Beto 100 Zk

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Beto 100 ZK (Meto-Succinat Sandoz)

95 mg, prolonged-release tablets

Metoprolol succinate
Beto 100 ZK and Meto-Succinat Sandoz are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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The leaflet should be kept so that it can be re-read if necessary.
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In case of any doubts, the doctor or pharmacist should be consulted.
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This medicine has been prescribed to a specific person. It should not be given to others.
The medicine may harm another person, even if the symptoms of their illness are the same.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

• 1. What is Beto 100 ZK and what is it 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 packaging and other information

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

Metoprolol succinate (selective beta-adrenergic blocker), the active substance of Beto 100 ZK, blocks certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 100 ZK is used:
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to treat high blood pressure,
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to treat chest pain,
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to treat heart rhythm disorders, including accelerated heart rate,
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for the prevention of heart attack,
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in case of unpleasant sensation of irregular and/or strong heartbeat,
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to prevent migraine,
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to treat heart failure.
In children and adolescents from 6 to 18 years old
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to treat high blood pressure(hypertension).

2. Important information before taking Beto 100 ZK

When not to take Beto 100 ZK

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if the patient is allergic to metoprolol succinate or to any of the other ingredients of this medicine (listed in section 6);
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if the patient is allergic to other beta-adrenergic blockers;
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if the patient has severe asthma or severe wheezing;
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if the patient is in shock due to severe heart problems;
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if the patient has conduction disorders in the heart (second or third degree atrioventricular block, high degree sinoatrial block) or heart rhythm disorders (sick sinus syndrome) unless they have a pacemaker;
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if the patient has severe circulatory problems (severe peripheral arterial disease);
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if the patient has untreated and uncontrolled heart failure (a disease that usually causes shortness of breath and swelling of the ankles);
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if the patient has a slow heart rate (<50 beats per minute at rest before treatment);
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if the patient has very low blood pressure (systolic blood pressure <90 mmhg);
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if the patient has a more acidic than usual blood reaction (so-called metabolic acidosis);
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if the patient is taking any of the following medicines:
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monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression;
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verapamil and diltiazem (medicines used to lower blood pressure);
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antiarrhythmic drugs, such as disopyramide (medicines used to treat irregular heartbeat).
In patients with chronic heart failure, metoprolol should not be used if:
they have unstable, uncontrolled heart failure (which may manifest as fluid accumulation in the lungs, poor circulation, or low blood pressure).
they are constantly or periodically taking medicines that increase the strength of the heart's contractions.
they have a slow heart rate (less than 68 beats per minute at rest before treatment).
their systolic blood pressure is consistently below 100 mmHg.

Warnings and precautions

Before starting to take Beto 100 ZK, the patient should discuss it with their doctor or pharmacist if:
they have asthma, bronchitis, or lung function disorders;
they have heart problems (e.g., slow heart rate) or circulatory problems (taking Beto 100 ZK may worsen their course);
they have diabetes;
they have thyroid function disorders;
they have severe liver disease;
they have had a severe allergic reaction to any allergen in the past;
they have a rare form of angina pectoris, so-called Prinzmetal's angina;
they need to undergo surgery that requires general anesthesia. The anesthesiologist should be informed about taking Beto 100 ZK.
they have a tumor of the adrenal gland that secretes hormones (pheochromocytoma): in such a case, it is necessary to use a medicine that blocks alpha-adrenergic receptors beforehand and at the same time.
they have psoriasis.
Taking metoprolol may cause positive results in doping tests.

Children and adolescents

Experience with the treatment of children under 6 years of age is limited.
Beto 100 ZK should not be used in children under 6 years of age.

Beto 100 ZK and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Beto 100 ZK interacts with many other medicines.
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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).
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Other beta-adrenergic blockers (also those contained in eye drops).
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Medicines that affect blood circulation in the limbs (fingers and toes), such as ergot alkaloids (which can be used to treat migraine).
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Medicines used to treat depression.
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Medicines used to treat other mental disorders.
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Antiretroviral medicines used to treat AIDS and some other diseases.
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Antihistamines (also available without a prescription, medicines used to treat hay fever and other allergies, colds, and other conditions).
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Medicines used to prevent malaria.
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Medicines used to treat fungal infections.
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Medicines that affect liver enzyme activity, rifampicin used to treat tuberculosis.
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Medicines used to treat heart rhythm disorders (also angina pectoris), such as amiodarone, digoxin, nitrates, and antiarrhythmic drugs.
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Other medicines that slow down the heart rate: taking fingolimod (a medicine used in adults, children, and adolescents to treat relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart-slowing effect in the first days after starting fingolimod.
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Other medicines that lower blood pressure: taking aldesleukin (a synthetic protein used to treat kidney cancer with metastases to other organs) with beta-blockers may cause enhanced blood pressure-lowering effect.
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Insulin and other anti-diabetic medicines.
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Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
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Local anesthetics containing lidocaine.
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A medicine called dipyridamole, which prevents blood clots.

Beto 100 ZK with food, drink, and alcohol

Beto 100 ZK and alcoholmay enhance each other's sedative effects. The concentration of alcohol in the blood may reach higher values and decrease more slowly.
During treatment with Beto 100 ZK, alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Beto 100 ZK can be used during pregnancy only if clearly necessary and after careful evaluation by the doctor of the expected benefits and possible risks. There is evidence that metoprolol reduces blood flow in the placenta, which can lead to fetal development disorders.
Treatment with Beto 100 ZK should be discontinued 48 to 72 hours before the expected delivery date. If this is not possible, the doctor will closely monitor the newborn for 48 to 72 hours after birth.
Breastfeeding
Beto 100 ZK passes into breast milk.
Metoprolol should not be taken during breastfeeding unless absolutely necessary.
Although the occurrence of side effects is unlikely when using the recommended doses, the breastfed infant should be closely monitored for signs of the drug's effects (e.g., the doctor will monitor the heart rate).

Driving and using machines

During treatment with Beto 100 ZK, dizzinessor fatiguemay occur. These symptoms may affect reaction speed to the extent that it impairs the ability to drive vehicles, operate machinery, and work in potentially hazardous conditions. Symptoms may occur especially when consuming alcohol, as well as when switching from one medicine to another.

Beto 100 ZK contains glucose, lactose monohydrate, and sucrose (sugar)

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Beto 100 ZK.

3. How to take Beto 100 ZK

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
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).
The doctor will inform how many tablets and when to take them. The prescribed dose depends on the type and severity of the disease.

If the doctor has not prescribed otherwise, the following dosing is usually used:

High blood pressure (hypertension)

• Patients with mild to moderate hypertensionshould take 47.5 mgof metoprolol succinate once a day.
• If necessary, the doctor may increase the dose to 95-190 mgof metoprolol succinate once a dayor use an additional blood pressure-lowering medicine.

Chest pain (angina pectoris)

• 95-190 mgof metoprolol succinate once a day.
• If necessary, the doctor may use an additional medicine for the treatment of coronary heart disease.

Heart rhythm disorders, including accelerated heart rate (arrhythmias)

• 95-190 mgof metoprolol succinate once a day.

Treatment after a heart attack

• 190 mgof metoprolol succinate once a day.

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

• 95 mgof metoprolol succinate once a day.
• If necessary, the doctor may increase the dose to 190 mgof metoprolol succinate once a day.

Migraine prevention

• 95-190 mgof metoprolol succinate once a day.

Heart failure (heart failure)
Before starting treatment for heart failure, the patient's condition must be stabilized with medicines usually used to treat heart failure, and then the dose of Beto 100 ZK should be adjusted individually for the patient.

• The recommended initial dose in the first weekfor patients with heart failure(classified as heart failure grade III-IVaccording to NYHA) is 11.88 mgof metoprolol succinate once a day. The doctor may increase the dose in the second weekto 23.75 mgof metoprolol succinate once a day. The recommended initial dose in the first 2 weeksfor patients with heart failure(classified as heart failure grade IIaccording to NYHA) is 23.75 mgof metoprolol succinate once a day.
• Then the doctor will double the dose. The dose can be doubled every two weeksuntil a dose of 190 mgof metoprolol succinate once a dayis reached or the maximum dose tolerated by the patient.
• The recommended dose for long-term maintenance treatmentis 190 mgof metoprolol succinate once a dayor the maximum dose tolerated by the patient.

Use in children and adolescents
High blood pressure
In children aged 6 and older, the dose depends on body weight. The doctor will determine the dose suitable for the patient.
Usually, the initial dose of metoprolol succinate is 0.48 mg/kg body weight once a day, but not more than 47.5 mg. The dose is adjusted to the nearest tablet strength. The doctor may increase the dose to 1.9 mg/kg body weight, depending on the blood pressure response. In children and adolescents, doses above 190 mg per day have not been studied.
Beto 100 ZK should not be used in children under 6 years of age.
The duration of treatment is determined by the doctor.
If the patient feels that the effect of Beto 100 ZK is too strong or too weak, they should contact their doctor or pharmacist.

Patients of advanced age

No studies have been conducted in patients over 80 years old, so in such patients, the doctor will be particularly cautious when increasing the dose of the medicine.
Beto 100 ZK is intended for oral administration.
Tablets should be taken once a day, preferably during breakfast. Tablets can be divided into equal doses. They can be swallowed whole or divided, but should not be crushed or chewed.
Tablets should be taken with water (at least 1/2 cup).

Taking a higher dose of Beto 100 ZK than recommended

The patient should immediately contact their doctor or go to the emergency department of the nearest hospital. Based on the severity of the symptoms of poisoning, the doctor will decide what action to take.
The packaging of the medicine should be shown to the doctor so that it is known what medicine was taken and what action should be taken.
Symptoms of overdose
Symptoms that may occur as a result of an overdose of Beto 100 ZK may include:
dangerously low blood pressure, severe heart problems, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple discoloration of the skin), and death.
The first symptoms of overdose occur after 20 minutes to 2 hours after taking Beto 100 ZK, and the effects of significant overdose may persist for several days.
Treatment of overdose
The patient should be treated in a hospital, in the intensive care unit. Even patients who seem to be in good condition and have only slightly overdosed on metoprolol will be closely monitored by the doctor for at least 4 hours for signs of poisoning.

Missing a dose of Beto 100 ZK

A double dose should not be taken to make up for a missed dose, but treatment should be continued as prescribed by the doctor.

Stopping treatment with Beto 100 ZK

Before stopping or prematurely discontinuing treatment with Beto 100 ZK, the patient should consult their doctor.
Beto 100 ZK should not be stopped abruptly, but its dose should be gradually reduced. Abrupt cessation of beta-blocker treatment may worsen the symptoms of heart failure and increase the risk of heart attack and sudden cardiac death.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Beto 100 ZK can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• feeling tired

Common (may affect up to 1 in 10 people):

• dizziness, headache
• slow heart rate (bradycardia),
• palpitations
• significantly lowered 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, diarrhea, constipation

Uncommon (may affect up to 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disorders, nightmares, concentration disorders
• abnormal sensation of tingling, prickling, or numbness of the skin (paresthesia)
• temporary worsening of heart failure symptoms (with ankle and foot swelling), first-degree atrioventricular block, chest pain (chest pain), poor heart function as a pump (cardiogenic shock) in patients with heart attack (acute myocardial infarction).
• bronchospasm
• skin rash (urticaria-like and 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
• visual impairment, dryness, or irritation of the eyes (noticeable when wearing contact lenses), conjunctivitis
• heart rhythm disorders (arrhythmia), conduction disorders
• 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):

• decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia)
• memory loss or memory disorders, confusion, hallucinations, personality changes (e.g., mood swings)
• ringing in the ears (tinnitus), hearing impairment
• tissue death (necrosis) in patients with severe circulatory disorders before treatment
• taste disorders
• hepatitis
• hypersensitivity to light with skin rashes after exposure to light, worsening 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 fats, such as cholesterol or triglycerides
• worsening of symptoms in patients with intermittent claudication or with vasospastic disorders of the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Beto 100 ZK

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The medicine should be stored out of sight and reach of children.
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This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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Do not store above 25°C.
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Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
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Translation of some abbreviations on the blister pack:

Ch.-B./verwendbar bis: see embossing - Batch number/Expiry date: see embossing.

6. Contents of the packaging and other information

What Beto 100 ZK contains

The active substanceis metoprolol succinate. Each prolonged-release tablet contains 95 mg of metoprolol succinate.
Other ingredients are:sucrose, pellets (sucrose, cornstarch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460), crospovidone, silicon dioxide, anhydrous.
Coating Opadry II [lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000], iron oxide yellow (E 172).

What Beto 100 ZK looks like and what the pack contains

Light yellow, elongated tablets with a dividing line on both sides.
The prolonged-release tablets are packaged in PP/Aluminum or PVC/Aclar-Aluminum blisters and placed in a cardboard box.
Pack sizes: 28, 30, or 60 prolonged-release tablets.
For more detailed information, the patient should 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorization number: 61509.02.00

Parallel import authorization number: 19/13 Date of leaflet approval: 13.01.2023

[Information about the trademark]