Beto 150 Zk

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Beto 150 ZK(MetoHEXAL Succ 142.5 mg)
142.5 mg, prolonged-release tablets
Metoprolol succinate
Beto 150 ZK and MetoHEXAL Succ 142.5 mg are different trade names for the same
drug.

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects 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 150 ZK and what is it used for
• 2. Important information before taking Beto 150 ZK
• 3. How to take Beto 150 ZK
• 4. Possible side effects
• 5. How to store Beto 150 ZK
• 6. Contents of the packaging and other information

1. What is Beto 150 ZK and what is it used for

Metoprolol succinate (selective beta-adrenergic blocker), the active substance of Beto 150 ZK, blocks
some beta-adrenergic receptors in the body, mainly located in the heart.
Beto 150 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 150 ZK

When not to take Beto 150 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 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 min 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 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 receiving drugs 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 less than 100 mmHg.

Warnings and precautions

Before starting to take Beto 150 ZK, you should discuss it with your doctor or pharmacist,
if:

• the patient has asthma, bronchitis, or lung function disorders;
• the patient has heart function disorders (e.g., slow heart rate) or circulatory disorders (taking Beto 150 ZK may worsen their course);
• the patient has diabetes;
• the patient has thyroid function disorders;
• the patient has severe liver disease;
• the patient has had a severe allergic reaction to any allergen;
• the patient has a rare form of chest pain, so-called Prinzmetal's angina;
• the patient needs to undergo surgery that requires general anesthesia. The anesthesiologist should be informed about taking Beto 150 ZK;
• the patient has 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;
• the patient has psoriasis.

Taking metoprolol may cause positive results in anti-doping tests.

Children and adolescents

Experience with treatment in children under 6 years old is limited.
Beto 150 ZK should not be used in children under 6 years old.

Beto 150 ZK and other medicines

You should tell your doctor or pharmacist about all medicines you are taking
currently or recently, and about medicines you plan to take.
Beto 150 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 (including those contained in eye drops).
• Medicines that affect blood circulation in the limbs (fingers and toes), such as ergot alkaloids (which can be used to treat migraine).
• Medicines used to treat depression.
• Medicines used to treat other psychiatric disorders.
• Antiretroviral medicines used to treat AIDS and some 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 that affect liver enzyme activity, rifampicin used to treat tuberculosis.
• Medicines used to treat heart rhythm disorders(including 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 few 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 anti-diabetic medicines.
• Non-steroidal anti-inflammatory medicines(NSAIDs), used to treat pain and inflammation.
• Local anesthetics containing lidocaine.
• A medicine called dipyridamole, which prevents blood clots.

Beto 150 ZK with food, drink, and alcohol

Beto 150 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 150 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 150 ZK can be used during pregnancy only if clearly necessary and after careful evaluation by the doctor of the expected benefits to the potential risk. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to fetal development disorders. Treatment with Beto 150 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 150 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 side effects of the medicine (e.g., the doctor will monitor heart rate).

Driving and using machines

During treatment with Beto 150 ZK, dizzinessor fatiguemay occur. These symptoms may
affect reaction speed to the extent of impairing the ability to drive vehicles, operate machines, and work in potentially hazardous conditions. Symptoms may occur especially when consuming alcohol, as well as when switching from one medicine to another.

Beto 150 ZK contains glucose, lactose monohydrate, and sucrose (sugar)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Beto 150 ZK.

3. How to take Beto 150 ZK

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

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

Hypertension (high blood pressure)

• 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 antihypertensive 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 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, it is necessary to stabilize the patient's condition with medicines usually used to treat heart failure, and then adjust the dose of Beto 150 ZK 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 maintenance doseis 190 mgof metoprolol succinate once a dayor the maximum dose tolerated by the patient.

• The recommended dose in 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 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 higher than 190 mg per day have not been studied.
Beto 150 ZK should not be used in children under 6 years old.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto 150 ZK is too strong or too weak, you should consult your 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 150 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 chewing or crushing them. Tablets should be washed down with water (at least ½ glass).

Taking a higher dose of Beto 150 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 150 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.
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 150 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 150 ZK

Before stopping or prematurely discontinuing treatment with Beto 150 ZK, you should consult your doctor.
Beto 150 ZK should not be stopped abruptly, but its dose should be gradually reduced.
Sudden discontinuation 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 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 of fatigue.

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

• dizziness, headache
• slow heart rate (bradycardia)
• palpitations
• significant 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 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):

• 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 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beto 150 ZK

• The medicine should be stored in a place invisible and inaccessible to children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Do not store above 25°C.
• 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. Such measures will help protect the environment.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: see imprint - batch number/expiry date: see imprint

6. Contents of the packaging and other information

What Beto 150 ZK contains

The active substanceis metoprolol succinate.Each prolonged-release tablet contains 142.5 mg of metoprolol succinate.
Other ingredients are:sucrose, pellets (sucrose, cornstarch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone, silicon dioxide, lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000.

What Beto 150 ZK looks like and contents of the pack

Beto 150 ZK tablets are white, oblong, with a dividing line on both sides.
Prolonged-release tablets are packaged in blisters of PP/Al foil or PVC/Aclar-Al foil and placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets
To obtain more detailed information, you 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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:61494.03.00
Parallel import authorization number:642/12
Date of leaflet approval: 12.10.2022
[Information about the trademark]