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 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 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 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 overcome to pump blood.
Carvetrend is used to treat:

• chronic heart failure (stable chronic heart failure of mild, moderate, and severe severity), as an addition to the usually administered 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 medicine (listed in section 6);
• If you have unstable or uncontrolled heart failure;
• If you have clinically manifest 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 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 drugs).

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 high blood pressure 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). During the initiation of Carvetrend treatment and dose increase, it is recommended to systematically monitor blood sugar 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, diffuse vascular changes, and (or) concomitant renal failure. during dose escalation of carvetrend, the doctor will monitor function parameters assess severity failure symptoms or signs vasodilation.< li>
• in patients wearing contact lenses. They should be aware of the possibility of reduced tear production.
• in patients with peripheral vascular disorders 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 the patient develops severe skin reactions that 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 those 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 strictly followed. Before starting Carvetrend treatment, the doctor will prescribe alpha-blocking drugs.
• 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 drugs
• if the heart rate slows down to below 55 beats per minute during Carvetrend treatment, you should contact your doctor, who may recommend reducing the dose of the medicine.

As with all beta-blockers, carvedilol should not be discontinued abruptly. This is especially important in patients with coronary heart 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 medicines

Inform your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you 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 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 drugs. The doctor will monitor the ECG and blood pressure.
• fluoxetine and paroxetine (antidepressants),
• insulin and oral antidiabetic drugs, as Carvetrend may enhance the effect of these drugs. The doctor may recommend monitoring blood sugar levels.
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• clonidine (used to treat high blood pressure or migraine),
• other blood pressure-lowering drugs. Carvetrend may enhance the effect of these drugs (e.g., alpha-adrenergic blocking agents) and drugs whose adverse effect is hypotension (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 (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 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 plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine. Animal studies have shown toxic effects on reproductive function. 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 if you experience dizziness and similar symptoms, you should 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 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 exactly as your doctor has instructed. If you are unsure, ask 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 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 in outpatient or hospital settings.
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 signs vasodilation.
In case of treatment interruption for more 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.
Use in the elderly
Dosing is the same as for adults.
Use in children and adolescents
The safety and efficacy of Carvetrend in children (under 18 years of age) have not been evaluated.

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 your 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 according to the doctor's instructions.
If you have any further questions about the use of this medicine, ask 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).

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

• 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, increased blood volume)
• 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, indigestion, abdominal pain
• limb pain
• renal failure and renal dysfunction in patients with diffuse vascular changes and (or) concomitant renal impairment, urinary disorders
• -pain.

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

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

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

• -thrombocytopenia (reduced platelet count in peripheral blood)
• nasal congestion (nasal obstruction)
• dryness of the mucous membranes 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., 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, diffuse vascular changes, and (or) concomitant renal failure, during Carvetrend 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. Sinus node inhibition may occur, which means the heart may beat very slowly or stop. 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 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 inform 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 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 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.
• 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 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.
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: