Betaloc zok 100

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging 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 you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, 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 adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of 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 rate (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 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 down 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 heart failure medications, to improve survival, reduce hospitalization rates, enhance left ventricular function, and improve quality of life.

Betaloc ZOK 100 is used in the 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,
• 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 acute 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. 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 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 need to adjust 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 abruptly stop treatment with Betaloc ZOK 100. If discontinuation 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, and continuing at this dose for at least four days before completely stopping.

Betaloc ZOK 100 and other medicines
Tell your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use. 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 for 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 100 simultaneously, and discontinuation of clonidine becomes necessary, Betaloc ZOK 100 should be discontinued several days before stopping clonidine. Information on discontinuation of Betaloc ZOK 100 is provided 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 become pregnant, 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, beta-adrenolytic medicines, 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.

Breastfeeding
Betaloc ZOK 100 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 100, as dizziness or fatigue may occur in some patients, which may impair mental and 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 taken exactly as directed by the physician. In case of doubt, consult a doctor 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 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 adults with mild to moderate hypertension is 50 mg once daily. If the response to the 50 mg dose is inadequate, 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 above 6 years of age, the dose depends on 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 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 blood pressure response.

Betaloc ZOK 100 should not be used in children below 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 1 tablet of 25 mg once daily for the first 2 weeks of treatment. For patients with more severe heart failure, the doctor may recommend starting with 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 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 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 have taken more Betaloc ZOK 100 than prescribed, 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, swelling around the ankles, 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 patients)

• fatigue.

Common (may affect less than 1 in 10 patients)

• dizziness,
• headache,
• slowing of 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 patients)

• depression,
• insomnia,
• nightmares,
• difficulty concentrating,
• drowsiness,
• sensation of burning, tingling or numbness (paraesthesiae),
• worsening of existing heart failure,
• disturbances in cardiac conduction, 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,
• chest pain,
• oedema,
• weight gain.

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

• restlessness,
• anxiety states,
• visual disturbances,
• dryness and/or irritation of the eyes,
• conjunctivitis,
• disturbances in cardiac conduction, cardiac arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, followed by redness of the fingers with accompanying 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 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,
• loss or disturbances of memory,
• taste disturbances,
• tinnitus,
• worsening of intermittent claudication (leg pain while 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 case 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 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 provide more information on the safety of this medicine.

5. How to store Betaloc ZOK 100

Keep this medicine out of 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 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.
• The other ingredients are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, paraffin, macrogol 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 on one side and marked "A/mS" on the other side. The score line is intended to facilitate breaking the tablet for easier swallowing only, and not for dividing the tablet into equal doses.

HDPE bottle containing 30 tablets, in a cardboard box.

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

Marketing Authorisation Holder in Romania, the 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

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
Poland

Marketing Authorisation Number in Romania, the country of export: 7136/2014/01
Parallel Import Authorisation Number: 69/25