CARVEDILOL NORMON 25 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carvedilol Normon 25 mg tablets EFG

Carvedilol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Carvedilol Normon and what is it used for
2. Before taking Carvedilol Normon
3. How to take Carvedilol Normon
4. Possible side effects
5. Storage of Carvedilol Normon
6. Further information

1. What is Carvedilol Normon and what is it used for

Carvedilol Normon contains carvedilol as the active ingredient, which belongs to a group of medicines known as alpha and beta blockers.

Carvedilol Normon has antioxidant, antihypertensive (reduces blood pressure), vasodilatory, and antianginal properties. It also reduces cardiac output and has favorable effects on blood circulation at the heart level.

Carvedilol Normon 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 degree, of ischemic or non-ischemic origin.
• Essential hypertension (high blood pressure).
• Ischemic heart disease (the heart receives little blood and oxygen).

2. Before taking Carvedilol Normon

Do not take Carvedilol Normon

• If you are hypersensitive (allergic) to carvedilol or any of the other components of Carvedilol Normon.

• If you have decompensated heart failure of class IV (the heart is unable to perform its pumping function during physical activity and at rest).
• If you have chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver is not functioning properly.
• If you have bronchial asthma.
• If you have a heart condition known as atrioventricular (A-V) block of second and third degree (unless a permanent pacemaker has been implanted).
• If your heart beats slowly (less than 50 heartbeats per minute).
• In case of heart failure (or shock, a condition in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• In case of a heart condition known as sinoatrial node block.
• In case of low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions

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

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

• If you have any lung disease.

• If you are diabetic.
• If you have heart disease.
• 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 have any thyroid disorder.
• If you are allergic and are receiving treatment for your allergy.
• If you have circulation 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 disease called pheochromocytoma.
• If you have psoriasis (skin disease).
• If you have Prinzmetal's angina (chest pain that starts during rest without obvious causes).
• If you are going to undergo surgery with anesthesia. You should inform the anesthesiologist.
• If you wear contact lenses, Carvedilol Normon may reduce tear production.
• If you have had severe adverse skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all beta-blocking medications, you should not stop treatment with Carvedilol Normon abruptly. The dose should be gradually reduced according to your doctor's instructions.

Athletes

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

Children and adolescents

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

Taking Carvedilol Normon with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

This is very important because taking several medications at the same time can increase or decrease their effect. Therefore, you should not take Carvedilol Normon with any other medication unless your doctor has allowed it.

Keep in mind that these instructions may also apply to medications that have been used before or may be used after.

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

• Fluoxetine and paroxetine (medications for depression).
• Cyclosporine and tacrolimus (medications used to prevent rejection in transplants).
• Digoxin, verapamil, diltiazem, and antiarrhythmic medications (medications used to treat heart problems and high blood pressure).
• Amiodarone (medication used to treat certain heart problems).
• Certain pain relievers such as aspirin and ibuprofen (NSAIDs).
• Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Diabetes medications (including insulin and oral antidiabetics).
• Clonidine (medication used to control blood pressure or migraines).
• Rifampicin (medication used to treat infections).
• Cimetidine (medication used to treat stomach problems).
• Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).
• Monoamine oxidase inhibitors (medications for depression).
• Bronchodilators beta-agonists (medications used to improve respiratory capacity, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Carvedilol Normon with food, drinks, and alcohol

Avoid taking carvedilol at the same time or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in the active ingredient carvedilol in the blood and cause unpredictable side effects. You should also avoid excessive and simultaneous or occasional consumption of alcohol because alcohol influences the effect of carvedilol. Your doctor or pharmacist will inform you about the meals with which you should take the medication.

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 medication.

Carvedilol Normon is not recommended during pregnancy and breastfeeding.

Carvedilol Normon may cause fetal death in the womb, as well as premature births. Additionally, side effects may occur in the fetus and newborn. After birth, the newborn has a higher risk of heart and lung problems.

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

Driving and using machines

Occasionally, Carvedilol Normon may impair your ability to drive or operate machines. This occurs especially when starting or changing treatment and when taking it in combination with alcohol.

Carvedilol Normon contains lactose

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

3. How to take Carvedilol Normon

Follow your doctor's instructions for taking Carvedilol Normon exactly. If you have any doubts, consult your doctor or pharmacist.

Essential hypertension

Adults:

Oral. The recommended starting dose is 12.5 mg once a day for the first two days.

Then, the recommended dose is 25 mg 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 starting dose is 12.5 mg once a day, which has provided satisfactory control in some patients. 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 starting dose is 12.5 mg twice a day (total 25 mg per day) for the first two days.

Then, 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 50 mg twice a day (total 100 mg per day).

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, monitoring you closely during the adjustment to higher doses.

In case you are using medications for heart disease (digitalis) or blood pressure control (diuretics and/or ACE inhibitors) and before starting treatment with Carvedilol Normon, your doctor will adjust the amount of these medications you should take.

In any case, the recommended starting dose for Carvedilol Normon in the treatment of symptomatic congestive heart failure is 3.125 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 then prescribe higher doses of Carvedilol Normon.

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 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 Normon.

As a general rule, regardless of your disease, the withdrawal of Carvedilol Normon 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 Normon is not recommended for use in children and adolescents under 18 years of age due to insufficient safety and efficacy data.

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 Normon while eating to avoid dizziness when standing up.

Remember to take your medication.

If you take more Carvedilol Normon than you should

If you take more Carvedilol Normon than you should, contact your doctor or go to the nearest hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562.04.20.

If you forget to take Carvedilol Normon

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

If you stop treatment with Carvedilol Normon

Treatment with Carvedilol Normon should not be stopped abruptly, especially if you have ischemic heart disease, a condition that causes the heart to pump blood poorly. Your doctor will gradually reduce the dose over a few days until you stop taking Carvedilol Normon completely.

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

4. Possible Adverse Effects

Like all medicines, Carvedilol Normon can produce adverse effects, although not all people suffer from them.

Adverse effects are classified into: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (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 unknown frequency (cannot be estimated from available data).

Infections and Infestations

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

Disorders of the Nervous System

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

Frequent: Presyncope, syncope (fainting), especially at the start of treatment.

Infrequent: Paresthesias (tingling sensation).

Psychiatric Disorders

Frequent: Depressed mood, depression.

Infrequent: Sleep disorders.

Unknown frequency: Hallucinations.

Cardiac Disorders

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

Frequent: Bradycardia (decreased heart rate), fluid overload, increased blood volume in the body.

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

Unknown frequency: Sinus arrest (a condition that makes the heartbeats become very slow or stop), especially in elderly patients or patients with other heart rhythm problems.

Vascular Disorders

Very frequent: Low blood pressure.

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

Respiratory, Thoracic, and Mediastinal Disorders

Frequent: Asthma and difficulty breathing in predisposed patients, fluid accumulation in the lungs.

Rare: Nasal congestion.

Gastrointestinal Disorders

Frequent: Gastrointestinal disorders with symptoms such as nausea, diarrhea, abdominal pain, indigestion, vomiting.

Infrequent: Constipation.

Rare: Dry mouth.

Disorders of the Skin and Subcutaneous Tissue

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

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

Disorders of the Blood and Lymphatic System

Frequent: Decreased red blood cell count (anemia).

Rare: Decreased platelet count (thrombocytopenia).

Very rare: Decreased white blood cell count (leukopenia).

Hepatobiliary Disorders

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

Eye Disorders

Frequent: Decreased tear production (dry eye), eye irritation, vision changes.

Renal and Urinary Disorders

Frequent: Acute renal failure (the kidney does not function properly) and renal function disorders in patients with diffuse vascular disease and/or altered renal function.

Rare: Urination problems.

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

Disorders of the Immune System

Very rare: Allergic reactions.

Musculoskeletal and Connective Tissue Disorders

Frequent: Pain in the limbs.

Disorders of the Reproductive System and Breast

Infrequent: Impotence.

Metabolic and Nutritional Disorders

Frequent: Worsening of blood sugar control in diabetic patients (hyperglycemia, hypoglycemia), weight gain, increased cholesterol in the blood.

Unknown frequency: It is possible that latent diabetes mellitus may manifest or that existing diabetes may worsen.

General Disorders and Administration Site Conditions

Very frequent: Fatigue.

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, 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 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 Normon

Keep out of sight and reach of children.

Store below 30°C.

Keep in the original packaging to protect it from light and moisture.

Do not use Carvedilol Normon after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE Point of your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of CARVEDILOL NORMON 25 mg

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

The other components (excipients) are: Lactose monohydrate, povidone, crospovidone, magnesium stearate, and colloidal silica.

Appearance of the Product and Packaging Contents

The Carvedilol NORMON 25 mg tablets are white or almost white, round, biconvex, with a break line, and marked with "C/25" on one face and anonymous on the other.

The packaging contains 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus:May 2024

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/.

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone).

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68877/P_68877.html.