Beto 25 Zk

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Beto 25 ZK (Metoprolol Succinate Sandoz Retard 25), 23.75 mg, Prolonged-Release Tablets

Prolonged-release
Metoprolol succinate
Beto 25 ZK and Metoprolol Succinate Sandoz Retard 25 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. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Metoprolol succinate, 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 rapid heart rate,
• for the prevention of heart attackafter an acute phase,
• in case ofunpleasant 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 you are allergic to metoprolol succinate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other beta-adrenergic blocking agents;
• if you have severe asthma or severe wheezing;
• if you have shock due to severe heart problems;
• if you have conduction disorders in the heart (second or third degree atrioventricular block, high degree sinoatrial block) or heart rhythm disorders (sick sinus syndrome) unless you have a pacemaker;
• if you have severe circulatory disorders (severe peripheral arterial disease);
• if you have untreated and uncontrolled heart failure (a disease that usually causes shortness of breath and swelling of the ankles);
• if you have slow heart rate (<50 beats min at rest before treatment);< li>
• if you have very low blood pressure (systolic blood pressure <90 mmhg);< li>
• if you have a more acidic than usual blood reaction (so-called metabolic acidosis);
• if you are 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 anti-arrhythmic medicines, 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 receiving medicines that increase the strength of heart contractions.
• they have 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 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 ZK may worsen their course);
• you have diabetes;
• you have thyroid function disorders;
• you have severe liver disease;
• you have 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 about taking Beto ZK.
• you 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.
• you have psoriasis.

Taking metoprolol may cause positive results in doping tests.

Children and adolescents

Experience with treatment in children under 6 years of age is limited. It is not recommended to use Beto ZK in children under 6 years of age.

Beto ZK and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you 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 blocking agents (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 liver enzyme activity, rifampicin used to treat tuberculosis.
• Medicines used to treat heart function disorders (also angina pectoris), such as amiodarone, digoxin, nitrates, and anti-arrhythmic medicines.
• Other medicines that slow down heart rate: the use of fingolimod (a medicine used in adults, children, and adolescents to treat relapsing-remitting multiple sclerosis) with beta-adrenergic blocking agents may enhance the heart rate slowing effect in the first 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 blocking agents may cause enhanced blood pressure lowering effect.
• Insulin and other anti-diabetic medicines.
• Non-steroidal anti-inflammatory medicines (so-called 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 mutually enhance their sedative effects. The blood alcohol concentration may reach higher values and decrease more slowly. During treatment with Beto 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, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Beto ZK can be used during pregnancy only if clearly necessary and after a careful assessment of the benefit to 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. 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 carefully monitor the breastfed infant for signs of metoprolol action (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 of impairing the ability to drive vehicles, operate machinery, and work in potentially hazardous conditions. Symptoms may occur especially when consuming alcohol, as well as after changing the medicine or its dose.

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

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

3. How to take Beto ZK

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how many tablets to take and when to take them. The prescribed dose depends on the type and severity of the disease.

If your 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, your doctor may increase the dose to 95-190 mgof metoprolol succinate once a dayor add another medicine that lowers blood pressure.

Angina pectoris

• 95-190 mgof metoprolol succinate once a day.
• If necessary, your doctor may add another medicine used to treat coronary heart disease.

Heart rhythm disorders, including rapid heart rate

• 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

• 95 mgof metoprolol succinate once a day.
• -If necessary, your 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 heart failure 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 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 over 6 years of age, the dose depends on body weight. The doctor will determine the dose suitable for the patient. The usual 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. It is not recommended to use Beto ZK in children under 6 years of age. The duration of treatment is determined by the doctor. If you feel that the effect of Beto ZK is too strong or too weak, contact 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 ZK is intended for oral use. The tablets should be taken once a day, preferably during breakfast. The tablets can be divided into equal doses. They can be swallowed whole or divided, but you should avoid crushing or chewing them. The tablets should be taken with water (at least ½ glass).

Taking a higher dose of Beto ZK than recommended

You should immediately contact your 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 doctor the packaging of the medicine so that it is known what medicine was taken and what action to take. Symptoms of overdose 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 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 ZK

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

Stopping treatment with Beto ZK

Before stopping or prematurely discontinuing treatment with Beto ZK, you should consult your doctor. You should not stop taking Beto ZK suddenly, but gradually reduce the dose. Stopping beta-adrenergic blocking agents abruptly may worsen the symptoms of heart failure and increase the risk of heart attack and sudden cardiac death. If you have any further questions about the use of this medicine, ask 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
• cold 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 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 vasospasm of the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Adverse Reaction 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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beto ZK

Medicines should be kept out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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. The other ingredients are: sucrose, cornstarch, liquid glucose, polyacrylate dispersion 30%, talc (E 553B), magnesium stearate (E 470b), microcrystalline cellulose (E 460), crospovidone, silica colloidal anhydrous (E 551). Coating [lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000].

What Beto ZK looks like and contents of the pack

Beto 25 ZK White, oblong 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. Blisters: Pack sizes: 30 and 60 prolonged-release tablets For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V. Veluwezoom 22 1327 AH Almere Netherlands

Manufacturer:

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

Parallel importer:

Aga Kommerz spol. s r.o. Frydecka 2006 737 01 Cesky Tesin Czech Republic

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY ul. Wł. Żeleńskiego 45 31-353 Kraków Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warsaw Netherlands marketing authorization number:RVG 32376

Netherlands parallel import authorization number: 90/22 Date of approval of the leaflet: 16.02.2022

[Information about the registered trademark]