Leaflet: information for the user

Carvedilol Almus 6.25 mg tablets EFG

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; do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Carvedilol Almus is indicated for the treatment of:

-Symptomatic congestive heart failure (the heart has lost part of its ability to pump blood) of moderate to severe origin, ischemic or non-ischemic.

-Essential hypertension (elevated blood pressure).

-Ischemic cardiopathy (little blood and oxygen reaches the heart).

Do not take Carvedilol Almus if you have the following:

• If you are allergic to carvedilol or any of the other components of this medication (listed in section 6).

• Unstable or decompensated heart failure or class IV (heart inability to pump blood during physical activity and at rest).
• Heart disease consisting of second- and third-degree atrioventricular block (except if a permanent pacemaker is placed).
• Heart disease called sick sinus syndrome (alteration of the sinoatrial node).
• If your heart beats very slowly (less than 50 beats per minute).
• Severe 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).
• Very low blood pressure (systolic pressure of less than 85 mmHg).
• If your liver does not function properly.
• Untreated phaeochromocytoma.

• History of bronchospasm or asthma.
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi being treated orally or inhaled.
• Metabolic acidosis.
• Severe peripheral arterial circulation disorders.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take carvedilol.

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

• If you have heart failure since your clinical situation may worsen temporarily and 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 (cardiac ischemia)
  • Diffuse vascular disease
  • Renal problems
• If you have had a heart attack. This should be treated before starting to take carvedilol.
• If you have any lung disease.
• If you are diabetic. You must carefully control your blood sugar levels.
• If you have a thyroid disease with an excess of thyroid hormones, since 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 medications, inform your doctor: digitalis (increases the force of the heart's beat), diuretics (increases urine production), ACE inhibitors (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (act on the heart's rhythm).
• If you wear contact lenses, you may experience dry eyes.
• If you are allergic and receive any allergy treatment.
• If you have circulatory problems in your hands and feet or Raynaud's disease.
• If you are undergoing surgery with anesthesia. Inform your responsible anesthesiologist.
• If you have psoriasis (skin disease).
• If you have phaeochromocytoma.
• If you have Prinzmetal's angina (chest pain that begins during rest without obvious causes).
• If you have severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

The treatment with Carvedilol Almus should not be interrupted suddenly, especially if you have heart problems. Withdrawal should be done gradually over a period of 1 to 2 weeks..

Carvedilol Almus with other medications:

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

Certain medications may interact with Carvedilol Almus and may increase the risk of adverse reactions; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

• Fluoxetine and paroxetine (medications for depression).
• MAO inhibitors (medications for depression).
• Ciclosporin (medication used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and other anti-arrhythmic medications (medications used to treat heart problems and/or high blood pressure).

• Amiodarone (medication used to treat certain heart problems).
• Other medications for high blood pressure, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.

• Clonidine (medication used to control blood pressure or migraine).
• Diabetes medications (including insulin and oral antidiabetic medications).
• Metabolism hepatic inducers or inhibitors (medications that modify the elimination of other medications from the body).

• Rifampicin, (medication for treating infections).
• Cimetidine (medication for treating gastrointestinal problems).
• Ergotamine (medication used to treat migraine).
• Anesthetics (if you are undergoing surgery).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), for example Ibuprofen, estrogens (medications used in hormone replacement therapy or as contraceptives) or corticosteroids (medications used to suppress inflammatory or allergic reactions).
• Neuromuscular blockers (muscle relaxants if you are undergoing surgery).
• Medications used to treat asthma or certain respiratory difficulties (β-agonist bronchodilators) or medications that increase the function of the sympathetic nervous system.

Carvedilol Almus with food and drinks:

You should avoid taking alcohol during treatment with carvedilol as it may modify its effects.

You do not need to take the dose with meals, although in patients with heart failure, carvedilol should be taken with food to reduce the incidence of adverse effects.

Pregnancy and breastfeeding:

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

Carvedilol Almus is not recommended during pregnancy.

Before starting to take the medication, you must inform your doctor if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.

Carvedilol Almus may cause damage to the fetus and the newborn, fetal death within the uterus, as well as premature births. After birth, the newborn has a higher risk of experiencing heart and lung problems.

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

Driving and operating machinery:

Some individual reactions may affect your ability to drive or operate machinery, especially at the beginning of treatment, with medication changes, or when taken with alcohol. If you notice symptoms of dizziness or fatigue, do not drive or operate machinery until you know how you tolerate the medication.

Important information about some of the components of Carvedilol Almus:

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

This medication contains saccharose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Warning to athletes:

It is informed to athletes that this medication contains a component, carvedilol, which may establish a positive analytical result for doping control.

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.

Essential Hypertension

Adults

Oral route. The recommended starting dose is 12.5 mg once a day for the first two days. Subsequently, the recommended dose is 25 mg of carvedilol once a day. If necessary, your doctor may 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.

Older patients

Oral route. The recommended starting dose is 12.5 mg once a day, which is usually sufficient. 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 is 12.5 mg twice a day (total 25 mg per day) for the first two days. Subsequently, the recommended dose is 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 100 mg once a day or in two doses of 50 mg each.

Older patients

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

Treatment of Symptomatic Congestive Heart Failure

Adults and older patients

Oral route

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

In case you are using heart disease medications (digitalis) or blood pressure control medications (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 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 due to the lack of sufficient data on safety and efficacy.

Guidelines for correct administration

Take the tablets with a sufficient amount of liquid, 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 the feeling of dizziness when standing up.

Remember to take your medication.

The tablet can be split into equal doses.

If you take more Carvedilol Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Carvedilol Almus

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

If you interrupt treatment with Carvedilol Almus

Treatment with carvedilol 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, Carvedilol Almus may cause side effects, although not everyone will experience them.

Side effects are classified as: 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 less than 1 in 10,000 patients) and isolated cases.

The side effects found for carvedilol have been:

Infections and infestations

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

Blood and lymphatic system disorders

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

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

Very rare: Reduction in the number of white blood cells in the blood (leucopenia), which may cause an increased susceptibility to infections.

Immune system disorders

Very rare: Hypersensitivity (allergic reaction).

Metabolism and nutrition disorders

Common: Weight gain, elevated levels of cholesterol in the blood, alteration of blood glucose levels (hyperglycemia, hypoglycemia) in patients with pre-existing diabetes mellitus.

Mental and behavioural disorders

Common: Depression, depressed mood.

Rare: Sleep disorders.

Nervous system disorders

Very common: Dizziness*, headache*.

Rare: Tingling sensation (paresthesia), fainting (syncope)*.

Eye disorders

Common: Vision impairment, decreased tear production (dry eyes), eye irritation.

Cardiac disorders

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

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

Rare: Atrioventricular (AV) blockage (heart problems), and chest pain (angina pectoris).

Vascular disorders

Very common: Low blood pressure.

Common: Dizziness upon standing (orthostatic hypotension), circulation problems (symptoms 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 (pain in the legs that worsens with 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, diarrhea, vomiting, digestive discomfort.

Hepatobiliary disorders

Very rare: Elevated levels of liver function tests seen in blood tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT)).

Skin and subcutaneous tissue disorders

Uncommon: Skin reactions (e.g. allergic exanthema, dermatitis, urticaria, pruritus, psoriasis, flat warty skin lesions).

Unknown frequency: Hair loss, severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome)..

Musculoskeletal and connective tissue disorders

Common: Limb pain.

Renal and urinary disorders

Common: Kidney failure and renal function disorders in patients with atherosclerosis and/or underlying renal alterations, urination problems.

Rare: Urination problems.

Unknown frequency: Urinary incontinence in women (disappears when the medication is stopped).

Reproductive and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very common: Weakness* (fatigue).

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

* These effects appear particularly at the beginning of treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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.

Do not use Carvedilol Almus after the expiration date indicated on the packaging. 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 packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition of Carvedilol Almus 6.25 mg tablets

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

The other components (excipients) are:

Sucrose with cornstarch (31.375 mg), lactose monohydrate (20.925 mg), povidone, anhydrous colloidal silica, crospovidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Carvedilol Almus 6.25 mg is presented in the form of white, round, and scored tablets on one side. Each package contains 28 tablets.

Manufacturer:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:farmacovigilancia@almusfarmaceutica.es

Responsible for manufacturing:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2. Abrunheira, Sintra 2710-089 Portugal

Last review date of this leaflet: 10/2019

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