Beto 50 zk

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Beto 50 ZK (MetoHEXAL Succ 47.5 mg),
47.5 mg, prolonged-release tablets
Metoprolol succinate
Beto 50 ZK and MetoHEXAL Succ 47.5 mg are different brand names of the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Beto 50 ZK is and what it is used for
2. Important information 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 heartbeat,
• in the prevention following the acute phase of myocardial infarction,
• 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-adrenolytic drugs;
• if the patient has severe asthma or severe wheezing attacks;
• if the patient is in shock due to severe heart dysfunction;
• 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 disorders (severe peripheral arterial disease);
• if the patient has untreated and uncontrolled heart failure (a condition usually causing breathlessness and ankle swelling);
• 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) – drugs used to treat depression;
• verapamil and diltiazem (drugs used to reduce blood pressure);
• antiarrhythmic drugs such as disopyramide (drugs 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 continuously or intermittently receiving drugs that increase heart contractility;
• 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 ZK, consult a doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders;
• the patient has heart function disorders (e.g. slow heart rate) or circulatory disorders (treatment with Beto 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, so-called Prinzmetal's angina;
• the patient is to undergo surgery requiring general anesthesia. The anesthesiologist must be informed about the use of Beto ZK.
• the patient has a hormone-secreting tumor of the adrenal medulla (pheochromocytoma): in such a case, prior and concomitant use of an alpha-adrenergic receptor blocker is required;
• the patient has psoriasis.

Use of metoprolol may lead to positive anti-doping test results.
Children and adolescents
Experience with treatment in children under 6 years of age is limited.
Beto ZK is not recommended for use 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 such as verapamil, diltiazem, or nifedipine).
• Other beta-adrenolytic drugs (including those contained in eye drops).
• Medicines affecting peripheral blood circulation (in fingers and toes), such as ergot alkaloids (used to treat migraine).
• Medicines used to treat depression.
• Medicines used to treat other psychiatric disorders.
• Antiretroviral drugs 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 drugs.
• 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-adrenolytics 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-adrenolytics 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 anesthetics containing lidocaine.
• A medicine called dipyridamole, used to prevent blood clots.

Beto 50 ZK with 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.
During treatment with Beto 50 ZK, alcohol consumption should be avoided.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 will be closely monitored by the 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 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 in 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.
The following products are available on the market: Beto 25 ZK, Beto 50 ZK, Beto 100 ZK, Beto 150 ZK, Beto 200 ZK.
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 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 ischemic heart disease.

Heart rhythm disorders, including rapid heartbeat (cardiac arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction (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, the patient's condition must first be stabilized with medicines typically used in heart failure treatment. The dose of Beto 50 ZK is then 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 to 23.75 mg of metoprolol succinate once daily in the second week.
  The recommended initial dose for 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 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 the doctor.

If you feel the effect of Beto 50 ZK is too strong or too weak, contact your doctor or pharmacist.

Elderly patients
Studies have not been conducted in patients over 80 years of age; therefore, your doctor will increase the dose particularly cautiously 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 half a 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 they know 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 heart function disturbances, 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 good condition after a minor overdose of metoprolol 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 directed by your doctor.

Stopping Beto 50 ZK
Before stopping or 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 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 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,
• significant drop in blood pressure, especially when changing 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 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 conduction block (first-degree AV block), chest pain (chest pain), poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction),
• respiratory tract constriction (bronchospasm),
• skin rash (psoriasiform or 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 disturbances (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 (necrosis) in patients with severe peripheral vascular disorders prior to treatment,
• taste disturbances,
• hepatitis,
• photosensitivity with skin rash 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 blood vessel spasms 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, inform your doctor or pharmacist. 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 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.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung – batch number / expiry date – see embossing.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
Other ingredients: 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 50 ZK looks like and contents of the pack
Beto 50 ZK tablets are white, elongated, with a score line on both sides.
Blister packs made of PP/Aluminum or PVC/Aclar/Aluminum, placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets.

For more detailed information about the medicine, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

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

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

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland

German Marketing Authorization Number (country of export): 61494.01.00
Parallel Import Authorization Number: 155/19