Coropres 6.25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Coropres 6.25 mg tablets

Carvedilol

Read the entire 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 questions, ask 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Coropres 6.25 mg tablets are and what they are used for
2. What you need to know before taking Coropres 6.25 mg tablets
3. How to take Coropres 6.25 mg tablets
4. Possible side effects
5. How to store Coropres 6.25 mg tablets
6. Contents of the pack and other information

1. What Coropres 6.25 mg tablets are and what they are used for

Coropres contains carvedilol as the active ingredient. It belongs to a group of medicines known as alpha and beta receptor blockers. Coropres has antioxidant, antihypertensive (reducing blood pressure), vasodilatory, and antianginal properties. It also reduces cardiac output and has beneficial effects on blood circulation in the heart.

Coropres is indicated for the treatment of:

• Symptomatic congestive heart failure (the heart has lost some of its ability to pump blood), moderate to severe, of ischemic or non-ischemic origin.
• Essential hypertension (high blood pressure).
• Ischemic heart disease (reduced blood and oxygen supply to the heart).

2. What you need to know before taking Coropres 6.25 mg tablets

Do not take Coropres 6.25 mg tablets if you have:

• Hypersensitivity to carvedilol or any of the excipients (listed in section 6).
• Decompensated heart failure of NYHA class IV (inability of the heart to perform its pumping function during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with bronchial obstruction (difficulty breathing).
• Impaired liver function.
• Bronchial asthma.
• Heart disease involving second- or 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 condition in which the heart is so damaged it cannot supply sufficient blood to the body's organs).
• Sinoatrial node block (a heart condition).
• Very low blood pressure (systolic pressure below 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Coropres 6.25 mg tablets.

Inform your doctor if you have any of the following conditions:

• Any lung disease.
• Diabetes.
• Any heart disease.
• If you are taking other medicines for the heart, especially if you are taking any of the following: digitalis (which increases the force of heart contractions), diuretics (which increase urine output), ACE inhibitors (antihypertensive medicines), calcium antagonists (antihypertensive medicines), or antiarrhythmics (medicines that affect heart rhythm).
• Any thyroid disorder.
• Allergy and are receiving treatment for it.
• Circulatory 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 condition called pheochromocytoma.
• Psoriasis (a skin condition).
• Prinzmetal's angina (chest pain occurring at rest without obvious causes).
• If you are undergoing surgery with anesthesia. Inform the anesthetist.
• If you wear contact lenses. Coropres may reduce tear production.
• If you suffer from severe skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medicines with beta-blocking activity, you must not stop treatment with Coropres abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

This medicine contains carvedilol, which may produce a positive result in doping control tests.

Children and adolescents

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

Taking Coropres with other medicines

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

This is very important because taking several medicines at the same time may increase or decrease their effects. Therefore, you should not take Coropres with any other medicine unless approved by your doctor.

Please note that these instructions may also apply to medicines you have taken previously or may take in the future.

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

• Fluoxetine and paroxetine (medicines for depression).
• Cyclosporine and tacrolimus (medicines used to prevent transplant rejection).
• Digoxin, verapamil, diltiazem, and antiarrhythmic medicines (used to treat heart and blood pressure problems).
• Amiodarone (a medicine used to treat certain heart conditions).
• Certain painkillers of the type aspirin and ibuprofen (NSAIDs).
• Other blood pressure medicines, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Medicines for diabetes (including insulin and oral antidiabetics).
• Clonidine (a medicine used to control blood pressure or migraine).
• Rifampicin (a medicine used to treat infections).
• Cimetidine (a medicine used to treat stomach problems).
• Inducers or inhibitors of hepatic metabolism (medicines that alter the elimination of other medicines from the body).
• Monoamine oxidase inhibitors (medicines for depression).
• β-agonist bronchodilators (medicines used to improve breathing, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Coropres 6.25 mg tablets with food, drinks, and alcohol

Avoid taking Coropres simultaneously or immediately after consuming grapefruit or grapefruit juice. Grapefruit or grapefruit juice may increase blood levels of the active ingredient carvedilol and cause unpredictable adverse effects. Excessive consumption of alcohol, especially simultaneously or occasionally with Coropres, should also be avoided, as alcohol may influence the effect of Coropres.

Your doctor or pharmacist will advise you about the meals with which you should take this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The use of Coropres is not recommended during pregnancy and breastfeeding.

Coropres may cause fetal death in utero and premature delivery. Adverse effects in the fetus and newborn may also occur. After birth, the newborn has an increased risk of heart and lung problems.

Coropres passes into breast milk; therefore, its use is not recommended during breastfeeding.

Driving and use of machines

Coropres may occasionally impair your ability to drive or operate machinery. This is especially likely when starting or changing treatment and when taking alcohol concomitantly.

Coropres 6.25 mg tablets contain sucrose and lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Coropres 6.25 mg tablets

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Essential hypertension

Adults:

Oral use. The recommended starting dose is 12.5 mg once daily for the first two days. Then, the recommended dose is 25 mg once daily. If necessary, your doctor may increase your dose (at intervals of at least two weeks) up to 50 mg once daily or in two divided doses of 25 mg each.

Elderly patients:

Oral use. The recommended starting dose is 12.5 mg once daily, which has provided satisfactory control in some patients. If the response is not adequate, your doctor will adjust your dose (at intervals of at least two weeks).

Ischaemic heart disease

Adults:

Oral use. The recommended starting dose is 12.5 mg twice daily (total 25 mg daily) for the first two days. Then, the recommended dose is 25 mg twice daily (total 50 mg daily). If necessary, your doctor may increase your dose (at intervals of at least two weeks) up to 50 mg twice daily (total 100 mg daily).

Elderly patients:

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

Treatment of symptomatic congestive heart failure

Adults and elderly patients:

Oral use. Your doctor will individually determine the dose you should take, monitoring you closely during dose escalation.

If you are already taking medications for heart conditions (digitalis) or for blood pressure control (diuretics and/or ACE inhibitors), your doctor will adjust the doses of these medications before starting Coropres treatment.

In any case, the recommended starting dose of Coropres for the treatment of symptomatic congestive heart failure is 3.125 mg twice daily (total 6.25 mg daily) for two weeks. If this dose is well tolerated, it may be increased later (at intervals of at least two weeks) to 6.25 mg twice daily (total 12.5 mg daily). Your doctor may then prescribe higher doses of Coropres (after at least two weeks).

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice daily (total 50 mg daily). If you weigh more than 85 kg, the maximum recommended dose is 50 mg twice daily (100 mg daily).

Your doctor will advise you on the duration of your treatment with Coropres 6.25 mg tablets.

As a general rule, regardless of your condition, discontinuation of Coropres 6.25 mg tablets should be done gradually over several days, reducing the dose by half every three days.

Use in children and adolescents

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

Instructions for correct administration

Take the tablets with a sufficient amount of liquid, such as a glass of water.

If you have congestive heart failure (your heart has lost some of its ability to pump blood and you may experience shortness of breath, weakness, and fluid accumulation), you should take Coropres with food to avoid dizziness upon standing.

Remember to take your medication.

If you take more Coropres than you should

If you take more Coropres than prescribed, contact your doctor immediately or go to the nearest hospital. Bring the medicine with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562.04.20.

If you forget to take Coropres

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

If you stop taking Coropres

Treatment with Coropres must not be stopped abruptly, especially if you have ischaemic heart disease, a condition that causes poor blood pumping by the heart. Your doctor will gradually reduce your dose over several days until you completely stop taking Coropres.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are classified as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and frequency not known (cannot be estimated from available data).

Infections and infestations

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

Disorders of the nervous system

Very common: Headache, dizziness, and weakness, which are usually mild and occur mainly at the beginning of treatment.

Common: Presyncope, syncope (fainting), especially at the beginning of treatment.

Uncommon: Paresthesia (tingling sensation).

Psychiatric disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Frequency not known: Hallucinations.

Cardiac disorders

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

Common: Bradycardia (reduced 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 causing the heartbeat to become very slow or stop), especially in elderly patients or patients with other cardiac rhythm disorders.

Vascular disorders

Very common: Low blood pressure.

Common: Postural hypotension (dizziness upon standing or changing body position), peripheral circulatory disorders (cold hands and feet), worsening of symptoms in patients with intermittent claudication (increased leg pain when walking) or Raynaud's phenomenon (reduced blood flow to fingers and toes, ears, and nose), hypertension.

Respiratory, thoracic and mediastinal disorders

Common: Asthma and breathing difficulties in predisposed patients, pulmonary edema (fluid accumulation in the lungs).

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: Skin reactions (e.g., allergic rash, dermatitis, urticaria, itching, psoriasis, lichen planus-type skin lesions).

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

Blood and lymphatic system disorders

Common: Decreased number of red blood cells in blood (anemia).

Rare: Reduced number of platelets in blood (thrombocytopenia).

Very rare: Reduced number of white blood cells in blood (leukopenia).

Hepatobiliary disorders

Very rare: Alterations in serum transaminases (changes in blood levels of certain liver enzymes).

Eye disorders

Common: Decreased tear production (dry eye), eye irritation, vision disturbances.

Renal and urinary disorders

Common: Acute renal failure (kidneys not functioning properly) and kidney function disorders in patients with diffuse vascular disease and/or impaired kidney function.

Rare: Urination difficulties.

Frequency not known: Urinary incontinence in women (resolves upon discontinuation of the medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Limb pain.

Reproductive system 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: Latent diabetes mellitus may become apparent, or pre-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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Coropres 6.25 mg tablets

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

Store in the original packaging to protect from light and moisture.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Coropres 6.25 mg tablets

• The active substance is carvedilol.
• The other components are lactose, sucrose, povidone, crospovidone, colloidal anhydrous silica, magnesium stearate and yellow iron oxide.

Appearance of the product and contents of the pack

Coropres 6.25 mg tablets are round, scored, yellow tablets, engraved with "BM" on one side and "F1" on the other.

Coropres 6.25 mg is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the most recent revision of this leaflet: October 2023

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