Beto 150 zk

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Beto 150 ZK (MetoHEXAL Succ 142.5 mg)
142.5 mg, prolonged-release tablets
Metoprololi succinas
Beto 150 ZK and MetoHEXAL Succ 142.5 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking 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 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, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Beto 150 ZK is and what it is used for
2. What you need to know before taking Beto 150 ZK
3. How to take Beto 150 ZK
4. Possible side effects
5. How to store Beto 150 ZK
6. Contents of the pack and other information

1. What Beto 150 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 150 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 150 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,
• for prophylaxis 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 150 ZK

When not to use Beto 150 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 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 that usually causes 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 high blood acidity (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 lower blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heart rhythm).

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 or have recently received medicines that increase heart contractility;
• they have a slow heart rate (less than 68 beats/min at rest before treatment);
• 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 or circulatory disorders (e.g. slow heart rate), as 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 called Prinzmetal's angina;
• the patient requires surgery under general anaesthesia. The anaesthetist must be informed about the use of Beto 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 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.
Beto 150 ZK is not recommended for use in children under 6 years of age.

Beto 150 ZK and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Beto 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 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 of fingolimod treatment.
• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein 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 150 ZK with food, drink and alcohol
Beto 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 ZK.

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 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 should 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, 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 150 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 occur especially when alcohol is consumed concurrently or when switching from one medicine to another.

Beto 150 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 150 ZK.

3. How to use Beto 150 ZK

This medicine should always be used exactly as directed by the physician. 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
of disease and its severity.
Unless otherwise directed by the physician, the usual dosages are as follows:
High blood pressure (hypertension)

• Patients with mild to moderate hypertension should take 47.5 mg of metoprolol succinate once daily.
• If necessary, the physician 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, the physician 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, the physician 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 initiating treatment for heart muscle weakness, the patient's condition must first be stabilized with medicines typically used in heart failure therapy. The dose of Beto 150 ZK is then individually adjusted for each patient.

• The recommended initial dose in 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. The physician may increase the dose in the second week to 23.75 mg of metoprolol succinate once daily.
• 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.
• Subsequently, the physician 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. The physician determines the appropriate dose for the patient.
The usual initial dose of metoprolol succinate is typically 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. The physician may increase the dose up to 1.9 mg/kg body weight, depending on the achieved blood pressure response. Doses exceeding 190 mg daily have not been studied in children and adolescents.
Beto 150 ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by the physician.
If you feel that the effect of Beto 150 ZK is too strong or too weak, contact your doctor or pharmacist.

Elderly patients
Clinical studies have not been conducted in patients over 80 years of age; therefore, physicians should increase the dose 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 ½ glass).

Taking more than the recommended dose of Beto 150 ZK
Seek immediate medical attention by contacting your doctor or going 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 action should be taken.

Symptoms of overdose
Symptoms that may occur following overdose of Beto 150 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 within 20 minutes to 2 hours after taking Beto 150 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 relatively good condition after a minor metoprolol overdose should be closely observed by a physician for at least 4 hours for any signs of poisoning.

Missed dose of Beto 150 ZK
Do not take a double dose to make up for a missed dose; continue treatment as directed by your doctor.

Stopping treatment with Beto 150 ZK
Before stopping or prematurely discontinuing treatment with Beto 150 ZK, consult your doctor.
Beto 150 ZK should not be discontinued abruptly, but the dose should be gradually reduced.
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 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 lowering of blood pressure, especially when changing body 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 problems
• 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 block (first-degree AV block), chest pain (angina pectoris), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchoconstriction)
• 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 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 circulatory disorders before treatment
• taste disturbances
• hepatitis
• photosensitivity with skin rash after exposure to light, exacerbation of psoriasis symptoms, development of psoriasis
• joint pain, muscle weakness

Frequency unknown (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 vasospasm of the blood vessels in 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, please 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 this medicine.

5. How to store the medicine Beto 150 ZK

• Keep the medicine out of the 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.
• 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 immediate packaging: Ch.-B./verwendbar bis: see imprint - Batch number/Expiry date: see embossing (on the blister).

6. Contents of the pack and other information

What Beto 150 ZK contains
The active substance is metoprolol succinate. Each prolonged-release tablet contains 142.5 mg of metoprolol succinate.
The other ingredients are: sucrose, granules (sucrose, corn starch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460), crospovidone, anhydrous colloidal silicon dioxide.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 150 ZK looks like and contents of the pack
Beto 150 ZK tablets are white, elongated, with two break lines on both sides.
Packs consist of PVC/Aclar-Aluminium blisters in a cardboard box.
Pack sizes: 30 or 60 prolonged-release tablets.

For more detailed information, please contact the responsible party or the 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): 61494.03.00
Parallel Import Licence Number: 567/15