CARVEDILOL ALMUS 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Carvedilol Almus 25 mg Tablets EFG

L, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Carvedilol Almus 25 mg Tablets are and what they are used for.
2. What you need to know before you take Carvedilol Almus 25 mg Tablets.
3. How to take Carvedilol Almus 25 mg Tablets.
4. Possible side effects.
5. Storage of Carvedilol Almus 25 mg Tablets.
6. Contents of the pack and other information.

1. What Carvedilol Almus 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 (reducing blood pressure), vasodilating, 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 some of its ability to pump blood) of moderate to severe origin, either ischemic or non-ischemic.
• Essential hypertension (high blood pressure).
• Ischemic heart disease (the heart receives little blood and oxygen).

2. What you need to know before you take Carvedilol Almus 25 mg Tablets

Do not take Carvedilol Almus if you have the following:

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

• A type of unstable/uncompensated heart failure or so-called class IV (the heart's inability to perform its pumping function during physical activity and at rest).
• A heart disease that consists of second and third degree AV block (except if a permanent pacemaker is implanted).
• A heart disease called sick sinus syndrome (alteration of the sino-atrial 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 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 bronchi that is being treated orally or by inhalation.
• A disease called metabolic acidosis.
• Severe peripheral arterial circulation disorders.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take carvedilol.

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

• If you have heart failure, as your clinical situation may temporarily worsen and you may need treatment with diuretics or dose adjustments.
• If you have heart failure accompanied by:
• • low blood pressure
  • compromised blood and oxygen supply to the heart (ischemic heart disease)
  • widespread vascular disease
  • kidney 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 should carefully monitor your blood sugar levels.
• If you have a thyroid disease with an excess of thyroid hormones, as carvedilol may mask the 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, you should inform your doctor: digitalis (increases the strength of the heartbeat), diuretics (increases urine production), ACE inhibitors (antihypertensive medication), calcium antagonists (antihypertensive medication), and antiarrhythmics (act on the heart rhythm).
• If you wear contact lenses, you may experience dry eyes.
• If you are allergic and are receiving treatment for your allergy.
• If you have circulation problems in your hands and feet or Raynaud's disease.
• If you are going to undergo surgery with anesthesia. You should inform your anesthesiologist.
• If you have psoriasis (skin disease).
• If you have a disease called pheochromocytoma.
• If you have Prinzmetal's angina (chest pain that starts 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 stopped suddenly, especially if you have heart problems. The withdrawal should be done gradually 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 take any other medicines.

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

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 for treating depression).
• Monoamine oxidase inhibitors (medicines for depression).
• Cyclosporine (medicine used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and other antiarrhythmic medicines (medicines used to treat heart problems and/or high blood pressure).

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

• Clonidine (medicine used to control blood pressure or migraines).
• Medicines for diabetes (including insulin and oral antidiabetics).
• Inducers or inhibitors of hepatic metabolism (medicines that modify the elimination of other medicines from the body).

• Rifampicin (medicine used to treat infections).
• Cimetidine (medicine used to treat stomach problems).
• Ergotamine (medicine used to treat migraines).
• Anesthetics (if you are going to undergo surgery).
• Anti-inflammatory medicines (NSAIDs), such as ibuprofen, estrogens (medicines used in hormone replacement therapy or as contraceptives), or corticosteroids (medicines used to suppress inflammatory or allergic reactions).
• Neuromuscular blockers (muscle relaxants if you are going to undergo surgery).
• Medicines used to treat asthma or certain respiratory difficulties (beta-agonist bronchodilators) or medicines that increase the function of the sympathetic nervous system.

Taking Carvedilol Almus with food and drinks:

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

It is not necessary to take the dose with meals, although in patients whose heart is not functioning properly, carvedilol should be taken with food to reduce the incidence of side 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 to take the medicine, you must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Carvedilol Almus may cause harm to the fetus and newborn, fetal death in the womb, as well as premature births. After birth, the newborn has a higher risk of heart and lung problems.

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

Driving and using machines:

Some individual reactions may affect the ability to drive or use machines, especially at the beginning of treatment, with changes in medication, or when taken together with alcohol. If you notice symptoms of dizziness or fatigue, do not drive or use machines 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 with them before taking this medicine.

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

Warning to athletes:

Athletes are informed that this medicine contains a component, carvedilol, which may result in a positive doping test.

3. How to take Carvedilol Almus 25 mg Tablets

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

Essential hypertension

Adults

Oral. The recommended dose for initiating treatment is 12.5 mg once a day for the first two days. Then, 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.

Elderly patients

Oral. The recommended dose for initiating therapy 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 heart disease

Adults

Oral. The recommended dose for initiating treatment is 12.5 mg twice a day (a total of 25 mg per day) for the first two days. Then, the recommended dose is 25 mg twice a day (a total of 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.

Elderly patients

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

Treatment of symptomatic congestive heart failure

Adults and elderly patients

Oral

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 medications you should take.

In any case, the recommended dose for initiating treatment with carvedilol in the treatment of symptomatic congestive heart failure is 3.12 mg twice a day (a total of 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 (a total of 12.5 mg per day).

Your doctor may prescribe higher doses of carvedilol later (after at least two weeks).

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice a day (a total of 50 mg per day). If your weight is over 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, the withdrawal of carvedilol should be done gradually over a few days, or the dose should be reduced by half 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 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 some of its ability to pump blood and may cause difficulty breathing, weakness, and fluid accumulation), you should take carvedilol while eating to avoid feeling dizzy when standing up.

Remember to take your medicine.

The tablet can be divided 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 medicine and the amount ingested. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Carvedilol Almus

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

If you stop taking Carvedilol Almus

The treatment with carvedilol should not be stopped abruptly, especially if you have ischemic heart disease, a disease that causes the heart to not 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Carvedilol Almus can cause adverse effects, although not all people suffer from them.

Effects are classified into: very frequent (affects more than 1 in 10 patients), frequent (affects between 1 and 10 in 100 patients), infrequent (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 effects found for carvedilol have been:

Infections and Infestations

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

Blood and Lymphatic System Disorders

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

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

Very rare: Reduction in the number of white blood cells in the blood (leukopenia), which can cause infections to be caught more easily.

Immune System Disorders

Very rare: Hypersensitivity (allergic reaction).

Metabolic and Nutritional Disorders

Frequent: Weight gain, high cholesterol levels in the blood, altered glucose levels in the blood (hyperglycemia, hypoglycemia) in patients with pre-existing diabetes mellitus.

Psychiatric Disorders

Frequent: Depression, depressed mood.

Rare: Sleep disorders.

Nervous System Disorders

Very frequent: Dizziness*, headache*.

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

Ocular Disorders

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

Cardiac Disorders

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

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

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

Vascular Disorders

Very frequent: Low blood pressure.

Frequent: Dizziness when standing up (orthostatic hypotension), circulation problems (signs include cold hands and feet), worsening of symptoms in patients with Raynaud's syndrome (fingers turn blue, then white and finally red and hurt) or intermittent claudication (leg pain that worsens when walking) hypertension.

Respiratory, Thoracic, and Mediastinal Disorders

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

Rare: Nasal congestion.

Gastrointestinal Disorders

Frequent: Nausea, abdominal pain, diarrhea, vomiting, digestive discomfort.

Hepatobiliary Disorders

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

Skin and Subcutaneous Tissue Disorders

Infrequent: Skin reactions (e.g., allergic exanthema, dermatitis, urticaria, itching, psoriasis, skin lesions of lichen planus type).

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

Musculoskeletal and Connective Tissue Disorders

Frequent: Limb pain.

Renal and Urinary Disorders

Frequent: Renal failure and kidney function disorders in patients with hardened arteries and/or underlying kidney problems, urination problems.

Rare: Urination problems.

Frequency not known: Urinary incontinence in women (disappears when the medication is stopped).

Reproductive System and Breast Disorders

Infrequent: Impotence.

General Disorders and Administration Site Conditions

Very frequent: Weakness* (fatigue).

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

• These effects appear particularly at the start of treatment.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Carvedilol Almus 25 mg Tablets

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30 °C.

Store in the original package.

Do not use Carvedilol Almus after the expiration date indicated on the package. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the drains or into the trash. Deposit the packages and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Carvedilol Almus 25 mg Tablets

The active ingredient is Carvedilol. Each tablet contains 25 mg of Carvedilol.

The other components (excipients) are:

Sucrose with cornstarch (125.500 mg), lactose monohydrate (83.700 mg), povidone, colloidal anhydrous silica, crospovidone, and magnesium stearate.

Appearance of the Product and Package Contents

Carvedilol Almus 25 mg is presented in the form of white, round, and scored tablets on one side. Each package contains 28 or 500 tablets.

Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 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 Last Revision of this Prospectus: 10/2019

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