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 ( MetoHEXAL Succ 190 mg)
190 mg, prolonged-release tablets
Metoprololi succinas
Beto 200 ZK and MetoHEXAL Succ 190 mg are different trade names for the same medicine.
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 doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others.
The medicine may harm another person, even if their symptoms are identical.
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 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, primarily located in the heart.
Beto 200 ZK is used for:

• Mild to moderate heart failure (ejection fraction ≤40%) that is stable and has remained unchanged for at least 4 weeks. Beto 200 ZK is used as an addition to standard treatment with vasodilators (ACE inhibitors) and diuretics, and, if necessary, cardiac glycosides.

Additionally, Beto 200 ZK is used:

• For the treatment of high blood pressure;
• For the treatment of chest pain or heart pain (angina pectoris);
• For the treatment of heart rhythm disorders, including rapid heartbeat;
• For the prevention following the acute phase of myocardial infarction;
• For unpleasant sensations of irregular and/or forceful heartbeat (hyperkinetic heart syndrome);
• For the prevention of migraine.

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 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 cardiac pacemaker implanted;
• 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 acidic blood condition (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 lower blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

When using Beto 200 ZK, certain antiarrhythmic drugs (calcium channel blockers such as verapamil and diltiazem or other antiarrhythmics) must not be administered intravenously. Inform your doctor that you are taking Beto 200 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 continuously or intermittently receiving 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 200 ZK, discuss with your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders, as 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 200 ZK may worsen these conditions);
• the patient has diabetes or 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, potentially resulting in complete block of impulse conduction;
• the patient has thyroid function disorders;
• the patient has severe liver disease (see section 3 “How to take Beto 200 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 200 ZK;
• the patient has a rare form of angina, so-called Prinzmetal's angina;
• the patient is undergoing surgery requiring general anesthesia. Inform the anesthesiologist that you are taking Beto 200 ZK;
• the patient has a hormone-secreting adrenal medulla tumor (pheochromocytoma): in such cases, prior and concomitant use of an alpha-adrenergic receptor-blocking medicine is necessary;
• the patient has psoriasis.

If the heart rate slows down or the rhythm becomes irregular, contact your doctor immediately. The doctor may prescribe a lower dose of metoprolol or gradually discontinue Beto 200 ZK.
In patients with acute myocardial infarction, treatment with metoprolol has been associated with an increased risk of severe hypotension (cardiogenic shock). Since this particularly affects patients with unstable circulation, metoprolol should only be administered after stabilization of circulation in patients with myocardial infarction.
Do not abruptly stop taking Beto 200 ZK (see section 3 “Discontinuing Beto 200 ZK”).
There is limited experience in treating patients with heart failure who:

• have very severe, variable-grade (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 for heart surgery, if Beto 200 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. Use of Beto 200 ZK is not recommended in children under 6 years of age.
Doping
Use of metoprolol may result in positive anti-doping test results.
Beto 200 ZK and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future 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 such as verapamil, diltiazem, or nifedipine). When clonidine and Beto 200 ZK are used together and clonidine is suddenly discontinued, blood pressure may rise abruptly and severely. Do not stop taking clonidine before discontinuing Beto 200 ZK several days earlier. Clonidine should be tapered gradually (consult your doctor). Do not start treatment with Beto 200 ZK until several days after stopping clonidine.
• 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 other heart disorders (including angina), such as amiodarone, digoxin, nitrates, and antiarrhythmic medicines.
• Other medicines that reduce heart rate: fingolimod (a medicine used in adults, children, and adolescents to treat relapsing-remitting multiple sclerosis) used together with beta-blockers may enhance the heart rate-slowing effect during the first days of fingolimod treatment.
• Other medicines that lower blood pressure: aldesleukin (a synthetic protein used to treat metastatic kidney cancer) used together with beta-blockers may cause pronounced hypotensive effects.
• Insulin and other antidiabetic medicines. Their hypoglycemic effect is enhanced by Beto 200 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 anesthetics containing lidocaine.
• A medicine called dipyridamole, used to prevent blood clots.

Beto 200 ZK with food, drink, and alcohol
Beto 200 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol levels may reach higher values 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 evaluation by the doctor of the benefit-risk ratio. There is evidence that metoprolol reduces placental blood flow, which may lead to fetal developmental disorders. Treatment with Beto 200 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 200 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. While taking Beto 200 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. Such symptoms may occur especially when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 200 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 200 ZK.

3. How to take Beto 200 ZK

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Available in 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 your doctor has not advised otherwise, the usual dosage 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, your 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)

• 47.5–190 mg of metoprolol succinate once daily.
• If necessary, your doctor may add another medicine used in the treatment of ischaemic 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, your 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, the patient's condition must first be stabilised 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. Your doctor may increase the dose in 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.

• Afterwards, your 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. 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 exceeding 190 mg daily 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
Studies have not been conducted in patients over 80 years of age, therefore your doctor will increase the dose with particular caution in such patients.

Beto 200 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 200 ZK than prescribed
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 overdose of Beto 200 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 (bluish or purplish 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 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 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 prescribed by your doctor.

Stopping Beto 200 ZK
Before stopping or discontinuing treatment with Beto 200 ZK, consult your doctor.
Do not stop taking Beto 200 ZK suddenly, but gradually reduce the dose.
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 not everybody 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
• marked decrease in blood pressure, especially when changing body position from lying down to standing up, 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 (paraesthesiae)
• transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular block (first-degree atrioventricular conduction block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchoconstriction)
• skin rash (pityriasis-like 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 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 disturbances, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing loss
• tissue necrosis (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 the 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 vasoconstriction of the blood vessels in the fingers of the hands and feet (Raynaud's phenomenon).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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 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 effects can also be reported to the marketing authorization holder or the parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Beto 200 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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date – see embossing.
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 in use. This will help protect the environment.

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, 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 200 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.
Blisters:
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
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

Marketing Authorization Number in Germany, the country of export: 61494.04.00
Parallel Import Authorization Number: 89/26