Beto 50 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Beto 50 ZK (Metoprolol Z 1a Pharma)
47.5 mg, prolonged-release tablets
Metoprololi succinas
Beto 50 ZK and Metoprolol Z 1a Pharma are different brand names of 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 questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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:

• in the treatment of high blood pressure,
• in the treatment of chest pain (angina),
• in the treatment of heart rhythm disorders, including rapid heart rate,
• in the prevention following the acute phase of myocardial infarction (heart attack),
• in cases of unpleasant sensation of irregular and (or) forceful heartbeat,
• in the prevention of migraine,
• in the treatment of heart failure.

In children and adolescents aged 6 to 18 years:

• in 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 cardiogenic shock due to serious 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 permanently implanted cardiac pacemaker;
• if the patient has severe 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 blood pressure <90 mmHg);
• if the patient has abnormally acidic 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 lower blood pressure);
• 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, decompensated 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 (e.g. slow heart rate) or circulatory disorders (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 requires surgery under general anaesthesia. Inform the anaesthetist that the patient is taking Beto 50 ZK;
• the patient has a hormone-secreting tumour of the adrenal medulla (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.
The use of Beto 50 ZK is not recommended in children under 6 years of age.
Beto 50 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 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, e.g. 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 (which may be used to treat 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 medicine used to treat 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.
• 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 concentration may reach higher levels and decrease more slowly. Alcohol consumption should be avoided during treatment with Beto 50 ZK.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant or is planning to become pregnant, 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 assessment by the doctor of the benefit-risk ratio. 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 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 adverse effects are unlikely when recommended doses are used, the breastfed infant should be carefully observed 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 be particularly pronounced 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 prescribed 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 disease.
If your doctor has not instructed otherwise, the usual dosing 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 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 (cardiac arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

• 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, the patient's condition must first be stabilized with medicines typically used in heart failure treatment. 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 during 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 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 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 above 190 mg daily have not been studied in children and adolescents.
Beto 50 ZK is not recommended for 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, contact 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 than the recommended dose of Beto 50 ZK
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 management.
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 a hospital, 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.
Sudden 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 may cause adverse effects, although not everyone will experience them.

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 position from lying down to standing up, 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 difficulties
• abnormal sensations of tingling, pricking, or numbness of the skin (paraesthesia)
• transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular block (first-degree AV block), chest pain (angina pectoris), poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (airway constriction)
• 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 when wearing contact lenses), conjunctivitis
• heart rhythm disorders (arrhythmia), conduction disorders
• 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 impairment
• tissue necrosis (necrosis) in patients with severe peripheral circulatory 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 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, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 packaging. The expiry date refers to the last day of the specified 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 in use. This will help protect the environment.

6. Contents of the packaging 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
White, elongated tablets with a break line on both sides.
Prolonged-release tablets are packed in blisters made of PP/Al foil or PVC/aclar/Al foil, and placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets.

For further detailed information about this medicinal product, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Hungary, country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen, Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A.
ul. Podlipie 16, 95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana, Slovenia

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Hungary, country of export: OGYI-T-10128/02
Parallel Import Authorisation Number: 355/22