Beto 200 zk

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Beto 200 ZK (Metoprololsuccinate - 1 A Pharma)
190 mg, prolonged-release tablets
Metoprololi succinas
Beto 200 ZK and Metoprololsuccinate - 1 A Pharma are different trade names for the same medicine.
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.
• This 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.

Table of contents of the leaflet:

1. What Beto 200 ZK is and what it is used for
2. What you need to know before taking Beto 200 ZK
3. How to take Beto 200 ZK
4. Possible side effects
5. How to store Beto 200 ZK
6. Contents of the pack and other information

1. What Beto 200 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 200 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 200 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 prophylaxis following the acute phase of myocardial infarction,
in cases 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 200 ZK

When not to use Beto 200 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 cardiogenic shock due to severe heart dysfunction;
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 severe circulatory disorders (severe peripheral arterial disease);
if the patient has untreated and uncontrolled heart failure (a condition usually causing
shortness of breath 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 high acidity of 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;
o verapamil and diltiazem (medicines used to reduce blood pressure);
o antiarrhythmic medicines such as disopyramide (medicines used to treat abnormal
heart rhythm).
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 continuously or intermittently receiving medicines that increase heart contractility;
they have a slow heart rate (less than 68 beats/min at rest before treatment);
their systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 200 ZK, consult your doctor or pharmacist if:
the patient has asthma, bronchitis, or lung function disorders;
the patient has heart or circulatory disorders (e.g. slow heart rate); treatment with Beto 200 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 the rare form of angina known as Prinzmetal's angina;
the patient is undergoing surgery requiring general anaesthesia. The anaesthetist must be informed about the use of Beto 200 ZK.
the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor blocker 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 200 ZK is not recommended in children under 6 years of age.

Beto 200 ZK and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Beto 200 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 in the treatment of 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 antiarrhythmic medicines.
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-lowering effect during the first days after starting fingolimod.
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.
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 200 ZK, food, drink and alcohol
Beto 200 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 200 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 200 ZK may be used during pregnancy only if clearly indicated and after careful assessment by the doctor of the benefit-risk ratio. Evidence shows that metoprolol reduces blood flow in the placenta, which may lead to disturbances in fetal development. Treatment with Beto 200 ZK should be discontinued 48 to 72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored by the doctor for 48 to 72 hours after birth.

Breastfeeding
Beto 200 ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding unless absolutely necessary. Although the occurrence of adverse effects at recommended doses is unlikely, breastfed infants should be carefully monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).

Driving and using machines
During treatment with Beto 200 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that impairs 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 200 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 200 ZK.

3. How to use Beto 200 ZK

This medicine should always be used exactly as directed by the doctor. 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).

The doctor will inform you how many tablets to take and when. The prescribed dose depends on the type and severity of the condition.

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 medicine to lower blood pressure.

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 ischemic 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, it is necessary to stabilize the patient's condition with medicines usually used in heart failure therapy. The dose of Beto 200 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. 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.
• 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 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 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 exceeding 190 mg per day have not been studied in children and adolescents.

Beto 200 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 200 ZK is too strong or too weak, contact your doctor or pharmacist.

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

Beto 200 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 than the recommended dose of Beto 200 ZK
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 200 ZK include: dangerously low blood pressure, severe disturbances in heart function, breathing difficulties, 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 200 ZK, and the effects of a significant overdose may persist for several days.

Treatment of overdose
The patient should be treated in a hospital, preferably 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 to monitor for signs of poisoning.

Missed dose of Beto 200 ZK
Do not take a double dose to make up for a missed dose. Continue treatment as directed by the doctor.

Stopping treatment with Beto 200 ZK
Before stopping or discontinuing treatment with Beto 200 ZK, consult your doctor.

Beto 200 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 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 lowering of 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 less than 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disturbances, nightmares, difficulty concentrating
• abnormal sensations of tingling, pricking, or numbness of the skin (paraesthesiae)
• transient worsening of symptoms of weakened heart muscle (with swelling of ankles and feet), first-degree atrioventricular conduction block (first-degree AV block), chest pain (angina), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute heart attack)
• bronchospasm (bronchoconstriction)
• skin rash (psoriasiform or dystrophic skin changes), excessive sweating
• muscle cramps

Rare (may affect less than 1 in 1000 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 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 vasospastic disorders of 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Beto 200 ZK

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Translation of some abbreviations appearing on the blister:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/Expiry date: see embossing (on the edge of the blister).

6. Contents of the packaging and other information

What Beto 200 ZK contains
Active substance:
Metoprolol succinate.
Each prolonged-release tablet contains 190 mg of metoprolol succinate, equivalent to
200 mg of metoprolol tartrate.
Other ingredients:
Sucrose, granules (sucrose, corn starch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460), crospovidone, colloidal anhydrous silica.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 200 ZK looks like and contents of the packaging
White, elongated tablets with a score line on both sides.
Prolonged-release tablets are packed in PVC/Aclar/Aluminium or PP/Aluminium blisters and placed in a cardboard box.
Blister packs:
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the responsible entity 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

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): 61499.04.00
Parallel Import Authorisation Number: 241/24