Betaloc zok 100

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaloc ZOK 100 (Betaloc ZOK)
95 mg, prolonged-release tablets
Metoprololi succinas
Betaloc ZOK 100 and Betaloc ZOK are different trade names for the same medicine.
Please read this leaflet carefully before using this 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 questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Betaloc ZOK 100 is and what it is used for
2. Important information before taking Betaloc ZOK 100
3. How to take Betaloc ZOK 100
4. Possible side effects
5. How to store Betaloc ZOK 100
6. Contents of the pack and other information

1. What Betaloc ZOK 100 is and what it is used for

Betaloc ZOK 100 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 psychological stress.
This results in a slower heart function (reduced heart rate).
Betaloc ZOK 100 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 down ventricular response,
• 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 enhance quality of life.

Betaloc ZOK 100 is used in prevention of:

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

Betaloc ZOK 100 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 100

When not to use Betaloc ZOK 100

• 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 β-adrenergic receptor blockers, such as atenolol or 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 β-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK 100, discuss this with your doctor. You should
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 had an asthma attack or wheezing – do not use this medicine without consulting a doctor,
• chest pain due to 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 the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 100 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 your dentist or anaesthesiologist that you are taking
Betaloc ZOK 100.
Do not suddenly stop treatment with Betaloc ZOK 100. 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 of a 25 mg tablet once daily, for at least four days before
completely stopping treatment.
Betaloc ZOK 100 and other medicines
Tell your doctor about all medicines currently used or recently used by the patient, as
well as medicines the patient plans to use. This includes eye drops, injectable medicines,
and over-the-counter medicines, 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 β-adrenergic receptor blockers (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 100 simultaneously and discontinuation of clonidine treatment is necessary, Betaloc ZOK 100 should be withdrawn a few days before stopping clonidine. Information on discontinuation of Betaloc ZOK 100 can be found in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, your doctor may adjust their dosage.

Betaloc ZOK 100 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 have a child, she should
consult her doctor before using this medicine.
Pregnancy
Betaloc ZOK 100 should not be used during pregnancy unless the benefits of treatment outweigh the risks to the fetus. In general, β-adrenolytic agents, including metoprolol, may cause fetal harm and premature delivery.
If a woman treated with Betaloc ZOK 100 becomes pregnant, she should inform her doctor as soon as possible.
Breast-feeding
Betaloc ZOK 100 should not be used during breast-feeding unless the benefits of treatment outweigh the risks to the breastfed child.
Driving and operating machinery
The patient should assess their individual response after taking Betaloc ZOK 100, as
some patients may experience dizziness or fatigue which may impair psycho-physical performance.
Betaloc ZOK 100 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 100

This medicine should always be used as directed by the doctor. If in doubt, consult a doctor or pharmacist.
The following are available on the market: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).
Betaloc ZOK 100 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed whole with liquid.
Betaloc ZOK 100 is usually taken once daily, with or without food. The doctor 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 inadequate, the doctor may increase it to 100–200 mg once daily and/or add another antihypertensive medicine.

Children and adolescents
In children and adolescents above the age of 6 years, the dose depends on the child's body weight. The doctor 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 strength closest to the calculated dose.
The doctor may increase the dose up to 2 mg/kg body weight depending on achieved blood pressure values.
Betaloc ZOK 100 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 doctor may prescribe Betaloc ZOK 100 in combination with other medicines used in the treatment of angina pectoris.

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

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

Functional cardiac disorders with palpitations
The recommended dose is 100 mg once daily. If necessary, the doctor 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 100 seems too strong or too weak, consult a doctor or pharmacist.

Taking more than the recommended dose of Betaloc ZOK 100
If more than the recommended dose of Betaloc ZOK 100 has been 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, weakly palpable pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missed dose of Betaloc ZOK 100
Do not take a double dose to make up for a missed dose.
If a dose of Betaloc ZOK 100 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 can cause adverse reactions, although not everyone experiences them.
Below is a list of adverse reactions that may occur during treatment with this medicine.

Very common (may occur in at least 1 out of 10 patients)

• fatigue.

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

• dizziness,
• headache,
• slowing of heart rate; inform your doctor immediately, as the doctor 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,
• cold sensation in hands and feet.

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

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• sensation of burning, tingling or numbness (paraesthesiae),
• worsening of existing heart failure,
• cardiac conduction disorders detected on ECG (first-degree heart 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 out of 1000 patients)

• nervousness,

• anxiety states,

• visual disturbances,

• dryness and/or eye irritation,

• conjunctivitis,

• cardiac conduction disorders, cardiac arrhythmias, worsening of existing atrioventricular block,

• pallor, cyanosis, followed by redness of the fingers with accompanying numbness and pain (Raynaud's syndrome),

• rhinitis,

• dryness of the oral mucosa,

• hair loss,

• erectile dysfunction (impotence),

• liver function disorders (detected in blood tests),

• positive antinuclear antibody titre (antibodies used in diagnosing connective tissue diseases).

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

• necrosis (tissue death) in patients with severe peripheral circulatory disorders,
• reduced 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 out of 100 people.
• psoriasis (a skin disease), circulatory disorders. These are rare adverse reactions, occurring in less than 1 out of 10,000 people.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betaloc ZOK 100

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Store in the original packaging.
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.
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. This will help protect the environment.

6. Contents of the pack and other information

What Betaloc ZOK 100 contains

• The active substance is metoprolol succinate.
• One tablet contains 95 mg of metoprolol succinate, equivalent to 100 mg of metoprolol tartrate.
• Other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, polyethylene glycol 6000, titanium dioxide.

What Betaloc ZOK 100 looks like and contents of the pack
White or almost white, round tablets with a diameter of 10 mm, with a score line on one side and marked "A/mS" on the other side. The score line is intended to facilitate swallowing and does not guarantee equal division of the tablet into halves.
HDPE bottle in a cardboard box.
30 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Lithuania, country of export:
Recordati Ireland Ltd
Raheens East, Ringaskiddy
Co. Cork, P43 KD30
Ireland

Manufacturer:
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 Utebo (Saragossa)
Spain
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
I-20148 Milan
Italy
Savio Industrial S.r.L.
Via Emilia, 21
27100 Pavia
Italy

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
Działkowa 56 Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/96/2252/006
Parallel Import Authorisation Number: 171/24