Beto 200 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Beto 200 ZK (MetoHEXAL Succ 190 mg)
190 mg, prolonged-release tablets
Metoprololi succinas
Beto 200 ZK and MetoHEXAL Succ 190 mg are different trade names for the same medicinal product.
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 doubts, consult your doctor, pharmacist, or nurse.
• 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 effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Beto 200 ZK is and what it is used for
2. Important information before taking Beto 200 ZK
3. How to take Beto 200 ZK
4. Possible side effects
5. How to store Beto 200 ZK
6. Contents of the pack and other information

1. What Beto 200 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 200 ZK, blocks certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 200 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 200 ZK

When not to use Beto 200 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 dysfunction;

• if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or cardiac arrhythmias (sick sinus syndrome), except in patients with a cardiac pacemaker implanted;

• 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 increased blood acidity (so-called metabolic acidosis);

• if the patient is taking any of the following medicines:
  o monoamine oxidase inhibitors (MAOIs) – medicines used in the treatment of depression;
  o verapamil and diltiazem (medicines used to reduce blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used in the treatment of 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 receiving continuously or intermittently medicines 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 200 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); taking Beto 200 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 pectoris, so-called Prinzmetal's angina;
• the patient is to undergo surgery requiring general anaesthesia. The anaesthetist must be informed about the use of Beto 200 ZK.
• the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor-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 200 ZK is not recommended in children under 6 years of age.
Beto 200 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 200 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 (which may be 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.
• Antihistamine medicines (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 in the treatment of tuberculosis.
• Medicines used to treat heart disorders (including angina pectoris), 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-slowing effect during the first days after starting fingolimod.
• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein used in the treatment of metastatic renal 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 200 ZK, food, drink, and alcohol
Beto 200 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 200 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 baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Beto 200 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 impaired fetal development. Treatment with Beto 200 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 200 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 monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).
Driving and operating machinery
During treatment with Beto 200 ZK, dizziness or fatigue may occur. These symptoms may impair reaction speed to an extent that may interfere with the ability to drive, operate machinery, or work under potentially hazardous conditions. These symptoms may be especially pronounced when alcohol is consumed concurrently or after switching from one medicine to another.
Beto 200 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 200 ZK.

3. How to use Beto 200 ZK

This medicine should always be taken exactly as instructed by your doctor. If in doubt, consult your doctor or pharmacist.
Available on the market are: 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 advised otherwise, the usual dosage is as follows:

Arterial hypertension (high blood pressure)

• 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.

Migraine prophylaxis

• 95–190 mg of metoprolol succinate once daily.

Heart muscle weakness (heart failure)
Before initiating treatment for heart muscle weakness, it is necessary to stabilize the patient’s condition with medicines typically used in heart failure therapy. The dose of Beto 200 ZK should then be individually adjusted for each patient.

• 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.
• Subsequently, 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 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 200 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 200 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Clinical studies have not included patients over 80 years of age, therefore your doctor will increase the dose cautiously in such patients.

Beto 200 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 than the recommended dose of Beto 200 ZK
Seek immediate medical advice or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the doctor will decide on 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 200 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 200 ZK, and the effects of a significant overdose may persist 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 metoprolol overdose should be closely observed by a doctor for at least 4 hours for signs of poisoning.

Missing a dose of Beto 200 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 200 ZK
Before stopping or prematurely discontinuing treatment with Beto 200 ZK, consult your doctor.
Do not stop taking Beto 200 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 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 disturbances, 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 conduction block (first-degree AV block), chest pain, poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchial spasm)
• skin rash (eczematous-like urticaria 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 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 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 fats, such as cholesterol or triglycerides
• worsening of symptoms in patients with intermittent claudication or with vasospastic disorders of the blood vessels in fingers and toes (Raynaud's phenomenon).

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

5. How to store the medicine Beto 200 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 specified 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 abbreviations appearing on the blister: Ch.-B./verwendbar bis: siehe Prägung - Batch number/Expiry date: see embossing (on the edge of the blister).

6. Contents of the packaging and other information

What Beto 200 ZK contains
The active substance is metoprolol succinate. Each prolonged-release tablet contains 190 mg of metoprolol succinate, equivalent to 200 mg of metoprolol tartrate.
Other ingredients are: sucrose, granules (sucrose, corn starch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460), crospovidone, colloidal anhydrous silica, lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 200 ZK looks like and contents of the pack
Beto 200 ZK tablets are white, elongated, with a score line on both sides.
Prolonged-release tablets are packed in PP/Aluminium or PVC/Aclar/Aluminium blisters and placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation 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:
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

German Marketing Authorisation Number (country of export): 61494.04.00
Parallel Import Authorisation Number: 193/24