Acecor

Package Leaflet: Information for the Patient

Acecor, 400 mg, Film-Coated Tablets

Acebutolol Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Acecor and What is it Used For
• 2. Important Information Before Taking Acecor
• 3. How to Take Acecor
• 4. Possible Side Effects
• 5. How to Store Acecor
• 6. Contents of the Pack and Other Information

1. What is Acecor and What is it Used For

Acecor belongs to a group of medicines called beta-blockers. It contains the active substance acebutolol, which acts mainly on receptors located in the heart, and less on receptors in the walls of blood vessels and bronchi. Acecor is used to treat high blood pressure, angina pectoris, and heart rhythm disorders.

2. Important Information Before Taking Acecor

When Not to Take Acecor

• if you are allergic to the active substance, beta-blockers, or any of the other ingredients of this medicine (listed in section 6) - symptoms of an allergic reaction are: rash, difficulty breathing or swallowing, swelling of the lips, face, throat, or tongue,
• if you have cardiogenic shock,
• if you have low blood pressure (100/60 mmHg or less),
• if you have second- or third-degree atrioventricular block,
• if you have sick sinus syndrome,
• if you have severe bradycardia, i.e., slow heart rate (less than 45-50 beats per minute),
• if you have uncontrolled heart failure,
• if you have metabolic acidosis, i.e., increased blood acidity,
• if you have severe peripheral circulation disorders,
• if you have an untreated pheochromocytoma.

If any of the above conditions apply to you, do not take Acecor. In case of doubt, consult your doctor before taking Acecor.

Warnings and Precautions

Before starting treatment with Acecor, discuss it with your doctor or pharmacist. Before starting treatment with Acecor, tell your doctor if you have any of the following conditions:

• kidney function disorders, especially severe kidney failure, depending on the degree of kidney failure, your doctor may reduce the dose of this medicine,
• breathing difficulties, asthma, or obstructive airway diseases,
• stable heart failure treated with other medicines - if during treatment with this medicine, a slowing of the heart rate occurs, your doctor may reduce the dose,
• chest pain, known as Prinzmetal's angina,
• peripheral artery disease, as Acecor may worsen it,
• Raynaud's syndrome, a condition characterized by blue discoloration and coldness of the hands and feet,
• hyperthyroidism, as this medicine may mask its symptoms,
• diabetes, as this medicine may mask the symptoms of low blood sugar (hypoglycemia),
• pheochromocytoma,
• psoriasis,
• allergy, as the group of medicines to which Acecor belongs may increase sensitivity to allergens and worsen the severity of anaphylactic reactions.

Before a planned surgical procedure, inform your doctor that you are taking Acecor, as it may affect the action of certain substances used for general anesthesia, such as ether, cyclopropane, and trichloroethylene. Like other beta-blockers, do not stop taking acebutolol abruptly. Discontinuation of Acecor should be gradual. This is especially important in patients with coronary heart disease.

Acecor and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. Acecor may affect the action of other medicines you are taking, or these medicines may affect the action of Acecor. In particular, inform your doctor if you are taking:

• medicines for angina pectoris, especially verapamil or diltiazem,
• other medicines for heart diseases, such as disopyramide, amiodarone, digoxin,
• insulin or oral medicines that lower blood sugar levels, such as glibenclamide,
• clonidine, used in high blood pressure,
• medicines for breathing disorders, such as aminophylline, theophylline, salbutamol, or terbutaline,
• non-steroidal anti-inflammatory medicines, used to relieve pain, such as ibuprofen, naproxen, diclofenac, indomethacin, piroxicam,
• medicines for depression, such as monoamine oxidase inhibitors, tricyclic antidepressants (e.g., amitriptyline), phenothiazine derivatives,
• medicines that facilitate sleep - barbiturates.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Pregnancy: Do not take Acecor during the first trimester of pregnancy. Acecor may be used in pregnant women only if absolutely necessary and under close medical supervision. Breastfeeding: Do not take this medicine if you are breastfeeding. Acecor passes into breast milk.

Driving and Operating Machines

Acecor, like other beta-blockers, may cause dizziness and fatigue. If you experience these symptoms, do not drive or operate machines. Acecor contains lactose(33 mg in 1 tablet), which is a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Acecor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Take this medicine by mouth. Swallow the tablet with a small amount of water. It is recommended to take the medicine during a meal. Recommended dose: For high blood pressure: Treatment starts with a dose of 400 mg once a day. If necessary, your doctor may decide to increase the dose to 800 mg per day in 2 divided doses. The maximum daily dose is 1200 mg. For angina pectoris: Usually, a dose of 400 mg is taken once a day. In severe cases, your doctor may increase the dose to 800 mg per day, given in 2-4 divided doses. For heart rhythm disorders: Treatment starts with a dose of 200 mg; the maximum therapeutic effect is observed after about 3 hours. Usually, a sufficient daily dose is 400 mg. If necessary, your doctor may decide to increase the dose to 1200 mg per day, given in divided doses.

Use in Children and Adolescents

The dosage of Acecor has not been established in children and adolescents. In cases where it is necessary, your doctor may prescribe the smallest effective dose.

Use in Patients with Kidney Function Disorders

In patients with kidney function disorders, your doctor may change the dose.

Use in Elderly Patients

In elderly patients, if they have kidney function disorders or severe liver function disorders, your doctor may change the dose.

Overdose of Acecor

If you take more Acecor than you should, you may experience the following symptoms: weakness, dizziness, breathing difficulties or shortness of breath, symptoms of hypoglycemia (low blood sugar), and severe heart failure symptoms. Contact your doctor or go to the emergency department of the nearest hospital immediately, taking the package, remaining tablets, or leaflet with you.

Missed Dose of Acecor

Do not take a double dose to make up for a forgotten dose, but take the next dose at the usual time.

Stopping Treatment with Acecor

Do not stop taking this medicine without consulting your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effects are: heart failure, atrioventricular block, bronchospasm. Stop taking this medicine and contact your doctor immediately if you experience symptoms of hypersensitivity, such as rash, swallowing or breathing difficulties, swelling of the lips, face, throat, or tongue. The following side effects are listed according to their frequency. Very Common(may affect more than 1 in 10 people):

• fatigue,
• gastrointestinal disorders,
• positive antinuclear antibody test. Common(may affect up to 1 in 10 people):
• shortness of breath,
• rash,
• depression, nightmares,
• dizziness, headache,
• nausea, diarrhea,
• vision disorders. Uncommon(may affect up to 1 in 100 people):
• lupus-like syndrome. Frequency Not Known(cannot be estimated)
• heart failure, first-degree atrioventricular block, worsening of existing atrioventricular block, slow heart rate (bradycardia),
• psychosis, hallucinations, confusion, decreased libido, sleep disorders,
• paresthesia (sensory disturbances in the form of tingling or numbness), central nervous system disorders,
• dry eyes,
• intermittent claudication (difficulty walking that requires frequent rest), Raynaud's syndrome (blue discoloration and coldness of the hands and feet), hypotension,
• pneumonitis, pulmonary infiltrates, bronchospasm (difficulty breathing),
• vomiting,
• withdrawal syndrome (symptoms resulting from too rapid discontinuation of the medicine).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Acecor

Store below 25°C. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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. Contents of the Pack and Other Information

What Acecor Contains

The active substance of the medicine is acebutolol hydrochloride. One film-coated tablet contains 444 mg of acebutolol hydrochloride, equivalent to 400 mg of acebutolol. The other ingredients are: lactose, cornstarch, povidone, magnesium stearate, talc, silica colloidal anhydrous, hypromellose, titanium dioxide, propylene glycol.

What Acecor Looks Like and Contents of the Pack

Acecor is a white, round, biconvex tablet with a score line. The packaging of the medicine is PVC/PVDC/Alu blisters in a cardboard box. The pack contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SPA – Societa Prodotti Antibiotici S.p.A. Via Biella 8, 20143 Milan, Italy

Manufacturer:

Doppel Farmaceutici S.r.l. Via Volturno 48, Quito de Stampi, Rozzano (MI) Italy

Representative of the Marketing Authorization Holder:

Angelini Pharma Polska Sp. z o.o. ul. Podleśna 83; 05-552 Łazy tel.: (22) 70 28 200 e-mail: [email protected] The patient leaflet in a format suitable for the blind and visually impaired is available at the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: