).
• Dihydropyridines (medications used to treat high blood pressure or angina).
• Rifampicin, (medication for treating infections).
• Cimetidine (medication for treating gastrointestinal problems).
• Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).
• MAO 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 anti-hypertensive medications (e.g., reserpine, guanetidine, alpha-methyldopa, guanfacine, alpha-blockers, or nitrate preparations).

Carvedilol Sandoz with food, drinks, and alcohol

Carvedilol should be avoided simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in carvedilol in the blood and cause unpredictable adverse effects. Excessive and simultaneous or occasional consumption of alcohol should also be avoided, as alcohol affects the effect of carvedilol.

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

Pregnancy and breastfeeding

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

Carvedilol is not recommended for use during pregnancy and breastfeeding.

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

Due to carvedilol excretion in breast milk, its administration during breastfeeding is not recommended.

Driving and operating machines

In some cases, carvedilol may impair the ability to drive or operate machines. This occurs especially when starting or changing treatment and when taken concurrently with alcohol.

Carvedilol Sandoz contains lactose

If your doctor has indicated that you have a intolerance to certain sugars, consult with him

before taking this medication.

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 route. The recommended starting dose is 12.5 mg once a day for the first two days, followed by a recommended dose of 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.

Advanced age

Oral route. The recommended starting dose for treatment 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 for treatment is 12.5 mg twice a day (total 25 mg per day) for the first two days. Followed by a recommended dose of 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).

Advanced age

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

Symptomatic congestive heart failure

Adults and advanced age

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

In case you are taking other 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 types of medications you should take.

In any case, the recommended starting dose for carvedilol treatment in 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 you 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 carvedilol.

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

Carvedilol is not recommended for use in children and adolescents under 18 years old as there are not enough data on safety and efficacy.

Guidelines for correct administration

The tablets should be taken with sufficient liquid, preferably with a glass of water.

If you have congestive heart failure (your heart has lost a little 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 getting 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Carvedilol Sandoz

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

If you interrupt treatment with Carvedilol Sandoz

Carvedilol treatment 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The frequencies of side 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 available data)

The side effects that have been observed are as follows:

Infections and infestations

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

Nervous system disorders

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 beginning of treatment.

Uncommon:Paresthesias (tingling sensation).

Mental and behavioural 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 (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), worsening of 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, pulmonary congestion.

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:Cutaneous reactions (e.g., allergic exanthema, dermatitis, urticaria, pruritus, 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).

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 kidney failure (kidney not functioning properly) and kidney function disorders in patients with diffuse vascular disease and/or altered kidney 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:Arm or leg pain.

Reproductive and breast disorders

Uncommon:Impotence.

Metabolism and nutrition disorders

Common:Worsening of blood sugar control in patients with diabetes (hyperglycaemia, hypoglycaemia), weight gain, increased blood cholesterol.

Frequency not known:It is possible that latent diabetes mellitus may be manifested, or that 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 that any of the side effects you are experiencing 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 Medicinal Products 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 to protect it from light.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Carvedilol Sandoz 6.25 mg:

• The active ingredient is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other components are: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K 30, anhydrous colloidal 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 components are: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K 30, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the packaging

Carvedilol Sandoz 6.25 mg are round, convex tablets, yellow in color, scored on both faces, and with the mark C2 on one face.

They are presented in packs of 28 tablets.

Carvedilol Sandoz 25 mg are round, convex tablets, white in color, scored on both faces, and with the mark C4 on one face.

They are presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Salutas Pharma GmbH

Otto Von Guericke Allee 1

39179 Barleben

Germany

Last review date of this leaflet:January 2025

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