Carvedilol Almus 6,25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carvedilol Almus 6.25 mg tablets EFG

Read the entire package 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 must not give it to others, even if they have the same symptoms as you, since 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.

Package leaflet contents

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

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

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

Carvedilol Almus 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 Carvedilol Almus 6.25 mg tablets

Do not take Carvedilol Almus if you have any of the following:

• You are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6).

• Unstable/decompensated heart failure or New York Heart Association (NYHA) Class IV heart failure (inability of the heart to pump blood adequately during physical activity and at rest).

• Second- or third-degree atrioventricular (A-V) block (unless a permanent pacemaker has been implanted).

• Sick sinus syndrome (a disorder of the sinoatrial node).

• If your heart beats very slowly (less than 50 beats per minute).

• Severe heart failure (or shock), a condition in which the heart is so damaged that it cannot supply sufficient blood to the body's organs.

• Very low blood pressure (systolic blood pressure less than 85 mmHg).

• If your liver is not functioning properly.

• Untreated pheochromocytoma.

• History of bronchospasm or asthma.

• Chronic obstructive pulmonary disease (COPD) with obstructed airways being treated with oral or inhaled medication.

• Metabolic acidosis.

• Severe peripheral arterial circulatory disorders.

Warnings and precautions:

Talk to your doctor or pharmacist before starting carvedilol.

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

• If you have heart failure, as your clinical condition may temporarily worsen and you may require treatment with diuretics or dose adjustments.

• If you have heart failure accompanied by:

  • low blood pressure
  • compromised blood and oxygen supply to the heart (ischaemic heart disease)
  • diffuse vascular disease
  • kidney problems

• If you have had a heart attack. This should be treated before starting carvedilol.

• If you have any lung disease.

• If you are diabetic. You must carefully monitor your blood sugar levels.

• If you have hyperthyroidism (excess thyroid hormones), as carvedilol may mask symptoms.

• If you have a very slow pulse (less than 55 beats per minute).

• If you are taking other heart medications, especially if you are taking any of the following, inform your doctor: digitalis (increases the force of heart contractions), diuretics (increase urine output), ACE inhibitors (antihypertensive drugs), calcium antagonists (antihypertensive drugs), and antiarrhythmics (affect heart rhythm).

• If you wear contact lenses, you may experience dry eyes.

• If you are allergic and receiving treatment for your allergy.

• If you have circulation problems in hands and feet or Raynaud's disease.

• If you are undergoing surgery with anaesthesia. You must inform the anaesthetist.

• If you have psoriasis (a skin disease).

• If you have pheochromocytoma.

• If you have Prinzmetal's angina (chest pain occurring at rest without obvious causes).

• If you have severe skin adverse reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

Treatment with Carvedilol Almus must not be stopped suddenly, especially if you have heart problems. Discontinuation should be gradual over a period of 1 to 2 weeks.

Taking Carvedilol Almus with other medicines:

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

Certain medicines may interact with Carvedilol Almus and increase the risk of adverse reactions; in such cases, it may be necessary to adjust the dose or discontinue one of the medicines.

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

• Fluoxetine and paroxetine (medicines used to treat depression).

• Monoamine oxidase inhibitors (medicines for depression).

• Cyclosporine (a medicine used to prevent transplant rejection).

• Digoxin, verapamil, diltiazem, and other antiarrhythmic medicines (used to treat heart problems and/or high blood pressure).

• Amiodarone (a medicine used to treat certain heart problems).

• Other medicines for high blood pressure, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.

• Clonidine (a medicine used to control blood pressure or migraine).

• Medicines for diabetes (including insulin and oral antidiabetics).

• Inducers or inhibitors of hepatic metabolism (medicines that alter the elimination of other medicines from the body).

• Rifampicin (a medicine used to treat infections).

• Cimetidine (a medicine used to treat gastric problems).

• Ergotamine (a medicine used to treat migraine).

• Anaesthetics (if you are undergoing surgery).

• Non-steroidal anti-inflammatory drugs (NSAIDs), for example ibuprofen, estrogens (used in hormone replacement therapy or as contraceptives), or corticosteroids (used to suppress inflammatory or allergic reactions).

• Neuromuscular blocking agents (muscle relaxants if you are undergoing surgery).

• Medicines used to treat asthma or certain breathing difficulties (β-agonist bronchodilators) or medicines that stimulate the sympathetic nervous system.

Taking Carvedilol Almus with food and drink:

You should avoid alcohol during treatment with carvedilol, as it may alter its effects.

It is not necessary to take the dose with food, although in patients with impaired heart function, carvedilol should be taken with food to reduce the incidence of adverse effects.

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.

The use of Carvedilol Almus is not recommended during pregnancy.

Before starting this medicine, you must inform your doctor if you are pregnant, planning to become pregnant, or trying to conceive.

Carvedilol Almus may cause harm to the foetus and newborn, foetal death in utero, and premature delivery. After birth, the newborn has an increased risk of heart and lung problems.

Carvedilol passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines:

Individual reactions may affect your ability to drive or operate machinery, especially at the beginning of treatment, when changing medication, or when taken together with alcohol. If you experience symptoms such as dizziness or fatigue, do not drive or operate machinery until you know how you tolerate the medicine.

Important information about some of the ingredients of Carvedilol Almus:

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

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

Warning for athletes:

Athletes are advised that this medicine contains a component, carvedilol, which may lead to a positive analytical finding in doping control tests.

3. How to take Carvedilol Almus 6.25 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, 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 of carvedilol once daily. If necessary, your doctor may increase your dose (at intervals of at least two weeks) up to 50 mg once daily or divided into two doses of 25 mg each.

Elderly patients

Oral use. The recommended starting dose is 12.5 mg once daily, which is usually sufficient. 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 100 mg once daily or divided into two doses of 50 mg each.

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 to higher levels.

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 amount of these medications before starting carvedilol treatment.

In any case, the recommended starting dose of carvedilol for the treatment of symptomatic congestive heart failure is 3.12 mg twice daily (total 6.25 mg daily) for two weeks. If this dose is well tolerated, it may subsequently be increased (at intervals of at least two weeks) to 6.25 mg twice daily (total 12.5 mg daily).

Your doctor may later prescribe higher doses of carvedilol (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 inform you about the duration of your carvedilol treatment.

As a general rule, regardless of your condition, carvedilol should be discontinued gradually over several days, or the dose should be halved every three days.

Use in children and adolescents

Carvedilol 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 carvedilol with food to avoid dizziness upon standing.

Remember to take your medicine.

The tablet may be divided into equal doses.

If you take more Carvedilol Almus than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Carvedilol Almus

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

If you stop taking Carvedilol Almus

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

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

4. Possible adverse effects

Like all medicines, Carvedilol Almus may produce adverse effects, although not everyone experiences them.

The effects are classified as follows: very common (affects more than 1 in 10 patients), common (affects between 1 and 10 in 100 patients), uncommon (affects between 1 and 10 in 1,000 patients), rare (affects between 1 and 10 in 10,000 patients), very rare (affects fewer than 1 in 10,000 patients), and isolated cases.

The effects reported for carvedilol have been:

Infections and infestations

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

Disorders of the blood and lymphatic system

Common: Reduction in the number of red blood cells in the blood (anaemia), which may cause tiredness.

Rare: Reduction in the number of platelets in the blood (thrombocytopenia), which may cause bleeding and bruising.

Very rare: Reduction in the number of white blood cells in the blood (leucopenia), which may make you more susceptible to infections.

Immune system disorders

Very rare: Hypersensitivity (allergic reaction).

Metabolism and nutrition disorders

Common: Weight gain, elevated blood cholesterol levels, altered blood glucose levels (hyperglycaemia, hypoglycaemia) in patients with pre-existing diabetes mellitus.

Psychiatric disorders

Common: Depression, depressed mood.

Uncommon: Sleep disorders.

Nervous system disorders

Very common: Dizziness*, headache*.

Uncommon: Tingling sensation (paraesthesia), fainting (syncope)*.

Eye disorders

Common: Visual impairment, reduced tear production (dry eyes), eye irritation.

Cardiac disorders

Very common: Heart failure (the heart has lost its ability to pump blood effectively).

Common: Decreased heart rate (bradycardia), fluid retention (oedema), increased circulating blood volume (hypervolemia), fluid overload.

Uncommon: Atrioventricular (AV) block (heart problems), and chest pain (angina pectoris).

Vascular disorders

Very common: Low blood pressure.

Common: Dizziness upon standing (orthostatic hypotension), impaired blood circulation (signs include cold hands and feet), worsening of symptoms in patients with Raynaud's syndrome (fingers turn blue, then white, and finally red and painful) or intermittent claudication (leg pain that worsens on walking), hypertension.

Respiratory, thoracic and mediastinal disorders

Common: Difficulty breathing, fluid retention in the lungs, and asthma in predisposed patients.

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Nausea, abdominal pain, diarrhoea, vomiting, indigestion.

Hepatobiliary disorders

Very rare: Elevated liver function test results observed in blood tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)).

Skin and subcutaneous tissue disorders

Uncommon: Skin reactions (e.g. allergic rash, dermatitis, urticaria, itching, psoriasis, lichenoid skin lesions).

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

Musculoskeletal and connective tissue disorders

Common: Limb pain.

Renal and urinary disorders

Common: Renal failure and kidney function disorders in patients with hardening of the arteries and/or underlying kidney problems, urinary difficulties.

Rare: Urinary problems.

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

Reproductive system and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very common: Weakness* (fatigue).

Common: Pain, oedema (fluid retention, swelling of legs, ankles and feet).

• These effects occur particularly at the beginning of treatment.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 Carvedilol Almus 6.25 mg tablets

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

Do not store above 30 °C.

Keep in the original packaging.

Do not use Carvedilol Almus after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly 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 Carvedilol Almus 6.25 mg tablets

The active substance is Carvedilol. Each tablet contains 6.25 mg of Carvedilol.

The other components (excipients) are:

Saccharose with maize starch (31.375 mg), monohydrate lactose (20.925 mg), povidone, anhydrous colloidal silica, crospovidone and magnesium stearate.

Appearance of the product and contents of the container

Carvedilol Almus 6.25 mg is presented as white, round, scored tablets on one side. Each pack contains 28 tablets.

Marketing Authorisation Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra 2710-228

Portugal

Date of the most recent revision of this leaflet: 10/2019

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