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)

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Carvetrend and what is it used for
• 2. Important information 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 is Carvetrend and what is it used for

Carvetrend tablets of 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg contain the active substance carvedilol.
Carvedilol is a beta-adrenergic blocker and a vasodilator, which lowers high blood pressure and reduces the resistance that the heart has to overcome when pumping blood.
Carvetrend is indicated for the treatment of:

• chronic heart failure (stable chronic heart failure of mild, moderate, and severe severity), as an addition to the usual basic treatment,
• hypertension,
• stable coronary artery disease,
• patients after myocardial infarction with left ventricular dysfunction (left ventricular ejection fraction (LVEF) ≤ 40%).

2. Important information before taking Carvetrend

When not to take Carvetrend:

• 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 clinically significant liver dysfunction;
• If you have atrioventricular block of second or third degree (except for patients with a permanently implanted pacemaker);
• If you have a significant reduction in heart rate (<50 beats per 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 failure (cardiogenic shock);
• If you have respiratory diseases with bronchospastic component or asthma;
• If you have significant fluid retention or heart overload requiring intravenous administration of positive inotropic drugs;
• If you have metabolic acidosis;
• If you have a pheochromocytoma (except for patients whose symptoms are effectively controlled with alpha-adrenergic blocking agents).

Warnings and precautions

Before starting treatment with Carvetrend, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Carvetrend

• in patients with chronic heart failure, as it may lead to worsening of heart failure symptoms or fluid retention
• in patients with hypertension and chronic heart failure, treated with digitalis glycosides, Carvetrend should be used with caution, 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 the early symptoms of acute hypoglycemia (low blood sugar). When starting treatment with Carvetrend and increasing the dose, it is recommended to systematically monitor blood sugar levels and adjust the doses of antidiabetic medications accordingly, as Carvetrend may worsen blood sugar control.
• in patients with chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary artery disease, diffuse vascular changes, and (or) concomitant renal failure. when increasing the dose of carvetrend in these patients, doctor will monitor function and, case deterioration, may discontinue treatment or reduce dose.< li>
• 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 worsening of vascular insufficiency symptoms when using beta-blockers. However, the additional alpha-1 receptor blockade by Carvetrend largely mitigates these symptoms.
• in patients with 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). Treatment with carvedilol should be discontinued if the patient develops severe skin reactions that may be associated with carvedilol use.
• in patients with psoriasis associated with beta-adrenergic blockers. The doctor should weigh the potential benefits and risks of using Carvetrend.
• in patients with hyperthyroidism, as Carvetrend may mask the symptoms of hyperthyroidism
• in patients undergoing surgery; beta-blockers increase the risk of hypotension, so caution should be exercised when administering carvedilol and anesthetics
• in patients with a history of severe hypersensitivity reactions, as well as in patients undergoing desensitization (Carvetrend, like other beta-blockers, increases sensitivity to allergens and enhances the severity of allergic reactions)
• in patients with pheochromocytoma. The doctor's instructions should be followed strictly. Before starting treatment with Carvetrend, the doctor will prescribe alpha-adrenergic blocking agents.
• in patients with suspected Prinzmetal's angina, as there is a risk of chest pain when using beta-blockers, but the additional alpha-1 receptor blockade by Carvetrend may prevent these symptoms
• in patients with a tendency to bronchospasm. You should tell your doctor if you experience any symptoms of bronchospasm during treatment with Carvetrend.
• in patients with left ventricular dysfunction after acute myocardial infarction. Before starting treatment with carvedilol, it is necessary for the patient to be clinically stable and receiving an ACE inhibitor for at least 48 hours, and the ACE inhibitor dose should be stable for the last 24 hours.
• in patients taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, antiarrhythmic medications
• if, during treatment with Carvetrend, the heart rate slows down to below 55 beats per minute, you should contact your doctor, who may recommend reducing the dose of the medicine.

As with all beta-adrenergic blockers, carvedilol should not be discontinued abruptly. This is especially true for patients with coronary artery 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, so it should not be used in this age group.

Carvetrend and other medicines

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

• containing digoxin (used to treat heart failure), as the doctor may decide to change the dose when using Carvetrend,
• rifampicin (an antibiotic used to treat tuberculosis), as it reduces the effect of Carvetrend,
• cyclosporine and tacrolimus taken orally (a medicine used to weaken the immune response to prevent organ rejection), as Carvetrend increases the effect of cyclosporine and tacrolimus,
• non-dihydropyridine calcium antagonists, amiodarone, or other antiarrhythmic medications. The doctor will monitor the ECG and blood pressure.
• fluoxetine and paroxetine (medicines used to treat depression),
• insulin and oral antidiabetic medications, as Carvetrend may enhance the effect of these medications. The doctor may recommend monitoring blood sugar levels.
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• clonidine (a medicine used to treat hypertension or migraine),
• other medicines that lower blood pressure, as Carvetrend may enhance their effect (e.g., alpha-adrenergic blockers) and medications whose side effect is a decrease in blood pressure (e.g., barbiturates - used to treat epilepsy, phenothiazines - used to treat psychoses, tricyclic antidepressants - used to treat depression, vasodilators, and alcohol).
• anesthetics,
• nonsteroidal anti-inflammatory drugs (NSAIDs), which may reduce the effect of Carvetrend,
• bronchodilators,
• adrenaline/epinephrine (medicines used to treat severe allergic reactions).

Carvetrend with food, drink, or alcohol

You should avoid drinking grapefruit juice at the same time or immediately after taking Carvetrend.
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 Carvetrend.
Patients with chronic heart failure should take Carvetrend during meals.
Patients with stable angina or essential hypertension can take the medicine regardless of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Animal studies have shown toxic effects on fertility. The potential risk to humans is unknown.
Carvetrend should not be used during pregnancy, unless the expected benefits of treatment outweigh the potential risk.
Carvetrend should not be used during breastfeeding.

Driving and using machines

As with other blood pressure-lowering medicines, you should remember that, in case of dizziness and similar symptoms, you should not drive vehicles or operate moving machinery. This is especially true when starting or changing treatment, as well as when consuming alcohol.

Carvetrend contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Carvetrend

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Carvetrend tablets should be swallowed with a sufficient amount of liquid. Patients with chronic heart failure should take the medicine during meals.
Chronic heart failure
The dose of the medicine is determined individually by the doctor for each patient.
Treatment with Carvetrend will be started under the supervision of a doctor experienced in the treatment of circulatory failure and after assessing the patient's clinical condition. Depending on the result of the assessment of the patient's clinical condition, the medicine will be administered on an outpatient or inpatient basis.
Adults
The recommended initial dose is 3.125 mg twice a day for two weeks. If the medicine is well tolerated, the doctor will gradually increase the dose at intervals of not less than two weeks according to the following scheme: 6.25 mg twice a day, then 12.5 mg twice a day, up to a dose of 25 mg twice a day. The goal is to administer the maximum tolerated dose by the patient.
The recommended maximum dose in all patients with severe heart failure, as well as in patients with mild to moderate heart failure with a body weight of less than 85 kg, is 25 mg twice a day. In patients with mild to moderate heart failure with a body weight of more than 85 kg, the recommended maximum dose is 50 mg twice a day.
In patients with systolic blood pressure <100 mmhg, when increasing the dose of carvetrend, there may be a worsening renal function and (or) exacerbation heart failure. therefore, before each subsequent increase, doctor will monitor parameters assess severity failure symptoms or related to vasodilation.
In case of interruption of therapy with Carvetrend for a period longer than two weeks, treatment should be restarted from a dose of 3.125 mg twice a day, and then the dose should be increased according to the above recommendations.
Use in elderly patients
Dosing is the same as for adults.
Use in children and adolescents
The safety and efficacy of the medicine in children (under 18 years of age) have not been evaluated.
Hypertension
Adults
The recommended initial dose is 12.5 mg once a day for the first two days. Then, the dose should be increased to 25 mg once a day. In most patients, this is a sufficient dose; however, if necessary, the doctor may increase the dose to a maximum of 50 mg, taken once a day or in two divided doses.
The dose should be increased at intervals of not less than two weeks.
Use in elderly patients
The recommended initial dose is 12.5 mg once a day. In many cases, this dose provides adequate blood pressure control. If satisfactory blood pressure reduction is not achieved, the doctor may gradually increase the dose to a maximum daily dose of 50 mg, taken once a day or in divided doses.
Use in children and adolescents
The safety and efficacy of the medicine in children (under 18 years of age) have not been evaluated.
Coronary artery disease
Adults
The recommended initial dose is 12.5 mg twice a day for the first two days. Then, the dose should be increased to 25 mg twice a day.
Elderly patients
The recommended maximum daily dose is 50 mg, taken in divided doses.
Use in children and adolescents
The efficacy and safety of the medicine in children and adolescents (under 18 years of age) have not been evaluated.
Use in patients with liver function disorders
The use of Carvetrend is contraindicated in patients with liver function disorders.
Use in patients with renal function disorders
There is no need to reduce the dose of the medicine in patients with systolic blood pressure > 100 mmHg.
Left ventricular dysfunction after acute myocardial infarction
In patients after myocardial infarction with left ventricular dysfunction, the recommended initial dose is 6.25 mg twice a day. After the first dose, the patient will be under observation for 3 hours.
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 the initial dose of 6.25 mg twice a day, the doctor will reduce the dose to 3.125 mg twice a day and will use 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 administer the maximum tolerated dose by the patient.

Overdose of Carvetrend

In case of overdose, you should immediately consult a doctor or go to the hospital.
In case of significant overdose, hypotension (too low blood pressure), bradycardia (excessive slowing of heart rate), heart failure, sinus arrest, cardiogenic shock (tissue and organ hypoperfusion due to heart failure), and cardiac arrest may occur. Respiratory disorders, bronchospasm, vomiting, disorders of consciousness, and generalized seizures may also occur.

Missed dose of Carvetrend

You should not take a double dose to make up for a missed dose.
In case of a missed dose, you should not increase the next dose of the medicine. You should take the next dose of the medicine as directed by your doctor.

Discontinuation of Carvetrend

You should not stop treatment on your own without consulting your doctor. Treatment with Carvetrend should not be discontinued abruptly. Abrupt discontinuation of treatment may lead to worsening of disease symptoms. The medicine should be discontinued gradually, slowly reducing the doses of carvedilol according to the doctor's instructions.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

• -dizziness and headaches, usually mild and occurring mainly at the beginning of treatment
• heart failure
• hypotension
• asthenia (feeling of fatigue).

Frequent (occurring in no more than 1 in 10 people):

• bronchitis, pneumonia, upper respiratory tract infection,
• urinary tract infections
• -anemia
• weight gain,
• hypercholesterolemia (elevated blood cholesterol),
• worsening of blood sugar control (hyperglycemia, hypoglycemia) in patients with known diabetes
• depression, low mood
• presyncope, syncope
• visual disturbances, reduced tear production (dry eye syndrome), eye irritation
• bradycardia (slow heart rate), edema, hypervolemia (fluid overload, increased blood volume)
• orthostatic hypotension (blood pressure drop when changing body position), peripheral circulation disorders (cold extremities, peripheral vascular disease, worsening of intermittent claudication, and Raynaud's phenomenon - blanching followed by cyanosis of fingers, toes, nose, or ears caused by vasospasm), hypertension
• dyspnea, pulmonary edema, asthma in susceptible patients
• nausea, diarrhea, vomiting, indigestion, 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 (occurring in no more than 1 in 100 people):

• sleep disorders
• paresthesia (tingling and numbness of limbs)
• atrioventricular block, angina pectoris
• constipation
• skin reactions (e.g., allergic rash, dermatitis, urticaria, pruritus, psoriatic and lichen planus-like skin changes),
• alopecia
• impotence, erectile dysfunction
• excessive sweating.

Rare (occurring in no more than 1 in 1,000 people):

• -thrombocytopenia (reduced platelet count in peripheral blood)
• nasal congestion (nasal obstruction)
• dryness of the mucous membrane of the mouth.

Very rare (occurring in less than 1 in 10,000 people):

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

In patients with congestive heart failure, when increasing the dose 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, diffuse vascular changes, and (or) concomitant renal failure, during treatment with carvedilol, transient worsening of renal function has been observed.
The frequency of side effects, except for dizziness, visual disturbances, and bradycardia, is not dose-dependent.
Due to the beta-adrenergic blocking properties of Carvetrend, it is possible to unmask latent diabetes, worsen blood sugar control, or inhibit glucose regulation mechanisms.
Additionally, during treatment with Carvetrend, hallucinations (delirium) may occur. Excessive sweating (hyperhidrosis) may occur. Sinus arrest may occur, which means that the heart may beat very slowly or stop beating. You may experience dizziness, unusual fatigue, and shortness of breath. These symptoms may occur especially in patients over 65 years of age or patients with other heart problems.
In some people, during treatment with Carvetrend, other side effects may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Carvetrend

Keep out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton after EXP:. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. You should 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 Carvetrend contains

• The active substance of the medicine 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, cornstarch, 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 the inscription CA3 on one side.
Carvetrend 6.25 mg: white or almost white, round, biconvex tablets with the inscription CA6 on one side.
Carvetrend 12.5 mg: white or almost white, round, biconvex tablets with the inscription CA12 on one side.
Carvetrend 25 mg: white or almost white, round, biconvex tablets with the inscription CA25 on one side.
Al/PVC/PVDC foil blisters in a cardboard box.
The pack contains 30 tablets in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Date of last revision of the leaflet: