Patient Information Leaflet

Carvedilol Aristo 25 mg Tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, 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.

Table of Contents:

1. What Carvedilol Aristo is and what it is used for
2. What you need to know before you start taking Carvedilol Aristo
3. How to take Carvedilol Aristo
4. Possible side effects
5. Storage of Carvedilol Aristo
6. Contents of the pack and additional information

Each tablet contains carvedilol as the active ingredient, which is an alpha and beta receptor blocker with antioxidant properties. It also has complementary actions of vasodilation, reduced cardiac output, anti-hypertensive properties (reduction of blood pressure), anti-anginal effects, and favorable effects on cardiac blood circulation.

Carvedilol Aristo is indicated for the treatment of symptomatic congestive heart failure (heart's inability to pump effectively) of moderate to severe degree, of ischemic or non-ischemic origin.

Do not take Carvedilol Aristo:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have decompensated heart failure of class IV (NYHA) (heart's inability to pump blood with physical activity and in most cases at rest) that requires the use of inotropic intravenous medications (medications that increase heart strength).
• If you have chronic obstructive pulmonary disease with a bronchoconstrictive component (chronic lung disease that produces difficulty breathing) in patients receiving oral or inhaled treatment.
• If you have clinically manifest liver dysfunction (liver alterations).
• If you have asthma.
• If you have a second- and third-degree atrioventricular block (cardiac block).
• If you have severe bradycardia (less than 50 heartbeats per minute).
• In case of cardiogenic shock (cardiac failure).
• In case of sinus disease (including sinoatrial block).
• In case of severe hypotension (systolic pressure less than 85 mmHg).

Warnings and precautions

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

• If you have diabetes mellitus (elevated blood sugar).
• If you have congestive heart failure and risk factors (hypotension, ischemic heart disease, diffuse vascular disease, and underlying renal insufficiency), as your doctor will need to monitor your renal function during the dose adjustment phase.

The treatment with Carvedilol Aristo should not be interrupted abruptly, especially in patients with ischemic heart disease. The withdrawal of Carvedilol Aristo should be gradual over a few days, or by reducing the dose by half every three days.

• Carvedilol Aristo should be administered with caution if you suspect having Prinzmetal's variant angina (angina caused by coronary spasms), as well as if you have severe peripheral circulation disorders. In rare cases, symptoms have worsened in patients with angina pectoris (chest pain).
• If you are about to undergo surgery, you must inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (skin disease that can be caused by multiple factors).
• If you have pheochromocytoma (suprarenal capsule alteration) that is not adequately controlled by alpha blockade.
• If you have thyroid disorders.
• If you have a history of severe hypersensitivity reactions (severe allergies) or are undergoing desensitization therapy (treatment for severe allergies).

Consult your doctor even if any of the mentioned circumstances have occurred at any time.

Children and adolescents

The efficacy and safety in children have not been established.

Use of Carvedilol Aristo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is extremely important, as taking multiple medications at the same time can either potentiate or weaken their effect. Therefore, do not take Carvedilol Aristo with any other medication unless your doctor has allowed it.

Carvedilol may interact with antihypertensives (medications to lower blood pressure), clonidine (medication to lower blood pressure), antiarrhythmics (medications to treat heart rhythm disorders), digitalis (medication to treat decreased heart function), calcium channel blockers (verapamil or diltiazem), sedatives or tranquilizers, antidepressants, narcotics, anesthetics, alcohol, migraine and asthma medications, anti-inflammatory medications, the antibiotic rifampicin, and cimetidine.

It may also potentiate or weaken the effect of medications used to reduce blood sugar levels, such as insulin or oral antidiabetic medications, so your doctor may adjust the dose of the antidiabetic medication and/or modify your diet.

Taking Carvedilol Aristo with food and beverages

You should avoid taking alcohol during treatment with Carvedilol Aristo as it may alter its effects. Your doctor or pharmacist will inform you about the meals with which it is recommended to take the medication.

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.

Pregnancy

There is not enough experience with carvedilol in pregnant women, so your doctor will evaluate the benefit/risk of administering carvedilol or not.

Breastfeeding

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

Driving and operating machinery

There may be individual reactions that alter alertness (e.g., the patients' ability to drive vehicles or operate machinery). This is mainly manifested when starting or changing treatment, as well as in conjunction with alcohol.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical result in doping control.

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

Remember to take your medication.

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

If you have congestive heart failure, you must take Carvedilol Aristo with foodto slow down your absorption rate and thus reduce the incidence of orthostatic effects (dizziness when standing up).

If you do not have congestive heart failure, it is not necessary to take Carvedilol Aristo with food.

The recommended dose is

Essential hypertension

Initial dose 12.5 mg once a day.

Maintenance dose 25 mg once a day.

If necessary, the dose can be increased in intervals of at least two weeks up to a maximum dose of 50 mg once a day (or administered in two doses).

This regimen is the same for adult patients and elderly patients.

Prolonged therapy for ischemic cardiopathy

Initial dose 12.5 mg, twice a day.

Maintenance dose 25 mg, twice a day.

If necessary, the dose can be increased in intervals of at least two weeks up to a maximum dose of 50 mg, twice a day.

The maximum recommended dose for elderly patients is 25 mg daily administered in two doses.

Symptomatic congestive heart failure

The dose should be determined individually and you should be closely monitored by your doctor during the adjustment to higher doses. You must strictly follow your doctor's instructions regarding the administration of this medication.

If you are taking other medication, it should be your doctor who establishes the treatment.

If you have previously taken lower doses of Carvedilol Aristo and your doctor has prescribed the continuation of treatment with Carvedilol Aristo, the recommended dose is 1 tablet (25 mg) twice a day for two weeks.

Your doctor will indicate the duration of your treatment with Carvedilol Aristo. Do not discontinue treatment before the indicated time, especially if you have ischemic cardiopathy. The withdrawal of Carvedilol Aristo should be gradual over a few days, or by reducing the dose to half every three days.

If you are taking other medication, it should be your doctor who establishes the treatment.

If you take more Carvedilol Aristo than you should

Consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Carvedilol Aristo

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

Instead, continue your usual dosing schedule and consult your doctor.

If you interrupt treatment with Carvedilol Aristo

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not all people may experience them.

The adverse effects that have been observed are as follows:

Central Nervous System: Occasionally, headache, dizziness, and fatigue, isolated cases of a depressive state, sleep disorders, and paresthesias (tingling, numbness, pins and needles).

Cardiovascular System: Occasionally, edema, hypotension (decreased blood pressure), postural hypotension, bradycardia (decreased heart rate), isolated cases of syncope, AV block (heart rhythm disorders), and heart failure during the dose escalation phase, peripheral circulation disorders (cold extremities); exacerbation of symptoms in patients with intermittent claudication or Raynaud's disease.

Respiratory System: Occasionally, nasal congestion, and in patients with a certain predisposition, asthma/dyspnea.

Gastrointestinal System: Occasionally, nausea, abdominal pain, diarrhea, and very rarely constipation and vomiting.

Hematology: Occasionally, thrombocytopenia (reduction of platelet count in peripheral blood).

Metabolism: Occasionally, hyperglycemia, in patients with existing diabetes mellitus, weight gain, and hypercholesterolemia (increased cholesterol in blood).

In isolated cases, skin allergic reactions, alterations of serum transaminases, and leukopenia, pain in the extremities, and decreased tear production have been reported.

Isolated cases of vision disorders, acute renal insufficiency, and renal function abnormalities in patients with diffuse vascular disease or renal function deterioration have also been reported.

The frequency of adverse effects is not proportional to the dose, except for dizziness, vision disorders, and bradycardia.

If any other adverse effect not described in this prospectus is observed, consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the national notification system: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C. Protect it from light.

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 trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carvedilol Aristo

• The active ingredient of Carvedilol Aristo 25 mg tablets is carvedilol.
• The other components are: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K 30, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

Carvedilol Aristo 25 mg are white, round, convex, scored, and oral tablets.

Packaging with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid - Spain

Responsible for manufacturing:

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1 (Barleben)

D-39179 - Germany

Ó

Laboratorios Medicamentos Internacionales S.A. (Medinsa)

C/Solana, 26

28850 – Torrejon de Ardoz

Madrid

This leaflet was approved in July 2004

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.gob.es/