CARVEDILOL ARISTO 25 mg TABLETS

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

Do not take Carvedilol Aristo:

• If you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• If you have decompensated heart failure of class IV (NYHA) (inability of the heart to perform its pumping function during physical activity and in most cases at rest) that requires the use of intravenous inotropics (medicines that increase heart strength).
• If you have chronic obstructive pulmonary disease with a bronchospastic component (chronic lung disease that produces difficulty breathing) in patients who are receiving oral or inhaled treatment.
• If you have clinically manifest hepatic dysfunction (liver disorders).
• If you have asthma.
• If you have a second or third degree AV block (cardiac block).
• If you have severe bradycardia (less than 50 heartbeats per minute).
• In case of cardiogenic shock (heart failure).
• In case of sinus disease (including sinoatrial block).
• In case of severe hypotension (systolic blood pressure less than 85 mmHg).

Warnings and precautions

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

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

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

• Carvedilol Aristo will be administered with caution if there is suspicion of having Prinzmetal's vasospastic angina, as well as if you have severe peripheral circulation disorders. In rare cases, worsening of symptoms has been seen in patients with angina pectoris (chest pain).
• If you are going to undergo surgery, you should inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (skin disease that can be caused by multiple causes).
• If you have pheochromocytoma (adrenal gland disorder) that is not properly controlled by alpha blockade.
• If you have any thyroid disorder.
• If you have a history of severe hypersensitivity reactions (severe allergies) or are undergoing desensitization therapy (treatment for these severe allergies).

Consult your doctor even if any of the mentioned circumstances have occurred to you at some point.

Children and adolescents

Efficacy and safety in children have not been established.

Use of Carvedilol Aristo with other medicines

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

This is extremely important, as taking more than one medicine at the same time can potentiate or weaken its effect. Therefore, you should not take Carvedilol Aristo with any other medicine, unless your doctor has allowed it.

Carvedilol may interact with antihypertensives (medicines to lower blood pressure), clonidine (medicine to lower blood pressure), antiarrhythmics (medicine for the treatment of heart rhythm disorders), digitalis (medicine for the treatment of decreased heart function), calcium antagonists (verapamil or diltiazem), hypnotics or tranquilizers, antidepressants, narcotics, anesthetics, alcohol, preparations against migraine and asthma, anti-inflammatory drugs, the antibiotic rifampicin, and cimetidine.

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

Taking Carvedilol Aristo with food and drinks

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

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 medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Use in athletes

Athletes are informed that this medicine contains a component that can result in a positive doping test.

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

3. How to take Carvedilol Aristo

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

Remember to take your medicine.

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

If you have congestive heart failure, you should take Carvedilol Aristo with foodto slow down its absorption rate and thus reduce the incidence of orthostatic effects (feeling of 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 at 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 in adult patients and elderly patients.

Long-term therapy for ischemic heart disease

Initial dose 12.5 mg, twice a day.

Maintenance dose 25 mg, twice a day.

If necessary, the dose can be increased at 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 2 doses.

Symptomatic congestive heart failure

The dose must be determined individually, and you must be closely monitored by your doctor during the dose adjustment phase. You must strictly follow your doctor's instructions regarding the administration of this medicine.

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 stop treatment before it is indicated, especially if you have ischemic heart disease. Withdrawal of Carvedilol Aristo should be gradual over a few days, or by reducing the dose by 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Carvedilol Aristo

Do not take a double dose to make up for forgotten doses.

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

If you stop treatment with Carvedilol Aristo

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that have been observed are the following:

Central nervous system: Occasionally headache, dizziness, and fatigue, isolated cases of depressive state, sleep disorders, and paresthesia (tingling, numbness, pinching).

Cardiovascular system: Occasionally edema, hypotension (decrease in blood pressure), postural hypotension, bradycardia (decrease in 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 pre-existing diabetes mellitus, weight gain, and hypercholesterolemia (increase in blood cholesterol).

In isolated cases, allergic skin 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 failure, and renal function abnormalities in patients with diffuse vascular disease or impaired renal function have also been reported.

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

If you notice any other side effect not mentioned in this package leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the national reporting system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carvedilol Aristo

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

Do not store above 30°C. Protect from light.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Carvedilol Aristo

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

Appearance of the product and pack contents

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

Packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid - Spain

Manufacturer:

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1 (Barleben)

D-39179 - Germany

Or

Laboratorios Medicamentos Internacionales S.A. (Medinsa)

C/Solana, 26

28850 – Torrejon de Ardoz

Madrid

This package leaflet was approved in July 2004

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.gob.es/