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 Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 is available in tablet form, with strengths of 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg, and contains the active substance carvedilol.
Carvedilol is a beta-blocker and a vasodilator, which lowers high blood pressure and reduces the resistance the heart has to pump blood against.
Carvetrend is indicated for the treatment of:

• chronic heart failure (stable, mild, moderate, or severe chronic heart failure) as an adjunct to usually employed basic treatment,
• high blood pressure,
• stable angina pectoris,
• patients after a heart attack 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 medication (listed in section 6);
• If you have unstable or uncontrolled heart failure;
• If you have clinically manifest liver dysfunction;
• If you have an atrioventricular (AV) block of second or third degree (except in patients with a permanently implanted pacemaker);
• If you have a marked 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 and are taking verapamil or diltiazem;
• If you have bronchial asthma or chronic obstructive pulmonary disease (COPD) with a history of bronchospasm;
• If you have significant fluid retention or heart failure requiring intravenous inotropic agents;
• If you have metabolic acidosis;
• If you have a pheochromocytoma (except in patients whose symptoms are effectively controlled with alpha-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 high blood pressure and chronic heart failure treated with cardiac glycosides, as Carvetrend should be used with caution, since both medications slow atrioventricular conduction
• in patients with chronic obstructive pulmonary disease (COPD) who are not being treated with oral or inhaled medications
• in patients with diabetes, as Carvetrend may mask or attenuate the early signs of acute hypoglycemia (low blood sugar). When starting treatment with Carvetrend and increasing the dose, it is recommended to monitor blood sugar levels regularly and adjust the dose 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 and or concomitant renal impairment. when increasing the dose of carvetrend in these patients, doctor will monitor kidney function, case deterioration, may discontinue reduce dose.< li>
• in patients wearing contact lenses, as they should be aware of the possibility of decreased tear production.
• in patients with peripheral vascular disease and Raynaud's phenomenon, as there is a risk of worsening of peripheral vascular symptoms when taking beta-blockers. However, the additional alpha-1 blocking effect of Carvetrend may alleviate these symptoms.
• in patients with severe skin reactions. During treatment with carvedilol, very rare cases of severe skin reactions have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme. Treatment with carvedilol should be discontinued if severe skin reactions occur.
• in patients with psoriasis, as beta-blockers may exacerbate or precipitate psoriasis. 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 allergic reactions, as well as those undergoing desensitization (Carvetrend, like other beta-blockers, may increase sensitivity to allergens and enhance allergic reactions)
• in patients with pheochromocytoma. The doctor's instructions should be followed strictly. Before starting treatment with Carvetrend, the doctor will prescribe alpha-blocking agents.
• in patients with suspected Prinzmetal's angina, as there is a risk of chest pain when taking beta-blockers. However, the additional alpha-1 blocking effect of Carvetrend may prevent these symptoms.
• in patients with a tendency to bronchospasm. If symptoms of bronchospasm occur during treatment with Carvetrend, the patient should inform the doctor.
• in patients with left ventricular dysfunction after a heart attack. 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, with a stable dose of ACE inhibitor for the last 24 hours.
• in patients taking other medications, such as digoxin, cyclosporine, rifampicin, anesthetics, or antiarrhythmic medications
• if the heart rate decreases to below 55 beats per minute during treatment with Carvetrend, the patient should contact the doctor, who may reduce the dose.

As with all beta-blockers, carvedilol should not be stopped abruptly. This is especially important in patients with coronary artery disease. Carvedilol should be discontinued gradually (over 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 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 about the following medications:

• containing digoxin (used to treat heart failure), as the doctor may decide to change the dose when taking Carvetrend,
• rifampicin (an antibiotic used to treat tuberculosis), as it may reduce the effect of Carvetrend,
• cyclosporine and tacrolimus (medications used to weaken the immune response to prevent organ rejection), as Carvetrend increases 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 (medications used to treat depression),
• insulin and oral antidiabetic medications, as Carvetrend may enhance their effects. The doctor may monitor blood sugar levels.
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• clonidine (a medication used to treat high blood pressure or migraine),
• other medications that lower blood pressure, as Carvetrend may enhance their effects (e.g., alpha-adrenergic blockers) and medications whose side effects include low blood pressure (e.g., barbiturates - used to treat epilepsy, phenothiazines - used to treat psychosis, 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 (medications 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. Grapefruit or its juice may increase the levels of carvedilol in the blood and cause unexpected side effects.
Do not drink alcohol during treatment, as it may affect the action of Carvetrend.
Patients with chronic heart failure should take Carvetrend with food.
Patients with stable angina or essential hypertension may take Carvetrend regardless of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Animal studies have shown toxic effects on fertility. The potential risk for humans is unknown.
Carvetrend should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.
Carvetrend should not be used during breastfeeding.

Driving and using machines

As with other medications that lower blood pressure, be aware that dizziness and similar symptoms may occur. Do not drive or operate machinery if you experience these symptoms. This is especially important when starting or changing treatment, as well as when consuming alcohol.

Carvetrend contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medication.

3. How to take Carvetrend

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Take the tablets with a sufficient amount of liquid. Patients with chronic heart failure should take Carvetrend with food.
Chronic heart failure
The dose of Carvetrend will be determined by your doctor, individually for each patient.
Treatment with Carvetrend 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 assessment of the patient's clinical condition, the medication will be administered in an outpatient or hospital setting.
Adults
The recommended initial dose is 3.125 mg twice daily for two weeks. If the medication 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 daily, then 12.5 mg twice daily, up to a dose of 25 mg twice daily. The goal is to achieve 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 below 85 kg, is 25 mg twice daily. In patients with mild to moderate heart failure and a body weight above 85 kg, the recommended maximum dose is 50 mg twice daily.
In patients with systolic blood pressure below 100 mmHg, when increasing the dose of Carvetrend, there may be a worsening of renal function and/or heart failure. Therefore, before each subsequent dose increase, the doctor will monitor renal function parameters and assess the severity of heart failure symptoms or signs of 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 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.

• The dose of Carvetrend for children has not been established.

Missed dose of Carvetrend

Do not take a double dose to make up for a forgotten dose.
If you miss a dose, do not increase the next dose. Take the next dose as recommended by your doctor.

Stopping treatment with Carvetrend

Do not stop treatment with Carvetrend without consulting your doctor first. Treatment with Carvetrend should not be stopped abruptly. Stopping treatment suddenly may worsen the symptoms of the disease. The medication should be discontinued gradually, reducing the dose of carvedilol 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, 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).

Common (occurring in less than 1 in 10 patients):

• bronchitis, pneumonia, upper respiratory tract infections,
• 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, decreased 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 circulatory disturbances (cold extremities, peripheral vascular disease, worsening of intermittent claudication, and Raynaud's phenomenon), hypertension
• dyspnea, pulmonary edema, asthma in susceptible patients
• nausea, diarrhea, vomiting, dyspepsia, abdominal pain
• limb pain
• renal failure and renal impairment in patients with diffuse vascular disease and/or concomitant renal impairment, urinary disturbances
• -pain.

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

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

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

• -thrombocytopenia (reduced platelet count in the blood)
• nasal congestion (nasal stuffiness)
• dryness of the mucous membranes of the mouth.

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

• -leukopenia (reduced white blood cell count in the 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 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 disease, and/or concomitant renal impairment, 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-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 may occur. Excessive sweating may occur. Sinus node inhibition may occur, which means 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 treatment with Carvetrend, other side effects may occur.

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 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 provide more information on the safety of this medication.
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 medication 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 medication if you notice signs of deterioration.
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 pack and other information

What Carvetrend contains

• The active substance is carvedilol. Carvetrend 3.125 mg tablets contain 3.125 mg of carvedilol. Carvetrend 6.25 mg tablets contain 6.25 mg of carvedilol. Carvetrend 12.5 mg tablets contain 12.5 mg of carvedilol. Carvetrend 25 mg tablets contain 25 mg of carvedilol.
• The 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 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: