CARVEDILOL NORMON 6.25 mg TABLETS

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 the so-called 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 that consists 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 a heart condition that consists of 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 a heart condition.
• 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 use contact lenses, Carvedilol Normon may reduce tear production.
• If you have 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.

Use in 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.

Note 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.
• Medications for diabetes (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 simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may lead to an increase in the active ingredient carvedilol in the blood and cause unpredictable side effects. Excessive and simultaneous or occasional consumption of alcohol should also be avoided 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.

The use of 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 experiencing 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 taken together 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 the administration instructions of Carvedilol Normon indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Essential hypertension

Adults:

Oral. The recommended dose to start treatment 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 dose to start therapy 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 dose to start 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 50 mg twice a day (a total of 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 heart medications (digitalis) or blood pressure medications (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 dose for starting treatment with Carvedilol Normon in the treatment of symptomatic congestive heart failure is 3.125 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 Normon 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 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 produce difficulty breathing, weakness, and fluid accumulation), you should take Carvedilol Normon while eating to avoid feeling dizzy 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 not 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 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 (AV) block (heart problems), and angina pectoris (chest pain).

Unknown frequency: Sinus arrest (a condition that makes the heartbeats 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 breathing difficulties 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 cutaneous adverse 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 (kidney dysfunction) 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. Storage 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 disposed of 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 unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

Carvedilol NORMON 6.25 mg tablets are yellow, round, biconvex, with a break line, and marked with "C/6.25" on one face and anonymous on the other. The packages contain 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/68876/P_68876.html.