Betaloc zok 100

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information in a foreign language!
Betaloc ZOK 100 (Betaloc ZOK)
95 mg, prolonged-release tablets
Metoprolol succinate
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, 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

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

Betaloc ZOK 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 activity (reduction in heart rate).
Betaloc ZOK 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 improve survival, reduce hospitalization rates, improve left ventricular function, and enhance quality of life.

Betaloc ZOK is used in prevention of:

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

Betaloc ZOK 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

When not to use Betaloc ZOK

• 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 blocking medicines, such as atenolol or 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, 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) treatment with positively inotropic agents stimulating β-adrenergic receptors.

Warnings and precautions
Before starting treatment with Betaloc ZOK, 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 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 during walking),
• diabetes (your doctor may recommend adjusting the dose of antidiabetic medicines),
• hyperthyroidism – Betaloc ZOK 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.
Do not suddenly stop treatment with Betaloc ZOK. If discontinuation of treatment is necessary, 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 the treatment.

Betaloc ZOK 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 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 for peptic ulcer disease (cimetidine), anti-inflammatory medicines (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other β-adrenergic receptor blocking medicines (e.g. eye drops), and other substances (e.g. alcohol, certain hormones).
• If the patient is taking clonidine and Betaloc ZOK simultaneously and treatment with clonidine needs to be discontinued, Betaloc ZOK should be withdrawn several days before stopping clonidine. Information on discontinuation of Betaloc ZOK is provided in the section "Warnings and precautions".
• If the patient is taking oral antidiabetic medicines, your doctor may adjust their dosage.

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

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

Driving and operating machinery
The patient should assess their individual response after taking Betaloc ZOK, as dizziness or fatigue may occur in some patients, which may impair psychomotor performance.

Betaloc ZOK 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

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist.

Available on the market are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).

Betaloc ZOK tablets (or their halves) must not be chewed or crushed. Tablets (or their halves) should be swallowed whole with liquid.

Betaloc ZOK 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 insufficient, the doctor may increase the dose 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 doctor will determine the appropriate dose.

The usual initial dose is 0.5 mg/kg body weight, not exceeding 50 mg, given once daily in the form of 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 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 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 advanced heart failure, the doctor will recommend taking half a 25 mg tablet once daily for the first week of treatment. The doctor will then 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 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 further 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 you feel that the effect of Betaloc ZOK is too strong or too weak, consult your doctor or pharmacist.

Taking more Betaloc ZOK than prescribed

If you take more Betaloc ZOK than prescribed, contact your doctor immediately 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

Do not take a double dose to make up for a missed dose.

If you miss a dose of Betaloc ZOK 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 experiences them.
The adverse reactions listed below may occur during treatment with this medicine.

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

• Fatigue.

Common (may affect less than 1 in 10 patients)

• 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,
• Diarrhea,
• Constipation,
• Cold sensation in hands and feet.

Uncommon (may affect less than 1 in 100 patients)

• Depression,
• Insomnia,
• Nightmares,
• Difficulty concentrating,
• Drowsiness,
• Burning, tingling or numbness sensation (paresthesia),
• Worsening of existing heart failure,
• Conduction disorders in the heart, detected on ECG (first-degree heart block),
• Sudden drop in blood pressure during heart attack (cardiogenic shock),
• Bronchospasm,
• Vomiting,
• Skin rash,
• Excessive sweating,
• Muscle cramps,
• Chest pain,
• Swelling (edema),
• Weight gain.

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

• Nervousness,
• Anxiety states,
• Visual disturbances,
• Dryness and/or irritation of the eyes,
• Conjunctivitis,
• Conduction disorders 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),
• Rhinitis,
• Dryness of the oral mucosa,
• Hair loss,
• Erectile dysfunction (impotence),
• Liver function disorders (detected in blood tests),
• Positive antinuclear antibody titer (antibodies used in diagnosing connective tissue diseases).

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

• Tissue necrosis (gangrene) 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 patients after myocardial infarction). These are uncommon adverse reactions, occurring in less than 1 in 100 people.
• Psoriasis (a skin condition), 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 Reactions to Medicinal Products, 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 to provide more information on the safety of the medicine.

5. How to store Betaloc ZOK

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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Betaloc ZOK 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, macrogol 6000, titanium dioxide (E 171)

What Betaloc ZOK looks like and contents of the pack

Betaloc ZOK 100
White or almost white, round tablets with a diameter of 10 mm, scored on one side and marked on the other side with "A/mS". The score line is intended to facilitate breaking the tablet for easier swallowing only, and is not intended to divide the tablet into equal doses.
HDPE bottle in a cardboard box containing 30 prolonged-release tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Romania, country of export:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 7136/2014/01
Parallel Import Licence Number: 301/22