Beto 25 zk

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging 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 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 questions, 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
See section 4.

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, mainly located in the heart.
Beto 25 ZK is used for:

• mild to moderate heart failure (ejection fraction less than or equal to 40%), which has been stable and unchanged for at least 4 weeks. Beto 25 ZK is used as an addition to standard treatment with vasodilating agents (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. 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 (beta-adrenolytics);
• if the patient has severe asthma or severe wheezing attacks;
• if the patient is in shock;
• if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or rhythm disorders (sick sinus syndrome), except in patients with a permanently 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 increased blood acidity (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 (used in Parkinson’s disease);
  • verapamil and diltiazem – medicines used to lower blood pressure;
  • antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heart rhythms).

When using Beto 25 ZK, intravenous administration of certain antiarrhythmic drugs (calcium channel blockers such as verapamil and diltiazem, or other antiarrhythmics) must not be used. 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 received intermittent or continuous treatment with drugs that increase the force of heart contractions (inotropes);
• 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

Talk to your doctor or pharmacist before taking Beto 25 ZK if:

• the patient has asthma, bronchitis, or lung function disorders, because treatment with bronchodilators may need to be initiated or, if the patient is already taking asthma medication, the dose of bronchodilator may need to be adjusted;
• the patient has heart function disorders (e.g. slow heart rate) or circulatory disorders (taking Beto 25 ZK may worsen these conditions);
• the patient has diabetes or blood sugar levels that fluctuate significantly;
• the patient is undernourished;
• the patient has mild conduction disturbances from the atria to the ventricles (first-degree atrioventricular block), as this may lead to worsening and potentially complete blockage of conduction;
• the patient has thyroid disorders;
• the patient has severe liver disease (see section 3 "How to take Beto 25 ZK");
• the patient has ever had a severe allergic reaction to any allergen. Severe allergic reactions may be more intense while taking medicines such as Beto 25 ZK;
• the patient has a rare form of angina called Prinzmetal's angina;
• the patient is to undergo surgery requiring general anaesthesia. Inform the anaesthesiologist that you are taking Beto 25 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.

If the heart rate slows down or becomes irregular, 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 affects patients with unstable circulation, metoprolol should only be administered after stabilisation of circulation in patients with myocardial infarction.

Do not abruptly stop taking Beto 25 ZK (see section 3 "Stopping treatment with Beto 25 ZK").

There is limited experience in treating patients with heart failure who:

• have very severe, varying degrees of (unstable) heart failure (NYHA class IV);
• have experienced chest pain or angina of varying severity 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 had or are scheduled to have heart surgery, if Beto 25 ZK is to be taken within the next four months.

Children and adolescents

Experience with treatment in children under 6 years of age is limited.

The 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.

Beto 25 ZK and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

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 sharply. Clonidine must not be stopped before Beto 25 ZK is discontinued several days earlier. Clonidine should be tapered gradually (consult your doctor). Beto 25 ZK must not be started until several days after stopping clonidine.

• Other beta-adrenolytic 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.

• 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), such as amiodarone, digoxin, nitrates, and antiarrhythmics.

• Other medicines that reduce heart rate: co-administration 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-lowering effect during the first days of fingolimod treatment.

• Other medicines that lower blood pressure: co-administration 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 blood sugar-lowering effect is enhanced by Beto 25 ZK. Warning symptoms of low blood sugar, especially rapid heartbeat and tremor, may be masked or reduced. Therefore, blood sugar levels should be monitored regularly.

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

• Local anaesthetics containing lidocaine.

• The medicine 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 levels may reach higher values 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. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to fetal developmental disorders.

Treatment with Beto 25 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 25 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 carefully monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).

Driving and using machines

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, operate machinery, or work under potentially hazardous conditions. These symptoms may be especially likely when alcohol is consumed concurrently or when switching from one medicine to another.

Beto 25 ZK contains 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 taken exactly as prescribed by your doctor. 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 and severity of the disease.
If your doctor has not advised otherwise, the usual dosage is as follows:
Heart failure (weakening of the heart muscle)
Before initiating treatment for heart muscle weakness (heart failure), the patient's condition must first be stabilised with medicines usually used in the treatment of heart failure. The dose of Beto 25 ZK is then 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 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 dose is then doubled by your doctor. The dose may be doubled every two weeks until a dose of 190 mg of metoprolol succinate once daily is reached, or until the highest dose tolerated by the patient is achieved.
• 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 higher than 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 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 your doctor 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 Beto 25 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 management.
Show the medicine packaging to the doctor so they know 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 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 a significant overdose may persist for several days.
Treatment of overdose
The patient should be treated in hospital, 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 any signs of poisoning.
Missed dose of Beto 25 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 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 all medicines, this medicine can 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 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, 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 (paraesthesiae)
• transient worsening of symptoms of heart muscle weakness (with ankle and foot swelling), first-degree atrioventricular conduction block (first-degree AV block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• respiratory tract constriction (bronchospasm)
• 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 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 loss
• 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 lipids, such as cholesterol or triglycerides
• worsening of symptoms in patients with intermittent claudication or with vasospastic disorders of 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, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 using the medicine.

5. How to store the medicine Beto 25 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 25 ZK contains
Active substance:
Metoprolol succinate.
Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, equivalent to
25 mg of metoprolol tartrate.

Other ingredients:
Sucrose, granules (sucrose, corn starch, liquid glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal anhydrous 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, and placed in a cardboard box.
Pack sizes: 30 or 60 prolonged-release tablets.

For more detailed information, please contact the Marketing Authorisation Holder 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

German Marketing Authorisation Number (country of export): 61499.00.00
Parallel Import Authorisation Number: 54/26