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 taking this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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 heart failure medications, to increase survival, reduce hospitalization rates, improve left ventricular function, and improve 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 beta-adrenergic receptor blockers, 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, ankle swelling),
• 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 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 experienced an asthma attack or wheezing – this medicine should not be used 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 when walking),
• diabetes (your doctor may recommend changing the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 100 may mask its symptoms,
• phaeochromocytoma,
• psoriasis.

Consult your doctor, even if the above warnings refer 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 treatment needs to be discontinued,
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 the medicine.
Betaloc ZOK 100 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,
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), some 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 100 simultaneously and treatment with clonidine needs to be discontinued, Betaloc ZOK 100 should be withdrawn several 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
Drinking 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 100 should not be used during pregnancy unless the benefits outweigh the risks to the fetus. In general, beta-adrenolytic medicines, including metoprolol,
may harm the fetus and cause premature delivery.
If a woman treated with Betaloc ZOK 100 becomes pregnant, she should inform her doctor
as soon as possible.
Breastfeeding
Betaloc ZOK 100 should not be used during breastfeeding 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
psychomotor performance.
Betaloc ZOK 100 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Betaloc ZOK 100

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not chew or crush Betaloc ZOK 100 tablets (or their halves). Swallow the tablets (or their halves) whole with liquid.
Available in the market are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).
Betaloc ZOK 100 is usually taken once daily, with or without food. Your doctor will inform you 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 a 50 mg dose is inadequate, your doctor may increase the dose to 100–200 mg once daily and/or add another antihypertensive medicine.

Children and adolescents
For children and adolescents over 6 years of age, the dose depends on body weight. Your doctor will determine the appropriate dose.
The usual initial dose is 0.5 mg/kg body weight, not exceeding 50 mg, given once daily as a tablet with strength closest to the calculated dose.
Your doctor may increase the dose up to 2 mg/kg body weight depending on blood pressure response.
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, your doctor may prescribe Betaloc ZOK 100 in combination with other medicines used to treat angina pectoris.

Symptomatic chronic heart failure
Your doctor will determine the dose. The recommended initial dose is 1 tablet of 25 mg once daily for the first 2 weeks of treatment. For patients with more advanced heart failure, your doctor may recommend starting with half a 25 mg tablet once daily for the first week. Thereafter, your doctor will double the dose every two weeks until reaching a maximum dose of 200 mg once daily or the maximum 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, your doctor may increase the dose to 200 mg once daily.

Prevention of further myocardial infarction or sudden cardiac 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 you feel that the effect of Betaloc ZOK 100 is too strong or too weak, consult your doctor or pharmacist.

Taking more Betaloc ZOK 100 than prescribed
If you take more Betaloc ZOK 100 than prescribed, seek immediate medical advice from your 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 100
Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 100 and less than 12 hours have passed since the scheduled time, take the missed dose immediately. If you remember the missed dose after 12 hours or more, skip the missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may occur during treatment with this medicine.

Very common (may affect at least 1 in 10 people)

• fatigue.

Common (may affect less than 1 in 10 people)

• dizziness,
• headache,
• slowing of the heart rate; inform your doctor immediately, as the dose may need to be reduced or the medicine gradually discontinued,
• 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 affect less than 1 in 100 people)

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

Rare (may affect less than 1 in 1,000 people)

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

Very rare (may affect less than 1 in 10,000 people)

• gangrene (tissue necrosis) in patients with severe peripheral vascular disorders,
• reduced platelet count, which may lead to easy bruising,
• confusion,
• hallucinations,
• loss or disturbances of memory,
• 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 disorder), 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, pharmacist or nurse. 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
Tel: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Betaloc ZOK 100

The medicine should be stored in a place inaccessible and not visible to children.
Store at a temperature not exceeding 30°C.
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 in use. This will help protect the environment.

6. Contents of the package 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 silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide (E 171).

What Betaloc ZOK 100 looks like and contents of the pack
White or almost white, round tablets, 10 mm in diameter, with a score on one side and marked on the other side with "A/mS". The score line is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
HDPE bottle containing 30 tablets, in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or 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
S-151 85 Södertälje
Sweden
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia
Italy
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300,
50180 Utebo (Zaragoza)
Spain

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Lithuania, country of export: LT/1/96/2252/006
Parallel Import Authorisation Number: 44/18