Acebutolol Gedeon Rihter

Package Leaflet: Information for the Patient

ACEBUTOLOL GEDEON RICHTER, 200 mg, coated tablets

ACEBUTOLOL GEDEON RICHTER, 400 mg, coated tablets

Acebutolol

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Acebutolol Gedeon Richter and what is it used for
• 2. Important information before taking Acebutolol Gedeon Richter
• 3. How to take Acebutolol Gedeon Richter
• 4. Possible side effects
• 5. How to store Acebutolol Gedeon Richter
• 6. Package contents and other information

1. What is Acebutolol Gedeon Richter and what is it used for

Acebutolol Gedeon Richter belongs to a group of medicines known as beta-adrenergic blockers.
The main effects of Acebutolol Gedeon Richter are: reducing heart rate frequency
(especially during exercise) and lowering blood pressure in patients with hypertension.
Acebutolol Gedeon Richter also has an anti-arrhythmic effect.
Acebutolol Gedeon Richter is a cardioselective (selective for the heart) beta-adrenergic blocker. It mainly inhibits the response to stimulation of adrenergic receptors located in the heart, while having less affinity for adrenergic receptors located in the bronchial wall and peripheral arteries.
Acebutolol Gedeon Richter has the ability of partial stimulation of beta-adrenergic receptors in the heart, also known as intrinsic sympathomimetic activity (ISA). In patients at rest, this ensures a balance of the negative dromotropic effect (slowing of electrical impulse conduction in the heart conduction system) and negative inotropic effect (decrease in heart muscle contraction force) of Acebutolol Gedeon Richter, thus reducing the risk of conduction disorders and heart failure.
Acebutolol Gedeon Richter counteracts the effects of excessive amounts of catecholamines in the blood (mainly adrenaline and noradrenaline) under stress conditions.

What is Acebutolol Gedeon Richter used for:

• treatment of hypertension (Acebutolol Gedeon Richter can be used as a single drug or in combination therapy);
• treatment of coronary heart disease;
• long-term treatment of certain heart rhythm disorders: supraventricular (tachycardia, atrial flutter and fibrillation, nodal tachycardia) and ventricular (ventricular tachycardia).

2. Important information before taking Acebutolol Gedeon Richter

When not to take Acebutolol Gedeon Richter

Acebutolol Gedeon Richter should not be taken if the patient has:

• hypersensitivity to the active substance, other beta-adrenergic blockers, or any of the other ingredients of this medicine (listed in section 6);
• second- and third-degree atrioventricular block in patients without a pacemaker;
• sick sinus syndrome;
• atrioventricular block;
• severe bradycardia (<50 beats per minute);< li>
• cardiogenic shock;
• severe forms of bronchial asthma and chronic obstructive pulmonary disease;
• uncompensated heart failure;
• vasospastic form of angina pectoris (Prinzmetal's type);
• severe peripheral circulatory disorders;
• untreated pheochromocytoma;
• metabolic acidosis;
• gluten intolerance due to the presence of wheat starch.

Children and adolescents

Acebutolol Gedeon Richter should not be taken by children.

Warnings and precautions

Bronchial asthma and chronic obstructive pulmonary disease
Acebutolol Gedeon Richter has a less pronounced bronchoconstrictive effect than other beta-adrenergic blockers, known as non-selective. Nevertheless, the medicine should be used in patients with bronchial asthma and chronic obstructive pulmonary disease only if necessary.
Beta-adrenergic blocker-induced bronchospasm is at least partially reversible by the use of a suitable bronchodilator (usually in the form of a pressure inhaler).
Heart failure
In case of heart failure (compensated), the medicine should be used with caution, under close medical supervision.
Bradycardia
If the patient's heart rate at rest is less than 45-50 beats per minute and symptoms of bradycardia occur (dizziness, fainting), the daily dose of Acebutolol Gedeon Richter should be reduced by the doctor.
Atrioventricular block I degree
Acebutolol Gedeon Richter should be used with caution in case of atrioventricular block I degree, as it slows down the conduction of impulses in the heart and may exacerbate the symptoms of this block.
Peripheral circulatory disorders
Acebutolol Gedeon Richter may exacerbate the symptoms of ischemia caused by peripheral artery insufficiency, such as in Raynaud's disease, Buerger's disease, other inflammatory artery diseases, and disseminated atherosclerotic changes in peripheral arteries in smokers or diabetic patients. In these diseases, the medicine should be used with caution. If the symptoms of ischemia worsen, the patient should consult a doctor.
Pheochromocytoma
In patients with pheochromocytoma, Acebutolol Gedeon Richter can be started after prior pharmacological blockade of alpha-adrenergic receptors.
Hyperthyroidism
Caution should be exercised when using Acebutolol Gedeon Richter in patients with hyperthyroidism, as the medicine may mask the symptoms of the disease.
Kidney disorders
Caution should be exercised when using Acebutolol Gedeon Richter in patients with severe kidney impairment. In patients with kidney disorders, the dose of the medicine should be adjusted by the doctor according to the laboratory parameter determining kidney function - creatinine clearance, while maintaining a once-daily dosing regimen.
Diabetes
At the beginning of treatment with Acebutolol Gedeon Richter, it should be remembered that the medicine may mask the symptoms of hypoglycemia, especially tachycardia (increased heart rate at rest above 100 beats/minute), palpitations, excessive sweating, and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic drugs called sulfonylureas (such as gliclazide, glibenclamide, glipizide, or tolbutamide), so blood sugar levels should be monitored more frequently.
Psoriasis
Acebutolol Gedeon Richter can be used in patients with psoriasis after weighing the benefits and risks of such treatment. Exacerbation of psoriasis and psoriatic skin symptoms has been reported after administration of beta-adrenergic blockers.
Hypersensitivity reactions
Acebutolol Gedeon Richter and other beta-adrenergic blockers may exacerbate hypersensitivity reactions.
Particular caution is recommended when using the medicine in patients who have previously experienced such reactions, for example, in connection with the use of iodine-containing contrast agents (used in some X-ray examinations) or after administration of flecainide.
General anesthesia
Acebutolol Gedeon Richter increases the risk of hypotension (blood pressure below 100/60 mmHg) in patients undergoing general anesthesia. It is recommended to discontinue the medicine 48 hours before general anesthesia. The anesthesiologist should be informed about the use of Acebutolol Gedeon Richter.
Athletes
Acebutolol Gedeon Richter contains an active substance that can cause positive results in anti-doping tests conducted by some sports federations and relevant authorities.
It is recommended to consult a doctor even if the above warnings refer to situations that have occurred in the past.

Acebutolol Gedeon Richter and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Medicines that should not be taken with Acebutolol Gedeon Richter or their use with Acebutolol Gedeon Richter requires special attention:

• flecainide, amiodarone. Do not takeamiodarone and flecainide in combination with Acebutolol Gedeon Richter;
• anti-arrhythmic drugs of class I (such as disopyramide) used simultaneously with Acebutolol Gedeon Richter cause disorders of heart automatism (increase the time of atrioventricular conduction), as well as increase the risk of bradycardia (slowing of heart rate).

Do not takethese medicines in combination with Acebutolol Gedeon Richter;

• calcium channel blockers. When using Acebutolol Gedeon Richter with calcium channel blockers, there is an increased risk of bradycardia (slowing of heart rate);
• verapamil.Do not takeverapamil with Acebutolol Gedeon Richter simultaneously or at a short interval (a few days);
• other calcium channel blockers, including diltiazem.Exercise special cautionwhen using other calcium channel blockers (especially diltiazem, as it may cause increased risk of depression) and Acebutolol Gedeon Richter.

Medicines that should be used with caution with Acebutolol Gedeon Richter:

• inhalation anesthetics. Before a planned surgical procedure under general anesthesia, inform the anesthesiologist about the use of Acebutolol Gedeon Richter;
• baclofen. Baclofen enhances the blood pressure-lowering effect of Acebutolol Gedeon Richter;
• insulin and oral antidiabetic drugs. When using Acebutolol Gedeon Richter and insulin or oral antidiabetic drugs, it may be necessary to reduce the dose of these drugs. Weakening of the effect of some oral antidiabetic drugs (glibenclamide) has also been observed when used in combination with Acebutolol Gedeon Richter;
• lidocaine. Acebutolol Gedeon Richter causes an increase in lidocaine blood levels. This may require a suitable reduction in the dose of Acebutolol Gedeon Richter by the doctor;
• iodine-containing contrast agents. It is not recommended to use iodine-containing contrast agents (used in some X-ray examinations) in patients taking Acebutolol Gedeon Richter due to the increased risk of hypersensitivity reactions;
• takrine. When using takrine with Acebutolol Gedeon Richter, there is an increased risk of bradycardia (decrease in heart rate);
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, ketoprofen, diclofenac). These drugs weaken the effect of Acebutolol Gedeon Richter on blood pressure;
• certain antidepressants, barbiturates, and certain antipsychotics. These drugs may cause a decrease in blood pressure. When used in combination with Acebutolol Gedeon Richter, they increase the risk of orthostatic hypotension (a sudden drop in blood pressure when changing body position from lying or sitting to standing). Before starting treatment with Acebutolol Gedeon Richter, inform your doctor about the use of these drugs;
• monoamine oxidase inhibitors. Concurrent use of monoamine oxidase inhibitors and high doses of Acebutolol Gedeon Richter may result in increased blood pressure;
• clonidine. Concurrent use of clonidine and Acebutolol Gedeon Richter is associated with an increased risk of bradycardia (decrease in heart rate);
• methylxanthines (e.g., theophylline, aminophylline) and β-adrenergic agonists (salbutamol, fenoterol). Acebutolol Gedeon Richter acts antagonistically to methylxanthines and β-adrenergic agonists used in bronchospasm. To achieve the desired effect, it may be necessary to use higher doses of these drugs;
• systemically acting corticosteroids. Systemically administered corticosteroids reduce the antihypertensive effect of Acebutolol Gedeon Richter;
• digoxin. Digoxin used in combination with Acebutolol Gedeon Richter increases the possibility of severe bradycardia (heart rate below 50 beats/minute).
• fingolimod (used in the treatment of multiple sclerosis). At the beginning of concurrent use, the doctor will closely monitor the patient due to the risk of slow heart rate.

Acebutolol Gedeon Richter with food and drink

The medicine should be taken orally. It is recommended to take the medicine during a meal. The tablet should be swallowed whole and washed down with water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Acebutolol Gedeon Richter should not be taken during pregnancy.
Beta-adrenergic blockers may reduce blood flow to the placenta, which can lead to premature birth, lower than expected birth weight, fetal death in the womb, and miscarriage.
Acebutolol Gedeon Richter passes into breast milk in significant amounts. Breastfeeding women should not take Acebutolol Gedeon Richter.

Driving and using machines

Acebutolol Gedeon Richter has a minor effect on the ability to drive and use machines.
The medicine may cause dizziness and fatigue in treated patients. If these symptoms occur, do not drive vehicles or operate machines.

Acebutolol Gedeon Richter contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.

Acebutolol Gedeon Richter contains wheat starch.

Each Acebutolol Gedeon Richter 200 mg coated tablet contains no more than 132 micrograms of gluten.
Each Acebutolol Gedeon Richter 400 mg coated tablet contains no more than 118 micrograms of gluten.
This medicine contains very small amounts of gluten (derived from wheat starch). Therefore, it is very unlikely to cause problems in patients with celiac disease.
Patient with wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Acebutolol Gedeon Richter

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The most commonly used dosage in hypertension is:

• the recommended daily dose is 1 tablet (400 mg) in the morning, during breakfast, or 1 tablet (200 mg) twice a day - in the morning and evening;
• the maximum daily dose is 800 mg per day in two divided doses.

The most commonly used dosage in coronary heart disease is:

• initially: 1 tablet (400 mg) in the morning, during breakfast, or 1 tablet (200 mg) twice a day - in the morning and evening;

Maintenance treatment:

• 600 mg (3 tablets of 200 mg) per day. In severe forms of angina pectoris, the daily dose is 900 mg, administered in 3 divided doses. The maximum daily dose is 1200 mg.

The most commonly used dosage in heart rhythm disorders is:

• 400 mg (1 tablet) to 1200 mg (3 tablets) per day.

Method of administration

Tablets are recommended to be taken during a meal, at the same time of day, swallowed whole, and washed down with water.
Taking the medicine at the same time of day helps to prevent missing a dose.
If you feel that the effect of Acebutolol Gedeon Richter is too strong or too weak, consult a doctor.

Using a higher than recommended dose of Acebutolol Gedeon Richter

In case of taking a higher dose of the medicine than recommended, immediately consult a doctor or go to the hospital. Show the doctor the package with the tablets.
In case of taking a higher dose of Acebutolol Gedeon Richter than recommended, the patient may experience severe bradycardia (less than 50 heartbeats per minute) (the heart rate may become very slow or the heart may stop) or hypotension (blood pressure below 100/60 mmHg). Other symptoms of overdose include: shock, atrioventricular block, sinoatrial block, and other conduction disorders, pulmonary edema, impaired consciousness, bronchospasm, hypoglycemia (blood glucose level below 50 mg/dl), and in rare cases, hyperkalemia (elevated potassium levels in the blood).

Missing a dose of Acebutolol Gedeon Richter

If a dose is missed and it has not been more than 8 hours since the planned time of taking the medicine, take it on the same day. If more than 8 hours have passed since the planned time of taking the medicine, take the next prescribed dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Do not stop taking Acebutolol Gedeon Richter abruptly, especially in patients with coronary heart disease. The doses should be gradually reduced over 1-2 weeks, if necessary, changing the treatment to prevent exacerbation of coronary heart disease.

4. Possible side effects

Like all medicines, Acebutolol Gedeon Richter can cause side effects, although not everybody gets them.
The side effects of Acebutolol Gedeon Richter are listed below.
If the side effect is described in the leaflet as:

• frequent - it means that it occurs in at least 1 in 100 but less than 1 in 10 treated patients;
• rare - it means that it occurs in at least 1 in 10,000 but less than 1 in 1,000 treated patients;
• very rare - it means that it occurs in less than 1 in 10,000 treated patients, including single cases;
• with unknown frequency - it means that the frequency cannot be estimated from the available data.
  Severe side effects are rare (most commonly observed is severe bradycardia).
  Other severe side effects include: bronchospasm, severe pneumonia, heart failure.
  Among other side effects, the most common are gastrointestinal disorders (gastrointestinal) and nervous system disorders (headache, dizziness, insomnia).
  Frequent side effects include:
  • headache, dizziness, insomnia;
  • nausea, vomiting, abdominal pain;
  • bradycardia (slowing of heart rate), hypotension (blood pressure below 100/60 mmHg);
  • cold extremities (feeling of cold feet);
  • shortness of breath;
  • asthenia (weakness);
  • decreased libido;
  • skin itching.

  Rare side effects include:

  • bloating, diarrhea, constipation;
  • conduction disorders, chest pain, edema (mainly of the feet and ankles), heart failure;
  • exacerbation of Raynaud's syndrome or occurrence of intermittent claudication (leg pain when walking, forcing the patient to stop frequently);
  • rhinitis and pharyngitis, sneezing, bronchospasm, pneumonia;
  • nightmares, hallucinations, disorientation, psychosis, and depression;
  • reduced tear secretion (which can make it difficult to use contact lenses);
  • hepatitis;
  • hives, rash, lupus erythematosus, exacerbation of psoriasis, and psoriatic skin symptoms;
  • muscle and joint pain, back pain;
  • urination disorders;
  • hypoglycemia (blood glucose level below 50 mg/dl), presence of antinuclear antibodies.

  Very rare side effects include:

  • systemic lupus erythematosus.

  Side effects with unknown frequency include:

  • sinoatrial block (the heart rate may become very slow or the heart may stop). This can occur especially in people over 65 years of age or in people with other heart rhythm disorders;
  • increased liver enzyme activity, liver damage, mainly affecting liver cells;
  • hair loss (alopecia).

  In case of any of the above rare and severe side effects, stop taking the medicine and consult a doctor or go to the hospital immediately.

  Reporting side effects

  If you experience any side effects, including any side effects 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
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to store Acebutolol Gedeon Richter

  Keep the medicine 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 package after: "EXP". The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

  6. Package contents and other information

  What does Acebutolol Gedeon Richter contain

  • The active substance of the medicine is acebutolol in the form of acebutolol hydrochloride. Each Acebutolol Gedeon Richter 200 mg coated tablet contains 200 mg of acebutolol in the form of acebutolol hydrochloride. Each Acebutolol Gedeon Richter 400 mg coated tablet contains 400 mg of acebutolol in the form of acebutolol hydrochloride.
  • Other ingredients are: wheat starch, lactose monohydrate, talc, anhydrous colloidal silica, povidone K-30, magnesium stearate, hypromellose, macrogol 20000.

  What Acebutolol Gedeon Richter looks like and what the package contains

  Acebutolol Gedeon Richter 200 mg coated tablets
  Round, biconvex coated tablets, 12 mm in diameter, white to cream-colored, with the inscription 200 embossed on one side of the tablet and a dividing line on the other side of the tablet. The dividing line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.
  Acebutolol Gedeon Richter 400 mg coated tablets
  Round, biconvex coated tablets, 12 mm in diameter, light cream to cream-colored, with the inscription 400 embossed on one side of the tablet and a dividing line on the other side of the tablet. The dividing line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.
  Acebutolol Gedeon Richter is packaged in blisters of aluminum/PVC foil placed in a cardboard box. The box contains 30 coated tablets and a patient information leaflet.

  Marketing authorization holder and manufacturer

  GEDEON RICHTER POLSKA Sp. z o.o.
  ul. Ks. J. Poniatowskiego 5
  05-825 Grodzisk Mazowiecki
  phone: (22) 755 50 81
  To obtain more detailed information about the medicine, please contact:
  GEDEON RICHTER POLSKA Sp. z o.o.
  ul. Ks. J. Poniatowskiego 5
  05-825 Grodzisk Mazowiecki
  Phone: +48 (22)755 96 48
  lekalert@grodzisk.rgnet.org

  Date of the last update of the leaflet:

  ((logo of the marketing authorization holder))
  ((pharmacode))