Beto 100 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Beto 100 ZK (Metoprololsuccinat – 1 A Pharma 95 mg)
95 mg, prolonged-release tablets
Metoprololi succinas
Beto 100 ZK and Metoprololsuccinat – 1 A Pharma 95 mg are different trade names for the same
medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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 of the leaflet:

1. What Beto 100 ZK is and what it is used for
2. Important information before taking Beto 100 ZK
3. How to take Beto 100 ZK
4. Possible side effects
5. How to store Beto 100 ZK
6. Contents of the pack and other information

1. What Beto 100 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 100 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 100 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 100 ZK is used as an addition to standard treatment with vasodilators (ACE inhibitors) and diuretics, and, if necessary, cardiac glycosides;
• treatment of high blood pressure;
• treatment of chest pain or heart pain (angina pectoris);
• treatment of heart rhythm disorders, including rapid heartbeat;
• prevention following the acute phase of myocardial infarction;
• in cases of uncomfortable sensation of irregular and (or) forceful heartbeat (hyperkinetic heart syndrome);
• prevention of migraine.

In children and adolescents aged 6 to 18 years:

• treatment of high blood pressure (hypertension).

2. Important information before using Beto 100 ZK

When not to use Beto 100 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;
• 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 permanently 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 breathlessness 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 acidic 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).

When using Beto 100 ZK, intravenous administration of certain antiarrhythmic drugs (calcium channel antagonists such as verapamil and diltiazem, or other antiarrhythmics) must be avoided. Inform your doctor that you are taking Beto 100 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 inotropic agents (medicines that increase the force of heart contractions);
• 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 100 ZK, consult your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders, because treatment with bronchodilators may be necessary or, if the patient is already taking asthma medication, the dose of bronchodilator may need adjustment;
• the patient has heart (e.g. slow heart rate) or circulatory disorders (taking Beto 100 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 between the atria and ventricles (first-degree atrioventricular block), as this may worsen and lead to complete blockage of conduction;
• the patient has thyroid disorders;
• the patient has severe liver disease (see section 3 “How to take Beto 100 ZK”);
• the patient has ever experienced a severe allergic reaction to any allergen. Severe hypersensitivity reactions may be more pronounced during treatment with medicines such as Beto 100 ZK;
• the patient has a rare form of angina, so-called Prinzmetal’s angina;
• the patient is to undergo surgery requiring general anaesthesia. Inform the anaesthesiologist that you are taking Beto 100 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 100 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 stabilisation of circulation in patients with myocardial infarction.
Do not abruptly stop taking Beto 100 ZK (see section 3 “Discontinuation of Beto 100 ZK”).
There is limited experience in treating patients with heart failure who:

• have very severe, variable (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 chambers;
• have had or are scheduled to have heart surgery, if Beto 100 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 100 ZK is not recommended in children under 6 years of age.
Doping
Use of metoprolol may result in positive anti-doping test results.
Beto 100 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 100 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 100 ZK are used together and clonidine is suddenly discontinued, blood pressure may rise abruptly and severely. Clonidine must not be stopped before Beto 100 ZK has been discontinued several days earlier. Clonidine should be tapered gradually (consult your doctor). Beto 100 ZK must not be started until several days after clonidine has been discontinued.
• 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 antiarrhythmics.
• 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 hypoglycaemic effect is enhanced by Beto 100 ZK. Warning symptoms of low blood sugar, especially rapid heartbeat and trembling, 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.
• A medicine called dipyridamole, used to prevent blood clots.

Beto 100 ZK, food, drink and alcohol
Beto 100 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 100 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 her doctor or pharmacist before using this medicine.
Pregnancy
Beto 100 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 100 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 100 ZK passes into breast milk.
Metoprolol succinate should not be taken during pregnancy unless absolutely necessary. Although adverse effects are unlikely with recommended doses, 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. Dizziness or fatigue may occur during treatment with Beto 100 ZK. These symptoms may affect reaction speed to an extent impairing the ability to drive vehicles, operate machinery or work in potentially hazardous conditions. Symptoms may be especially pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 100 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 100 ZK.

3. How to use Beto 100 ZK

This medicine should always be used as directed by the physician. If in doubt, consult a 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 the doctor has not advised otherwise, the usual dosing 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)

• 47.5–190 mg of metoprolol succinate once daily.
• If necessary, the doctor may add another medicine used in the treatment of ischemic heart disease.
• If chest pain or heart pain occurs at night, tablets may be taken in the evening.

Heart rhythm disorders, including rapid heartbeat (cardiac arrhythmias)

• 47.5–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

• 95–190 mg of metoprolol succinate once daily.

Unpleasant sensation of irregular and/or forceful heartbeat (palpitations)

• 47.5 or 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, it is necessary to stabilize the patient's condition with medicines commonly used in heart failure therapy, followed by individual dose adjustment of Beto 100 ZK.

• 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 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.
• Then the 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. The 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. The 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 100 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 100 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, so the doctor will increase the dose particularly cautiously in such patients.

Beto 100 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 100 ZK than recommended
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 was taken and what action should be taken.

Symptoms of overdose
Symptoms that may occur due to overdose of Beto 100 ZK include:
dangerously low blood pressure, severe disturbances in heart function, 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 appear within 20 minutes to 2 hours after taking Beto 100 ZK, and the effects of a 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 relatively 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 100 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 100 ZK
Before stopping or prematurely discontinuing treatment with Beto 100 ZK, consult your doctor.
Beto 100 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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
• marked decrease 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 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 (paresthesia)
• 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)
• bronchoconstriction (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 (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 the 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 this medicine.

5. How to store Beto 100 ZK

• Keep this 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. Translations of information from the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung - Batch number/Expiry date: see imprint.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Beto 100 ZK contains
The active substance is metoprolol succinate.
Each prolonged-release tablet contains 95 mg of metoprolol succinate, equivalent to
100 mg of metoprolol tartrate.
Other ingredients are: sucrose, granules (sucrose, corn starch, glucose), polyacrylate
dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal anhydrous
silica.
Coating: monohydrate lactose, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide
(E 172).
What Beto 100 ZK looks like and contents of the pack
Light yellow, elongated tablets with a break line on both sides.
Prolonged-release tablets are packed in blisters made of PP/Aluminum foil or PVC/Aclar/Aluminum foil, and placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Germany, country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego Street 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. Forteczna Street 35-37 Tymiankowa Street 24/28
Działkowa Street 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
German Marketing Authorisation Number, country of export: 61499.02.00
Parallel Import Authorisation Number: 91/26
This medicinal product is authorised in the European Economic Area member states under the following names:
Poland Beto 100 ZK, 95 mg, prolonged-release tablets
Hungary Metoprolol Z 1a Pharma 100 mg retard tabletta