Carvedilol Normon 6.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carvedilol Normon 6.25 mg tablets EFG

Carvedilol

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Leaflet contents:

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

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

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

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

Carvedilol Normon 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. Before taking Carvedilol Normon

Do not take Carvedilol Normon

• If you are hypersensitive (allergic) to carvedilol or to any of the other components of Carvedilol Normon.
• If you have decompensated heart failure of the so-called class IV (inability of the heart 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 second- or third-degree atrioventricular (A-V) block (unless a permanent pacemaker has been implanted).
• If your heart beats slowly (less than 50 beats per minute).
• In case of heart failure (or shock, a condition in which the heart is so damaged that it cannot supply sufficient blood to the body's organs).
• In case of a heart condition known as sinoatrial node block.
• In case of low blood pressure (systolic blood pressure less than 85 mmHg).

Warnings and precautions

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

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

• If you have any lung disease.

• If you are diabetic.

• If you have a heart condition.

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

• If you have a 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 condition called pheochromocytoma.

• If you have psoriasis (a skin condition).

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

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

• If you wear contact lenses, Carvedilol Normon 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 should not stop treatment with Carvedilol Normon abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

This medicine contains carvedilol, which may result in a positive doping test.

Children and adolescents

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

Taking Carvedilol Normon with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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

Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.

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 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 problems).
  • Certain painkillers such as aspirin and ibuprofen (NSAIDs).
  • Other blood pressure medicines, barbiturates, phenothiazines, tricyclic antidepressants, vasodilating agents, and alcohol.
  • Medicines for diabetes (including insulin and oral antidiabetics).
  • Clonidine (a medicine used to control blood pressure or migraine).
  • Rifampicin (a medicine to treat infections).
  • Cimetidine (a medicine used to treat gastric 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 Carvedilol Normon with food, drinks, and alcohol

You should avoid taking carvedilol 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 and simultaneous or occasional consumption of alcohol should also be avoided, as alcohol affects the action of carvedilol. Your doctor or pharmacist will advise you on which meals to take the medicine with.

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 Carvedilol Normon is not recommended during pregnancy and breastfeeding.

Carvedilol Normon may cause fetal death in utero as well as premature delivery. In addition, adverse effects may occur in the fetus and newborn. After birth, the newborn has an increased risk of developing heart and lung problems.

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

Driving and using machines

Carvedilol Normon may occasionally impair your ability to drive or operate machinery. This is especially likely when starting or changing treatment and when taken together with alcohol.

Carvedilol Normon contains lactose

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

3. How to take Carvedilol Normon

Follow exactly the administration instructions for Carvedilol Normon provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Essential hypertension

Adults:

Oral administration. 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 divided into two 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 the dose (at intervals of at least two weeks).

Ischaemic heart disease

Adults:

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

Elderly patients:

Oral use. The maximum recommended dose for elderly patients is 50 mg given 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 adjustments 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 amounts of these medications before starting treatment with Carvedilol Normon.

In any case, the recommended starting dose of Carvedilol Normon 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 subsequently be increased (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 Carvedilol Normon (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 Carvedilol Normon.

As a general rule, regardless of your condition, discontinuation of Carvedilol Normon should be gradual over several days, reducing the dose 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 data on safety and efficacy.

Instructions for proper 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 Normon with food to help prevent dizziness upon standing.

Remember to take your medication.

If you take more Carvedilol Normon than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562.04.20.

If you forget to take Carvedilol Normon

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

If you stop taking Carvedilol Normon

Treatment with Carvedilol Normon must not be stopped abruptly, especially if you have ischemic heart disease, a condition that impairs the heart's ability to pump blood effectively. Your doctor will gradually reduce your dose over several days until you completely stop taking Carvedilol Normon.

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 Normon may produce 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.

Nervous system disorders

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, increase in 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), disorders of peripheral circulation (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, lichenoid 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: Changes in serum transaminases (changes in levels of certain liver enzymes in the blood).

Eye disorders

Common: Reduced tear production (dry eye), eye irritation, visual 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 renal function.

Rare: Problems with urination.

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 diabetic patients (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 via 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 Normon

Keep out of sight and reach of children.

Store below 30°C.

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

Do not use Carvedilol Normon after the expiry date stated on the packaging after EXP. 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 collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Carvedilol NORMON

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

The other components (excipients) are: Monohydrate lactose, povidone, crospovidone, magnesium stearate, yellow iron oxide (E-172) and colloidal silica.

Appearance of the product and contents of the pack

Carvedilol NORMON 6.25 mg tablets are yellow, round, biconvex, with a break line and marked with “C/6.25” on one side and unmarked on the other. The packs contain 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/68876/P_68876.html.