BETALOC 95 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Betaloc ZOK 25, 23.75 mg, prolonged-release tablets
3. Betaloc ZOK 50, 47.5 mg, prolonged-release tablets
4. Betaloc ZOK 100, 95 mg, prolonged-release tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Betaloc ZOK and what is it used for
6. Important information before taking Betaloc ZOK
   1. When not to take Betaloc ZOK
   2. Warnings and precautions
   3. Betaloc ZOK and other medicines
   4. Betaloc ZOK with food, drink, or alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Betaloc ZOK contains sodium
7. How to take Betaloc ZOK
   1. Taking a higher dose of Betaloc ZOK than recommended
   2. Missing a dose of Betaloc ZOK
8. Possible side effects
   1. Very common (may affect at least 1 in 10 people)
   2. Common (may affect less than 1 in 10 people)
   3. Uncommon (may affect less than 1 in 100 people)
   4. Rare (may affect less than 1 in 1000 people)
   5. Very rare (may affect less than 1 in 10,000 people)
   6. Conditions that may worsen
   7. Reporting side effects
9. How to store Betaloc ZOK
10. Contents of the packaging and other information
    1. What Betaloc ZOK contains
    2. What Betaloc ZOK looks like and what the pack contains
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Betaloc ZOK 25, 23.75 mg, prolonged-release tablets

Betaloc ZOK 50, 47.5 mg, prolonged-release tablets

Betaloc ZOK 100, 95 mg, prolonged-release tablets

Metoprolol succinate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Betaloc ZOK contains the active substance metoprolol, which belongs to a group of medicines called beta-blockers.
Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion.
This leads to a slowing of the heart rate (reduction of 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 heart attack or stroke) and death (including sudden death) from cardiovascular causes,
• chest pain (angina pectoris) caused by insufficient blood supply to the heart,
• irregular heart rhythm (arrhythmia), especially supraventricular tachycardia, ventricular extrasystoles, and atrial fibrillation, to slow down the heart rate,
• palpitations (awareness of heart action) 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 is used in the prevention of:

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

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

2. Important information before taking Betaloc ZOK

When not to take 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 beta-adrenergic blocking agents, 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, which may cause fainting,
• severe peripheral circulatory disorders,
• metabolic acidosis,
• untreated pheochromocytoma,
• suspected acute heart attack, if the heart rate is less than 45 beats per minute, the PQ interval is longer than 0.24 seconds, or the 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, the patient should discuss it with their doctor. The patient should inform their doctor if they have:

• asthma, wheezing, or other similar 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 medicine 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 (leg pain or cramping during walking),
• diabetes (the doctor may recommend changing the dose of antidiabetic drugs),
• hyperthyroidism - Betaloc ZOK may mask its symptoms,
• pheochromocytoma,
• psoriasis.

The patient should consult their doctor, even if the above warnings refer to past situations.
Before planned anesthesia, the patient should inform their dentist or anesthesiologist about taking Betaloc ZOK.
The patient should not suddenly stop taking Betaloc ZOK. If it is necessary to stop treatment, the medicine 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 medicine.

Betaloc ZOK and other medicines

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

• Medicines used to treat cardiovascular diseases (such as digitalis glycosides, calcium antagonists, antiarrhythmic drugs, drugs blocking sympathetic ganglia, hydralazine),
• Other medicines, such as monoamine oxidase inhibitors (MAOIs), inhaled anesthetics, antibiotics (rifampicin), medicines used to treat stomach ulcers (cimetidine), nonsteroidal anti-inflammatory drugs (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 and it is necessary to stop clonidine treatment, Betaloc ZOK should be discontinued a few days before stopping clonidine. Information on discontinuing Betaloc ZOK 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 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Betaloc ZOK should not be used in pregnant women, unless the benefits of its use outweigh the risks to the fetus. In general, beta-adrenergic blocking agents, including metoprolol, may cause fetal damage and premature birth.
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 its use outweigh the risks to the breastfed child.

Driving and using machines

The patient should check their individual reaction to Betaloc ZOK, as it may cause dizziness or fatigue that impairs psychophysical performance.

Betaloc ZOK contains sodium

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

3. How to take Betaloc ZOK

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Tablets of Betaloc ZOK (or their halves) should not be chewed or crushed. The tablets (or their halves) should be swallowed with a liquid.
It is usually recommended to take Betaloc ZOK 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 Betaloc ZOK 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 it 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 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 should not be used in children under 6 years of age.
Angina pectoris
The recommended dose of Betaloc ZOK is 100-200 mg once daily. If necessary, the doctor may prescribe Betaloc ZOK in combination with other medicines 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 daily 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 daily 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 daily or the maximum tolerated dose by the patient.
Arrhythmias
The recommended dose of Betaloc ZOK is 100-200 mg once daily.
Functional heart 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 another heart attack or sudden death after the acute phase of a heart attack
Prevention of another heart attack
The recommended dose is 200 mg once daily.
Migraine prophylaxis
The recommended dose is 100-200 mg once daily.
If the patient feels that the effect of Betaloc ZOK is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Betaloc ZOK than recommended

In case of taking a higher dose of Betaloc ZOK than recommended, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital.
In case of significant overdose, 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, cold skin, weak pulse, confusion, anxiety, cardiac arrest, partial or complete loss of consciousness/coma, nausea, vomiting, and cyanosis.

Missing a dose of Betaloc ZOK

The patient should not take a double dose to make up for a missed dose.
If the patient misses a dose of Betaloc ZOK and it has been less than 12 hours since the planned time of taking the dose, they 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 medicines, Betaloc ZOK can cause side effects, although not everybody gets them.
The following side effects 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,
• slow heart rate; the patient should immediately inform their doctor, as they may reduce the dose of the medicine 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 affect less than 1 in 100 people)

• 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 the ECG (first-degree atrioventricular block),
• severe 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 affect less than 1 in 1000 people)

• Anxiety,
• fear,
• vision disorders,
• dryness and (or) irritation of the eyes,
• conjunctivitis,
• conduction disorders in the heart, arrhythmias, worsening of existing atrioventricular block,
• pallor, cyanosis, and subsequent 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 antibodies (antibodies used in the diagnosis of connective tissue diseases).

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

• 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 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 of the ankles (in case of a heart attack). 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 side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Betaloc ZOK

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 30°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton after: Expiry date (EXP:). The expiry date refers to the last day of the month.
Do not take this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Betaloc ZOK contains

• The active substance of the medicine is metoprolol succinate.
• One tablet contains 23.75 mg, 47.5 mg, or 95 mg of metoprolol succinate, which corresponds to 25 mg, 50 mg, or 100 mg of metoprolol tartrate.
• The other ingredients of the medicine are: ethylcellulose, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, paraffin, macrogol (6000), titanium dioxide.

What Betaloc ZOK looks like and what the pack contains

Betaloc ZOK 25
White or almost white, oval tablets with dimensions of 5.5 mm x 10.5 mm, with a notch on both sides, marked with "A/β" on one side. The tablet can be divided into equal doses.
Betaloc ZOK 50
White or almost white, round tablets with a diameter of 9 mm, with a notch on one side, marked with "A/mO" on the other side. The notch is designed to facilitate breaking the tablet only for easier swallowing, not for dividing the tablet into equal doses.
Betaloc ZOK 100
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 is designed to facilitate breaking the tablet only for easier swallowing, not for dividing the tablet into equal doses.
PVC/PVDC/Al blisters in a cardboard box. Blisters with day-of-the-week markings.
28 tablets - 2 blisters of 14 tablets each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milan
Italy

Manufacturer

AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milan
Italy
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia (PV)
Italy
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel: +48 22 206 84 50

Date of last revision of the leaflet:

"Betaloc ZOK" is a trademark owned by the AstraZeneca group of companies.