Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Beto 150 ZK (MetoHEXALSucc 142.5 mg)
142.5 mg, prolonged-release tablets
Metoprolol succinate
Beto 150 ZK and MetoHEXALSucc 142.5 mg are different trade names for the same medicine.
Please read this leaflet carefully before using 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, 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Beto ZK is and what it is used for
Important information before taking Beto ZK
How to take Beto ZK
Possible side effects
How to store Beto ZK
Contents of the pack and other information

1. What Beto ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto ZK, blocks certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto ZK is used:
for the treatment of high blood pressure,
for the treatment of chest pain (angina),
for the treatment of heart rhythm disorders, including rapid heartbeat,
for prophylaxis following the acute phase of myocardial infarction,
in cases of unpleasant sensation of irregular and (or) forceful heartbeat,
for the prevention of migraine,
for the treatment of heart failure.
In children and adolescents aged 6 to 18 years:

for the treatment of high blood pressure (hypertension).

2. Important information before using Beto ZK

When not to use Beto ZK

if the patient is allergic to metoprolol succinate or to any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to other beta-blocking agents;
if the patient has severe asthma or severe wheezing attacks;
if the patient is in shock due to severe heart problems;
if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or rhythm disorders (sick sinus syndrome), except in patients with a pacemaker implanted;
if the patient has serious circulatory problems (severe peripheral arterial disease);
if the patient has untreated and uncontrolled heart failure (a condition usually causing breathlessness and swelling around the ankles);
if the patient has a slow heart rate (<50 beats/min at rest before treatment);
if the patient has very low blood pressure (systolic pressure <90 mmHg);
if the patient has an abnormally high level of acidity in the blood (so-called metabolic acidosis);
if the patient is taking any of the following medicines:
- monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression;
- verapamil and diltiazem – medicines used to reduce blood pressure;
- antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heart rhythm).

Metoprolol must not be used in patients with chronic heart failure if:

they have unstable, uncompensated heart failure (which may manifest as fluid accumulation in the lungs, poor circulation, or low blood pressure);
they are receiving or have recently received medicines that increase the force of heart contractions;
they have a slow heart rate (less than 68 beats/min at rest before treatment);
systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting Beto ZK, consult your doctor or pharmacist if:

the patient has asthma, bronchitis, or lung function disorders;
the patient has heart or circulation problems (e.g. slow heart rate); treatment with Beto ZK may worsen these conditions;
the patient has diabetes;
the patient has thyroid disorders;
the patient has severe liver disease;
the patient has ever experienced a severe allergic reaction to any allergen;
the patient has a rare form of angina called Prinzmetal's angina;
the patient is scheduled for surgery requiring general anaesthesia. Inform the anaesthetist that the patient is taking Beto ZK;
the patient has a hormone-secreting tumour of the adrenal gland (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor blocker is required;
the patient has psoriasis.

Use of metoprolol may lead to positive results in anti-doping tests.

Children and adolescents
Experience with treatment in children under 6 years of age is limited. Use of Beto ZK is not recommended in children under 6 years of age.

Beto ZK and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Beto ZK interacts with many other medicines.

Medicines used to treat high blood pressure (including prazosin, clonidine, hydralazine, guanethidine, betanidine, reserpine, alpha-methyldopa, and so-called calcium antagonists such as verapamil, diltiazem, or nifedipine).
Other beta-blocking agents (including those contained in eye drops).
Medicines affecting peripheral blood circulation (in fingers and toes), such as ergot alkaloids (used in the treatment of migraine).
Medicines used to treat depression.
Medicines used to treat other psychiatric disorders.
Antiretroviral medicines used in the treatment of AIDS and certain other diseases.
Antihistamines (including over-the-counter medicines used to treat hay fever and other allergies, colds, and other conditions).
Medicines used to prevent malaria.
Medicines used to treat fungal infections.
Medicines affecting liver enzyme activity, such as rifampicin used to treat tuberculosis.
Medicines used to treat heart disorders (including angina), such as amiodarone, digoxin, nitrates, and antiarrhythmic agents.
Other medicines that reduce heart rate: concomitant use of fingolimod (a medicine used in adults, children, and adolescents for the treatment of relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart rate-lowering effect during the first days of fingolimod treatment.
Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein used in the treatment of metastatic kidney cancer) with beta-blockers may result in an enhanced blood pressure-lowering effect.
Insulin and other antidiabetic medicines.
Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
Local anaesthetics containing lidocaine.
A medicine called dipyridamole, used to prevent blood clots.

Beto ZK, food, drink, and alcohol
Beto ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto ZK, alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Beto ZK may be used during pregnancy only if clearly indicated and after careful evaluation by the doctor of the benefit-risk ratio. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to fetal developmental disorders. Treatment with Beto ZK should be discontinued 48 to 72 hours before the expected delivery date. If this is not possible, the newborn should be closely monitored by a doctor for 48 to 72 hours after birth.

Breastfeeding
Beto ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding unless absolutely necessary. Although adverse effects are unlikely when recommended doses are used, breastfed infants should be closely observed for possible drug-related symptoms (e.g. the doctor will monitor heart function).

Driving and operating machinery
During treatment with Beto ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that impairs the ability to drive vehicles, operate machinery, or work under potentially hazardous conditions. These symptoms may be particularly likely when alcohol is consumed concurrently or when switching from one medicine to another.

Beto ZK contains glucose, lactose, and sucrose (sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Beto ZK.

3. How to use Beto ZK

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take and when. The prescribed dose depends on the type and severity of the condition.

Unless otherwise advised by your doctor, the usual dosages are as follows:

High blood pressure (hypertension)

Patients with mild to moderate hypertension should take 47.5 mg of metoprolol succinate once daily.
If necessary, your doctor may increase the dose to 95–190 mg of metoprolol succinate once daily, or add another antihypertensive medicine.

Chest pain (angina pectoris)

95–190 mg of metoprolol succinate once daily.
If necessary, your doctor may add another medicine used in the treatment of ischemic heart disease.

Heart rhythm disorders, including rapid heartbeat (arrhythmias)

95–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

190 mg of metoprolol succinate once daily.

Uncomfortable sensation of irregular and/or forceful heartbeat (palpitations)

95 mg of metoprolol succinate once daily.
If necessary, your doctor may increase the dose to 190 mg of metoprolol succinate once daily.

Prevention of migraine

95–190 mg of metoprolol succinate once daily.

Heart muscle weakness (heart failure)
Before starting treatment for heart muscle weakness, the patient's condition must be stabilized with medicines typically used in heart failure therapy. The dose of Beto ZK should then be individually adjusted.

The recommended initial dose during the first week for patients with heart muscle weakness (classified as NYHA class III–IV heart failure) is 11.88 mg of metoprolol succinate once daily.
Your doctor may increase the dose in the second week to 23.75 mg of metoprolol succinate once daily.
The recommended initial dose during the first 2 weeks for patients with heart muscle weakness (classified as NYHA class II heart failure) is 23.75 mg of metoprolol succinate once daily.
Your doctor will then double the dose. The dose may be doubled every two weeks until reaching 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.
The recommended dose for long-term maintenance therapy is 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.

Use in children and adolescents
High blood pressure:
In children aged 6 years and older, the dose depends on body weight. Your doctor will determine the appropriate dose.
The usual starting dose of metoprolol succinate is 0.48 mg/kg body weight once daily, but not exceeding 47.5 mg. The dose should be adjusted to the nearest available tablet strength. Your doctor may increase the dose up to 1.9 mg/kg body weight, depending on the blood pressure response. Doses above 190 mg daily have not been studied in children and adolescents.
Beto ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Studies have not been conducted in patients over 80 years of age, so your doctor will increase the dose with particular caution in such patients.

Beto ZK is intended for oral administration.
Tablets should be taken once daily, preferably with breakfast. Tablets may be divided into equal doses. They may be swallowed whole or divided, but should not be chewed or crushed. Tablets should be taken with water (at least ½ glass).

Taking more Beto ZK than prescribed
Seek immediate medical advice from your doctor or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the doctor will decide on the appropriate course of action.
Show the medicine packaging to the doctor so they know which medicine has been taken and what treatment is required.

Symptoms of overdose
Symptoms that may occur following overdose of Beto ZK include dangerously low blood pressure, severe heart function disturbances, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (bluish or violet skin discoloration), and death.
The first symptoms of overdose may appear between 20 minutes and 2 hours after taking Beto ZK, and the effects of a significant overdose may last for several days.

Treatment of overdose
The patient should be treated in a hospital, in an intensive care unit. Even patients who appear to be in good condition after a minor metoprolol overdose should be closely monitored by a doctor for at least 4 hours for signs of poisoning.

Missed dose of Beto ZK
Do not take a double dose to make up for a missed dose. Continue treatment as prescribed by your doctor.

Stopping treatment with Beto ZK
Before stopping or prematurely discontinuing treatment with Beto ZK, consult your doctor.
Do not stop taking Beto ZK abruptly, but gradually reduce the dose. Sudden discontinuation of beta-blockers may worsen heart failure symptoms and increase the risk of myocardial infarction and sudden cardiac death.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Very common (may affect more than 1 in 10 people):

feeling of fatigue

Common (may affect less than 1 in 10 people):

dizziness, headache
slow heart rate (bradycardia)
palpitations
marked decrease in blood pressure, especially when changing body position from lying down to standing, very rarely with loss of consciousness
coldness of hands and feet
breathing difficulties during exertion in predisposed patients (e.g. patients with asthma)
nausea, abdominal pain, diarrhoea, constipation

Uncommon (may affect less than 1 in 100 people):

weight gain
depression, drowsiness, sleep disturbances, nightmares, concentration difficulties
abnormal sensations of tingling, pricking or numbness of the skin (paraesthesiae)
transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular block (first-degree AV block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
bronchospasm (bronchoconstriction)
skin rash (psoriasiform or dystrophic skin changes), increased sweating
muscle cramps

Rare (may affect less than 1 in 1,000 people):

worsening of diabetes without characteristic symptoms (latent diabetes)
nervousness, blurred vision, dryness or irritation of the eyes (noticeable when wearing contact lenses), conjunctivitis
heart rhythm disorders (arrhythmia), conduction disturbances
nasal congestion
dry mouth
abnormal liver function test results
hair loss
impotence and libido disorders, Peyronie's disease (plastic induration of the penis)

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

reduced number of blood platelets (thrombocytopenia), reduced number of white blood cells (leukopenia)
forgetfulness or memory disturbances, confusion, hallucinations, personality changes (e.g. mood swings)
ringing in the ears (tinnitus), hearing impairment
tissue necrosis (necrosis) in patients with severe peripheral circulation disorders prior to treatment
taste disturbances
hepatitis
photosensitivity with skin rash after exposure to light, exacerbation of psoriasis symptoms, development of psoriasis
joint pain, muscle weakness

Frequency not known (frequency cannot be estimated from available data):

abnormal blood levels of certain types of fats, such as cholesterol or triglycerides
worsening of symptoms in patients with intermittent claudication or with vasospasm of blood vessels in fingers and toes (Raynaud's phenomenon).

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

5. How to store Beto ZK

Keep the medicine out of sight and reach of children.
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 store above 25°C.
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.

Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint

6. Contents of the pack and other information

What Beto 150 ZK contains
The active substance is metoprolol succinate.
The other ingredients are: sucrose, granules (sucrose, corn starch, glucose),
polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460),
crospovidone, colloidal anhydrous silica.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 150 ZK looks like and contents of the pack
Beto 150 ZK tablets are white, elongated, with two score lines on both sides.
Blister packs made of PP/Aluminum foil in a cardboard box.
Pack size: 30 prolonged-release tablets.

For further information, please contact the responsible party or the parallel importer.

Responsible party in Germany, country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Poland
IVA Pharm Sp. z o.o.
Drawska 14/1
02-202 Warsaw
Poland
CANPOLAND JOINT STOCK COMPANY
Beskidzka 190
91-610 Łódź
Poland
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

German marketing authorization number (country of export): 61494.03.00
Parallel import authorization number: 12/19

Beto 150 zk