CARVEDILOL KRKA 25 mg TABLETS

2. What you need to know before you take Carvedilol Krka

Do not take Carvedilol Krka

• If you are allergic to carvedilol or any of the other ingredients of this medicinal product (listed in section 6).
• If you have a certain type of decompensated heart failure 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 beats per minute).
• If you suffer from 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).
• A heart condition that consists of sinoatrial 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 medicinal product.

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 problems.
• 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 an operation with anesthesia. You should inform the anesthesiologist.
• If you use contact lenses. Carvedilol may reduce tear production.
• If you have had severe skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all beta-blocking medications, treatment with this medicinal product should not be stopped abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

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

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

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

This is very important because taking several medicines at the same time can increase or decrease their effect. Therefore, you should not take this medicinal product with any other medicine unless your doctor has allowed it.

Note that these instructions may also apply to medicines 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 medicines:

• Fluoxetine and paroxetine (medicines for depression).
• Cyclosporine and tacrolimus (medicines used to prevent rejection in transplants).

• Digoxin, Verapamil, Diltiazem, and antiarrhythmic medications (medicines used to treat heart problems and high blood pressure).

• Amiodarone (a medicine used to treat certain heart problems).
• Certain pain relievers of the aspirin and ibuprofen type (NSAIDs).
• Other blood pressure medications, 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 modify the elimination of other medicines from the body).
• Monoamine oxidase inhibitors (medicines for depression).
• Beta-agonist bronchodilators (medicines used to improve respiratory capacity, such as in asthma).

Taking Carvedilol Krka with food, drinks, and alcohol

You should avoid taking carvedilol at the same time 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 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 medicinal product.

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 medicinal product.

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

Carvedilol 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 suffering heart and lung problems.

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

Driving and using machines

Occasionally, this medicinal product may impair your ability to drive or operate machines. This occurs especially when starting or changing treatment and when taken together with alcohol.

Carvedilol Krka contains sucrose and lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicinal product.

3. How to take Carvedilol Krka

Follow exactly the administration instructions of this medicinal product indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Essential hypertension

Adults:

Orally. 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:

Orally. 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:

Orally. The recommended starting dose 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:

Orally. 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:

Orally. Your doctor will tell you individually the dose you should take, closely monitoring you during dose 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 this medicinal product, your doctor will adjust the amount of these medications you should take.

In any case, the recommended starting dose for the treatment of symptomatic congestive heart failure with this medicinal product 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 this medicinal product 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 this medicinal product.

As a general rule, regardless of your disease, withdrawal of this medicinal product should be done gradually over a few days, or the dose should be reduced by half every three days.

Use in children and adolescents

This medicinal product 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 this medicinal product while eating to avoid dizziness when standing up.

Remember to take your medicine.

The tablet can be divided into equal doses.

If you take more Carvedilol Krka than you should

If you take more carvedilol than you should, contact your doctor or go to the nearest hospital immediately. Bring the medicinal product 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 Krka

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

If you stop taking Carvedilol Krka

Treatment with carvedilol should not be stopped abruptly, especially if you suffer from ischemic heart disease, a disease 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 completely.

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

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

Side effects are classified into: 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 not known (cannot be estimated from the 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 start of treatment.

Uncommon: Paresthesia (tingling sensation).

Psychiatric disorders:

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Not known: Hallucinations.

Cardiac disorders

Very common: Increased 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 (A-V) block (heart problems), and angina pectoris (chest pain).

Not known: 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 common: Low blood pressure.

Common: 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 pain in the legs when walking) or Raynaud's phenomenon (decreased blood flow to the fingers of the hands and feet, ears, and nose), hypertension.

Respiratory, thoracic, and mediastinal disorders

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

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal disorders 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 exanthem, dermatitis, urticaria, itching, psoriasis, lichen planus-like skin lesions).

Not known: Hair loss, severe skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Blood and lymphatic system disorders

Common: 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

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

Renal and urinary disorders

Common: 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.

Not known: Urinary incontinence in women (disappears when the medication is stopped).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Pain in the limbs.

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 cholesterol in the blood.

Not known: It is possible that latent diabetes mellitus may manifest or that existing diabetes may worsen.

General disorders and administration site conditions

Very common: Fatigue.

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

If you consider that any of the side effects you are experiencing is serious 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 side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofCarvedilol Krka 25 mg:

• The active ingredient is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other ingredients 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 Package Contents

Carvedilol Krka 25 mg tablets are white, round, and scored on one side. They are available in packages 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

You can request more information about this medicine by contacting 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 Last Revision of this Leaflet:March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).