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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication 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, tell 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 Package 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
expands 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 the usual basic medications,
• 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 the patient is allergic to carvedilol or any of the other ingredients of this medication (listed in section 6);
• if the patient has unstable or uncontrolled heart failure;
• if the patient has overt clinical liver dysfunction;
• if the patient has atrioventricular block of second or third degree (unless they have a permanently implanted pacemaker);
• if the patient has a slow heart rate (<50 beats minute);< li>
• if the patient has sick sinus syndrome (including sinoatrial block);
• if the patient has severe hypotension (systolic blood pressure <85 mmhg);< li>
• if the patient has severe heart disease (cardiogenic shock);
• if the patient has a respiratory disease associated with bronchospasm or asthma;
• if the patient has significant fluid retention in the body or cardiac overload requiring intravenous administration of medications that increase cardiac contractility;
• if the patient has metabolic acidosis;
• if the patient has a pheochromocytoma (unless their symptoms are effectively controlled with alpha-adrenergic blocking medications).

Warnings and Precautions

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

When to Exercise Particular Caution When Taking Vivacor

• if the patient has chronic heart failure, as it may lead to worsening of heart failure or fluid retention;
• if the patient has hypertension and chronic heart failure treated with digitalis glycosides (lanatoside), caution should be exercised when taking Vivacor, as both digitalis glycosides and Vivacor slow atrioventricular conduction;
• if the patient has chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary artery 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 the patient has 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 the patient has chronic obstructive pulmonary disease (COPD) or has a tendency to bronchospasm but is not being treated with oral or inhaled medications. If bronchospasm occurs during treatment with Vivacor, the patient should tell their doctor;
• if the patient has diabetes, as Vivacor may worsen glucose tolerance and mask or attenuate the early signs and symptoms of hypoglycemia (low blood sugar). When initiating Vivacor or increasing its dose, it is recommended to regularly monitor blood glucose levels and adjust the doses of antidiabetic medications, as the use of Vivacor may lead to worsening of glucose tolerance;
• if the patient has peripheral circulatory disorders and Raynaud's syndrome, as the administration of beta-adrenergic blocking medications may increase the risk of worsening of peripheral vascular disorders;
• if the patient has hyperthyroidism, as Vivacor may mask the signs and symptoms of hyperthyroidism;
• if the heart rate is slower than 55 beats/minute, the patient should consult their doctor, who will decide whether to reduce the dose;
• if the patient has ever experienced severe hypersensitivity reactions and is undergoing desensitization treatment (like other medications in this class, Vivacor may increase sensitivity to allergens and exacerbate anaphylactic reactions);
• if the patient experiences severe skin reactions. During treatment with carvedilol, very rare cases of severe skin reactions, such as erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome, have been reported (see section 4 Possible Side Effects). Carvedilol should be discontinued if the patient experiences severe skin reactions that may be related to carvedilol;
• if the patient has psoriasis associated with beta-adrenergic blocking medications. The doctor should weigh the potential risks and benefits of using Vivacor;
• if the patient is taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, or antiarrhythmic medications;
• if the patient has a pheochromocytoma, they should strictly follow their doctor's instructions. Before administering Vivacor, the doctor will recommend the use of an alpha-adrenergic blocking medication;
• if there is a suspicion of Prinzmetal's angina, as the administration of beta-adrenergic blocking medications that only block beta-adrenergic receptors may be associated with a risk of chest pain. However, the additional alpha-1-adrenergic blocking properties of Vivacor may prevent such an effect;
• if the patient wears contact lenses, as it is possible to reduce tear secretion.

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

Vivacor and Other Medications

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

• medications containing digoxin (used to treat heart failure), as your doctor may need to adjust their dosage when used in combination with Vivacor;
• oral cyclosporine (an immunosuppressive medication 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 (medications used to treat depression);
• insulin and oral antidiabetic medications, as Vivacor may enhance their effects. Your doctor may recommend more frequent monitoring of blood glucose levels;
• reserpine (a medication that affects blood pressure) and monoamine oxidase inhibitors (a type of antidepressant medication), as these medications may cause additional slowing of the heart rate and/or lowering of blood pressure;
• non-dihydropyridine calcium channel blockers, amiodarone, and other antiarrhythmic medications. Your doctor will monitor your ECG and blood pressure;
• clonidine (a medication 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 side effects may include lowering blood pressure (e.g., barbiturates used to treat epilepsy, phenothiazine derivatives used to treat psychoses, tricyclic antidepressants used to treat depression, vasodilators) and alcohol;
• anesthetics;
• nonsteroidal anti-inflammatory medications (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 medication.
Animal studies have shown a harmful effect on fertility. The potential risk to humans is not known.
Do not take Vivacor during pregnancy, unless the expected benefits of treatment outweigh the potential risks.
Do not take Vivacor during breastfeeding, unless the expected benefits of treatment outweigh the potential risks.

Driving and Operating Machinery

As with many other medications used to treat hypertension, remember that if you experience dizziness or other similar side effects, do not drive or operate machinery. This applies especially when starting treatment or changing your treatment, or when taking the medication 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 diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medication.

Each Vivacor 12.5 mg and 25 mg Tablet Contains Sodium.

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Vivacor

Always take this medication 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 medication individually for each patient.
Treatment with Vivacor will be initiated under the supervision of a doctor experienced in the treatment of heart failure and will be preceded by an assessment of the patient's clinical condition. Depending on the outcome of the clinical assessment, the medication will be administered in an outpatient or hospital setting.
Adults
The recommended initial dose is 3.125 mg twice a day for 2 weeks. If the medication 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 a day, then to 12.5 mg twice a day, and up to 25 mg twice a day. The goal 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 of less than 85 kg is 25 mg twice a day. For patients with mild or moderate heart failure with a body weight of more than 85 kg, the maximum recommended dose is 50 mg twice a day.
In patients with systolic blood pressure <100 mmhg, during dose escalation of vivacor, there may be a worsening renal function and or exacerbation heart failure. therefore, before each increase, the doctor will monitor assess severity subjective objective symptoms failure vasodilation.
If treatment with Vivacor is interrupted for a period longer than 2 weeks, re-initiation of the medication should start with a dose of 3.125 mg twice a day and the 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 the medication in children and adolescents (under 18 years of age) have not been established.

Hypertension

It is recommended to take the medication once a day.
Adults
The recommended initial dose is 12.5 mg once a day for the first 2 days. Then, the dose should be increased to 25 mg once a day. In most patients, this dose is sufficient, but if necessary, the doctor may increase the dose to a maximum of 50 mg, taken 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 per day. 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 a maximum recommended dose of 50 mg, taken as a single dose or in divided doses.
Children and Adolescents
The safety and efficacy of the medication in children and adolescents (under 18 years of age) have not been established.

Angina Pectoris

Adults
The recommended initial dose is 12.5 mg twice a day for the first 2 days. Then, the dose should be increased to 25 mg twice a day.
Elderly Patients
The maximum recommended daily dose is 50 mg in divided doses.
Children and Adolescents
The safety and efficacy of the medication in children and adolescents (under 18 years of age) 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 a day. 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 a day, and then to 25 mg twice a day. In patients who do not tolerate a dose of 6.25 mg twice a day, the doctor will reduce the dose to 3.125 mg twice a day and will continue this dose for 3-10 days. If this dose is well tolerated, it will be increased to 6.25 mg twice a day, and then gradually to 25 mg twice a day. The goal 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 dysfunction.

Patients with Concomitant Renal Impairment

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

Taking a Higher Than Recommended Dose of Vivacor

If you take more than the recommended dose of the medication, 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 (insufficient blood supply to tissues and organs due to heart failure), and cardiac arrest. Respiratory disorders, bronchospasm, vomiting, disorders of consciousness, and generalized seizures have also been observed.

Missing a Dose of Vivacor

Do not take a double dose to make up for a missed 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. Abrupt cessation of treatment may lead to the occurrence of chest pain and increased blood pressure, especially in patients with angina pectoris. The medication should be discontinued gradually, according to the doctor's instructions.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Vivacor can cause side effects, although not everybody gets them.
Frequency of Possible Side Effects
Very Common (affecting more than 1 in 10 people):

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

Common (affecting up to 1 in 10 people):

• 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 sugar) or hypoglycemia (low blood sugar)
• depression, low mood
• presyncope, syncope
• visual disturbances
• reduced tear secretion (dry eye syndrome), eye irritation
• bradycardia (slow heart rate)
• hyperolemia (increased blood volume) and fluid overload
• edema (including generalized, peripheral, orthostatic, and localized edema in the genital area and lower limbs),
• 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 the 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 pre-existing vascular disease and/or renal dysfunction
• pain

Uncommon (affecting up to 1 in 100 people):

• sleep disorders
• paresthesia (tingling and numbness of the 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 of the type of psoriasis and lichen planus)
• alopecia
• erectile dysfunction, impotence

Rare (affecting up to 1 in 1,000 people):

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

Very Rare (affecting up to 1 in 10,000 people):

• 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 a worsening of heart failure and fluid retention.
In patients with chronic heart failure and low blood pressure, coronary artery 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.
Given that Vivacor has beta-adrenergic blocking properties, during treatment, there may be a worsening of glucose tolerance and masking or attenuation of the early signs and symptoms of hypoglycemia (low blood sugar).
There have been reports of individual cases of urinary incontinence in women, 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, tell your doctor or pharmacist. Side effects can be reported directly to:
Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 medication.

5. How to Store Vivacor

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

6. Contents of the Package and Other Information

What Vivacor Contains

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

What Vivacor Looks Like and Contents of the Package

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

Marketing Authorization Holder

PROTERAPIA Spółka z o.o.
Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
For more detailed information, please contact the representative of the marketing authorization holder:
PROTERAPIA Spółka z o.o.
Komitetu Obrony Robotników 45 D
02-146 Warsaw
tel. (22) 417 92 00

Date of Last Revision of the Leaflet: 28.07.2021