PATIENT INFORMATION LEAFLET

Carvedilol NORMON6.25mg film-coated tablets

Carvedilol

Read this 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

Carvedilol NORMON 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 NORMON 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 degree, of ischemic or non-ischemic origin.
• Essential hypertension (elevated blood pressure).
• Ischemic cardiopathy (little blood and oxygen reaches the heart).

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 (heart's inability to perform its pumping function with physical activity and at rest).
• If you have chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver does not function properly.
• If you have bronchial asthma.
• If you have a heart disease consisting of 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 state in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• In case of heart disease consisting of sino-auricular 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.

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

• If you have any lung disease.

• If you are diabetic.
• If you have a heart disease.
• 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 the amount of urine), ACE inhibitors (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (acts on the heart's rhythm).
• If you have a thyroid disorder.
• If you are allergic and receiving allergy treatment.
• 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 begins during rest without obvious causes).
• If you are undergoing anesthesia. Inform your anesthesiologist.
• If you wear contact lenses, Carvedilol Normon may reduce tear production.
• If you have severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

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

Use in athletes

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

Children and adolescents

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

Carvedilol Normon use with other medications

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

This is very important, as taking multiple medications at the same time may increase or decrease their effect. Therefore, do not take Carvedilol Normon with any other medication unless your doctor has allowed it.

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

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

-Fluoxetine and paroxetine (depression medications).

-Ciclosporin and tacrolimus (medications used to prevent transplant rejection).

• Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medications used to treat heart and blood pressure problems).
• Amiodarone (medication used to treat certain heart problems).
• Certain analgesics of the type of aspirin and ibuprofen (NSAIDs).
• Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Diabetes medications (including insulin and oral antidiabetic medications).
• 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).
• MAO inhibitors (medications for depression).
• Bronchodilators?-agonists (medications used to improve respiratory function, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Carvedilol Normon use with food, beverages, and alcohol

Avoid taking carvedilol simultaneously 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 adverse effects. Also, avoid excessive and simultaneous or occasional consumption of alcohol, as alcohol affects the effect of carvedilol. Your doctor or pharmacist will inform you about the foods with which you should take the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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, adverse 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 it is not recommended to use it during breastfeeding.

Driving and operating machinery

In some cases, Carvedilol Normon may impair your ability to drive or operate machinery. This occurs especially when starting or changing treatment and when taking it with alcohol.

Carvedilol Normon contains lactose

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

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

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

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 the case of using medications for heart diseases (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 types of medications you should take.

In any case, the recommended starting dose for Carvedilol NORMON treatment in 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 prescribe higher doses of Carvedilol NORMON later (at least two weeks after).

If you weigh less than85 kg, the maximum recommended dose is 25 mg twice a day (total 50 mg per day). If your weight is greater than85 kg, the maximum recommended dose is 50 mg twice a day (total 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 reduce 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 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 produce difficulty breathing, weakness, and fluid accumulation), you should take Carvedilol NORMON while eating, to avoid the feeling of dizziness when getting 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 immediately or go to the nearest hospital. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 562.04.20.

If you forget to take Carvedilol NORMON

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

If you interrupt treatment with Carvedilol NORMON

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

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

Like all medicines, Carvedilol Normon can cause side effects, although not everyone will experience them.

Side 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 that are usually mild and occur mainly at the beginning of treatment.

Common: Lightheadedness, fainting, especially at the start of treatment.

Uncommon: Paresthesias (tingling sensation).

Mental and behavioural 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 (decreased heart rate), fluid overload, increased blood volume in the body.

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

Frequency not known: Sinus arrest (a condition that makes heartbeats very slow or stop), especially in elderly patients or patients with other heart rhythm problems.

Vascular disorders

Very common: Low blood pressure.

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

Respiratory, thoracic and mediastinal disorders

Common: Asthma and breathing difficulties in predisposed patients, accumulation of fluid in the lungs.

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal disturbances 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 exanthema, dermatitis, urticaria, pruritus, psoriasis, lichen planus-like skin lesions).

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

Haematological disorders

Common: Decreased red blood cell count in blood (anemia).

Rare: Decreased platelet count in blood (thrombocytopenia).

Very rare: Decreased white blood cell count in blood (leucopenia).

Hepatobiliary disorders

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

Ocular disorders

Common: Decreased tear production (dry eye), eye irritation, visual disturbances.

Renal and urinary disorders

Common: Acute renal failure (kidney not functioning well) and kidney function disorders in patients with diffuse vascular disease and/or altered renal function.

Rare: Urination problems.

Frequency not known: Urinary incontinence in women (disappears when stopping medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Pain in the limbs.

Reproductive and breast disorders

Uncommon: Impotence.

Metabolism and nutrition disorders

Common: Worsening of blood sugar control in patients with diabetes (hyperglycaemia, hypoglycaemia), weight gain, increased blood cholesterol.

Frequency not known: Possible manifestation of latent diabetes, or worsening of existing diabetes.

General disorders and administration site conditions

Very common: Fatigue.

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

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not appearing 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 out of the sight and reach of children.

Store below 30°C.

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

Do not use Carvedilol NORMON after the expiration date that appears on the packaging after CAD. 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 the packaging and medicines you no longer need at your local SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Carvedilol NORMON

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

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

Appearance of the product and contents of the packaging

Carvedilol NORMON 6.25 mg tablets are yellow, round, biconvex, with a breaking bar and marked with “C/6.25” on one face and anonymous on the other. The packaging contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:May 2024

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/.