Beto 25 zk

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language!
Beto 25 ZK (MetoHEXAL Succ 23.75 mg)
23.75 mg, prolonged-release tablets
Metoprololi succinas
Beto 25 ZK and MetoHEXAL Succ 23.75 mg are different trade names for the same medicinal product.
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 doubts, 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 another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet,
please inform your doctor, pharmacist, or nurse. See section 4.
Leaflet contents:

1. What Beto 25 ZK is and what it is used for
2. What you need to know before taking Beto 25 ZK
3. How to take Beto 25 ZK
4. Possible side effects
5. How to store Beto 25 ZK
6. Contents of the pack and other information

1. What Beto 25 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 25 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 25 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 the prevention following the acute phase of myocardial infarction (heart attack),
• for the relief of unpleasant sensations 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 25 ZK

When not to use Beto 25 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 of the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or cardiac arrhythmias (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:
  o monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression;
  o verapamil and diltiazem (medicines used to reduce blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

In patients with chronic heart failure, metoprolol must not be used 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 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 25 ZK, consult a 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 25 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 undergoing surgery requiring general anesthesia. The anaesthetist must be informed about the use of Beto 25 ZK.
• the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant use of an alpha-adrenergic receptor-blocking medicine 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. Use of Beto 25 ZK is not recommended in children under 6 years of age.
Beto 25 ZK and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Beto 25 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 (used in the treatment of migraine).
• Medicines used to treat depression.
• Medicines used to treat other psychiatric disorders.
• Antiretroviral medicines used to treat 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 to treat 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 fingolimod initiation.
• 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 enhanced blood pressure-lowering effects.
• Insulin and other antidiabetic medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
• Local anaesthetics containing lidocaine.
• The medicine called dipyridamole, used to prevent blood clots.

Beto 25 ZK with food, drink and alcohol
Beto 25 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 25 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 child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Beto 25 ZK may be used during pregnancy only if clearly indicated and after careful evaluation by the physician of the benefit-risk ratio. Evidence exists that metoprolol reduces placental blood flow, which may lead to impaired fetal development.
Treatment with Beto 25 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 physician for 48 to 72 hours after birth.
Breastfeeding
Beto 25 ZK passes into breast milk.
Metoprolol succinate should not be taken 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 physician will monitor heart function).
Driving and operating machinery
During treatment with Beto 25 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 especially pronounced when alcohol is consumed concomitantly or after switching from one medicine to another.
Beto 25 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 25 ZK.

3. How to use Beto 25 ZK

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
The doctor will inform you how many tablets to take and when. The prescribed dose depends on the type of illness and its severity.
Unless otherwise advised by the 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, the 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, the doctor may add another medicine used in the treatment of ischaemic 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 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 stabilised with medicines usually used in the treatment of heart failure. The dose of Beto 25 ZK should then be individually adjusted for each patient.

• The recommended starting 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 doctor may increase the dose in the second week to 23.75 mg of metoprolol succinate once daily.

The recommended starting dose for the first 2 weeks in patients with heart muscle weakness (classified as NYHA class II heart failure) is 23.75 mg of metoprolol succinate once daily.

• The 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. The doctor will determine the appropriate dose for the patient.
The usual initial dose of metoprolol succinate is usually 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 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 25 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 25 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Studies have not been conducted in patients over 80 years of age, therefore the doctor will increase the dose particularly cautiously in such patients.

Beto 25 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 Beto 25 ZK than recommended
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 25 ZK include: dangerously low blood pressure, severe disturbances in heart function, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (bluish or violet skin discoloration), and death.
The first symptoms of overdose may appear between 20 minutes and 2 hours after taking Beto 25 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 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.

Missing a dose of Beto 25 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 25 ZK
Before stopping or prematurely discontinuing treatment with Beto 25 ZK, consult your doctor.
Beto 25 ZK should not be stopped 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 any medicine, this medicine may cause adverse effects, although they do not occur in everyone.
Very common (may affect more than 1 in 10 people):

• feeling of fatigue

Common (may affect up to 1 in 10 people):

• dizziness, headache
• slow heartbeat (bradycardia)
• palpitations
• significant drop in blood pressure, especially when changing position from lying to standing, 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 up to 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disorders, nightmares, concentration disturbances
• abnormal sensations of tingling, pricking or numbness of the skin (paraesthesia)
• transient worsening of symptoms of heart muscle weakness (with ankle and foot swelling), first-degree atrioventricular conduction block (first-degree AV block), chest pain, impaired heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchial constriction (bronchospasm)
• skin rash (psoriasiform or dystrophic skin changes), excessive sweating
• muscle cramps

Rare (may affect up to 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 up to 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 circulation 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 (cannot be estimated from the 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 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 allows the collection of further information on the safety of the medicine.

5. How to store the medicine Beto 25 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.
Translation of some abbreviations appearing on the blister pack:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/Expiry date: see imprint (on the blister).
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 25 ZK contains
The active substance is metoprolol succinate.
Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, which corresponds to 25 mg of metoprolol tartrate.
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 25 ZK looks like and contents of the pack
Beto 25 ZK tablets are white, elongated, with a score line on both sides.
Blister packs made of PP/Aluminium foil or blister packs made of PVC/Aclar/Aluminium foil in a cardboard box.
Pack size: 30 or 60 prolonged-release tablets.
For further detailed information, please contact the marketing authorisation holder 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing authorisation number in Germany, the country of export: 61494.00.00
Parallel import authorisation number: 269/22