Betaloc zok 25

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Betaloc ZOK 25 (SELOZOK 25)
23.75 mg, prolonged-release tablets
Metoprolol succinate
Betaloc ZOK 25 and SELOZOK 25 are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Betaloc ZOK 25 is and what it is used for
2. Important information before taking Betaloc ZOK 25
3. How to take Betaloc ZOK 25
4. Possible side effects
5. How to store Betaloc ZOK 25
6. Contents of the pack and other information

1. What Betaloc ZOK 25 is and what it is used for

Betaloc ZOK 25 contains the active substance metoprolol, which belongs to a group of medicines called
beta-blockers.
Metoprolol reduces the effects of stress hormones on the heart during physical and emotional stress.
This results in a slower heart rate (reduced heart rate).
Betaloc ZOK 25 is used in the treatment of:

• high blood pressure (hypertension), to lower blood pressure and reduce the risk of complications (such as myocardial infarction or stroke) and death (including sudden cardiac death) due to cardiovascular causes,
• chest pain caused by insufficient oxygen supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow ventricular rate,
• palpitations (awareness of heartbeat) due to non-organic (functional) heart disorders,
• chronic heart failure (with symptoms such as breathlessness and ankle swelling), in combination with other medicines used in heart failure, to increase survival, reduce hospitalization rates, improve left ventricular function, and improve quality of life.

Betaloc ZOK 25 is used in preventing:

• recurrence of myocardial infarction or sudden death after the acute phase of myocardial infarction,
• migraine attacks.

Betaloc ZOK 25 is used in the treatment of high blood pressure (hypertension) in children and adolescents aged 6 to 18 years.

2. Important information before using Betaloc ZOK 25

When not to use Betaloc ZOK 25

• if the patient is allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other beta-adrenergic receptor blocking agents, e.g. atenolol, propranolol.
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker has been implanted),
• second- or third-degree atrioventricular block,
• decompensated heart failure (shortness of breath, swelling around the ankles),
• bradycardia (slowed heart rate below 45 beats per minute),
• very low blood pressure which may cause fainting,
• severe peripheral arterial circulatory disorders,
• metabolic acidosis,
• untreated phaeochromocytoma,
• suspected recent myocardial infarction, if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 s, or systolic blood pressure is less than 100 mmHg.
• if the patient is receiving (short- or long-term) drugs with positive inotropic action stimulating beta-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK 25, discuss this with your doctor. Inform your doctor if the patient has:

• bronchial asthma, wheezing or other similar breathing disorders, or allergic reactions, e.g. to insect venom, food, or other substances. If the patient has ever experienced an asthmatic attack or wheezing, do not use this medicine without consulting a doctor,
• chest pain caused by Prinzmetal's angina,
• circulatory disorders or heart failure,
• liver disease,
• first-degree heart block (conduction disturbances in the heart),
• intermittent claudication (tiring and weakening of one or both legs while walking),
• diabetes (your doctor may recommend adjusting doses of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 25 may mask its symptoms,
• phaeochromocytoma,
• psoriasis.

Consult your doctor, even if the above warnings relate to conditions that occurred
in the past.
Before planned anaesthesia, inform the dentist or anaesthesiologist that the patient is taking
Betaloc ZOK 25.
Do not suddenly stop treatment with Betaloc ZOK 25. If discontinuation of treatment is necessary,
the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, with
decreasing doses down to half a 25 mg tablet once daily, for at least four days before completely
stopping intake.

Betaloc ZOK 25 and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as
well as any medicines the patient plans to take. This includes eye drops, injectable medicines,
and medicines available without a prescription, including herbal remedies and dietary supplements.
Some medicines may affect the action of other medicines. Consult your doctor if the patient
is taking any of the following medicines:

• Medicines used to treat cardiovascular diseases (such as digitalis glycosides/digoxin, calcium antagonists, antiarrhythmics, ganglion-blocking agents, hydralazine).
• Other medicines such as monoamine oxidase inhibitors (MAO inhibitors), inhaled anaesthetics, antibacterial medicines (rifampicin), medicines used in peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic receptor blockers (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 25 simultaneously, and discontinuation of clonidine treatment becomes necessary, Betaloc ZOK 25 should be withdrawn several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 25 is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, the doctor may adjust their dosage.

Betaloc ZOK 25 with food, drink or alcohol
Consuming alcohol while taking metoprolol may enhance the effect of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should
consult her doctor before using this medicine.
Pregnancy
Betaloc ZOK 25 should not be used during pregnancy unless the benefits of treatment outweigh the risks to the fetus. In general, beta-adrenergic blocking agents, including metoprolol, may cause fetal harm and premature delivery.
If a woman treated with Betaloc ZOK 25 becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK 25 should not be used during breastfeeding unless the benefits of treatment outweigh the risks to the breastfed infant.

Driving and operating machinery
The patient should assess their individual response after taking Betaloc ZOK 25, as dizziness or fatigue may occur in some patients, impairing psycho-physical performance.

Betaloc ZOK 25 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Betaloc ZOK 25

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Tablets of Betaloc ZOK 25 (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed with liquid.
Betaloc ZOK 25 is usually taken once daily, with or without food. The physician will inform the patient how and when to take the tablets.

Hypertension
Adults
The recommended dose for patients with mild to moderate hypertension is 50 mg once daily. If the response to the 50 mg dose is insufficient, the physician may increase it to 100–200 mg once daily and/or add another antihypertensive medicine.

Children and adolescents
In children and adolescents over 6 years of age, the dose depends on the child's body weight. The physician will determine the appropriate dose.
The usual initial dose is 0.5 mg/kg body weight, not exceeding 50 mg, administered once daily as a tablet with strength closest to the calculated dose.
The physician may increase the dose up to 2 mg/kg body weight depending on the achieved blood pressure values.
Betaloc ZOK 25 should not be used in children under 6 years of age.

Angina pectoris
The recommended dose is 100–200 mg once daily. If necessary, the physician may prescribe Betaloc ZOK 25 in combination with other medicines used in the treatment of angina pectoris.

Symptomatic chronic heart failure
The dose will be determined by the physician. The recommended initial dose is 1 tablet of 25 mg once daily for the first 2 weeks of treatment. For patients with more severe heart failure, the physician will recommend taking half a 25 mg tablet once daily during the first week of treatment. The physician will then double the dose every 2 weeks until reaching the maximum dose of 200 mg once daily or the highest dose tolerated by the patient.

Cardiac arrhythmias
The recommended dose of Betaloc ZOK 25 is 100–200 mg once daily.

Functional cardiac disorders with palpitations
The recommended dose is 100 mg once daily. If necessary, the physician may increase the dose to 200 mg once daily.

Prevention of recurrent myocardial infarction or sudden death after the acute phase of myocardial infarction
The recommended dose is 200 mg once daily.

Migraine prophylaxis
The recommended dose is 100–200 mg once daily.

If the effect of Betaloc ZOK 25 seems too strong or too weak, consult a doctor or pharmacist.

Taking more Betaloc ZOK 25 than recommended
If more than the recommended dose of Betaloc ZOK 25 is taken, seek immediate medical advice from a doctor or go to the nearest hospital emergency department.
In case of significant overdose, the following symptoms may occur: slow or irregular heartbeat, shortness of breath, ankle swelling, sensation of strong heartbeat, dizziness, fainting, chest pain or tightness, cold skin, weak pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missed dose of Betaloc ZOK 25
Do not take a double dose to make up for a missed dose.
If a dose of Betaloc ZOK 25 is missed and less than 12 hours have passed since the scheduled time, the missed dose should be taken immediately. If the patient remembers the missed dose after 12 hours or more, the missed dose should be skipped. The next dose should be taken at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although they do not occur in everyone.
The adverse reactions listed below may occur during treatment with this medicine.
Very common (may occur in at least 1 in 10 patients)

• fatigue.

Common (may occur in less than 1 in 10 patients)

• dizziness,
• headache,
• slowing of the heart rate; you should inform your doctor immediately, as they may reduce the dose or gradually discontinue the medicine,
• palpitations,
• changes in blood pressure related to change in body position (very rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhoea,
• constipation,
• sensation of coldness in hands and feet.

Uncommon (may occur in less than 1 in 100 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling or numbness sensation (paraesthesiae),
• worsening of existing heart failure,
• cardiac conduction disturbances, detected on ECG (first-degree atrioventricular block),
• sudden drop in blood pressure during myocardial infarction (cardiogenic shock),
• bronchospasm,
• vomiting,
• skin rash,
• excessive sweating,
• muscle cramps,
• retrosternal pain,
• oedema,
• weight gain.

Rare (may occur in less than 1 in 1000 patients)

• restlessness,
• anxiety states,
• visual disturbances,
• dryness and (or) irritation of the eyes,
• conjunctivitis,
• cardiac conduction disturbances, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, followed by redness of the fingers, accompanied by numbness and pain (Raynaud's phenomenon),
• nasal mucosal inflammation,
• dryness of the oral mucosa,
• hair loss,
• erectile dysfunction (impotence),
• liver function disorders (detected in blood tests),
• positive antinuclear antibody titre (antibodies used in the diagnosis of connective tissue diseases).

Very rare (may occur in less than 1 in 10,000 patients)

• tissue necrosis (gangrene) in patients with severe peripheral circulatory disorders,
• decreased platelet count, which may lead to easy bruising,
• confusion,
• hallucinations,
• memory loss or memory disturbances,
• taste disturbances,
• tinnitus,
• worsening of intermittent claudication (leg pain during walking),
• hepatitis,
• photosensitivity,
• exacerbation of psoriasis,
• joint pain.

Conditions that may worsen
The following conditions may worsen during treatment with this medicine:

• shortness of breath, feeling of fatigue or swelling around the ankles (in cases of myocardial infarction). These are uncommon adverse reactions, occurring in less than 1 in 100 people.
• psoriasis (a skin disease), circulatory disorders. These are rare adverse reactions, occurring in less than 1 in 10,000 people.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Betaloc ZOK 25

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not take this medicine if the packaging is damaged.
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 Betaloc ZOK 25 contains

• The active substance is metoprolol succinate.
• One tablet contains 23.75 mg of metoprolol succinate, equivalent to 25 mg of metoprolol tartrate.
• Other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide.

What Betaloc ZOK 25 looks like and contents of the pack
White or almost white, oval tablets measuring 5.5 mm x 10.5 mm, with notches on both sides,
marked on one side with “A/β”. The tablet may be divided into equal doses.
PVC/PVDC/Al blisters in a cardboard box. Blister packs with days of the week marking.
28 tablets – 2 blisters containing 14 tablets each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, the country of export:
Recordati Ireland Ltd.
Raheens East
Ringaskiddy Co. Cork
Ireland
Manufacturer:
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia
Italy
AstraZeneca AB
Gartunavagen
SE-151 85 Sodertalje
Sweden
AstraZeneca GmbH
Tinsdaler Weg 183
D-22880 Wedel
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation number in Belgium, the country of export: BE 260294
Parallel import authorisation number: 17/22