Dilatrend

Leaflet attached to the packaging: patient information

Dilatrend, 6.25 mg, tablets

Dilatrend, 12.5 mg, tablets

Dilatrend, 25 mg, tablets

Carvedilol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dilatrend and what is it used for
• 2. Important information before taking Dilatrend
• 3. How to take Dilatrend
• 4. Possible side effects
• 5. How to store Dilatrend
• 6. Contents of the packaging and other information

1. What is Dilatrend and what is it used for

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

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

2. Important information before taking Dilatrend

When not to take Dilatrend

Warnings and precautions

Before starting to take Dilatrend, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Dilatrend

• in patients with chronic heart failure, as it may lead to worsening of heart failure symptoms or fluid retention in the body
• in patients with hypertension and chronic heart failure, treated with cardiac glycosides, Dilatrend should be used with caution, as both cardiac glycosides and Dilatrend slow down 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 Dilatrend may mask or weaken the early symptoms of acute hypoglycemia (decrease in blood glucose levels). During the initiation of treatment with Dilatrend and increasing the dose of the medicine in these patients, it is recommended to systematically monitor blood glucose levels and adjust the doses of antidiabetic medications accordingly, as the administration of Dilatrend may worsen blood glucose control.
• in patients with chronic heart failure and low blood pressure (systolic blood pressure <100 mmhg), coronary artery disease, widespread vascular changes and (or) concomitant renal failure. when increasing the dose of dilatrend in these patients, doctor will monitor function, case its deterioration, may decide to discontinue medicine or reduce used.< li>
• in patients wearing contact lenses. They should be aware of the possibility of reduced tear secretion.
• in patients with peripheral vascular diseases and Raynaud's phenomenon, as there is a risk of worsening of vascular insufficiency symptoms when using beta blockers. However, the additional alpha receptor blockade by Dilatrend largely mitigates these symptoms.
• in patients with severe skin reactions. During treatment with carvedilol, very rare cases of severe skin reactions have been reported, such as polymorphic erythema, toxic epidermal necrolysis, or Stevens-Johnson syndrome (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 Dilatrend.
• in patients with hyperthyroidism, as Dilatrend may mask the symptoms of hyperthyroidism.
• in patients who have had severe hypersensitivity reactions in the past, as well as patients undergoing desensitization (Dilatrend, 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 Dilatrend, 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 receptor blockade by Dilatrend may prevent the occurrence of these symptoms.
• in patients with a tendency to bronchospasm. The doctor should be informed if any symptoms of bronchospasm occur during treatment with Dilatrend
• 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, 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
• in case of heart rate slowing to below 55 beats per minute during treatment with Dilatrend, the doctor should be contacted, who may recommend reducing the dose of the medicine. Like all beta-adrenergic blockers, carvedilol should not be discontinued abruptly. This applies in particular to 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 the age of 18 have not been established,
therefore, it should not be used in this age group.

Dilatrend and other medicines

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

• containing digoxin (used to treat heart failure), as the doctor may decide to change the dose when using Dilatrend,
• cyclosporine and tacrolimus taken orally (a medicine that weakens the body's immune system, preventing the rejection of a transplanted organ), as Dilatrend enhances the effect of cyclosporine and tacrolimus,
• rifampicin (an antibiotic used to treat tuberculosis), as it weakens the effect of Dilatrend.
• fluoxetine and paroxetine (medicines used to treat depression),
• insulin and oral antidiabetic medications, as Dilatrend may enhance the effect of these medications. The doctor may recommend monitoring blood glucose levels,
• reserpine (affecting blood pressure) and monoamine oxidase inhibitors (a type of antidepressant), as they may cause further slowing of heart rate and (or) lowering of blood pressure,
• non-dihydropyridine calcium channel blockers, amiodarone, or other antiarrhythmic medications. The doctor will monitor the ECG recording and blood pressure,
• clonidine (a medicine used to lower blood pressure or treat migraines)
• other medications that lower blood pressure. Dilatrend may enhance the effect of blood pressure-lowering medications (e.g., alpha-adrenergic blockers) and medications whose undesirable 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);

do not take this medicine with grapefruit juice, as it 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 Dilatrend.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you think you may be pregnant, or are planning 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 not known.
Dilatrend should not be used during pregnancy unless the expected benefits of treatment outweigh the potential risk.
Dilatrend should not be used during breastfeeding.

Driving and operating machinery

As with other blood pressure-lowering medications, you should remember that if dizziness and similar symptoms occur, you should not drive vehicles or operate machinery. This applies especially to situations where treatment is started or changed, as well as when consuming alcohol.

Dilatrend contains lactose and sucrose.

Dilatrend contains lactose and sucrose. One tablet contains: for Dilatrend 6.25 mg: 51.80 mg of lactose and 21.25 mg of sucrose; for Dilatrend 12.5 mg: 59.10 mg of lactose and 12.50 mg of sucrose; for Dilatrend 25 mg: 10.00 mg of lactose and 25.00 mg of sucrose.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Dilatrend

This medicine should always be taken according to the doctor's instructions. In case of doubts, you should consult a doctor or pharmacist.
Dilatrend tablets should be taken 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 Dilatrend 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 largest dose tolerated 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 dilatrend, there may be a worsening renal function and (or) heart failure symptoms. for this reason, before each subsequent increase, doctor will monitor parameters determining function, as well assess severity symptoms or related to vasodilation.
In case of discontinuation of therapy with Dilatrend 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.
Elderly
Dosing is the same as for adults.

Use in children and adolescents

The safety and efficacy of Dilatrend in children (under the age of 18) 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 is recommended to 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 two divided doses.
The dose of the medicine should be increased at intervals of not less than two weeks.
Elderly
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 the recommended maximum daily dose of 50 mg, administered once a day or in divided doses.

Use in children and adolescents

The safety and efficacy of Dilatrend in children (under the age of 18) 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 is recommended to be increased to 25 mg twice a day.
Elderly
The recommended maximum daily dose is 50 mg, administered in divided doses.
Use in children and adolescents
The safety and efficacy of Dilatrend in children and adolescents (under the age of 18) have not been evaluated.
Patients with concomitant liver disease
The use of Dilatrend is contraindicated in patients with concomitant liver dysfunction.
Patients with concomitant renal impairment
In patients with systolic blood pressure >100 mmHg, it is not necessary to reduce the dose of the medicine.
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 largest dose tolerated by the patient.

Use of a higher than recommended dose of Dilatrend

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

Missing a dose of Dilatrend

You should not take a double dose to make up for a missed dose. If you miss a dose, you should not increase the next dose of the medicine. You should take the next dose of the medicine according to the doctor's instructions.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

• very common: occurring more frequently than in 1 in 10 people,
• dizziness and headaches, usually mild and occurring mainly at the beginning of treatment,
• fatigue,
• hypotension,
• asthenia (feeling of weakness),
• heart failure,

common: occurring more frequently than in 1 in 100, but less frequently than in 1 in 10 people,

• weight gain,
• hypercholesterolemia (increased blood cholesterol levels),
• in patients with diabetes, hyperglycemia (increased blood sugar levels), hypoglycemia (decreased blood sugar levels), and impaired glucose tolerance are also often observed,
• bradycardia (slow heart rate),
• orthostatic hypotension (decrease in blood pressure when changing body position),
• edema (including generalized, peripheral, orthostatic, and localized in the genital area, edema of the lower limbs, hypervolemia (fluid overload, increased circulating blood volume)),
• renal failure and worsening of renal function in patients with widespread vascular changes and (or) concomitant renal impairment,
• pain,
• bronchitis, pneumonia, upper respiratory tract infection,
• urinary tract infections,
• urination disorders,
• anemia,
• depression, low mood,
• peripheral circulation disorders (cooling of the limbs, peripheral vascular diseases, worsening of intermittent claudication (pain in the calf muscles when walking), Raynaud's syndrome - pallor, followed by cyanosis of the fingers of the hands, feet, nose, or ears caused by vasospasm),
• dyspnea, pulmonary edema, and asthma in susceptible patients,
• gastrointestinal disorders (such as nausea, indigestion, abdominal pain, diarrhea, and vomiting),
• limb pain,
• visual disturbances,
• decreased tear secretion (dry eye syndrome), eye irritation.
• syncope, pre-syncopal states. uncommon: occurring more frequently than in 1 in 1,000, but less frequently than in 1 in 100 people,
• atrioventricular block (disturbances of conduction of impulses within the heart muscle),
• sleep disorders,
• paresthesia (tingling and numbness of the limbs),
• hypotension,
• angina pectoris (including chest pain),
• constipation,
• skin reactions (e.g., allergic rash, dermatitis, urticaria, itching, changes resembling psoriasis or lichen planus),
• hair loss,
• erectile dysfunction, impotence,
• dermatitis,
• increased sweating. rare: occurring more frequently than in 1 in 10,000, but less frequently than in 1 in 1,000 people,
• decreased platelet count in the peripheral blood (thrombocytopenia),
• nasal congestion,
• dryness of the mucous membrane of the mouth. very rare: occurring less frequently than in 1 in 10,000 people.
• hypersensitivity (allergic reaction),
• abnormal liver function test results (increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase),
• decreased white blood cell count in the peripheral blood (leukopenia),
• urinary incontinence in women,
• severe skin reactions (such as polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis). In patients with congestive heart failure, when increasing the dose of carvedilol, there may be a worsening of heart failure symptoms and fluid retention in the body. In patients with chronic heart failure and low blood pressure, coronary artery disease, widespread vascular changes, 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-adrenergic blocking properties of Dilatrend, it is possible to unmask latent diabetes, worsen blood glucose control, and impair glucose regulation mechanisms. Additionally, during treatment with Dilatrend, hallucinations may occur. Excessive sweating may occur. Sinoatrial arrest may occur, which means that the heart may beat very slowly or stop beating. 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 people, during treatment with Dilatrend, other side effects may occur. Reporting side effects If you experience any side effects, including any side effects not listed in the 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 PL-02 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dilatrend

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 30°C, in a closed packaging. Protect from light and moisture.
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 specified month.
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 packaging and other information

What Dilatrend contains

• The active substance of the medicine is carvedilol. Each tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol.
• The other ingredients are: lactose monohydrate, sucrose, povidone K 25, crospovidone type A, colloidal anhydrous silica, magnesium stearate; additionally, 6.25 mg tablets - yellow iron oxide, 12.5 mg tablets - yellow iron oxide, red iron oxide.

What Dilatrend looks like and contents of the pack

Dilatrend is packaged in blisters placed in a cardboard box.
The packaging contains: 30, 50, or 100 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

Date of last revision of the leaflet: 10/2023