Carvetrend

Package leaflet: Information for the user

Carvetrend, 3.125 mg, tablets
Carvetrend, 6.25 mg, tablets
Carvetrend, 12.5 mg, tablets
Carvetrend, 25 mg, tablets
(Carvedilol)
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Carvetrend is and what it is used for

Carvetrend tablets (3.125 mg, 6.25 mg, 12.5 mg or 25 mg) contain the active substance carvedilol.
Carvedilol is a beta-adrenoreceptor blocking agent (beta-blocker) and a vasodilator that lowers high blood pressure and reduces the resistance the heart must overcome when pumping blood.

Carvetrend is indicated for the treatment of:

• Chronic heart failure (stable form of chronic heart failure of mild, moderate, and severe severity), as an addition to standard background therapy;
• Arterial hypertension;
• Stable angina pectoris;
• Patients after myocardial infarction with documented left ventricular dysfunction (left ventricular ejection fraction (LVEF) ≤ 40%).

2. Important information before using Carvetrend

When not to use Carvetrend:

• If the patient is allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• If the patient has unstable or decompensated heart failure;
• If the patient has clinically apparent liver function disorders;
• If the patient has been diagnosed with second- or third-degree atrioventricular block (except in patients with a permanently implanted cardiac pacemaker);
• If the patient has marked slowing of heart rate (< 50 beats per minute);
• If the patient has been diagnosed with sick sinus syndrome (including sinoatrial block);
• If the patient has severe hypotension (systolic blood pressure < 85 mm Hg);
• If the patient has severe cardiac dysfunction (cardiogenic shock);
• If the patient has respiratory diseases associated with bronchospasm or asthma;
• If the patient has significant fluid retention (fluid accumulation) or cardiac overload requiring intravenous administration of drugs that increase myocardial contractility;
• If the patient has metabolic acidosis;
• If the patient has a pheochromocytoma (except in patients whose symptoms are effectively controlled with alpha-blocking agents).

Warnings and precautions
Before starting treatment with Carvetrend, discuss this with your doctor or pharmacist.
Special caution is required when using Carvetrend

• in patients with chronic heart failure, as symptoms of heart failure or fluid retention may worsen;
• in patients with hypertension and chronic heart failure treated with digitalis glycosides, Carvetrend should be used cautiously, as both drugs slow atrioventricular conduction;
• in patients with chronic obstructive pulmonary disease (COPD) who are not treated with oral or inhaled medications;
• in patients with diabetes, as Carvetrend may mask or weaken early symptoms of acute hypoglycemia (low blood glucose). During initiation of treatment with Carvetrend and dose escalation, regular monitoring of blood glucose levels and appropriate adjustment of antidiabetic medications are recommended, since administration of Carvetrend may impair glucose control.
• in patients with chronic heart failure and low blood pressure (systolic blood pressure < 100 mm Hg), ischemic heart disease, peripheral vascular disease, and/or concomitant renal impairment. During dose escalation of Carvetrend in these patients, the doctor will monitor kidney function and may recommend discontinuation or dose reduction if renal function worsens.
• in patients wearing contact lenses. They should be aware of the possibility of reduced tear production.
• in patients with peripheral vascular disease and Raynaud's phenomenon, as there is a risk of occurrence or worsening of arterial insufficiency symptoms during treatment with beta-blocking agents. However, additional blockade of the alpha receptor by Carvetrend largely helps alleviate these symptoms.
• in patients with 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 (see section 4 Possible side effects). Treatment with carvedilol must be completely discontinued if severe skin reactions occur that may be related to carvedilol use.
• in patients with psoriasis associated with beta-blocking agents. The doctor should consider the potential benefits and risks of using Carvetrend.
• in patients with hyperthyroidism, as Carvetrend may mask symptoms of hyperthyroidism;
• in patients undergoing surgical procedures; beta-blockers increase the risk of hypotension, so caution is required when administering carvedilol and anesthetic agents used during general anesthesia;
• in patients who have previously experienced severe hypersensitivity reactions, as well as in patients undergoing desensitization therapy (Carvetrend, like other drugs in this class, may increase sensitivity to allergens and intensify allergic reactions);
• in patients with pheochromocytoma. Strict adherence to medical advice is required. Before starting Carvetrend, the doctor will recommend treatment with alpha-blocking agents.
• in patients suspected of having Prinzmetal's angina, as there is a risk of chest pain during treatment with beta-blocking agents alone; however, additional blockade of the alpha1 receptor by Carvetrend may prevent these symptoms;
• in patients prone to bronchospasm. Inform the doctor if any symptoms of bronchospasm occur during treatment with Carvetrend;
• in patients with left ventricular dysfunction after acute myocardial infarction. Before starting treatment with carvedilol, the patient must be clinically stable and have received an ACE inhibitor for at least 48 hours, with a stable dose of the ACE inhibitor maintained for the last 24 hours;
• in patients taking other medicines concurrently, e.g., digoxin, cyclosporine, rifampicin, anesthetics, antiarrhythmic drugs;
• if heart rate slows to below 55 beats per minute during treatment with Carvetrend, contact the doctor, who may recommend reducing the dose.

As with all beta-blocking agents, carvedilol should not be discontinued abruptly. This is particularly important for patients with ischemic heart disease. Carvedilol should be discontinued gradually (over a period of two weeks).

Children and adolescents
The safety and efficacy of carvedilol in children and adolescents under 18 years of age have not been established; therefore, it should not be used in this age group.

Carvetrend with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
It is especially important to inform the doctor about the use of the following medicines:

• those containing digoxin (used in the treatment of heart failure), as the doctor may decide to adjust the dose during treatment with Carvetrend;
• rifampicin (an antibiotic used to treat tuberculosis), as it reduces the effectiveness of Carvetrend;
• oral cyclosporine and tacrolimus (medicines used to suppress immune responses to prevent organ transplant rejection), as Carvetrend enhances the effects of cyclosporine and tacrolimus;
• non-dihydropyridine calcium antagonists, amiodarone, or other antiarrhythmic drugs. The doctor will monitor ECG and blood pressure;
• fluoxetine and paroxetine (medicines used to treat depression);
• insulin and oral antidiabetic drugs, as Carvetrend may enhance the effects of these drugs. The doctor may recommend monitoring blood glucose levels;
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (MAOIs) (used in the treatment of depression);
• clonidine (a medicine used to treat hypertension or migraine);
• other antihypertensive drugs. Carvetrend may enhance the effects of these drugs (e.g., alpha-adrenergic receptor blockers) and drugs whose side effect is lowering of blood pressure (e.g., barbiturates – used in epilepsy treatment, phenothiazines – used in psychosis treatment, tricyclic antidepressants – used in depression treatment, vasodilators, and alcohol);
• anesthetic drugs;
• non-steroidal anti-inflammatory drugs (NSAIDs), which may reduce the effectiveness of Carvetrend;
• bronchodilators;
• adrenaline/epinephrine (drugs used in the treatment of severe allergic reactions).

Carvetrend with food, drink, or alcohol
Avoid drinking grapefruit juice at the same time or immediately after taking Carvetrend. Grapefruit or its juice may increase the blood concentration of the active substance carvedilol and cause unexpected side effects.
Do not drink alcohol during treatment, as alcohol affects the action of Carvetrend.
Patients with chronic heart failure should take Carvetrend with food.
Patients with stable angina pectoris or essential hypertension may take the medicine independently of meals.

Pregnancy, breastfeeding, and fertility
During pregnancy, breastfeeding, or if there is suspicion of pregnancy or plans to become pregnant, the woman should consult her doctor or pharmacist before using this medicine. Animal studies have shown toxic effects on fertility. The potential risk in humans is unknown.
Carvetrend should not be used during pregnancy unless the expected benefits of treatment outweigh the potential risks.
Carvetrend should not be used during breastfeeding.

Driving and operating machinery
As with other medicines that lower blood pressure, remember that if dizziness or similar symptoms occur, driving motor vehicles or operating mechanical equipment should be avoided. This is especially relevant at the beginning of or changes in treatment, as well as when alcohol is consumed concurrently.

Carvetrend contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Carvetrend

This medicine should always be used exactly as instructed by your doctor. If in doubt, consult your doctor or pharmacist.
Carvetrend tablets should be taken with an adequate amount of liquid. Patients with chronic heart failure should take the medicine during a meal.

Chronic heart failure
The dose of this medicine is individually determined by the doctor for each patient.
Treatment with Carvetrend will be initiated under the supervision of a physician experienced in managing circulatory disorders and preceded by an assessment of the patient's clinical condition. Depending on the results of this clinical assessment, the medicine will be administered either in an outpatient setting or in hospital.

Adults
The recommended initial dose is 3.125 mg twice daily for two weeks. If the medicine is well tolerated, the doctor will gradually increase the dose at intervals of no less than two weeks, according to the following scheme: 6.25 mg twice daily, then 12.5 mg twice daily, up to a dose of 25 mg twice daily. The aim is to administer the highest dose tolerated by the patient.
The recommended maximum dose for all patients with severe heart failure, as well as for patients with mild to moderate heart failure weighing less than 85 kg, is 25 mg twice daily. For patients with mild to moderate heart failure weighing more than 85 kg, the recommended maximum dose is 50 mg twice daily.
In patients with systolic blood pressure < 100 mm Hg, increasing the dose of Carvetrend may lead to worsening renal function and/or worsening of heart failure. For this reason, before each subsequent dose increase, the doctor will monitor parameters indicating kidney function and will also assess the severity of heart failure symptoms or symptoms related to vasodilation.
If treatment with Carvetrend is interrupted for more than two weeks, treatment should be restarted at a dose of 3.125 mg twice daily, and the dose should then be increased according to the recommendations outlined above.

Use in elderly patients
Dosage as in adults.

Use in children and adolescents
The safety and efficacy of this medicine have not been evaluated in children (under 18 years of age).

Hypertension

Adults
The recommended initial dose is 12.5 mg once daily for the first two days. This should then be increased to 25 mg once daily. This dose is sufficient for most patients; however, if necessary, the doctor may increase the dose up to the maximum dose of 50 mg, administered once daily or in two divided doses.
Dose increases should be made at intervals of no less than two weeks.

Use in elderly patients
The recommended initial dose is 12.5 mg daily. In many cases, this dose provides adequate blood pressure control. If blood pressure is not satisfactorily reduced, the doctor may gradually increase the dose up to a maximum daily dose of 50 mg, administered once daily or in divided doses.

Use in children and adolescents
The safety and efficacy of this medicine have not been evaluated in children (under 18 years of age).

Coronary artery disease

Adults
The recommended initial dose is 12.5 mg twice daily for the first two days. This should then be increased to 25 mg twice daily.

Elderly patients
The recommended maximum daily dose is 50 mg, administered in divided doses.

Use in children and adolescents
The efficacy and safety of this medicine have not been evaluated in children and adolescents (under 18 years of age).

Use in patients with hepatic impairment
Carvetrend is contraindicated in patients with hepatic impairment.

Use in patients with renal impairment
There is no need to reduce the dose in patients with systolic blood pressure > 100 mm Hg.

Left ventricular dysfunction following acute myocardial infarction
In patients with left ventricular dysfunction following myocardial infarction, the recommended initial dose is 6.25 mg twice daily. After the first dose, the patient should remain under observation for 3 hours.
The doctor will increase the dose every 3 to 10 days to 12.5 mg twice daily, and then to 25 mg twice daily. In patients who do not tolerate the initial dose of 6.25 mg twice daily, the doctor will reduce the dose to 3.125 mg twice daily and maintain this dose for 3 to 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 administer the highest dose tolerated by the patient.

Taking more than the recommended dose of Carvetrend
If you take more than the recommended dose, seek medical advice immediately from your doctor or go to hospital.
In case of significant overdose, hypotension (abnormally low blood pressure), bradycardia (excessive slowing of the heart rate), heart failure, sinus arrest, cardiogenic shock (tissue and organ hypoperfusion due to heart failure), and circulatory arrest may occur. Respiratory disturbances, bronchospasm, vomiting, disturbances of consciousness, and generalized convulsions may also occur.

Missed dose of Carvetrend
Do not take a double dose to make up for a missed dose.
If you miss a dose, do not increase the next dose. Take the next dose as prescribed by your doctor.

Stopping treatment with Carvetrend
Do not stop treatment on your own without first consulting your doctor. Treatment with Carvetrend should not be stopped abruptly. Sudden discontinuation of treatment may worsen symptoms of the disease. The medicine should be discontinued gradually, with a stepwise reduction in carvedilol dose according to your doctor's instructions.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Frequency of adverse reactions:

Very common (occur in more than 1 in 10 people):

• Dizziness and headache, usually mild and occurring mainly at the beginning of treatment
• Heart failure
• Hypotension
• Asthenia (feeling of fatigue)

Common (occur in up to 1 in 10 people):

• Bronchitis, pneumonia, upper respiratory tract infections
• Urinary tract infections
• Anaemia
• Weight gain
• Hypercholesterolaemia (increased blood cholesterol levels)
• Worsening of blood glucose control (hyperglycaemia, hypoglycaemia) in patients with diagnosed diabetes
• Depression, low mood
• Pre-syncope, syncope (fainting)
• Visual disturbances, decreased tear production (dry eye syndrome), eye irritation
• Bradycardia (slowing of the heart rate), oedema, hypervolaemia (fluid overload, increased circulating blood volume)
• Orthostatic hypotension (drop in blood pressure upon changing body position), peripheral circulatory disorders (cold extremities, peripheral vascular diseases, worsening of intermittent claudication and Raynaud's syndrome - pallor followed by cyanosis of fingers, toes, nose or ears caused by vasoconstriction), hypertension
• Dyspnoea, pulmonary oedema, asthma in susceptible patients
• Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
• Limb pain
• Renal failure and renal function disorders in patients with diffuse vascular changes and/or concomitant renal impairment, urinary disorders
• Pain

Uncommon (occur in up to 1 in 100 people):

• Sleep disorders
• Paraesthesiae (tingling and numbness of limbs)
• Atrioventricular block, angina pectoris
• Constipation
• Skin reactions (e.g. allergic rash, dermatitis, urticaria, pruritus, psoriasiform or lichenoid skin lesions)
• Alopecia
• Impotence, erectile dysfunction
• Increased sweating

Rare (occur in up to 1 in 1000 people):

• Thrombocytopenia (reduced number of platelets in peripheral blood)
• Nasal mucosal congestion (nasal obstruction)
• Dryness of the oral mucosa

Very rare (occur in fewer than 1 in 10,000 people):

• Leukopenia (reduced number of white blood cells in peripheral blood)
• Hypersensitivity (allergic reaction)
• Abnormal liver function test results [increased alanine aminotransferase (AlAT), aspartate aminotransferase (AspAT), and gamma-glutamyl transferase (GGT) activity]
• Severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Urinary incontinence in women

In patients with congestive heart failure, increasing the dose of carvedilol may lead to worsening of heart failure and fluid retention.
In patients with chronic heart failure and low blood pressure, ischaemic heart disease, diffuse vascular changes and/or concomitant renal failure, transient worsening of renal function has been observed during carvedilol therapy.
The frequency of adverse reactions, except for dizziness, visual disturbances and bradycardia, is not dependent on the dose of the medicine used.
Due to the beta-blocking properties of Carvetrend, latent diabetes may be unmasked, blood glucose control may worsen, and mechanisms regulating blood glucose levels may be inhibited.
In addition, hallucinations may occur during treatment with Carvetrend.
Excessive sweating (hyperhidrosis) may occur. Sinus bradycardia may occur, meaning the heart may beat very slowly or stop beating. The patient may experience dizziness, unusual fatigue, and shortness of breath. These symptoms may occur particularly in patients over 65 years of age or in patients with other heart-related problems.
Other adverse reactions may occur in some individuals during treatment with Carvetrend.

Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Carvetrend

Keep out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP):. The expiry date refers to the last day of the specified month.
Do not use this medicine if signs of deterioration are observed.
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 Carvetrend contains

• The active substance is carvedilol. Carvetrend 3.125 mg tablet contains 3.125 mg of carvedilol. Carvetrend 6.25 mg tablet contains 6.25 mg of carvedilol. Carvetrend 12.5 mg tablet contains 12.5 mg of carvedilol. Carvetrend 25 mg tablet contains 25 mg of carvedilol.
• Other ingredients are: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, maize starch, magnesium stearate, colloidal silicon dioxide, talc.

What Carvetrend looks like and contents of the pack
Carvetrend 3.125 mg: white or almost white, round, biconvex tablets with an imprint
CA3 on one side.
Carvetrend 6.25 mg: white or almost white, round, biconvex tablets with an imprint
CA6 on one side.
Carvetrend 12.5 mg: white or almost white, round, biconvex tablets with an imprint
CA12 on one side.
Carvetrend 25 mg: white or almost white, round, biconvex tablets with an imprint
CA25 on one side.
Blister packs made of Al/PVC/PVDC foil in a cardboard box.
The pack contains 30 tablets in a cardboard box.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków