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 you.

• You should keep this 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. 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.
Carvedilol is a beta-adrenergic blocker and a vasodilator, it lowers high blood pressure and reduces the resistance that the heart has to overcome to pump blood.
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 coronary artery disease
• patients after myocardial infarction with 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 (including severe liver dysfunction);
• if you have an atrioventricular block of the second or third degree (unless you have a permanently implanted pacemaker);
• if you have a slow heart rate (severe bradycardia <50 beats minute);< li>
• if you have a sick sinus syndrome (including sinoatrial block);
• if you have severe hypotension (severe hypotension with 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 (leading to acid-base imbalance in the blood)
• if you have a pheochromocytoma (a specific adrenal gland tumor associated with high blood pressure) unless its symptoms are effectively treated with alpha-adrenergic receptor blockers.

Warnings and precautions

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

When to be particularly careful when taking Vivacor

• if you have chronic heart failure, as it may worsen heart failure or fluid retention;
• if you have hypertension and chronic heart failure treated with cardiac glycosides, you should be careful when taking Vivacor, as both cardiac glycosides and Vivacor slow down atrioventricular conduction;
• if you have chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary artery disease, peripheral vascular disease and or concomitant renal dysfunction. during the dose increase of vivacor in these patients, doctor will monitor function and, case deterioration, 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, at an unchanged dose for at least 24 hours;
• if you have chronic obstructive pulmonary disease (COPD) or are prone to bronchospasm but are not being treated with oral or inhaled medications. If you experience any signs or symptoms of bronchospasm while taking Vivacor, you should inform your doctor;
• if you have diabetes, as Vivacor may worsen glucose control 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 Vivacor may impair glucose control;
• if you have peripheral circulatory disorders and Raynaud's syndrome, as beta-adrenergic blockers may increase the risk of exacerbating circulatory disorders. However, the additional alpha-1 adrenergic receptor blocking properties of Vivacor may largely mitigate these effects.
• if you have hyperthyroidism, as Vivacor may mask the signs and symptoms of hyperthyroidism;
• if your heart rate is slower than 55 beats per minute, you should 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 had severe skin reactions. During treatment with carvedilol, very rare cases of severe skin reactions, such as toxic epidermal necrolysis or Stevens-Johnson syndrome, have been reported. Carvedilol should be completely discontinued if the patient experiences severe skin reactions that may be related to carvedilol;
• if you have psoriasis associated with beta-adrenergic blockers. The doctor should consider the potential risks and benefits of using Vivacor;
• if you are taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, or antiarrhythmic medications;
• if you have a pheochromocytoma, you should strictly follow your doctor's instructions. Before administering Vivacor, your doctor will prescribe an alpha-adrenergic blocker;
• if you suspect Prinzmetal's angina, as the administration of beta-adrenergic blockers alone may be associated with the risk of chest pain. However, the additional alpha-1 adrenergic receptor blocking properties of Vivacor may prevent this effect;
• if you wear contact lenses, as it is possible to reduce tear secretion.

As with all beta-adrenergic blockers, carvedilol should not be stopped abruptly.
This applies especially to patients with coronary artery disease. The dose of carvedilol should be
reduced gradually (over 2 weeks).
Children and adolescents
The safety and efficacy of carvedilol in children and adolescents under 18 years of age have not been established,
and therefore it should not be used in this age group.

Vivacor and other medicines

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

• medicines containing digoxin (used to treat heart failure), as your doctor may recommend adjusting their doses when used concomitantly with Vivacor;
• oral cyclosporine and tacrolimus (an immunosuppressive drug used to prevent organ rejection), as Vivacor may enhance the effects of cyclosporine and tacrolimus;
• rifampicin (an antibiotic used to treat tuberculosis), as it may weaken the effect of Vivacor;
• fluoxetine and paroxetine (medicines used to treat depression);
• insulin and oral antidiabetic medications, as Vivacor may enhance the effects of these medications. Your doctor may recommend more frequent monitoring of blood glucose levels;
• reserpine (a medicine that affects blood pressure) and monoamine oxidase inhibitors (a type of antidepressant), 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 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 blockers) and medications whose adverse effect may be 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;
• non-steroidal anti-inflammatory drugs (NSAIDs), which may weaken the effect of Vivacor;
• bronchodilators.

Taking Vivacor with food and alcohol

You should avoid drinking grapefruit juice at the same time or immediately after taking Vivacor.
Grapefruit or its juice may increase the concentration of the active substance carvedilol in the blood and
cause unexpected side effects.
During treatment, you should not drink alcohol, as it affects the action of Vivacor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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 not known.
You should not take Vivacor during pregnancy, unless the expected benefits of treatment are greater than the potential risk.
You should not take Vivacor during breastfeeding.

Driving and using machines

As with many other medicines used to treat hypertension, you should remember that if you experience dizziness or other similar side effects, you should not drive or operate machinery. This applies especially when starting treatment or changing treatment, increasing the dose, or 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 lactose (as 50 mg lactose monohydrate) and 12.5 mg sucrose.
Each Vivacor 12.5 mg tablet contains lactose (as 62.5 mg lactose monohydrate).
Each Vivacor 25 mg tablet contains lactose (as 125 mg lactose monohydrate).
If you have been told that you have an intolerance to some sugars, you should 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 that it is essentially 'sodium-free'.

3. How to take Vivacor

This medicine should always be taken 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, you should consult your doctor or pharmacist. The tablets should be swallowed with at least half a glass of water, do not chew the tablets.
Vivacor tablets should be taken with sufficient fluid. Patients with chronic heart failure should take the tablets with food (during meals).
Vivacor tablets are available in the following strengths:
6.25 mg, 12.5 mg, and 25 mg

Chronic heart failure

Your doctor will adjust the dose of this medicine individually for each patient.
Treatment with Vivacor will be started under the supervision of a doctor experienced in the treatment of heart failure and after assessing the patient's clinical condition. Depending on the result of the clinical assessment, the medicine will be administered in outpatient or hospital settings.
Adults
The recommended initial dose is 3.125 mg twice a day for 2 weeks. The dose of 3.125 mg can be obtained by dividing a 6.25 mg tablet in half. 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 a day, then to 12.5 mg twice a day, 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 the dose increase of vivacor, there may be a worsening renal function and or exacerbation heart failure. therefore, before each increase, 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 medicine should start with a dose of 3.125 mg twice a day 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 under 18 years of age have not been established.

Hypertension

It is recommended to take the dose 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, 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 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, given as a single dose or in divided doses.
Children and adolescents
The safety and efficacy of Vivacor in children and adolescents under 18 years of age have not been established.

Coronary artery disease

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 Vivacor 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. The dose of 3.125 mg can be obtained by dividing a 6.25 mg tablet in half.
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.

Patient with liver disease

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

Patient with renal impairment

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

Overdose of Vivacor

In case of overdose, you should immediately contact your doctor or go to the nearest hospital.
Significant overdose may cause hypotension (low blood pressure), bradycardia (slow heart rate), heart failure, sinoatrial arrest, 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.

Missed dose of Vivacor

You should not take a double dose to make up for a missed dose. In case of a missed dose (or several doses), you should not increase the next dose. The next dose should be taken at the usual time. Treatment should be continued according to your doctor's recommendations.

Stopping treatment with Vivacor

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

4. Possible side effects

Like all medicines, this medicine 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 beginning of treatment
• heart failure
• low blood pressure
• fatigue (weakness)

Common (occurring in 1 in 10 patients):

• bronchitis, pneumonia, upper respiratory tract infection
• urinary tract infection
• anemia
• weight gain
• hypercholesterolemia (elevated cholesterol levels in the blood)
• in diabetic patients, decreased glucose control, which may cause hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar)

Uncommon (occurring in 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)
• erectile dysfunction, impotence

Rare (occurring in 1 in 1,000 patients):

• low platelet count (thrombocytopenia)
• 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):

• low white blood cell count (leukopenia)
• hypersensitivity (allergic reaction)
• abnormal liver function test results (elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase)
• urinary incontinence in women

In patients with congestive heart failure, during the dose increase 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 manifestation of latent diabetes, worsening of glucose control, and impairment of glucose regulation.
There have been reports of individual cases of urinary incontinence in women, which resolved after discontinuation of treatment.
Additionally, during treatment with Vivacor, hallucinations may occur.
It may occur (uncommonly) hair loss (alopecia), excessive sweating (hyperhidrosis), and (very rarely) severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis.
There may be sinoatrial arrest, which means that the heart may beat very slowly or stop.
These symptoms may occur especially in patients over 65 years of age or patients with other heart problems.
In some patients treated with Vivacor, other side effects may occur.

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:
Department for the Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides,
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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 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 medicine after the expiry date (EXP) stated on the packaging. 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 that are no longer needed. 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.
Other ingredients of the medicine are:
Vivacor, 6.25 mg, tablets - lactose monohydrate, crospovidone, sucrose, colloidal anhydrous silica, povidone K-25, magnesium stearate, quinoline yellow (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 pack

Vivacor, 6.25 mg, tablets
Light yellow, oval 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, oval, 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 packs 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 packs containing 30 or 60 tablets in PVC/Aluminum blisters, packed in cardboard boxes.

Marketing authorization holder

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

Manufacturer

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

Date of the last revision of the leaflet: