Beto 100 zk

Package leaflet: Information for the patient

Warning! Keep the leaflet – information on the outer 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 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, consult your doctor, pharmacist, or nurse.
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 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 for:

• mild to moderate heart failure (ejection fraction less than or equal to 40%), which has remained stable and unchanged 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 heart rate;
• prevention following the acute phase of myocardial infarction;
• in cases of unpleasant sensation of irregular and/or strong 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 medicines;
• 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 heart 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 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 an abnormally high level of acidity in the 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, except MAO-B inhibitors (medicines used in Parkinson’s disease);
  o verapamil and diltiazem (medicines used to reduce blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heart rhythm).

When Beto 100 ZK is being used, intravenous administration of certain antiarrhythmic drugs
(calcium channel blockers such as verapamil and diltiazem or other antiarrhythmics) must not be given. Inform the doctor that the patient is taking Beto 100 ZK.
Metoprolol must not be used in patients with chronic heart failure 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 drugs 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, discuss with your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders, because treatment with bronchodilator medicines may need to be initiated or, if the patient is already taking asthma medication, the dose of bronchodilator may need adjustment;
• the patient has heart function disorders (e.g. slow heart rate) or circulatory disorders (taking Beto 100 ZK may worsen these conditions);
• the patient has diabetes or experiences significant fluctuations in blood sugar levels;
• 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 gland disorders;
• the patient has severe liver disease (see section 3 “How to use Beto 100 ZK”);
• the patient has ever experienced a severe allergic reaction to any allergen. Severe hypersensitivity reactions may be more pronounced while taking medicines such as Beto 100 ZK;
• the patient has a rare form of angina called Prinzmetal’s angina;
• the patient is scheduled for surgery requiring general anaesthesia. Inform the anaesthesiologist that the patient is taking Beto 100 ZK;
• the patient has a hormone-secreting adrenal medulla tumour (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor blocker is required;
• the patient has psoriasis.

If the patient experiences slowing or irregularity of the heartbeat, contact a 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 affects patients with unstable circulation, metoprolol should only be administered after haemodynamic stabilisation in patients with myocardial infarction.
Do not abruptly stop taking Beto 100 ZK (see section 3 “Stopping treatment with 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 for heart surgery, if Beto 100 ZK is to be initiated within the next four months.

Children and adolescents
Experience with use 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 lead to positive results in anti-doping tests.

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, e.g. verapamil, diltiazem or nifedipine). If clonidine and Beto 100 ZK are used together and clonidine is suddenly discontinued, blood pressure may rise sharply and abruptly. Clonidine must not be stopped before Beto 100 ZK is discontinued several days earlier. Clonidine should be tapered gradually (consult your doctor). Beto 100 ZK must not be started until several days after stopping clonidine.
• Other beta-blocking medicines (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, e.g. 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 tremor, may be masked or diminished. 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 dipyrithiamine, used to prevent blood clot formation.

Beto 100 ZK with 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 or 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 100 ZK may be used during pregnancy only if clearly indicated and after careful evaluation by the doctor of the expected benefits versus possible risks. There is evidence that metoprolol reduces placental blood flow, which may lead to fetal developmental disorders. Treatment with Beto 100 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 100 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 operating machinery
Treatment with this medicine requires regular medical supervision. During treatment with Beto 100 ZK, dizziness or fatigue may occur. These symptoms may impair reaction speed to a degree that may affect the ability to drive, operate machinery or work under potentially hazardous conditions. These symptoms may be particularly 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 taken 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 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, the tablets may be taken in the evening.

Heart rhythm disorders, including rapid heartbeat (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 initiating treatment for heart muscle weakness, it is necessary to stabilize the patient's condition with medicines typically 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 to 23.75 mg of metoprolol succinate once daily in the second week. 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.
• Subsequently, 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 maximum tolerated dose.

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 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 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
Clinical studies have not included patients over 80 years of age, therefore the doctor will increase the dose cautiously in such patients.

Beto 100 ZK is intended for oral administration.
The 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.
The tablets should be taken with water (at least half a 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 discoloration of the skin), and death.
The first symptoms of overdose may appear between 20 minutes and 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 any signs of poisoning.

Missed 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 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 up to 1 in 10 people):

• dizziness, headache
• slow heart rate (bradycardia)
• palpitations
• significant drop in blood pressure, especially when changing from lying to standing position, very rarely with loss of consciousness
• cold 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, difficulty concentrating
• 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 block (impaired conduction of impulses from the atria to the ventricles), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchoconstriction (bronchospasm)
• skin rash (psoriasiform or dystrophic skin changes), increased 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 platelet count (thrombocytopenia), reduced white blood cell count (leukopenia)
• forgetfulness or memory disorders, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing impairment
• 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 blood vessel spasms in the fingers and toes (Raynaud's phenomenon).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 more information on the safety of the medicine to be collected.

5. How to store the medicine 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.
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 100 ZK contains
Active substance: metoprolol succinate.
Each prolonged-release tablet contains 95 mg of metoprolol succinate, equivalent to
100 mg of metoprolol tartrate.
Other ingredients: sucrose, granules (sucrose, corn starch, liquid glucose),
polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone,
anhydrous colloidal silicon dioxide.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172).

What Beto 100 ZK looks like and contents of the packaging
Light yellow, 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 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): 61499.02.00
Parallel Import Licence Number: 64/26