BETALOC 95 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Betaloc ZOK 100 (Betaloc ZOK)
4. 95 mg, prolonged-release tablets
   1. Before taking the drug, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Betaloc ZOK 100 and what is it used for
6. Important information before taking Betaloc ZOK 100
   1. When not to take Betaloc ZOK 100
   2. Warnings and precautions
   3. Betaloc ZOK 100 and other drugs
   4. Betaloc ZOK 100 with food, drink, or alcohol
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Betaloc ZOK 100 contains sodium
7. How to take Betaloc ZOK 100
   1. Taking a higher dose of Betaloc ZOK 100 than recommended
   2. Missing a dose of Betaloc ZOK 100
8. Possible side effects
   1. Very common (may occur in at least 1 in 10 patients)
   2. Common (may occur in less than 1 in 10 patients)
   3. Uncommon (may occur in less than 1 in 100 patients)
   4. Rare (may occur in less than 1 in 1000 patients)
   5. Very rare (may occur in less than 1 in 10,000 patients)
   6. Conditions that may worsen
   7. Reporting side effects
9. How to store Betaloc ZOK 100
10. Contents of the packaging and other information
    1. What Betaloc ZOK 100 contains
    2. What Betaloc ZOK 100 looks like and what the packaging contains
    3. Marketing authorization holder in Lithuania, in the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import license number: 44/18

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. 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 drug.

Before taking the drug, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Betaloc ZOK 100 and what is it 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 packaging and other information

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

Betaloc ZOK 100 contains the active substance metoprolol, which belongs to a group of drugs called beta-adrenergic blockers.
Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion.
This leads to a slowing of heart rate (reduction of heart rate).
Betaloc ZOK 100 is used in the treatmentof:

• high blood pressure (hypertension) to lower blood pressure and reduce the risk of complications (such as heart attack or stroke) and death (including sudden death) from cardiovascular causes,
• chest pain caused by insufficient blood supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow down the heart rate,
• palpitations (awareness of heart rate) due to non-organic (functional) heart disorders,
• chronic heart failure (with symptoms such as shortness of breath and swelling of the ankles), in combination with other heart failure medications, to increase survival, reduce hospitalization, improve left ventricular function, and improve quality of life.

Betaloc ZOK 100 is used in the preventionof:

• another heart attack or sudden death after the acute phase of a heart attack,
• migraine attacks.

Betaloc ZOK 100 is used to treat high blood pressure (hypertension) in children and adolescents aged 6 to 18 years.

2. Important information before taking Betaloc ZOK 100

When not to take Betaloc ZOK 100

• if the patient is allergic to metoprolol tartrate or any of the other ingredients of this drug (listed in section 6),
• if the patient is allergic to other beta-adrenergic blockers, such as atenolol, propranolol,
• if the patient has:
• cardiogenic shock,
• sick sinus syndrome (unless a pacemaker is implanted),
• second- or third-degree atrioventricular block,
• uncontrolled heart failure (shortness of breath, swelling of the ankles),
• bradycardia (heart rate below 45 beats per minute),
• very low blood pressure that may cause fainting,
• severe peripheral circulatory disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute myocardial infarction, if heart rate is less than 45 beats per minute, PQ interval is longer than 0.24 seconds, or systolic blood pressure is less than 100 mmHg,
• if the patient is taking (short- or long-term) drugs with positive inotropic effects, stimulating beta-adrenergic receptors.

Warnings and precautions

Before starting treatment with Betaloc ZOK 100, the patient should discuss it with their doctor. The patient should inform their doctor if they have:

• asthma, wheezing, or other respiratory disorders or allergic reactions, such as to insect bites, food, or other substances. If the patient has ever had an asthma attack or wheezing, they should not take this drug without consulting their doctor,
• chest pain caused by Prinzmetal's angina,
• circulatory disorders or heart failure,
• liver disease,
• first-degree atrioventricular block (conduction disorders in the heart),
• intermittent claudication (fatigue and weakness in one or both legs when walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic drugs),
• hyperthyroidism - Betaloc ZOK 100 may mask its symptoms,
• pheochromocytoma,
• psoriasis.

The patient should consult their doctor, even if the above warnings relate to past situations.
Before planned anesthesia, the patient should inform their dentist or anesthesiologist about taking Betaloc ZOK 100.
The patient should not suddenly stop taking Betaloc ZOK 100. If it is necessary to stop treatment, the drug should be discontinued gradually, if possible, over a period of at least two weeks, in decreasing doses, to half a 25 mg tablet per day, for at least four days before completely stopping the drug.

Betaloc ZOK 100 and other drugs

The patient should tell their doctor about all drugs they are currently taking or have recently taken, as well as any drugs they plan to take. This includes eye drops, injectable drugs, over-the-counter drugs, including herbal medicines and dietary supplements.
Some drugs may affect the action of other drugs. The patient should consult their doctor if they are taking any of the following drugs:

• Drugs used to treat cardiovascular diseases (such as digitalis/digoxin, calcium antagonists, antiarrhythmic drugs, sympathetic nerve blockers, hydralazine),
• Other drugs, such as monoamine oxidase inhibitors (MAOIs), inhaled anesthetics, antibiotics (rifampicin), drugs used to treat ulcers (cimetidine), anti-inflammatory drugs (e.g., indomethacin, celecoxib), some antidepressants and antipsychotics, antihistamines, other beta-adrenergic blockers (e.g., eye drops), and other substances (e.g., alcohol, some hormones),
• If the patient is taking clonidine and Betaloc ZOK 100 and it is necessary to stop clonidine treatment, Betaloc ZOK 100 should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 100 can be found in the "Warnings and precautions" section.
• If the patient is taking oral antidiabetic drugs, the doctor may change their dosage.

Betaloc ZOK 100 with food, drink, or alcohol

Consuming alcohol while taking metoprolol may enhance the effect of the drug.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this drug.
Pregnancy
Betaloc ZOK 100 should not be taken by pregnant women unless the benefits of its use outweigh the risks to the fetus. In general, beta-adrenergic blockers, including metoprolol, may cause fetal damage and premature birth.
If a woman taking Betaloc ZOK 100 becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Betaloc ZOK 100 should not be taken during breastfeeding unless the benefits of its use outweigh the risks to the breastfed child.

Driving and operating machinery

The patient should check their individual reaction to Betaloc ZOK 100, as some patients may experience dizziness or fatigue that impairs their physical and mental performance.

Betaloc ZOK 100 contains sodium

This drug contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Betaloc ZOK 100

This drug should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Tablets of Betaloc ZOK 100 (or their halves) should not be chewed or crushed. The tablets (or their halves) should be swallowed with a liquid.
Available are: Betaloc ZOK 25 (23.75 mg), Betaloc ZOK 50 (47.5 mg), Betaloc ZOK 100 (95 mg).
It is usually recommended to take Betaloc ZOK 100 once a day, with or without food. The doctor will inform the patient how and when to take the tablets.
Hypertension
Adults
The recommended dose of the drug for patients with mild to moderate hypertension is 50 mg once a day. If the response to the 50 mg dose is insufficient, the doctor may increase it to 100-200 mg once a day and (or) add another antihypertensive drug.
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 more than 50 mg, given once a day in the form of a tablet with a strength close to the estimated dose.
The doctor may increase the dose to 2 mg/kg body weight, depending on the achieved blood pressure values.
Betaloc ZOK 100 should not be taken by children under 6 years of age.
Angina pectoris
The recommended dose of the drug is 100-200 mg once a day. If necessary, the doctor may recommend Betaloc ZOK 100 in combination with other drugs used to treat 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 a day for the first 2 weeks of treatment. Patients with more severe heart failure may be advised by their doctor to take half a 25 mg tablet once a day for the first week of treatment. Then the doctor will double the dose every two weeks, up to a maximum dose of 200 mg once a day or the maximum dose tolerated by the patient.
Arrhythmias
The recommended dose of Betaloc ZOK 100 is 100-200 mg once a day.
Functional heart disorders with palpitations
The recommended dose is 100 mg once a day. If necessary, the doctor may increase the dose to 200 mg once a day.
Prevention of another myocardial infarction or sudden death after the acute phase of myocardial infarction
The recommended dose is 200 mg once a day.
Migraine prophylaxis
The recommended dose is from 100 mg to 200 mg once a day.
If the patient feels that the effect of Betaloc ZOK 100 is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Betaloc ZOK 100 than recommended

In case of taking a higher dose of Betaloc ZOK 100 than recommended, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital.
In case of significant overdose of the drug, the following symptoms may occur: slow or irregular heart rate, shortness of breath, swelling of the ankles, feeling of strong heartbeat, dizziness, fainting, pain or pressure in the chest, cool skin, weak pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missing a dose of Betaloc ZOK 100

The patient should not take a double dose to make up for a missed dose.
If a dose of Betaloc ZOK 100 is missed, and it has been less than 12 hours since the planned time of taking the dose, the patient should take the missed dose immediately. If the patient remembers the missed dose after 12 or more hours, they should skip the missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all drugs, Betaloc ZOK 100 may cause side effects, although not everyone will experience them.
The following side effects may occur when taking this drug.

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

• fatigue.

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

• dizziness,
• headache,
• slow heart rate; the patient should immediately inform their doctor, as they may reduce the dose of the drug or gradually discontinue it,
• palpitations,
• changes in blood pressure related to changes in body position (rarely with fainting),
• shortness of breath during exertion,
• nausea,
• abdominal pain,
• diarrhea,
• constipation,
• feeling of cold hands and feet.

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

• depression,
• insomnia,
• nightmares,
• concentration disorders,
• drowsiness,
• feeling of burning, tingling, or numbness (paresthesia),
• worsening of existing heart failure,
• conduction disorders in the heart, detected in ECG (first-degree atrioventricular block),
• sudden drop in blood pressure during a heart attack (cardiogenic shock),
• bronchospasm,
• vomiting,
• skin rash,
• increased sweating,
• muscle cramps,
• joint pain,
• edema,
• weight gain.

Rare (may occur in less than 1 in 1000 patients)

• nervousness,
• anxiety,
• vision disorders,
• dryness and (or) irritation of the eyes,
• conjunctivitis,
• conduction disorders in the heart, arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, and then redness of the fingers with accompanying numbness and pain (Raynaud's syndrome),
• rhinitis,
• dryness of the mucous membrane of the mouth,
• hair loss,
• erectile dysfunction (impotence),
• liver function disorders (detected in blood tests),
• positive antinuclear antibody titer (antibodies used in the diagnosis of connective tissue diseases).

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

• gangrene (tissue death) in patients with severe peripheral circulatory disorders,
• decreased platelet count, which may cause easy bruising,
• confusion,
• hallucinations,
• memory loss or disorders,
• taste disorders,
• tinnitus,
• worsening of intermittent claudication (leg pain when walking),
• hepatitis,
• photosensitivity,
• psoriasis exacerbation,
• joint pain.

Conditions that may worsen

The following conditions may worsen when taking this drug:

• shortness of breath, feeling of fatigue, or swelling of the ankles (in case of myocardial infarction). These are uncommon side effects, occurring in less than 1 in 100 people.
• psoriasis (skin disease), circulatory disorders. These are rare side effects, occurring in less than 1 in 10,000 people.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Betaloc ZOK 100

The drug should be stored in a place that is invisible and inaccessible to children.
Store at a temperature up to 30°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the given month. Do not take this drug if the packaging is damaged.
Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Betaloc ZOK 100 contains

• The active substance of the drug is metoprolol succinate.
• One tablet contains 95 mg of metoprolol succinate, which corresponds to 100 mg of metoprolol tartrate.
• The other ingredients of the drug 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 what the packaging contains

White or almost white, round tablets with a diameter of 10 mm, with a notch on one side, marked with "A/mS" on the other side. The notch line is intended to facilitate breaking the tablet only for easier swallowing, not for dividing the tablet into equal doses.
A HDPE bottle containing 30 tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, in the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian license number, in the country of export: LT/1/96/2252/006

Parallel import license number: 44/18

Date of leaflet approval:19.01.2023
[Information about the trademark]