Betaloc zok 50

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Betaloc ZOK 50 (Betaloc ZOK)
47.50 mg, prolonged-release tablets
Metoprololi succinas
Betaloc ZOK 50 and Betaloc ZOK 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, please 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 another person, 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.

Table of contents of the leaflet

1. What Betaloc ZOK 50 is and what it is used for
2. Important information before taking Betaloc ZOK 50
3. How to take Betaloc ZOK 50
4. Possible side effects
5. How to store Betaloc ZOK 50
6. Contents of the pack and other information

1. What Betaloc ZOK 50 is and what it is used for

Betaloc ZOK 50 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 slowing of heart function (reduction in heart rate).
Betaloc ZOK 50 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 cardiovascular death (including sudden death),
• 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 enhance quality of life.

Betaloc ZOK 50 is used in prevention of:

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

Betaloc ZOK 50 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 50

When not to use Betaloc ZOK 50

• 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 blocking agents, e.g. atenolol, propranolol.
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a cardiac pacemaker has been implanted),
• second- or third-degree atrioventricular block,
• uncontrolled 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 50, discuss this with your doctor. Inform your doctor if the patient has:

• bronchial asthma, wheezing or other similar breathing problems, 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 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 need to adjust the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 50 may mask its symptoms,
• phaeochromocytoma,
• psoriasis.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Before a planned anaesthesia, inform the dentist or anaesthesiologist that you are taking Betaloc ZOK 50.
Do not suddenly stop treatment with Betaloc ZOK 50. If treatment needs to be discontinued, the medicine should be withdrawn gradually, if possible, over a period of at least two weeks, reducing the dose stepwise down to half a 25 mg tablet once daily, maintained for at least four days before completely stopping.

Betaloc ZOK 50 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 disorders (such as digitalis glycosides/digoxin, calcium antagonists, antiarrhythmics, ganglion-blocking agents, hydralazine).
• Other medicines such as monoamine oxidase inhibitors (MAO inhibitors), inhaled anaesthetics, antibacterial agents (rifampicin), medicines used in peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic blocking agents (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK 50 simultaneously, and discontinuation of clonidine becomes necessary, Betaloc ZOK 50 should be withdrawn several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 50 is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, the doctor may adjust their dosage.

Betaloc ZOK 50 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 50 should not be used during pregnancy unless the benefits outweigh the risks to the fetus. In general, beta-adrenolytic agents, including metoprolol, may cause fetal harm and premature delivery.
If a woman treated with Betaloc ZOK 50 becomes pregnant, she should inform her doctor as soon as possible.

Breastfeeding
Betaloc ZOK 50 should not be used during breastfeeding unless the benefits outweigh the risks to the breastfed infant.

Driving and using machines
The patient should assess their individual response after taking Betaloc ZOK 50, as dizziness or fatigue may occur in some patients, which could impair psycho-physical performance.

Betaloc ZOK 50 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 50

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult your
physician or pharmacist.
The following products are available on the market: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc
ZOK 100 (95 mg).
Betaloc ZOK 50 tablets (or their halves) must not be chewed or crushed. Tablets (or their halves)
should be swallowed whole with liquid.
Betaloc ZOK 50 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 of the medicine in patients with mild to moderate hypertension is 50
mg once daily. If the response to the 50 mg dose is inadequate, your 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 with 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 50 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 50 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 1 tablet of 25 mg once daily for the first 2 weeks of treatment. In patients with more advanced heart failure, the doctor may recommend taking half a 25 mg tablet once daily during the first week of treatment. Then the doctor will double the dose every two weeks until reaching the maximum dose of 200 mg once daily or the maximum dose tolerated by the patient.

Cardiac arrhythmias
The recommended dose of Betaloc ZOK 50 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 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 mg to 200 mg once daily.

If you feel that the effect of Betaloc ZOK 50 is too strong or too weak, consult your doctor or pharmacist.

Taking more Betaloc ZOK 50 than prescribed
If you take more Betaloc ZOK 50 than prescribed, contact your doctor immediately or go to the emergency department of the nearest hospital.
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 50
Do not take a double dose to make up for a missed dose.
If you miss a dose of Betaloc ZOK 50 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 may 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 affect at least 1 in 10 people)

• fatigue

Common (may affect up to 1 in 10 people)

• dizziness,
• headache,
• slowing of heart rate; inform your doctor immediately, as the dose may need to be reduced or the treatment gradually discontinued,
• palpitations,
• changes in blood pressure related to changes 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 up to 1 in 100 people)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• burning, tingling, or numbness sensations (paraesthesia),
• worsening of existing heart failure,
• disturbances in cardiac conduction observed 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 affect up to 1 in 1,000 people)

• nervousness,

• anxiety states,

• visual disturbances,

• dryness and/or irritation of the eyes,

• conjunctivitis,

• disturbances in cardiac conduction, cardiac arrhythmias, worsening of pre-existing atrioventricular block,

• pallor, cyanosis, followed by redness of the fingers, accompanied by numbness and pain (Raynaud's phenomenon),

• rhinitis,

• dryness of the oral mucosa,

• hair loss,

• erectile dysfunction (impotence),

• liver function abnormalities (detected in blood tests),

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

Very rare (may affect up to 1 in 10,000 people)

• gangrene (tissue necrosis) 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, fatigue, or swelling around the ankles (in patients after myocardial infarction). These are uncommon adverse reactions, occurring in fewer than 1 in 100 people.
• psoriasis (a skin disorder), circulatory disturbances. These are rare adverse reactions, occurring in fewer than 1 in 10,000 people.

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

5. How to store Betaloc ZOK 50

Keep this medicine out of the sight and reach of children.
Store below 30°C 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Betaloc ZOK 50 contains

• The active substance is metoprolol succinate.
• One tablet contains 47.5 mg of metoprolol succinate, equivalent to 50 mg of metoprolol tartrate.
• Other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, macrogol 6000, titanium dioxide.

What Betaloc ZOK 50 looks like and contents of the pack
White or almost white, round tablets, 9 mm in diameter, with a score line on one side and marked on the other side with “A/mO”. The score line is intended to facilitate tablet swallowing and is not intended for dividing the tablet into equal doses.
HDPE bottle in a cardboard box.
30 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, country of export:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
I-20148 Milan
Italy
Manufacturer:
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 Utebo (Zaragoza)
Spain
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorisation number in Romania, country of export: 7135/2014/01
Parallel import licence number: 406/24