Beto 100 zk

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Beto 100 ZK (MetoHEXAL Succ 95 mg)
95 mg, prolonged-release tablets
Metoprololi succinas
Beto 100 ZK and MetoHEXAL Succ 95 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 for future reference.
• If you have any doubts, 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:

1. What Beto 100 ZK is and what it is used for
2. What you need to know 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, primarily located in the heart.
Beto 100 ZK is used:

• in the treatment of high blood pressure,
• in the treatment of chest pain (angina),
• in the treatment of heart rhythm disorders, including rapid heartbeat,
• in the prevention following the acute phase of myocardial infarction (heart attack),
• in cases of unpleasant sensations of irregular and/or forceful heartbeat,
• in the prevention of migraine,
• in the treatment of heart failure.

In children and adolescents aged 6 to 18 years:

• in the 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 due to serious heart dysfunction;
• if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or cardiac arrhythmias (sick sinus syndrome), except in patients with an 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 abnormally acidic 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 lower blood pressure);
  o antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

In patients with chronic heart failure, metoprolol must not be used 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);
• systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 100 ZK, consult a 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 100 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 a rare form of angina called Prinzmetal's angina;
• the patient is scheduled for surgery requiring general anaesthesia. The anaesthetist must be informed about the use of Beto 100 ZK.
• the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic blocking agent 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.
The use of Beto 100 ZK is not recommended in children under 6 years of age.
Interaction of Beto 100 ZK with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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).
• 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 antiarrhythmics.
• 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 lead to an enhanced blood pressure-lowering effect.
• Insulin and other antidiabetic medicines.
• Non-steroidal anti-inflammatory drugs (so-called NSAIDs), used to treat pain and inflammation.
• Local anaesthetics containing lidocaine.
• The 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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 disturbances in 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 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 at recommended doses, breastfed infants should be carefully monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).
Driving and operating machinery
During treatment with Beto 100 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 pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 100 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 100 ZK.

3. How to use Beto 100 ZK

This medicine should always be taken exactly as directed 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 condition.

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)

• 95–190 mg of metoprolol succinate once daily.
• If necessary, your doctor may add another medicine used in the treatment of ischaemic heart disease.

Heart rhythm disorders, including rapid heartbeat (arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after heart attack (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, 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 the treatment of heart failure. The dose of Beto ZK should then be individually adjusted for each patient.

• The recommended starting dose in 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 starting dose for 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.
• Your doctor will then 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 treatment 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 starting 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 100 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 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; therefore, your doctor will increase the dose particularly cautiously in such patients.

Beto 100 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 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 course of action.

Show the medicine packaging to the doctor so they know which medicine has been taken and what treatment is required.

Symptoms of overdose

Symptoms that may occur following an overdose of Beto 100 ZK include: dangerously low blood pressure, severe heart function disturbances, 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 100 ZK, and the effects of a significant overdose may last 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 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 prescribed by your doctor.

Stopping treatment with Beto 100 ZK

Before stopping or discontinuing treatment with Beto 100 ZK, consult your doctor.

Do not stop taking Beto 100 ZK suddenly, but gradually reduce the dose.

Abruptly stopping treatment with 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 everyone 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
• significant drop in blood pressure, especially when changing 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 less than 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disorders, nightmares, concentration disturbances
• 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 conduction block (first-degree atrioventricular block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchoconstriction)
• skin rash (eczematous 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 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 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 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 blood vessel spasms in 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 100 ZK

• Keep the medicine out of the 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 abbreviations appearing on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung - Batch number/expiry date: see imprint.
• 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 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 (E 460), crospovidone, colloidal anhydrous silicon dioxide.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

What Beto 100 ZK looks like and contents of the pack
Beto 100 ZK tablets are light yellow, elongated, and scored on both sides.
Packs consist of PVC/Aclar-aluminium blisters or PP/aluminium blisters in a cardboard box.
Pack sizes: 30 or 60 prolonged-release tablets.

For more detailed information, please contact the responsible party or parallel importer.

Responsible party 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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

German marketing authorization number, country of export: 61494.02.00
Parallel import authorization number: 566/15