Beto 50 zk

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is 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 trade names for the same medicine.
Please read this leaflet carefully before taking 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 questions, please 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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),
• for the treatment of heart rhythm disorders, including rapid heartbeat,
• for prophylaxis following the acute phase of myocardial infarction,
• in cases of unpleasant sensations of irregular and (or) forceful heartbeats,
• 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. 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 wheezing attacks;
• 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 an implanted cardiac pacemaker;
• if the patient has severe circulatory problems (e.g. 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 per minute at rest before treatment);
• if the patient has very low blood pressure (systolic blood pressure <90 mmHg);
• if the patient has abnormally high blood acidity (so-called metabolic acidosis);
• if the patient is taking any of the following medicines:
  • monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression;
  • verapamil or diltiazem (used to lower blood pressure);
  • antiarrhythmic medicines such as disopyramide (used to treat irregular heart rhythms).

Metoprolol should 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 drugs that increase the force of heart contractions;
• they have a slow heart rate (less than 68 beats per minute at rest before treatment);
• 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 circulation problems (e.g. slow heart rate), as treatment with Beto 50 ZK may worsen these conditions;
• the patient has diabetes;
• the patient has thyroid dysfunction;
• 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 anaesthesiologist about the use of 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 receptor blocker is necessary;
• 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.
The use of Beto 50 ZK is not recommended in children under 6 years of age.
Interaction of Beto 50 ZK with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 mental disorders.
• Antiretroviral medicines used in the treatment of AIDS and certain other diseases.
• Antihistamines (including over-the-counter medicines used for 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, e.g. rifampicin (used in the treatment of 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 lead to 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.
• The medicine dipyrithiamine, 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 concentration may rise to higher levels 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 baby, 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 expected benefits versus possible risks. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to impaired fetal development. Treatment with Beto 50 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 the doctor for 48 to 72 hours after birth.
Breastfeeding
Beto 50 ZK passes into breast milk.
Metoprolol succinate should not be used during breastfeeding unless absolutely necessary. Although adverse effects are unlikely at recommended doses, breastfed infants 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 impair reaction speed to an extent that may affect the ability to drive, operate machinery, or work under potentially hazardous conditions. These symptoms may occur especially when alcohol is consumed concurrently or when switching from one medicine to another.
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 directed by your doctor. If in doubt, consult your doctor or pharmacist.

The following products are available on the market: Beto 25 ZK (23.75 mg), Beto 50 ZK (47.5 mg), Beto 100 ZK (95 mg), Beto 150 ZK (142.5 mg), Beto 200 ZK (190 mg).

Your doctor will inform you how many tablets to take and when. The prescribed dose depends on the type and severity of the condition.

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 add another medicine used in the treatment of ischaemic heart disease.

Heart rhythm disorders, including rapid heartbeat (arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after heart attack

• 190 mg of metoprolol 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, it is necessary to stabilise the patient’s condition with medicines usually used in the treatment of heart failure. The dose of Beto 50 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 for the patient.

The usual initial 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 higher than 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 the 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 half a glass).

Taking more Beto 50 ZK than prescribed

Seek immediate medical advice or go to the nearest hospital emergency department. The doctor will decide on appropriate management based on the severity of poisoning symptoms.

Show the medicine packaging to the doctor so that it is clear which medicine has been taken and what action should be taken.

Symptoms of overdose

Symptoms that may occur following an overdose of Beto 50 ZK include: dangerously low blood pressure, severe heart dysfunction, 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 a hospital, preferably in an intensive care unit. Even patients who appear to be in relatively good condition after a minor metoprolol overdose should be closely observed by a doctor for at least 4 hours for 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 treatment with Beto 50 ZK

Before stopping or prematurely discontinuing treatment with Beto 50 ZK, consult your doctor.

Do not stop taking Beto 50 ZK suddenly, but gradually reduce the dose. Abrupt discontinuation of beta-blockers may worsen symptoms of heart failure and increase the risk of heart attack and sudden cardiac death.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, 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 during change of body position from lying to standing, very rarely with loss of consciousness
• cold 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, difficulty concentrating
• abnormal sensations of tingling, pricking, or numbness of the skin (paresthesia)
• transient worsening of symptoms of heart muscle weakness (with ankle and foot swelling), first-degree atrioventricular conduction block (AV block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• respiratory tract constriction (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 (latent diabetes)
• nervousness
• blurred vision, dryness or irritation of the eyes (noticeable during contact lens use), 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 platelet count (thrombocytopenia), reduced white blood cell count (leukopenia)
• forgetfulness or memory disorders, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing loss
• tissue necrosis (necrosis) in patients with severe peripheral circulation disorders prior to treatment
• taste disturbances
• hepatitis
• photosensitivity with skin rashes appearing 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 blood vessels in the fingers of hands and feet (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions
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
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store the medicine Beto 50 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.
• Store below 25°C. Keep 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 in use. This will 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: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 50 ZK looks like and contents of the pack
Beto 50 ZK tablets are white, elongated, with a score line on both sides.
Prolonged-release tablets are packed in PP/Aluminum blisters or PVC/Aclar/Aluminum blisters, placed in a cardboard box.
Pack size: 30 prolonged-release tablets.

For further information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Lithuania, 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. Podlipie 16, 95-010 Stryków, Poland
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Numbers in Lithuania, country of export:
LT/1/05/0175/003
LT/1/0175/012
LT/1/01/0175/060
LT/1/05/0175/004

Parallel Import Licence Number: 236/25