Beto 25 Zk

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Beto 25 ZK(MetoHEXAL Succ 23.75 mg)

23.75 mg, prolonged-release tablets

Metoprolol succinate
Beto 25 ZK and MetoHEXAL Succ 23.75 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. 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 any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Beto 25 ZK and what is it used for
• 2. Important information before taking Beto 25 ZK
• 3. How to take Beto 25 ZK
• 4. Possible side effects
• 5. How to store Beto 25 ZK
• 6. Contents of the package and other information

1. What is Beto 25 ZK and what is it used for

Metoprolol tartrate (selective beta-adrenergic blocker), the active substance of Beto 25 ZK, blocks certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 25 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 25 ZK

When not to take Beto 25 ZK

• •if the patient is allergic to metoprolol tartrate or to 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 disorders;
• •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 the patient has a pacemaker;
• •if the patient has severe circulatory disorders (severe peripheral arterial disease);
• •if the patient has untreated and uncontrolled heart failure (a disease that usually causes shortness of breath and swelling of the ankles);
• •if the patient has a slow heart rate (<50 beats per minute at rest before treatment);< li>
• •if the patient has very low blood pressure (systolic blood pressure <90 mmhg);< li>
• •if the patient has a more than usual acidic 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 heartbeat).

In patients with chronic heart failure, metoprolol should not be used if:

• •they have unstable, uncontrolled heart failure (which may be manifested by 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 per minute at rest before treatment).
• •their systolic blood pressure is consistently less than 100 mmHg.

Warnings and precautions

Before starting to take Beto 25 ZK, you should discuss it with your doctor or pharmacist if:

• •you have asthma, bronchitis, or lung function disorders;
• •you have heart function disorders (e.g., slow heart rate) or circulatory disorders (taking Beto 25 ZK may worsen their course);
• •you have diabetes;
• •you have thyroid function disorders;
• •you have severe liver disease;
• •you have ever had a severe allergic reaction to any allergen;
• •you have a rare form of angina pectoris, so-called Prinzmetal's angina;
• •you need to undergo surgery that requires general anesthesia. You should inform the anesthesiologist that you are taking Beto 25 ZK.
• •you have a tumor of the adrenal gland that secretes hormones (phaeochromocytoma): in such a case, it is necessary to use a medicine that blocks alpha-adrenergic receptors beforehand and at the same time.
• •you 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. It is not recommended to use Beto 25 ZK in children under 6 years of age.

Beto 25 ZK and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Beto 25 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 peripheral blood circulation (in fingers and toes), such as 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, 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 that affect the activity of liver enzymes, 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 reduce heart rate: the use of fingolimod (a medicine used in adults, children, and adolescents to treat relapsing-remitting multiple sclerosis) with beta-adrenergic blockers may enhance the heart rate-slowing effect in the first few days after starting fingolimod.
• •Other medicines that lower blood pressure: the use of aldesleukin (a synthetic protein medicine used to treat kidney cancer with metastases to other organs) with beta-adrenergic 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 25 ZK with food, drink, and alcohol

Beto 25 ZK and alcoholmay mutually enhance their sedative effects. The concentration of alcohol in the blood may reach higher values and decrease more slowly.
During treatment with Beto 25 ZK, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Beto 25 ZK can be used during pregnancy only if clearly necessary and after a careful assessment by the doctor of the ratio of expected benefits to possible risks. There is evidence that metoprolol reduces blood flow in the placenta, which can lead to fetal development disorders.
Treatment with Beto 25 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 25 ZK passes into breast milk.
You should not take metoprolol during breastfeeding if it is not absolutely necessary.
Although the occurrence of side effects is unlikely when using the recommended doses, you should closely monitor the breastfed infant for possible symptoms caused by the medicine (e.g., the doctor will monitor heart rate).

Driving and using machines

During treatment with Beto 25 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 to another medicine.

Beto 25 ZK contains glucose, lactose monohydrate, and sucrose (sugar)

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking Beto 25 ZK.

3. How to take Beto 25 ZK

This medicine should always be taken as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
The doctor will inform you 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 dosage is usually used:

High blood pressure:

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

Chest pain (angina pectoris)

• 95-190 mgof metoprolol tartrate once a day.
• If necessary, the doctor may use an additional medicine used to treat coronary heart disease.

Heart rhythm disorders, including accelerated heart rate (arrhythmias)

• 95-190 mgof metoprolol tartrate once a day.

Treatment after heart attack

• 190 mgof metoprolol tartrate once a day.

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

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

Migraine prevention

• 95-190 mgof metoprolol tartrate once a day.

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 to treat heart failure, and then adjust the dose of Beto 25 ZK individually for the patient.

• -The recommended initial dose in the first weekfor patients with heart muscle weakness(classified as heart failure grade III-IVaccording to NYHA) is 11.88 mgof metoprolol tartrate once a day. The doctor may increase the dose in the second weekto 23.75 mgof metoprolol tartrate once a day.

The recommended initial dose in the first 2 weeksfor patients with heart muscle weakness(classified as heart failure grade IIaccording to NYHA) is 23.75 mgof metoprolol tartrate once a day.

• -Then the doctor will double the dose. The dose can be doubled every two weeksuntil a dose of 190 mgof metoprolol tartrate once a dayis reached or the maximum dose tolerated by the patient.
• -The recommended dose for long-term maintenance treatmentis 190 mgof metoprolol tartrate once a dayor the maximum dose tolerated by the patient.

Use in children and adolescents
High blood pressure:
In children over 6 years old, the dose depends on body weight. The doctor will determine the dose suitable for the patient.
Usually, the initial dose of metoprolol tartrate 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 25 ZK should not be used in children under 6 years of age.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto 25 ZK is too strong or too weak, you should consult your doctor or pharmacist.

Elderly patients

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 25 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 you should avoid crushing or chewing them. Tablets should be washed down with water (at least 1/2 cup).

Taking a higher dose of Beto 25 ZK than recommended

You should immediately consult a 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.
You should show the packaging of the medicine to the doctor, so that 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 25 ZK may 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.
The first symptoms of overdose occur after 20 minutes to 2 hours after taking Beto 25 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 should be closely monitored by the doctor for at least 4 hours for symptoms of poisoning.

Missing a dose of Beto 25 ZK

You should not take a double dose to make up for a missed dose, but continue treatment as directed by your doctor.

Stopping treatment with Beto 25 ZK

Before stopping or prematurely discontinuing treatment with Beto 25 ZK, you should consult your doctor.
Beto 25 ZK should not be stopped abruptly, but its dose should be gradually reduced.
Sudden discontinuation of beta-adrenergic blockers may cause worsening of heart failure symptoms and increase the risk of heart attack and sudden cardiac death.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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
• 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, 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 swelling of the ankles and feet), 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 (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):

• reduced platelet count (thrombocytopenia), reduced 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 necrosis (gangrene) in patients with severe peripheral 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 vasospasm of the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Beto 25 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 packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.

Translation of some abbreviations on the blister pack:

Ch.-B./verwendbar bis: see embossing - Batch number/Expiry date: see embossing (on the blister pack).
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Beto 25 ZK contains

The active substanceis metoprolol tartrate.
Each prolonged-release tablet contains 23.75 mg of metoprolol tartrate, which corresponds to 25 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: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 25 ZK looks like and what the package contains

Beto 25 ZK tablets are white, elongated, with a dividing line on both sides.
Blisters of PP/Aluminum or PVC/Aclar/Aluminum foil in a cardboard box.
Package size: 30 or 60 prolonged-release tablets.
To obtain more detailed information, you should contact the marketing authorization holder or 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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Germany, the country of export: 61494.00.00
Parallel import authorization number: 269/22
Date of leaflet approval: 29.06.2022
[Information about the trademark]