Beto 200 Zk

Leaflet accompanying the packaging: patient information

Beto 25 ZK, 23.75 mg, prolonged-release tablets

Beto 50 ZK, 47.5 mg, prolonged-release tablets

Beto 100 ZK, 95 mg, prolonged-release tablets

Beto 150 ZK, 142.5 mg, prolonged-release tablets

Beto 200 ZK, 190 mg, prolonged-release tablets

Metoprolol succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Beto ZK and what is it used for
• 2. Important information before taking Beto ZK
• 3. How to take Beto ZK
• 4. Possible side effects
• 5. How to store Beto ZK
• 6. Contents of the packaging and other information

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

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

2. Important information before taking Beto ZK

When not to take Beto ZK

if the patient is allergic to metoprolol succinate or any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to other beta-adrenergic blockers;
if the patient has severe asthma or severe wheezing;
if the patient is in shock due to severe heart problems;
if the patient has conduction disorders in the heart (second or third degree atrioventricular block or high degree sinoatrial block) or heart rhythm disorders (sick sinus syndrome) unless they have a pacemaker;
if the patient has severe circulatory disorders (severe peripheral arterial disease);
if the patient has untreated and uncontrolled heart failure (the disease usually causes shortness of breath and swelling of 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 a more acidic than usual blood reaction (so-called metabolic acidosis);
if the patient is taking any of the following medicines:
monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression;
verapamil and diltiazem (medicines used to lower blood pressure);
antiarrhythmic drugs, such as disopyramide (medicines used to treat irregular heart rhythm).
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 heart contractions.
they have a slow heart rate (less than 68 beats/min at rest before treatment).
their systolic blood pressure is consistently below 100 mmHg.

Warnings and precautions

Before starting to take Beto ZK, the patient should discuss it with their doctor or pharmacist if:
they have asthma, bronchitis, or lung function disorders;
they have heart function disorders (e.g., slow heart rate) or circulatory disorders (taking Beto 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 chest pain, so-called Prinzmetal's angina;
they need to undergo surgery that requires general anesthesia. They should inform the anesthesiologist about taking Beto 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 ZK should not be used in children under 6 years of age.

Beto ZK and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Beto 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-adrenergic blockers (also those contained in eye drops).
Medicines that affect blood circulation in the fingers and toes (e.g., ergot alkaloids, which can be used to treat migraine).
Medicines used to treat depression.
Medicines used to treat other mental disorders.
Antiretroviral medicines used to treat AIDS and some other diseases.
Antihistamines (also available without a prescription, used to treat hay fever and other allergies, colds, and other conditions).
Medicines used to prevent malaria.
Medicines used to treat fungal infections.
Medicines that affect liver enzyme activity, rifampicin used to treat tuberculosis.
Medicines used to treat heart function disorders (also angina pectoris), such as amiodarone, digoxin, nitrates, and antiarrhythmic drugs.
Other medicines that slow down 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 rate-slowing effect in the first days after starting fingolimod.
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.
Insulin and other antidiabetic medicines.
Nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
Local anesthetics containing lidocaine.
A medicine called dipyridamole, which prevents blood clots.

Beto ZK with food, drinks, and alcohol

Beto ZK and alcoholmay enhance each other's sedative effects. The blood alcohol concentration may reach higher values and decrease more slowly.
During treatment with Beto ZK, the patient should avoid drinking alcohol.

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 ZK can be used during pregnancy only if clearly necessary and after a careful assessment of the benefit-risk ratio by the doctor. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to fetal development disorders. Treatment with Beto 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 ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding if it is not 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 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 ZK contains glucose, lactose, and sucrose (sugar)

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

3. How to take Beto ZK

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
The doctor will inform the patient about the number of 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:

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 medicine to lower blood pressure.

Chest pain (angina pectoris)

• 95-190 mgof metoprolol succinate once a day.
• If necessary, the doctor may use an additional medicine to treat 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
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 ZK should be adjusted individually for the patient.

• The recommended initial dose in the first weekfor patients with heart failure(classified as NYHA class III-IV) 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 NYHA class II) 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
Hypertension:
In children over 6 years of age, 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/day have not been studied.
Beto 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 ZK is too strong or too weak, they should consult their doctor or pharmacist.

Patient over 65

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 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 glass).

Taking a higher dose of Beto 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 overdose, the doctor will decide what action to take.
The patient should show the packaging of the medicine to the doctor, so it is known what medicine was taken and what action to take.
Symptoms of overdose
Symptoms that may occur as a result of an overdose of Beto ZK include: dangerously low blood pressure, severe heart function disorders, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple discoloration of the skin), and death.
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 ZK

The patient should not take a double dose to make up for a missed dose but continue treatment as prescribed by the doctor.

Stopping treatment with Beto ZK

Before stopping or prematurely discontinuing treatment with Beto ZK, the patient should consult their doctor.
Beto ZK should not be stopped abruptlybut the dose should be gradually reduced. Abrupt cessation of beta-blocker treatment may worsen heart failure symptoms 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 ZK can cause side effects, although not everybody gets 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 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)
• transient worsening of heart failure symptoms (with ankle edema), 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 (bronchospasm)
• skin rash (urticaria-like and dystrophic skin changes), increased sweating
• muscle cramps

Rare (may affect up to 1 in 1000 people):

• worsening of diabetes without characteristic symptoms (latent diabetes)
• nervousness- visual impairment, dryness or irritation of the eyes (notable 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, 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 vasospastic disorders of the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Beto ZK

The medicine should be stored out of 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 month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Shelf life after first opening:
Bottles: 6 months
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.

6. Contents of the packaging and other information

What Beto ZK contains

The active substanceis metoprolol succinate.
Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, which corresponds to 25 mg of metoprolol tartrate.
Each prolonged-release tablet contains 47.5 mg of metoprolol succinate, which corresponds to 50 mg of metoprolol tartrate.
Each prolonged-release tablet contains 95 mg of metoprolol succinate, which corresponds to 100 mg of metoprolol tartrate.
Each prolonged-release tablet contains 142.5 mg of metoprolol succinate, which corresponds to 150 mg of metoprolol tartrate.
Each prolonged-release tablet contains 190 mg of metoprolol succinate, which corresponds to 200 mg of metoprolol tartrate.
Other ingredients are: sucrose, pellets (sucrose, cornstarch, glucose syrup), polyacrylate, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal silica, anhydrous.
Coating Opadry II [lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000].
In addition, Beto 100 ZK tablets contain yellow iron oxide (E172).

What Beto ZK looks like and contents of the pack

Beto 25 ZK, Beto 50 ZK, and Beto 200 ZK
White, elongated tablets, with a dividing line on both sides.
Beto 100 ZK
Light yellow, elongated tablets, with a dividing line on both sides.
Beto 150 ZK
White, elongated tablets, with two dividing lines on both sides.
Prolonged-release tablets are packaged in blisters of PP/Aluminum foil or PVC/Aclar/Aluminum foil, and placed in a carton, or in HDPE bottles with HDPE caps, placed in a carton.
Blisters:
Pack sizes: 28, 30, and 60 prolonged-release tablets
Bottle:
Pack sizes: 60 prolonged-release tablets

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia