Acecor

Package leaflet: information for the patient

Acecor, 400 mg, coated tablets
Acetbutololum hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Acecor is and what it is 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 Acecor is and what it is used for

Acecor belongs to a group of medicines called beta-blockers. It contains the active substance
acebutolol, which acts primarily on receptors located in the heart, and has weaker effects
on receptors in blood vessel walls and bronchi.
Acecor is used in the treatment of hypertension, angina pectoris, and cardiac arrhythmias.

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 allergic reaction include: rash, difficulty breathing or swallowing, swelling of lips, face, throat, or tongue,
• if you have cardiogenic shock,
• if you have low blood pressure (100/60 mm Hg or lower),
• if you have second- or third-degree atrioventricular block,
• if you have sick sinus syndrome,
• if you have severe bradycardia, i.e. slowed heart function (less than 45–50 beats/min),
• if you have uncompensated heart failure,
• if you have metabolic acidosis, i.e. increased blood acidity,
• if you have severe peripheral circulatory disorders,
• if you have untreated phaeochromocytoma.

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

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

• kidney function disorders, especially severe renal failure – depending on the degree of impairment, your doctor may reduce the dose of this medicine,
• breathing difficulties, asthma, or obstructive respiratory diseases,
• stabilized heart failure treated with other medicines – if bradycardia occurs during treatment, your doctor may reduce the dose,
• chest pain known as Prinzmetal's angina,
• peripheral arterial disorders, as Acecor may worsen them,
• a disease caused by peripheral circulatory disorders, manifested by bluish discoloration and coldness of hands and feet,
• hyperthyroidism, as this medicine may mask its symptoms,
• diabetes, as this medicine may mask symptoms of low blood glucose (hypoglycaemia),
• phaeochromocytoma,
• psoriasis,
• allergies, 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, you should inform the doctor that you are taking
Acecor, as it may alter the effects of certain substances used in general anaesthesia, such as ether, cyclopropane, and trichloroethylene.
Like other beta-blocking agents, acebutolol should not be discontinued abruptly.
Acecor should be withdrawn gradually.
This is especially important for patients with ischaemic heart disease.

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

• medicines used for angina pectoris, especially verapamil or diltiazem,
• other medicines used for heart diseases, such as disopyramide, amiodarone, digoxin,
• insulin or oral glucose-lowering medicines, e.g. glibenclamide,
• clonidine, used for hypertension,
• medicines used for respiratory disorders, such as aminophylline, theophylline, salbutamol, or terbutaline,
• non-steroidal anti-inflammatory drugs used for pain relief, such as ibuprofen, naproxen, diclofenac, indomethacin, piroxicam,
• medicines used for depression, such as monoamine oxidase inhibitors, tricyclic antidepressants (e.g. amitriptyline), phenothiazine derivatives,
• sedatives – barbiturates.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy:
Acecor should not be used during the first trimester of pregnancy.
Acecor may be used in pregnant women only if strictly necessary and under close medical supervision.

Breastfeeding:
This medicine should not be used if you are breastfeeding. Acecor passes into breast milk.

Driving and operating machinery
Acecor, like other beta-blockers, may cause dizziness and fatigue.
If you experience these symptoms, do not drive or operate machinery.

Acecor contains lactose (33 mg per tablet), a type of sugar. If you have been diagnosed with intolerance to certain sugars, you should consult your doctor before using this medicine.

3. How to take Acecor

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally. Swallow the tablet with a small amount of water. It is recommended to take the medicine during a meal.

Recommended dose:

For hypertension:
Treatment starts with a dose of 400 mg once daily. If necessary, your doctor may decide to increase the dose to 800 mg daily, divided into two doses. The maximum daily dose is 1200 mg.

For angina pectoris:
The usual dose is 400 mg once daily. In particularly severe cases, your doctor may increase the dose to 800 mg daily, administered in 2 to 4 divided doses.

For cardiac arrhythmias:
Treatment starts with a dose of 200 mg; the maximum therapeutic effect is observed after about 3 hours. The usual effective daily dose is 400 mg.
If necessary, your doctor may decide to increase the dose to 1200 mg daily, given in divided doses.

Use in children and adolescents
The dosage of Acecor has not been established in children and adolescents. In necessary cases, the doctor may prescribe the lowest effective dose.

Use in patients with impaired kidney function
In patients with impaired kidney function, your doctor may adjust the dose.

Use in elderly patients
In elderly patients with impaired kidney or severe liver function, your doctor may adjust the dose.

Taking more Acecor than prescribed
If you take more Acecor than prescribed, the following symptoms may occur:
weakness, dizziness, breathing difficulties or shortness of breath, symptoms of hypoglycaemia (low blood glucose), and severe symptoms of heart failure.
Seek immediate medical attention or go to the nearest hospital emergency department, taking with you the medicine packaging, any remaining tablets, or this leaflet.

Missing a dose of Acecor
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions include: heart failure, atrioventricular block, bronchospasm.
You should stop taking this medicine and contact your doctor immediately if you experience symptoms of hypersensitivity such as rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
The following adverse reactions are listed according to their frequency of occurrence.
Very common (may occur in more than 1 in 10 people):

• fatigue,
• gastrointestinal disturbances,
• positive titer (presence) of antinuclear antibodies in blood. Common (may occur in less than 1 in 10 people):
• dyspnea,
• rash,
• depression, nightmares,
• dizziness, headache,
• nausea, diarrhea,
• visual disturbances. Uncommon (may occur in less than 1 in 100 people):
• lupus-like syndrome. Frequency unknown (cannot be estimated):
• heart failure, first-degree atrioventricular block, worsening of pre-existing atrioventricular block, slow heart rate (bradycardia),
• psychosis, hallucinations, confusion, decreased libido, sleep disorders,
• paresthesia (sensory disturbances such as tingling or numbness), central nervous system disturbances,
• dry eyes,
• intermittent claudication (difficulty walking requiring frequent rest), Raynaud's syndrome (bluish discoloration and coldness of hands and feet), hypotension,
• pulmonary inflammation, lung infiltrates, bronchospasm (difficulty breathing),
• vomiting,
• withdrawal syndrome (symptoms resulting from stopping the medicine too quickly).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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, e-mail: [email protected].
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Acecor

Store below 25°C.
Keep the 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 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 Acecor contains
The active substance is acebutolol hydrochloride. One coated tablet contains 444 mg of
acebutolol hydrochloride, equivalent to 400 mg of acebutolol.
The other ingredients are: lactose, maize starch, povidone, magnesium stearate, talc, colloidal anhydrous silica, 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 medicine is packaged in PVC/PVDC/Alu blisters, packed in a cardboard box.
The pack contains 30 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
ul. Podleśna 83; 05-552 Łazy
tel.: (22) 70 28 200
e-mail: [email protected]
representative of the Marketing Authorisation Holder.