Beto 25 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Beto 25 ZK (Metoprololsuccinat – 1 A Pharma 23.75 mg)
23.75 mg, prolonged-release tablets
Metoprololi succinas
Beto 25 ZK and Metoprololsuccinat – 1 A Pharma 23.75 mg are different trade names for the
same medicinal product.
Please read the entire 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 others, even if their symptoms are identical.
• 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 of the leaflet:

1. What Beto 25 ZK is and what it is used for
2. Important information 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, primarily located in the heart.
Beto 25 ZK is used in:

• mild to moderate heart failure (ejection fraction less than or equal to 40%), the severity of which has remained stable for at least 4 weeks. Beto 25 ZK is used as an addition to standard treatment with vasodilators (ACE inhibitors) and diuretics, and, if necessary, cardiac glycosides.

In children and adolescents aged 6 to 18 years:

• 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-adrenergic blocking agents (beta-blockers);
• if the patient has severe asthma or severe wheezing attacks;
• if the patient is in shock;
• 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 an implanted cardiac pacemaker;

• if the patient has serious circulatory disorders (severe peripheral arterial disease);
• if the patient has untreated and uncontrolled heart failure (a condition usually causing shortness of breath 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 high acidity of the blood (so-called metabolic acidosis);
• if the patient is taking any of the following medicines:
  • monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression, except MAO-B inhibitors (medicines used in Parkinson's disease);
  • verapamil and diltiazem (medicines used to lower blood pressure);
  • antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

In patients receiving Beto 25 ZK, intravenous administration of certain antiarrhythmic drugs
(calcium channel antagonists such as verapamil and diltiazem, or other antiarrhythmic drugs) is contraindicated. Inform your doctor that you are taking Beto 25 ZK.
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 drugs 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 your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders, as treatment with bronchodilators may be required or, if the patient is already taking asthma medication, the dose of bronchodilator may need adjustment;
• the patient has heart rhythm disorders (e.g. bradycardia) or circulatory disorders (taking Beto 25 ZK may worsen these conditions);
• the patient has diabetes or experiences significant fluctuations in blood glucose levels;
• the patient is malnourished;
• the patient has first-degree atrioventricular block (delayed conduction from atria to ventricles), as this may progress to higher-grade block, potentially leading to complete conduction block;
• the patient has thyroid dysfunction;
• the patient has severe liver disease (see section 3 "How to take Beto 25 ZK");
• the patient has ever experienced a severe allergic reaction to any allergen. Severe hypersensitivity reactions may be more pronounced during treatment with drugs such as Beto 25 ZK;
• the patient has a rare form of angina pectoris, so-called Prinzmetal's angina;
• the patient requires surgery under general anesthesia. Inform the anesthesiologist that the patient is taking Beto 25 ZK;
• the patient has a catecholamine-secreting tumor of the adrenal medulla (pheochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor blocker is required;
• the patient has psoriasis. In case of bradycardia or slowing of heart rhythm, contact your doctor immediately. The doctor may prescribe a lower dose of metoprolol or gradually discontinue Beto 25 ZK.

In patients with acute myocardial infarction, treatment with metoprolol has been associated with
an increased risk of severe drop in blood pressure (cardiogenic shock). Since this particularly
affected patients with unstable circulation, metoprolol should only be administered after
hemodynamic stabilization in patients with myocardial infarction.
Do not abruptly stop taking Beto 25 ZK (see section 3 "Discontinuation of Beto 25 ZK").
There is limited experience in treating heart failure patients who:

• have very severe, variable (unstable) heart failure (NYHA class IV);
• have experienced chest pain (angina pectoris) of varying intensity within the last four weeks;
• have kidney or liver dysfunction;
• are over 80 or under 40 years of age;
• have heart valve disease affecting heart function;
• have cardiomyopathy causing narrowing of the heart cavity;
• have undergone or are scheduled for heart surgery, if Beto 25 ZK is to be initiated within the next four months.

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.
Doping
Use of metoprolol may lead to positive results in anti-doping tests.
Interaction of Beto 25 ZK with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
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 such as verapamil, diltiazem, or nifedipine). If clonidine and Beto 25 ZK are used together and clonidine is suddenly discontinued, blood pressure may rise abruptly and severely. Clonidine must not be stopped before Beto 25 ZK is discontinued several days earlier. Clonidine should be tapered gradually (consult your doctor). Do not start treatment with Beto 25 ZK until several days after stopping clonidine.

• Other beta-adrenergic blocking agents (including those contained in eye drops).

• Medicines affecting peripheral 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 for 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 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-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 enhance the blood pressure-lowering effect.

• Insulin and other antidiabetic medicines. Their hypoglycemic effect is enhanced by Beto 25 ZK. Warning symptoms of low blood sugar, especially rapid heartbeat and tremor, may be masked or diminished. Therefore, blood glucose levels should be monitored regularly.

• Non-steroidal anti-inflammatory drugs (so-called NSAIDs), used to treat pain and inflammation.

• Local anesthetics containing lidocaine.

• A 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 become pregnant, she should consult her 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 doctor of the benefit-risk ratio. Evidence suggests 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 doctor for 48 to 72 hours after birth.
Breastfeeding
Beto 25 ZK passes into breast milk.
Metoprolol succinate should not be taken during pregnancy unless absolutely necessary.
Although adverse effects are unlikely when recommended doses are used, breastfed infants should be closely monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).
Driving and operating machinery
Treatment with this medicine requires regular medical supervision. 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 vehicles, operate machinery, or work under potentially hazardous conditions. These symptoms may occur especially when alcohol is consumed concurrently, or after switching from one medicine to another.
Beto 25 ZK contains liquid glucose, 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 as directed by the physician. If in doubt, consult a 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.
Unless otherwise directed by the physician, the following dosing is generally recommended:
Heart muscle weakness (heart failure)
Before initiating treatment for heart muscle weakness, it is necessary to stabilize the patient's condition with medications commonly used in the treatment of heart failure. The dose of Beto 25 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. The physician may increase the dose during the second week to 23.75 mg of metoprolol succinate once daily. The recommended initial 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.
• Subsequently, the physician will double the dose. The dose may be doubled every two weeks until reaching a dose of 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.
• The recommended maintenance dose for long-term 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. The physician 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. The physician may increase the dose up to 1.9 mg/kg body weight, depending on the blood pressure response. Doses exceeding 190 mg daily have not been studied in children and adolescents.
Beto 25 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 25 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 the physician will increase the dose particularly cautiously in such patients.
Beto 25 ZK is intended for oral administration.
Tablets should be taken once daily, regardless of meals. 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 25 ZK
Seek immediate medical advice or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the physician 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 25 ZK include:
dangerously low blood pressure, severe heart dysfunction, breathing difficulties, bronchospasm, shock, 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 25 ZK, and the effects of significant overdose may persist 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 physician for at least 4 hours for 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 the physician.
Stopping treatment with Beto 25 ZK
Before stopping or prematurely discontinuing treatment with Beto 25 ZK, consult your physician.
Beto 25 ZK should not be discontinued abruptly, but the dose should be gradually reduced. Sudden discontinuation of beta-blockers may worsen heart failure symptoms 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 will experience them.

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 heart rate (bradycardia)
• palpitations
• significant drop in blood pressure, especially when changing body 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 disturbances, nightmares, concentration difficulties
• 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 atrioventricular block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchial spasm)
• skin rash (lichenoid and 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 during contact lens use), conjunctivitis
• heart rhythm disorders (arrhythmia), conduction disturbances
• nasal obstruction
• 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 (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 (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 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 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 .
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Beto 25 ZK

• Keep this 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 specified month.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung - batch number/expiry date - see imprint.
• 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. These measures 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,
corresponding to 25 mg of metoprolol tartrate.
The other ingredients are: sucrose, granules (sucrose, corn starch, liquid glucose),
polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone,
anhydrous colloidal silica.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000.

What Beto 25 ZK looks like and contents of the pack
White, elongated tablets with a score line on both sides.
The prolonged-release tablets are packed in blisters made of PP/Aluminium foil or PVC/Aclar/Aluminium foil,
placed in a cardboard box.
Pack sizes: 30 and 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:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Poland
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

German Marketing Authorisation Number (country of export): 61499.00.00
Parallel Import Authorisation Number: 56/26

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Poland: Beto 25 ZK, 23.75 mg, prolonged-release tablets
Hungary: Metoprolol Z 1a Pharma 25 mg retard tabletta