CARVETREND 3.125 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Carvetrend, 3.125 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Carvetrend and what is it used for
4. Important information before taking Carvetrend
   1. When not to take Carvetrend:
   2. Warnings and precautions
   3. Children and adolescents
   4. Carvetrend and other medicines
   5. Carvetrend with food, drink, or alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Carvetrend contains lactose
5. How to take Carvetrend
   1. Overdose of Carvetrend
   2. Missed dose of Carvetrend
   3. Stopping treatment with Carvetrend
6. Possible side effects
   1. Reporting side effects
7. How to store Carvetrend
8. Contents of the pack and other information
   1. What Carvetrend contains
   2. What Carvetrend looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet accompanying the packaging: 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 leaflet carefully before taking the medicine, 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 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 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 contain the active substance carvedilol.
Carvedilol is a beta-blocker and a vasodilator, it lowers high blood pressure and reduces the resistance that the heart has to overcome to pump blood.
Carvetrend is indicated for the treatment of:

• chronic heart failure (stable chronic heart failure of mild, moderate and severe severity), as a supplement to the usually administered basic treatment,
• hypertension,
• stable angina pectoris,
• 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 slowing of 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 (fluid overload) or heart overload requiring intravenous administration of drugs increasing cardiac contractility;
• 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, discuss it with your doctor or pharmacist.
Particular caution should be exercised 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 cardiac 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). During the initiation of Carvetrend treatment and dose increase, it is recommended to systematically monitor blood glucose levels and adjust the doses of antidiabetic medications accordingly, as Carvetrend administration may worsen blood sugar control.
• in patients with chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary heart disease, widespread vascular changes and (or) concomitant renal impairment. during dose escalation of carvetrend, the doctor will monitor function parameters assess severity failure symptoms or related to vasodilation.< 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 peripheral 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 carvedilol treatment, very rare cases of severe skin reactions, such as polymorphic erythema, toxic epidermal necrolysis, or Stevens-Johnson syndrome, have been reported (see section 4 Possible side effects). Carvedilol treatment should be discontinued if severe skin reactions occur, which may be associated with carvedilol use.
• in patients with psoriasis associated with beta-adrenergic blocking agents. 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 surgical procedures; 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 drugs in this class, 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 Carvetrend treatment, the doctor will recommend taking 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. The doctor should be informed if any symptoms of bronchospasm occur during Carvetrend treatment.
• in patients with left ventricular dysfunction after acute myocardial infarction. Before starting carvedilol treatment, it is necessary for the patient to be clinically stable and receiving ACE inhibitor therapy for at least 48 hours, with a stable ACE inhibitor dose for the last 24 hours.
• in patients taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, antiarrhythmic medications
• if during Carvetrend treatment, the heart rate slows down to below 55 beats per minute, the doctor should be consulted, who may recommend reducing the dose of the medication.

As with all beta-adrenergic blocking agents, carvedilol should not be discontinued abruptly. This is especially important in patients with coronary 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 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might 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 during Carvetrend treatment,
• rifampicin (an antibiotic used to treat tuberculosis), as it weakens the effect of Carvetrend,
• cyclosporine and tacrolimus (oral immunosuppressants used to prevent organ rejection), as Carvetrend enhances the effect of cyclosporine and tacrolimus,
• non-dihydropyridine calcium channel blockers, 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 glucose levels.
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• clonidine (a medicine used to treat hypertension or migraine),
• other medications that lower blood pressure, as Carvetrend may enhance the effect of these medications (e.g., alpha-adrenergic blocking agents) and medications whose side effect is lowering blood pressure (e.g., barbiturates - used to treat epilepsy, phenothiazines - 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 Carvetrend,
• bronchodilators,
• adrenaline/epinephrine (medicines used to treat severe allergic reactions).

Carvetrend with food, drink, or alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 toxic effects on fertility. The potential risk for humans is not known.
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 medications, remember that if you experience dizziness or similar symptoms, do not drive vehicles or operate machinery. This is especially important when starting or changing treatment, as well as when consuming alcohol.

Carvetrend contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Carvetrend

Always take this medicine exactly as your doctor has told you.
In case of doubt, 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 by the doctor individually for each patient.
Treatment with Carvetrend will be initiated under the supervision of a doctor experienced in the treatment of circulatory failure and after assessing the patient's clinical condition. Depending on the assessment of the patient's clinical condition, the medicine will be administered on an outpatient or hospital 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, during dose escalation of carvetrend, there may be a worsening renal function and (or) exacerbation heart failure. therefore, before each subsequent increase, the doctor will monitor parameters assess severity failure symptoms or related to vasodilation.
In case of treatment interruption for a period longer than two weeks, treatment should be restarted at a dose of 3.125 mg twice a day, and then the dose should be increased according to the above recommendations.
Elderly patients
Dosing is the same as for adults.
Children and adolescents
The safety and efficacy of Carvetrend 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, administered once a day or in divided doses.
The dose should be increased at intervals of not less than two weeks.
Elderly patients
The recommended initial dose is 12.5 mg per 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, administered once a day or in divided doses.
Children and adolescents
The safety and efficacy of Carvetrend in children (under 18 years of age) have not been evaluated.
Angina pectoris
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, administered in divided doses.
Children and adolescents
The efficacy and safety of Carvetrend in children and adolescents (under 18 years of age) have not been evaluated.
Patients with liver dysfunction
Carvetrend is contraindicated in patients with liver dysfunction.
Patients with renal dysfunction
No dose adjustment is necessary 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 monitored 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. The goal is to administer the maximum tolerated dose by the patient.

Overdose of Carvetrend

In case of overdose, seek medical attention immediately.
In case of significant overdose, hypotension (low blood pressure), bradycardia (slow heart rate), heart failure, cardiac arrest, and cardiogenic shock may occur. Respiratory disorders, bronchospasm, vomiting, disorders of consciousness, and generalized seizures may also occur.

Missed dose of Carvetrend

Do not take a double dose to make up for a missed dose.
In case of a missed dose, do not increase the next dose of the medicine. Take the next dose of the medicine as recommended by the doctor.

Stopping treatment with Carvetrend

Do not stop treatment without consulting your doctor first. Treatment with Carvetrend should not be stopped abruptly. Abrupt discontinuation of treatment may worsen the symptoms of the disease. The medicine should be discontinued gradually, with a gradual reduction in carvedilol doses, as recommended by the doctor.
In case of any further doubts about the use of this medicine, 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 less than 1 in 10 patients):

• bronchitis, pneumonia, upper respiratory tract infection,
• urinary tract infections
• -anemia
• weight gain,
• hypercholesterolemia (elevated cholesterol levels in the blood),
• 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, hyperolemia (fluid overload)
• orthostatic hypotension (low blood pressure when changing body position), peripheral circulation disorders (cold extremities, peripheral vascular disease, worsening of intermittent claudication and Raynaud's phenomenon - pallor followed by cyanosis of fingers, toes, nose, or ears caused by vasospasm), hypertension
• dyspnea, pulmonary edema, asthma in susceptible patients
• nausea, diarrhea, vomiting, dyspepsia, abdominal pain
• limb pain
• renal failure and renal dysfunction in patients with widespread vascular changes and (or) concomitant renal impairment, urinary disorders
• -pain.

Uncommon (occurring in less than 1 in 100 patients):

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

Rare (occurring in less than 1 in 1000 patients):

• -thrombocytopenia (reduced platelet count in peripheral blood)
• nasal congestion (nasal obstruction)
• dryness of the oral mucosa.

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

• -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., polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• urinary incontinence in women.

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 heart disease, widespread vascular changes, and (or) concomitant renal impairment, during carvedilol treatment, 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 impair glucose regulation mechanisms.
Additionally, during Carvetrend treatment, hallucinations may occur. Excessive sweating may occur. Cardiac arrest may occur, which means that the heart may beat very slowly or stop. The patient 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 individuals, during Carvetrend treatment, other side effects may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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
Jerozolimskie Avenue 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 provide more information on the safety of this 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.
Do not use this medicine if you notice signs of deterioration.
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 Carvetrend contains

• The active substance of Carvetrend 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 CA3 embossing on one side.
Carvetrend 6.25 mg: white or almost white, round, biconvex tablets with CA6 embossing on one side.
Carvetrend 12.5 mg: white or almost white, round, biconvex tablets with CA12 embossing on one side.
Carvetrend 25 mg: white or almost white, round, biconvex tablets with CA25 embossing 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.
Emilii Plater 53, 00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

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