Beto 50 zk

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Beto 50 ZK (Metoprolol HEXAL Z)
47.5 mg, prolonged-release tablets
Metoprololi succinas
Beto 50 ZK and Metoprolol HEXAL Z are different brand names of the same medicine.
Please read the entire leaflet carefully before using 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others.
This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet,
inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:

1. What Beto 50 ZK is and what it is used for
2. What you need to know before taking Beto 50 ZK
3. How to take Beto 50 ZK
4. Possible side effects
5. How to store Beto 50 ZK
6. Contents of the pack and other information

1. What Beto 50 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 50 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 50 ZK is used:
for the treatment of high blood pressure,
for the treatment of chest pain (angina pectoris),
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) strong 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 50 ZK

When not to use Beto 50 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 attacks of wheezing;
if the patient is in shock due to serious heart problems;
if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or rhythm disorders (sick sinus syndrome), except in patients with a permanently implanted cardiac pacemaker;
if the patient has severe circulatory problems (severe peripheral arterial disease);
if the patient has untreated or 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 abnormally acidic blood (so-called metabolic acidosis);
if the patient is taking any of the following medicines:
o monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression;
o verapamil and diltiazem (medicines used to reduce blood pressure);
o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

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 continuously or intermittently receiving medicines that increase the force of heart contractions;
they have a slow heart rate (less than 68 beats/min at rest before treatment);
their systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 50 ZK, consult your doctor or pharmacist if:
the patient has asthma, bronchitis, or lung function disorders;
the patient has heart or circulatory disorders (e.g. slow heart rate), as treatment with Beto 50 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 undergoing surgery requiring general anaesthesia. Inform the anaesthesiologist that the patient is taking Beto 50 ZK;
the patient has a hormone-secreting tumour of the adrenal gland (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic blocking agent 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 50 ZK is not recommended in children under 6 years of age.

Beto 50 ZK and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Beto 50 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 to treat 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 medicines.
Other medicines that reduce heart rate: concomitant use of fingolimod (a medicine used in adults, children and adolescents to treat relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart rate-lowering effect during the first days after starting fingolimod.
Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein used to treat metastatic kidney cancer) with beta-blockers may cause a pronounced 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 50 ZK, food, drink and alcohol
Beto 50 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol levels may reach higher values and decrease more slowly.
During treatment with Beto 50 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 50 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 disturbances in fetal development. Treatment with Beto 50 ZK should be discontinued 48 to 72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored by the doctor for 48 to 72 hours after birth.

Breastfeeding
Beto 50 ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding unless absolutely necessary. Although the occurrence of adverse effects is unlikely when recommended doses are used, the breastfed infant should be carefully monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).

Driving and operating machinery
During treatment with Beto 50 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that impairs the ability to drive, operate machinery, or work in potentially hazardous conditions. These symptoms may occur especially when alcohol is consumed concurrently or when switching from another medicine.

Beto 50 ZK contains glucose, monohydrate 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 50 ZK.

3. How to use Beto 50 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 to take them. The prescribed dose depends on the type of illness and its severity.
If your doctor has not advised otherwise, the usual dosage is 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 medicine to lower blood pressure.

Chest pain (angina pectoris)

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

Heart rhythm disorders, including rapid heartbeat (cardiac arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

• 190 mg of metoprol0l succinate once daily.

Unpleasant 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 first be stabilised with medicines usually used in heart failure treatment. The dose of Beto 50 ZK is then individually adjusted for each patient.

• The recommended starting 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 during the second week to 23.75 mg of metoprolol succinate once daily.
• The recommended starting 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.
• Afterwards, your doctor will 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 treatment 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 for the patient.
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 achieved. Doses above 190 mg daily have not been studied in children and adolescents.
Beto 50 ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by your doctor.
If you feel that the effect of Beto 50 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
No studies have been conducted in patients over 80 years of age, therefore your doctor will increase the dose particularly cautiously in such patients.

Beto 50 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 50 ZK than prescribed
Seek immediate medical advice 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 that it is clear which medicine has been taken and what treatment is required.

Symptoms of overdose
Symptoms that may occur following an overdose of Beto 50 ZK include:
dangerously low blood pressure, severe disturbances in heart function, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple skin discoloration), and death.
The first symptoms of overdose may appear between 20 minutes and 2 hours after taking Beto 50 ZK, and the effects of a significant overdose may last for several days.

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

Missed dose of Beto 50 ZK
Do not take a double dose to make up for a missed dose. Continue treatment as prescribed by your doctor.

Stopping Beto 50 ZK treatment
Before stopping or prematurely discontinuing treatment with Beto 50 ZK, consult your doctor.
Beto 50 ZK should not be stopped suddenly, but its dose should be gradually reduced. Abrupt discontinuation of beta-blockers may worsen symptoms of heart failure 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
• significant lowering of 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 disorders, nightmares, concentration disturbances
• abnormal sensations of tingling, pricking or numbness of the skin (paraesthesiae)
• transient worsening of symptoms of heart muscle weakness (with ankle and foot swelling), first-degree atrioventricular conduction block (first-degree atrioventricular block), chest pain (chest pain), poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchoconstriction (bronchospasm)
• skin rash (psoriasiform and dystrophic skin changes), excessive sweating
• muscle cramps

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

• worsening of diabetes without characteristic symptoms (silent 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 loss
• tissue necrosis in patients with severe peripheral circulatory disorders prior to treatment
• taste disturbances
• hepatitis
• photosensitivity with skin rash occurring 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 lipids, such as cholesterol or triglycerides
• worsening of symptoms in patients with intermittent claudication or with vasospastic disorders of the fingers and toes (Raynaud's phenomenon).

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, 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

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Beto 50 ZK

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and
cardboard box after “EXP”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Beto 50 ZK contains
Active substance: metoprolol succinate.
Each prolonged-release tablet contains 47.5 mg of metoprolol succinate, equivalent to
50 mg of metoprolol tartrate.
Other ingredients: sucrose granules: sucrose, corn starch, liquid glucose;
polyacrylate dispersion 30%; talc; magnesium stearate; microcrystalline cellulose (E 460);
crospovidone; colloidal anhydrous silica.
Coating: Opadry II: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 50 ZK looks like and contents of the pack
White, elongated tablets with a division line on both sides.
Prolonged-release tablets are packed in PP/Aluminium blisters or PVC/Aclar/Aluminium blisters in a cardboard box.
Blister packs:
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
HEXAL AG
Industriestrasse 25
D-83607 Holzkirchen
Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
LEK S.A.
ul. Domaniewska 50 c
02-672 Warsaw
Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

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

Marketing Authorisation Number in Latvia, country of export: 05-0090
Parallel Import Licence Number: 227/24