Acebutolol gedeon richter

Package leaflet: Information for the patient

ACEBUTOLOL GEDEON RICHTER, 200 mg, film-coated tablets
ACEBUTOLOL GEDEON RICHTER, 400 mg, film-coated tablets
Acidum ascorbicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Acebutolol Gedeon Richter is and what it is 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. Contents of the pack and other information

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

Acebutolol Gedeon Richter belongs to a group of medicines known as beta-adrenergic blocking agents (beta-blockers).
The main effects of Acebutolol Gedeon Richter are reduction of heart rate (especially during physical exertion) and lowering of blood pressure in patients with arterial hypertension.
Acebutolol Gedeon Richter also has antiarrhythmic properties.
Acebutolol Gedeon Richter is a cardioselective (heart-selective) beta-adrenergic blocking agent. It primarily blocks the response to stimulation of β₁-adrenergic receptors located in the heart, while having less affinity for β₂-adrenergic receptors located, among others, in the bronchial walls and peripheral arteries.
Acebutolol Gedeon Richter has the ability to partially stimulate cardiac beta-adrenergic receptors, also known as intrinsic sympathomimetic activity (ISA). In resting patients, this balances the negative dromotropic (slowing of electrical impulse conduction in the heart's conduction system) and negative inotropic (reduction of myocardial contractile force) effects of the administered Acebutolol Gedeon Richter, thereby reducing the risk of conduction disturbances and heart failure.
Acebutolol Gedeon Richter counteracts the effects of excessive levels of catecholamines in the blood (mainly adrenaline and noradrenaline) under stress conditions.

Acebutolol Gedeon Richter is used for:

• Treatment of arterial hypertension (Acebutolol Gedeon Richter may be used alone or in combination therapy);
• Treatment of coronary artery disease;
• Long-term treatment of certain cardiac arrhythmias: supraventricular (tachycardia, atrial flutter and atrial fibrillation, nodal tachycardia) and ventricular (ventricular tachycardia).

2. Important information before using Acebutolol Gedeon Richter

When not to use Acebutolol Gedeon Richter
Do not use Acebutolol Gedeon Richter if the patient has:

• hypersensitivity to the active substance, other beta-blocking agents, or to any of the other components of this medicine (listed in section 6);
• second- or third-degree atrioventricular block in patients without a pacemaker;
• sick sinus syndrome;
• sinoatrial block;
• marked bradycardia (< 50 beats per minute);
• cardiogenic shock;
• severe forms of bronchial asthma and chronic obstructive pulmonary disease;
• decompensated heart failure;
• vasospastic angina (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 used in children.

Warnings and precautions
Bronchial asthma and chronic obstructive pulmonary disease
Acebutolol Gedeon Richter has less bronchoconstrictive effect than other beta-blocking agents known as non-selective. Nevertheless, the medicine should be used in patients with bronchial asthma and chronic obstructive pulmonary disease only if necessary.
Bronchospasm induced by beta-blockers is at least partially reversible by administration of an appropriate bronchodilator (usually in the form of a pressurized inhaler).

Heart failure
In patients with compensated heart failure, the medicine should be used with caution under strict medical supervision.

Bradycardia
If the resting heart rate is less than 45–50 beats per minute and symptoms of bradycardia occur (e.g. visual disturbances, dizziness, fainting), the daily dose of Acebutolol Gedeon Richter should be reduced by a physician.

First-degree atrioventricular block
Acebutolol Gedeon Richter should be used with caution in first-degree atrioventricular block, as it slows cardiac conduction and may worsen the symptoms of this block.

Peripheral circulatory disorders
Acebutolol Gedeon Richter may worsen symptoms of ischemia caused by peripheral arterial insufficiency, for example in: Raynaud's disease and syndrome, Buerger's disease, other inflammatory arterial diseases, diffuse atherosclerotic changes in peripheral arteries in patients who smoke or have diabetes. The medicine should be used with caution in these conditions. If ischemic symptoms worsen, contact a physician.

Pheochromocytoma
In patients with pheochromocytoma, treatment with Acebutolol Gedeon Richter may be initiated only after prior pharmacological blockade of alpha-adrenergic receptor activity.

Hyperthyroidism
Caution should be exercised when using Acebutolol Gedeon Richter in patients with hyperthyroidism, as the medicine may mask symptoms of the disease.

Renal function impairment
Caution should be exercised when using Acebutolol Gedeon Richter in patients with severe renal impairment. In patients with impaired renal function, the dose should be adjusted by the physician according to the laboratory parameter of renal function – creatinine clearance – maintaining once-daily dosing.

Diabetes
At the beginning of treatment with Acebutolol Gedeon Richter, it should be remembered that the medicine may mask symptoms of hypoglycemia, especially tachycardia (resting heart rate over 100 beats/minute), palpitations, and excessive sweating, and may increase the risk of severe hypoglycemia when used with certain oral antidiabetic drugs known as sulfonylureas (e.g. glipizide, glyburide, glimepiride, tolbutamide, gliclazide, glipizide). Therefore, blood glucose levels should be monitored more frequently.

Psoriasis
Acebutolol Gedeon Richter may be used in patients with psoriasis after careful consideration of the benefits and risks of such treatment. Worsening of psoriatic symptoms and psoriasiform skin reactions have been reported after administration of beta-blocking agents.

Hypersensitivity reactions
Acebutolol Gedeon Richter and other beta-blocking agents may exacerbate hypersensitivity reactions. Particular caution is advised in patients who have previously experienced such reactions, for example in connection with iodine-containing contrast agents (used in certain X-ray examinations) or after flecainide administration.

General anesthesia
Acebutolol Gedeon Richter increases the risk of hypotension (arterial blood pressure below 100/60 mm Hg) in patients undergoing general anesthesia. It is recommended to discontinue the medicine 48 hours before general anesthesia. Inform the anesthesiologist that you are taking Acebutolol Gedeon Richter.

Sportsmen
Acebutolol Gedeon Richter contains an active substance that may lead to positive results in anti-doping controls conducted by certain sports federations and relevant authorities.
Consult your doctor even if the above warnings relate to conditions that occurred in the past.

Acebutolol Gedeon Richter and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Medicines that should not be used together with Acebutolol Gedeon Richter, or whose combined use requires special attention:

• flecainide, amiodarone. Do not use amiodarone and flecainide in combination with Acebutolol Gedeon Richter;
• class I antiarrhythmic drugs (e.g. disopyramide) used concomitantly with Acebutolol Gedeon Richter may cause disturbances in cardiac automaticity (prolonged atrioventricular conduction) and increase the risk of bradycardia (slowing of heart function).

Do not use these medicines in combination with Acebutolol Gedeon Richter;

• calcium channel blockers. Concurrent use of Acebutolol Gedeon Richter with calcium channel blockers increases the risk of bradycardia (slowing of heart function);
• verapamil. Do not use verapamil together with Acebutolol Gedeon Richter or within a short time interval (several days);
• other calcium channel blockers, including diltiazem. Exercise particular caution when using other calcium channel blockers (especially diltiazem, as it may increase the risk of depression) together with Acebutolol Gedeon Richter.

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

• inhaled agents used in general anesthesia. Before a planned surgical procedure under general anesthesia, inform the anesthesiologist that you are taking Acebutolol Gedeon Richter;
• baclofen. Baclofen enhances the blood pressure-lowering effect of Acebutolol Gedeon Richter;
• insulin and oral antidiabetic drugs. When Acebutolol Gedeon Richter is used concomitantly with insulin or oral antidiabetic drugs, a reduction in the dose of these drugs may be necessary. A reduced effect of some oral antidiabetic drugs (e.g. glyburide) has also been observed when used together with Acebutolol Gedeon Richter;
• lidocaine. Acebutolol Gedeon Richter increases the blood concentration of lidocaine. This may require appropriate dose reduction of Acebutolol Gedeon Richter by a physician;
• iodine-containing contrast agents. The use of iodine-containing contrast agents (used in certain X-ray examinations) is not recommended in patients taking Acebutolol Gedeon Richter due to an increased risk of hypersensitivity reactions;
• tacrine. When tacrine is used concomitantly with Acebutolol Gedeon Richter, an increased risk of bradycardia (reduced heart rate) should be expected;
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, ketoprofen, diclofenac). These drugs reduce the antihypertensive effect of Acebutolol Gedeon Richter;
• certain antidepressants, barbiturates, and certain antipsychotics. These drugs may lower blood pressure. When used together with Acebutolol Gedeon Richter, they increase the risk of orthostatic hypotension (sudden drop in blood pressure upon changing from lying or sitting to standing position). Inform your doctor about taking these medicines before starting treatment with Acebutolol Gedeon Richter;
• monoamine oxidase inhibitors. Concurrent use of monoamine oxidase inhibitors and high doses of Acebutolol Gedeon Richter may result in elevated blood pressure;
• clonidine. Concurrent use of clonidine and Acebutolol Gedeon Richter increases the risk of bradycardia (reduced heart rate);
• methylxanthines (e.g. theophylline, aminophylline) and β-adrenergic agonists (e.g. salbutamol, fenoterol). Acebutolol Gedeon Richter acts antagonistically to methylxanthines and β-adrenergic agonists used in bronchospastic conditions. Higher doses of these drugs may be required to achieve the desired effect;
• systemic corticosteroids. Systemic administration of corticosteroids reduces the antihypertensive effect of Acebutolol Gedeon Richter;
• digoxin. Digoxin used in combination with Acebutolol Gedeon Richter increases the risk of marked bradycardia (heart rate below 50 beats per minute);
• fingolimod (used in the treatment of multiple sclerosis). At the beginning of concomitant use, the physician will closely monitor the patient due to the risk of bradycardia.

Acebutolol Gedeon Richter with food and drink
The medicine is taken orally. It is recommended to take it during a meal. The tablet should be swallowed whole, without chewing, and taken with water.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Acebutolol Gedeon Richter during pregnancy.
Beta-blocking agents may reduce blood flow to the placenta, which may lead to premature delivery, lower than expected birth weight, intrauterine fetal death, 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 influence on the ability to drive and operate machinery.
The medicine may cause dizziness and fatigue in treated patients. If these symptoms occur, do not drive or operate machinery.

Acebutolol Gedeon Richter contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Acebutolol Gedeon Richter contains wheat starch.
Each tablet of Acebutolol Gedeon Richter 200 mg, coated tablets, contains no more than 132 micrograms of gluten.
Each tablet of Acebutolol Gedeon Richter 400 mg, coated tablets, 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.
Patients with wheat allergy (other than celiac disease) should not use this medicine.

3. How to use Acebutolol Gedeon Richter

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

The most commonly used dosage for arterial hypertension is:

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

The most commonly used dosage for coronary heart disease is:

• initial treatment: 1 tablet (400 mg) in the morning with breakfast, or 1 tablet (200 mg) twice daily –
  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 three divided doses. The maximum daily dose is 1200 mg.

The most commonly used dosage for cardiac arrhythmias is:

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

Method of administration
Tablets should be taken during a meal, at the same time each day, swallowed whole with water.
Taking the medicine at the same time every day helps prevent missed doses.
If you feel that the effect of Acebutolol Gedeon Richter is too strong or too weak, you should
consult your doctor.

Overdose of Acebutolol Gedeon Richter
If you take more than the recommended dose, you should contact your doctor immediately or go to a hospital.
You should show the tablet packaging to the doctor.
In case of overdose with Acebutolol Gedeon Richter, the patient may experience severe bradycardia (below 50 heartbeats per minute) (heartbeat may become very slow or the heart may stop) or hypotension (arterial blood pressure below 100/60 mmHg). Other symptoms of overdose include shock, atrioventricular block, sinoatrial block and other conduction disorders, pulmonary edema, disturbances of consciousness, bronchospasm, hypoglycemia (decreased blood glucose concentration below normal range), and in rare cases hyperkalemia (increased potassium concentration in blood).

Missed dose of Acebutolol Gedeon Richter
If you miss a dose and less than 8 hours have passed since the scheduled time of administration, you should take the missed dose as soon as possible within the same day. If more than 8 hours have passed since the scheduled time, you should take the next prescribed dose at the regularly 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 dose should be gradually reduced over 1–2 weeks, and if necessary, the treatment regimen should be changed to prevent worsening of coronary heart disease.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects associated with the use of Acebutolol Gedeon Richter are listed below.
If a side effect in this leaflet is described as occurring:
frequently – this means it occurs in at least 1 in 100 but less than 1 in 10 patients treated;
rarely – this means it occurs in at least 1 in 10,000 but less than 1 in 1,000 patients treated;
very rarely – this means it occurs in less than 1 in 10,000 patients treated, including isolated cases;
frequency not known – this means the frequency cannot be estimated from the available data.

Severe adverse effects occur rarely (bradycardia of significant degree has been most commonly observed).
Other severe adverse effects include: bronchospasm, severe pneumonia, heart failure.
Among other adverse effects, gastrointestinal and nervous system disorders are most common (headache, dizziness, insomnia).

Frequently observed:

• headache, dizziness, insomnia;
• nausea, vomiting, abdominal pain;
• bradycardia (slowing of heart rate), hypotension (arterial blood pressure below 100/60 mmHg);
• cold extremities (feeling of cold feet);
• shortness of breath;
• asthenia (weakness);
• decreased libido;
• skin itching.

Rarely observed:

• bloating, diarrhoea, constipation;
• disturbances in cardiac conduction, chest pain, oedema (mainly in feet and lower legs), heart failure;
• onset or worsening of Raynaud's syndrome, worsening or onset of intermittent claudication (limb pain during walking, forcing the patient to stop frequently);
• rhinitis and pharyngitis, sneezing, bronchospasm, pneumonia;
• nightmares, hallucinations, disorientation, psychosis and depression;
• decreased tear secretion (which may make wearing contact lenses difficult);
• hepatitis;
• urticaria, rash, lupus erythematosus, worsening of psoriasis symptoms and psoriasiform eruptions;
• muscle and joint pain, back pain;
• urinary disorders;
• hypoglycaemia (blood glucose concentration below 50 mg/dl), presence of antinuclear antibodies.

Very rarely observed:

• systemic lupus erythematosus.

Frequency not known:

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

If any of the above rare and severe symptoms underlined with a line occur, treatment with the medicine should be stopped immediately and you should contact your doctor or go to hospital.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Acebutolol Gedeon Richter

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging following "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Acebutolol Gedeon Richter contains

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

What Acebutolol Gedeon Richter looks like and contents of the pack
Acebutolol Gedeon Richter 200 mg, coated tablets
Round, biconvex coated tablets, 12 mm in diameter, white-cream in colour, with the imprint "200" on one side of the tablet and a breakline on the other side. The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.
Acebutolol Gedeon Richter 400 mg, coated tablets
Round, biconvex coated tablets, 12 mm in diameter, light cream to cream in colour, with the imprint "400" on one side of the tablet and a breakline on the other side. The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.
Acebutolol Gedeon Richter is packed in aluminium/PVC blisters placed in cartons.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81
For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]
((logo of the marketing authorisation holder))
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