Vivacor

Package Leaflet: Information for the User

Vivacor, 6.25 mg, tablets

Vivacor, 12.5 mg, tablets

Vivacor, 25 mg, tablets

Carvedilol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Vivacor and what is it used for
• 2. Important information before taking Vivacor
• 3. How to take Vivacor
• 4. Possible side effects
• 5. How to store Vivacor
• 6. Contents of the pack and other information

1. What is Vivacor and what is it used for

Vivacor, 6.25 mg, 12.5 mg or 25 mg, tablets contain the active substance carvedilol, which dilates blood vessels by blocking alpha-1 adrenergic receptors and inhibits the renin-angiotensin-aldosterone system by blocking beta-adrenergic receptors. Vivacor is indicated for the treatment of:

• symptomatic chronic heart failure (stable mild, moderate or severe chronic heart failure), in addition to conventional basic treatments,
• hypertension,
• stable angina pectoris,
• patients after myocardial infarction with documented left ventricular dysfunction (left ventricular ejection fraction (LVEF) ≤ 40%).

2. Important information before taking Vivacor

When not to take Vivacor

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if you have unstable or uncontrolled heart failure;
• if you have overt clinical liver dysfunction;
• if you have atrioventricular block of second or third degree (unless you have a permanently implanted pacemaker);
• if you have a slow heart rate (<50 beats minute);< li>
• if you have sick sinus syndrome (including sinoatrial block);
• if you have severe hypotension (systolic blood pressure <85 mmhg);< li>
• if you have severe heart disease (cardiogenic shock);
• if you have a respiratory disease associated with bronchospasm or asthma;
• if you have significant fluid retention in the body or cardiac overload requiring intravenous administration of positive inotropic drugs;
• if you have metabolic acidosis;
• if you have a pheochromocytoma (unless its symptoms are effectively controlled with alpha-adrenergic blocking agents).

Warnings and precautions

Before starting treatment with Vivacor, discuss it with your doctor or pharmacist.

When to be particularly cautious when taking Vivacor

• if you have chronic heart failure, as it may worsen heart failure or lead to fluid retention;
• if you have hypertension and chronic heart failure treated with cardiac glycosides (lanatosides), be cautious when taking Vivacor, as both cardiac glycosides and Vivacor slow atrioventricular conduction;
• if you have chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary heart disease, peripheral vascular disease and or concomitant renal dysfunction. during dose escalation of vivacor in these patients, the doctor will monitor function and, if deteriorates, discontinue treatment reduce dose;< li>
• if you have left ventricular dysfunction after acute myocardial infarction. Before starting treatment with carvedilol, the patient's condition must be stable and they must have been receiving an ACE inhibitor for at least 48 hours, with an unchanged dose for at least 24 hours;
• if you have chronic obstructive pulmonary disease (COPD) or have a tendency to bronchospasm but are not being treated with oral or inhaled medications. If you experience any signs or symptoms of bronchospasm while taking Vivacor, tell your doctor;
• if you have diabetes, as Vivacor may worsen blood glucose control and mask or attenuate the early signs and symptoms of hypoglycemia (low blood glucose). When initiating Vivacor or increasing the dose, it is recommended to regularly monitor blood glucose levels and adjust the doses of antidiabetic medications, as Vivacor may impair blood glucose control;
• if you have peripheral circulatory disorders and Raynaud's syndrome, as beta-adrenergic blocking agents may increase the risk of exacerbation of peripheral vascular disorders;
• if you have hyperthyroidism, as Vivacor may mask the signs and symptoms of hyperthyroidism;
• if your heart rate is slower than 55 beats/minute, consult your doctor, who will decide whether to reduce the dose;
• if you have ever had severe hypersensitivity reactions and are undergoing desensitization treatment (like other drugs in this class, Vivacor may increase sensitivity to allergens and exacerbate anaphylactic reactions);
• if you have experienced severe skin reactions. Very rare cases of severe skin reactions, such as erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome, have been reported during treatment with carvedilol. Carvedilol should be discontinued if you experience severe skin reactions that may be related to carvedilol;
• if you have psoriasis associated with beta-adrenergic blocking agents. The doctor should weigh the potential risks and benefits of using Vivacor;
• if you are taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, or antiarrhythmic agents;
• if you have a pheochromocytoma, you should strictly follow your doctor's instructions. Before taking Vivacor, your doctor will instruct you to take an alpha-adrenergic blocking agent;
• if you suspect Prinzmetal's angina, as beta-adrenergic blocking agents may be associated with an increased risk of chest pain. However, the additional alpha-1 adrenergic blocking properties of Vivacor may prevent this effect;
• if you wear contact lenses, as it is possible to reduce tear production.

As with all beta-adrenergic blocking agents, carvedilol should not be stopped abruptly. This is especially important for patients with coronary artery disease. The dose of carvedilol should be reduced gradually (over 2 weeks).

Vivacor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• medicines containing digoxin (used to treat heart failure), as your doctor may need to adjust their dosage when taken with Vivacor;
• oral cyclosporine (an immunosuppressive agent used to prevent organ rejection), as Vivacor may enhance the effects of cyclosporine;
• rifampicin (an antibiotic used to treat tuberculosis), as it may reduce the effectiveness of Vivacor;
• fluoxetine and paroxetine (medicines used to treat depression);
• insulin and oral antidiabetic agents, as Vivacor may enhance their effects. Your doctor may need to monitor your blood glucose levels more frequently;
• reserpine (a medicine that affects blood pressure) and monoamine oxidase inhibitors (a type of antidepressant), as these medicines may cause additional slowing of the heart rate and/or lowering of blood pressure;
• non-dihydropyridine calcium channel blockers, amiodarone, and other antiarrhythmic agents. Your doctor will monitor your ECG and blood pressure;
• clonidine (a medicine used to lower blood pressure and treat migraines);
• other blood pressure-lowering medications. Vivacor may enhance the effects of concomitantly used blood pressure-lowering medications (e.g., alpha-adrenergic receptor antagonists) and medications whose adverse effect may be a decrease in blood pressure (e.g., barbiturates used to treat epilepsy, phenothiazine derivatives used to treat psychoses, tricyclic antidepressants used to treat depression, and vasodilators) as well as alcohol;
• anesthetics;
• nonsteroidal anti-inflammatory drugs (NSAIDs), which may reduce the effectiveness of Vivacor;
• bronchodilators.

Taking Vivacor with food and alcohol

Vivacor can be taken with or without food. Vivacor may enhance the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Animal studies have shown a harmful effect on fertility. The potential risk to humans is unknown. Do not take Vivacor during pregnancy, unless the expected benefits of treatment outweigh the potential risks. Do not take Vivacor while breastfeeding, unless the expected benefits of treatment outweigh the potential risks.

Driving and using machines

As with many other medicines used to treat hypertension, remember that if you experience dizziness or other similar adverse effects, do not drive or operate machinery. This is especially important when starting treatment or changing your treatment, or when taking the medicine with alcohol.

All Vivacor tablets contain lactose, and Vivacor 6.25 mg tablets also contain sucrose.

Each Vivacor 6.25 mg tablet contains 50 mg of lactose and 12.5 mg of sucrose. Each Vivacor 12.5 mg tablet contains 62.5 mg of lactose. Each Vivacor 25 mg tablet contains 125 mg of lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Each Vivacor 12.5 mg and 25 mg tablet contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Vivacor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of Vivacor is too strong or too weak, talk to your doctor or pharmacist. Swallow the tablets with at least half a glass of water. Vivacor tablets should be taken with sufficient fluid. Patients with chronic heart failure should take the tablets with food. Vivacor tablets are available in the following strengths: 6.25 mg, 12.5 mg, and 25 mg.

Symptomatic chronic heart failure

Your doctor will adjust the dose of this medicine individually for you. Treatment with Vivacor will be started under the supervision of a doctor experienced in the treatment of heart failure and after assessing your clinical condition. Depending on the outcome of the clinical assessment, the medicine will be given in an outpatient or hospital setting.

Adults

The recommended initial dose is 3.125 mg twice daily for 2 weeks. If the medicine is well tolerated, the doctor will increase the dose at intervals of at least 2 weeks, according to the following scheme: to 6.25 mg twice daily, then to 12.5 mg twice daily, and up to 25 mg twice daily. The aim is to achieve the maximum tolerated dose by the patient. The maximum recommended dose for all patients with severe chronic heart failure and for patients with mild or moderate heart failure with a body weight below 85 kg is 25 mg twice daily. For patients with mild or moderate heart failure with a body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.

In patients with systolic blood pressure <100 mmhg, during dose escalation of vivacor, there may be a worsening renal function and or an exacerbation heart failure. therefore, before each increase, the doctor will monitor assess severity subjective objective symptoms failure vasodilation.< p>

If treatment with Vivacor is interrupted for a period longer than 2 weeks, re-initiation of the medicine should start at a dose of 3.125 mg twice daily, and this dose should be gradually increased according to the above recommendations for dosing.

Elderly patients

Dosing is the same as for adults.

Children and adolescents

The safety and efficacy of Vivacor in children and adolescents (below 18 years) have not been established.

Hypertension

It is recommended to take the dose once daily.

Adults

The recommended initial dose is 12.5 mg once daily for the first 2 days. Then, the dose should be increased to 25 mg once daily. In most patients, this dose is sufficient, but if necessary, the doctor may increase the dose to a maximum of 50 mg, given as a single dose or in divided doses. Dose increases should be made at intervals of not less than 2 weeks.

Elderly patients

The recommended initial dose is 12.5 mg once daily. In many cases, this dose provides adequate blood pressure control. If the blood pressure-lowering effect is insufficient, the doctor may gradually increase the dose to the maximum recommended dose of 50 mg, given as a single dose or in divided doses.

Children and adolescents

The safety and efficacy of Vivacor in children and adolescents (below 18 years) have not been established.

Angina pectoris

Adults

The recommended initial dose is 12.5 mg twice daily for the first 2 days. Then, the dose should be increased to 25 mg twice daily.

Elderly patients

The maximum recommended daily dose is 50 mg, given in divided doses.

Children and adolescents

The safety and efficacy of Vivacor in children and adolescents (below 18 years) have not been established.

Left ventricular dysfunction after acute myocardial infarction

In patients with left ventricular dysfunction after myocardial infarction, the recommended initial dose is 6.25 mg twice daily. The patient will be monitored for 3 hours after the first dose. The doctor will increase the dose every 3-10 days to 12.5 mg twice daily, and then to 25 mg twice daily. In patients who do not tolerate a dose of 6.25 mg twice daily, the doctor will reduce the dose to 3.125 mg twice daily and continue this dose for 3-10 days. If this dose is well tolerated, it will be increased to 6.25 mg twice daily, and then gradually to 25 mg twice daily. The aim is to achieve the maximum tolerated dose by the patient.

Patients with concomitant liver disease

Administration of Vivacor is contraindicated in patients with concomitant liver disease.

Patients with concomitant renal impairment

In patients with systolic blood pressure > 100 mmHg, there is no need to reduce the dose.

Overdose of Vivacor

If you have taken more than the prescribed dose of Vivacor, contact your doctor or go to the nearest hospital immediately. Significant overdose may cause hypotension (low blood pressure), bradycardia (slow heart rate), heart failure, cardiogenic shock (inadequate blood supply to tissues and organs due to heart failure), and cardiac arrest. Respiratory disorders, bronchospasm, vomiting, impaired consciousness, and generalized seizures have also been observed.

Missed dose of Vivacor

Do not take a double dose to make up for a forgotten dose. If you miss a dose (or several doses), do not increase the next dose. Take the next dose at the usual time. Continue treatment as recommended by your doctor.

Stopping treatment with Vivacor

Treatment with Vivacor is long-term. Stopping the treatment abruptly may lead to the occurrence of chest pain and an increase in blood pressure, especially in patients with angina pectoris. The medicine should be discontinued gradually, according to your doctor's instructions. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vivacor can cause side effects, although not everybody gets them. Frequency of possible side effects:

Very common (occurring in more than 1 in 10 patients):

• dizziness, headache, usually mild and occurring at the start of treatment
• heart failure
• low blood pressure
• fatigue (weakness)

Common (occurring in up to 1 in 10 patients):

• bronchitis, pneumonia, upper respiratory tract infection
• urinary tract infection
• anemia
• weight gain
• hypercholesterolemia (elevated cholesterol levels)
• in patients with diabetes, decreased glucose tolerance, which may cause hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose)
• depression, low mood
• presyncope, syncope
• visual disturbances
• reduced tear production (dry eye syndrome), eye irritation
• bradycardia (slow heart rate)
• hyperolemia (increased blood volume) and fluid overload
• edema (including generalized, peripheral, orthostatic, and genital),
• orthostatic hypotension (sudden drop in blood pressure when changing position)
• peripheral circulatory disorders (cold extremities, peripheral vascular disease, exacerbation of intermittent claudication - pain in the calf muscles when walking, Raynaud's syndrome - pallor and cyanosis of fingers and toes, nose, or ears due to vasospasm)
• hypertension
• dyspnea, pulmonary edema, asthma in susceptible patients
• gastrointestinal disorders (including nausea, diarrhea, vomiting, dyspepsia, abdominal pain),
• limb pain
• renal failure and worsening of renal function in patients with generalized vascular disease and/or pre-existing renal dysfunction
• pain

Uncommon (occurring in up to 1 in 100 patients):

• sleep disorders
• paresthesia (tingling and numbness of limbs)
• atrioventricular block (disorders of impulse conduction in the heart muscle)
• angina pectoris (chest pain)
• constipation
• skin reactions (e.g., allergic rash, dermatitis, urticaria, pruritus, skin changes like psoriasis and lichen planus)
• alopecia
• erectile dysfunction, impotence

Rare (occurring in up to 1 in 1000 patients):

• thrombocytopenia (low platelet count)
• nasal congestion (swelling of the nasal mucosa)
• dryness of the oral mucosa
• urination disorders

Very rare (occurring in up to 1 in 10,000 patients):

• leukopenia (low white blood cell count)
• hypersensitivity (allergic reaction)
• abnormal liver function test results (elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase)
• urinary incontinence in women
• severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

In patients with congestive heart failure, during dose escalation of carvedilol, there may be an exacerbation of heart failure and fluid retention. In patients with chronic heart failure and low blood pressure, coronary heart disease, peripheral vascular disease, and/or concomitant renal dysfunction, during treatment with carvedilol, reversible worsening of renal function has been observed. The frequency of side effects does not depend on the dose, except for dizziness, visual disturbances, and bradycardia. The profile of side effects in patients with hypertension and angina pectoris treated with Vivacor is similar to that observed in patients with heart failure, although the frequency of these side effects is lower. Due to the beta-adrenergic blocking effect of Vivacor, during treatment, there may be an unmasking of latent diabetes, worsening of blood glucose control, and impairment of glucose regulation. Isolated cases of urinary incontinence in women have been reported, which resolved after discontinuation of treatment. Some patients treated with Vivacor may experience other side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vivacor

Store in a temperature below 25°C. Vivacor 6.25 mg tablets: Store in the original package to protect from light and moisture. Vivacor 12.5 mg and 25 mg tablets: Store in the original package to protect from light. Keep out of the sight and reach of children. Do not use the medicine after the expiry date (EXP) stated on the package. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vivacor contains

The active substance of Vivacor is carvedilol. One tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The other ingredients of Vivacor are: Vivacor 6.25 mg tablets - lactose monohydrate, crospovidone, sucrose, colloidal anhydrous silica, povidone K-25, magnesium stearate, and quinoline yellow (E 104). Vivacor 12.5 mg tablets - potato starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, sodium croscarmellose, and colloidal anhydrous silica. Vivacor 25 mg tablets - potato starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, sodium croscarmellose, and colloidal anhydrous silica.

What Vivacor looks like and contents of the pack

Vivacor 6.25 mg tablets: Light yellow, elongated tablets with the marking "E 341" on one side and a score line on the other side. Vivacor 12.5 mg tablets: White or almost white, elongated, biconvex tablets with a score line on one side. Vivacor 25 mg tablets: White or almost white, round, biconvex tablets with a score line on one side. The tablets can be divided into equal doses. Vivacor 6.25 mg tablets are available in packs containing 30 or 60 tablets in OPA/Al/PVC/Al blisters, packaged in cardboard boxes. Vivacor 12.5 mg and 25 mg tablets are available in packs containing 30 or 60 tablets in PVC/Aluminum blisters, packaged in cardboard boxes.

Marketing authorization holder

PROTERAPIA Sp. z o.o., ul. Komitetu Obrony Robotników 45 D, 02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC, 1165 Budapest, Bökényföldi út 118-120, Hungary