Package Leaflet: Information for the User

Carvedilol Krka 6.25 mg Tablets EFG

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 and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medicine 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 Krka

• If you are allergic to carvedilol or any of the other components of this medication (listed in section 6).
• If you have a type of heart failure that is decompensated, known as class IV (heart inability to pump blood 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 consisting of second- and 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 have 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).
• If you have a heart condition consisting of sino-atrial block.
• If you have very low blood pressure (systolic pressure of less than 85 mmHg).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medication. 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 (act on the heart's rhythm).
• If you have any thyroid problems.
• 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 responsible anesthesiologist.
• If you wear contact lenses. Carvedilol may reduce tear production.
• If you have severe skin adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all medications with beta-blocking activity, do not stop treatment 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.

Other medications and Carvedilol Krka

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

This is very important, as taking multiple medications at the same time may increase or decrease their effect. Therefore, do not take this medication 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 problems and high blood pressure).
• 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 high blood pressure or migraine).
• Rifampicin (medication used to treat infections).
• Cimetidine (medication used to treat gastrointestinal problems).
• Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).
• MAO inhibitors (medications used to treat depression).
• Beta-agonist bronchodilators (medications used to improve respiratory function, such as in asthma).

Carvedilol Krka with food, drinks, and alcohol

Avoid taking carvedilol simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in carvedilol levels in the blood and cause unpredictable 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 if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

This medication is not recommended for use 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 experiencing heart and lung problems.

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

Driving and operating machinery

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

Carvedilol Krka contains saccharose and lactose

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

Followexactly theadministration instructionsfor this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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) to 50 mg once a day or in two doses of 25 mg each.

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

Elderly patients:

Oral route. The maximum recommended dose for elderly patients is 50 mg administered in divided doses (twice a day).

Chronic Heart Failure

Adults and elderly 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 this medication, your doctor will adjust the amount of these types of medications you should take.

In any case, the recommended starting dose for this medication in the treatment of 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) to 6.25 mg twice a day (total 12.5 mg per day). Your doctor may prescribe higher doses of this medication later (at least two weeks after).

If you weigh less than 85 kg, the maximum recommended dose is 25 mg twice a day (total 50 mg per day). If your weight is greater than 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 medication.

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

Use in children and adolescents

This medication 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 cause difficulty breathing, weakness, and fluid accumulation), you should take this medication while eating, to avoid the feeling of dizziness when getting up.

Remember to take your medication.

The tablet can be split 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. Bring the medication with you.In case of overdose or accidental administration to another person, consult the toxicology information service. Phone: 91 562 04 20.

If you forgot to take Carvedilol Krka

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

If you interrupt treatment with Carvedilol Krka

Treatment with carvedilol should not be interrupted abruptly, especially if you have ischemic cardiopathy, a disease that causes the heart not to 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Carvedilol Krka 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 unknown frequency (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, syncope (fainting), especially at the beginning of treatment.

Uncommon: Paresthesias (tingling sensation).

Mental and behavioural disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Unknown frequency: 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).

Unknown frequency: Sinus arrest (a serious condition that makes heartbeats very slow or stop), especially in elderly patients or patients with other heart rhythm disorders.

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, and 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).

Unknown frequency: Hair loss, severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Haematological and lymphatic system 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 kidney function.

Rare: Urination problems.

Unknown frequency: Urinary incontinence in women (disappears when stopping medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Pain in the extremities.

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.

Unknown frequency: 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 the legs, ankles, and feet).

If you consider that any of the side effects you are experiencing 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 that does not appear 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 this medicationout of the sight and reach of children.

This medication does not require any special temperature for conservation.

Do not use Carvedilol Krkaafter 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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This way, you will help protect the environment.

Composition ofCarvedilol Krka 6,25 mg:

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

Appearance of the product and contents of the packaging

Carvedilol Krka 6,25 mg tablets are white, oval-shaped, and scored on one side. They are presented in packaging of 28 and 500 tablets for oral administration.

Holder of the marketing authorization and responsible manufacturer

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

Further information about this medicinal product can be obtained 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 review of this leaflet:March2024

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