Carvedilol Krka 6.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carvedilol Krka 6.25 mg tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Carvedilol Krka is and what it is used for
2. What you need to know before taking Carvedilol Krka
3. How to take Carvedilol Krka
4. Possible adverse effects
5. How to store Carvedilol Krka
6. Contents of the pack and other information

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

This medicine contains carvedilol as the active substance, which belongs to a group of medicines known as alpha and beta receptor blockers. Carvedilol has antioxidant, antihypertensive (reduction of blood pressure), vasodilatory, and antianginal properties. It also reduces cardiac output and has beneficial effects on blood circulation in the heart.

This medicine 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. What you need to know before taking Carvedilol Krka

Do not take Carvedilol Krka

• If you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6).
• 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 does not function 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).
• If you are suffering from heart failure (or shock, a condition in which the heart is so damaged that it cannot supply enough blood to the body's organs).
• If you have a heart condition known as sino-auricular node block.
• If you have very low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine. Inform your doctor if you have any of the following conditions:

• Any lung disease.
• Diabetes.
• A heart condition.
• If you are taking other medicines for the heart, especially if you are taking any of the following medicines, inform your doctor: digitalis (increases the force of the heartbeat), diuretics (increase urine output), ACE inhibitors (antihypertensive medicines), calcium channel blockers (antihypertensive medicines), and antiarrhythmics (affect heart rhythm).
• Any thyroid problems.
• If you are allergic and are receiving treatment for your allergy.
• Circulatory 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 phaeochromocytoma.
• 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 may reduce tear production.
• If you have severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medicines with beta-blocking activity, you must not stop treatment with this medicine 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.

Other medicines and Carvedilol Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is very important because taking several medicines at the same time may increase or decrease their effects. Therefore, you must not take this medicine 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, vasodilators, and alcohol.
• Medicines for diabetes (including insulin and oral antidiabetics).
• Clonidine (a medicine used to control blood pressure or migraine).
• Rifampicin (a medicine used to treat infections).
• Cimetidine (a medicine used to treat stomach 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, for example in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Carvedilol Krka with food, drinks, and alcohol

You should avoid taking carvedilol simultaneously or immediately after consuming grapefruit or grapefruit juice. Grapefruit or grapefruit juice may lead to increased levels of the active ingredient carvedilol in the blood and cause unpredictable 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 about the meals with which you should take the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

The use of this medicine is not recommended during pregnancy and breastfeeding.

Carvedilol may cause fetal death in utero as well as premature births. Adverse effects in the fetus and newborn may also occur. After birth, the newborn has an increased risk of developing heart and lung problems.

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

Driving and using machines

This medicine 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 Krka contains sucrose and lactose

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

3. How to take Carvedilol Krka

Follow exactly your doctor's instructions on how to take this medicine. If in doubt, consult your doctor or pharmacist again.

Essential hypertension

Adults:

Oral use. 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 inadequate, your doctor will adjust your dose (at intervals of at least two weeks).

Ischaemic heart disease

Adults:

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

Elderly patients:

Oral use. The maximum recommended dose for elderly patients is 50 mg administered 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 escalation.

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 doses of these medications before starting treatment with this medicine.

In any case, the recommended starting dose of this medicine for the treatment of symptomatic congestive heart failure is 3.125 mg twice daily (total 6.25 mg per day) for two weeks. If this dose is well tolerated, it may be increased subsequently (at intervals of at least two weeks) to 6.25 mg twice daily (total 12.5 mg per day). Your doctor may then prescribe higher doses (after at least two weeks).

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice daily (total 50 mg per day). If you weigh more than 85 kg, the maximum recommended dose is 50 mg twice daily (100 mg per day).

Your doctor will advise you on the duration of your treatment with this medicine.

As a general rule, regardless of your condition, discontinuation of this medicine should be gradual over several days, reducing the dose by half every three days.

Use in children and adolescents

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

Instructions for correct 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 ability to pump blood and you may experience shortness of breath, weakness, and fluid accumulation), you should take this medicine with food to avoid dizziness upon standing.

Remember to take your medicine.

The tablet can be divided into equal doses.

If you take more Carvedilol Krka than you should

If you have taken more carvedilol than you should, contact your doctor immediately or go to the nearest hospital. Take the medicine with you. In case of overdose or accidental ingestion by another person, contact the toxicology information service. Telephone: 91 562 04 20.

If you forget to take Carvedilol Krka

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

If you stop taking Carvedilol Krka

Treatment with carvedilol should not be stopped abruptly, especially if you have ischaemic heart disease, a condition that causes poor blood pumping by the heart. Your doctor will gradually reduce your dose over several days until you completely stop taking carvedilol.

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 Krka may cause adverse effects, although not everyone experiences them.

Adverse effects are classified as follows: 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.

Disorders of the nervous system

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, increased blood volume in the body.

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

Frequency not known: Sinus arrest (a serious 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, severe cutaneous 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 the blood (anemia).

Rare: Reduced number of platelets in the blood (thrombocytopenia).

Very rare: Reduced number of white blood cells in the blood (leukopenia).

Hepatobiliary disorders

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

Eye disorders

Common: Decreased 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: Urination difficulties.

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 patients with diabetes (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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carvedilol Krka

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Do not use Carvedilol Krka after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carvedilol Krka 6.25 mg:

• The active substance is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other components are: lactose monohydrate, sucrose, povidone K25, crospovidone, colloidal anhydrous silica, and magnesium stearate. See section 2 “Carvedilol Krka contains lactose and sucrose”.

Appearance of the product and pack contents

Carvedilol Krka 6.25 mg tablets are white, oval, and scored on one side. They are available in packs of 28 and 500 tablets for oral administration.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, Pta Baja, Oficina 1, 28108, Alcobendas, Madrid, Spain

Date of the most recent review of this leaflet: August 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).