Beto 50 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Beto 50 ZK (MetoSuccinat Sandoz 47.5 mg)
47.5 mg, prolonged-release tablets
Metoprololi succinas
Beto 50 ZK and MetoSuccinat Sandoz 47.5 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Beto 50 ZK is and what it is used for
2. Important information before taking Beto 50 ZK
3. How to take Beto 50 ZK
4. Possible side effects
5. How to store Beto 50 ZK
6. Contents of the pack and other information

1. What Beto 50 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic), the active substance in Beto 50 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 50 ZK is used:

• in the treatment of high blood pressure,
• in the treatment of chest pain (angina),
• in the treatment of heart rhythm disorders, including rapid heartbeat,
• in the prevention following the acute phase of myocardial infarction,
• in cases of unpleasant sensations of irregular and/or forceful heartbeat,
• in the prevention of migraine,
• in the treatment of heart failure.

In children and adolescents aged 6 to 18 years:

• in the treatment of high blood pressure (hypertension).

2. Important information before using Beto 50 ZK

When not to use Beto 50 ZK

• if the patient is allergic to metoprolol succinate or to any of the other ingredients of this medicine (listed in section 6);

• if the patient is allergic to other beta-blocking agents;

• if the patient has severe asthma or severe attacks of wheezing;

• if the patient is in shock due to severe heart dysfunction;

• if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or cardiac rhythm disorders (sick sinus syndrome), except in patients with a cardiac pacemaker implanted;

• if the patient has serious circulatory disorders (severe peripheral arterial disease);

• if the patient has untreated and uncontrolled heart failure (a condition usually causing breathlessness and swelling around 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 abnormally high acidity of the blood (so-called metabolic acidosis);

• if the patient is 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 antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heartbeat).

Metoprolol must not be used in patients with chronic heart failure if:

• they have unstable, uncompensated heart failure (which may manifest as fluid accumulation in the lungs, poor circulation, or low blood pressure);
• they are receiving or have periodically received medicines that increase the force of heart contractions;
• they have a slow heart rate (less than 68 beats/min at rest before treatment);
• systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 50 ZK, consult your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders;
• the patient has heart or circulatory disorders (e.g. slow heart rate); treatment with Beto 50 ZK may worsen these conditions;
• the patient has diabetes;
• the patient has thyroid dysfunction;
• the patient has severe liver disease;
• the patient has ever experienced a severe allergic reaction to any allergen;
• the patient has a rare form of angina called Prinzmetal's angina;
• the patient is to undergo surgery requiring general anaesthesia. Inform the anaesthetist about the use of Beto 50 ZK.
• the patient has a hormone-secreting tumour of the adrenal gland (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic receptor blocker is required;
• the patient has psoriasis.

Use of metoprolol may lead to positive results in anti-doping tests.
Children and adolescents
Experience with treatment in children under 6 years of age is limited.
The use of Beto 50 ZK is not recommended in children under 6 years of age.
Beto 50 ZK and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Beto 50 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-blocking agents (including those contained in eye drops).
• Medicines affecting peripheral blood circulation (in fingers and toes), such as ergot alkaloids (which may be used to treat migraine).
• Medicines used to treat depression.
• Medicines used to treat other psychiatric disorders.
• Antiretroviral medicines used to treat AIDS and certain 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 affecting liver enzyme activity, rifampicin used to treat tuberculosis.
• Medicines used to treat heart disorders (including angina), such as amiodarone, digoxin, nitrates and antiarrhythmic medicines.
• Other medicines that reduce heart rate: concomitant use of 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 during the first days after starting fingolimod.
• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein medicine used to treat metastatic kidney cancer) with beta-blockers may enhance the blood pressure-lowering effect.
• Insulin and other antidiabetic medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
• Local anaesthetics containing lidocaine.
• A medicine called dipyridamole, used to prevent blood clots.

Beto 50 ZK, food, drink and alcohol
Beto 50 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 50 ZK, alcohol consumption should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Beto 50 ZK may be used during pregnancy only if clearly indicated and after careful evaluation by the doctor of the benefit-risk ratio. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to disturbances in fetal development. Treatment with Beto 50 ZK should be discontinued 48 to 72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored by the doctor for 48 to 72 hours after birth.
Breastfeeding
Beto 50 ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding unless absolutely necessary. Although adverse effects are unlikely at recommended doses, breastfed infants should be closely observed for possible drug-related symptoms (e.g. the doctor will monitor heart function).
Driving and operating machinery
During treatment with Beto 50 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that may impair the ability to drive, operate machinery or work in potentially hazardous conditions. These symptoms may occur especially when alcohol is consumed concurrently, as well as after switching from one medicine to another.
Beto 50 ZK contains glucose, monohydrate lactose and sucrose (sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Beto 50 ZK.

3. How to use Beto 50 ZK

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 to take and when. The prescribed dose depends on the type of disease and its severity.
Unless otherwise directed by your doctor, the usual dosage is as follows:

High blood pressure (hypertension)

• Patients with mild to moderate hypertension should take 47.5 mg of metoprolol succinate once daily.
• If necessary, your doctor may increase the dose to 95–190 mg of metoprolol succinate once daily, or add another antihypertensive medicine.

Chest pain (angina pectoris)

• 95–190 mg of metoprolol succinate once daily.
• If necessary, your doctor may add another medicine used in the treatment of ischemic heart disease.

Heart rhythm disorders, including rapid heartbeat (arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

• 190 mg of metoprolol succinate once daily.

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

• 95 mg of metoprolol succinate once daily.
• If necessary, your doctor may increase the dose to 190 mg of metoprolol succinate once daily.

Prevention of migraine

• 95–190 mg of metoprolol succinate once daily.

Heart muscle weakness (heart failure)
Before starting treatment for heart muscle weakness, the patient's condition must first be stabilized with medicines usually used in heart failure therapy. The dose of Beto 50 ZK is then individually adjusted for each patient.

• The recommended initial dose during the first week for patients with heart muscle weakness (classified as NYHA class III–IV heart failure) is 11.88 mg of metoprolol succinate once daily. Your doctor may increase the dose during the second week to 23.75 mg of metoprolol succinate once daily. The recommended initial dose during the first 2 weeks for patients with heart muscle weakness (classified as NYHA class II heart failure) is 23.75 mg of metoprolol succinate once daily.
• Then, your doctor will double the dose. The dose may be doubled every two weeks until reaching 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.
• The recommended dose for long-term maintenance treatment is 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.

Use in children and adolescents
High blood pressure:
In children aged 6 years and older, the dose depends on body weight. Your doctor will determine the appropriate dose for the patient.
The usual initial dose of metoprolol succinate is 0.48 mg/kg body weight once daily, but not exceeding 47.5 mg. The dose should be adjusted to the nearest available tablet strength. Your doctor may increase the dose up to 1.9 mg/kg body weight depending on the blood pressure response. Doses above 190 mg daily have not been studied in children and adolescents.
Beto 50 ZK is not recommended for children under 6 years of age.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto 50 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Studies have not been conducted in patients over 80 years of age, so your doctor will increase the dose particularly cautiously in such patients.

Beto 50 ZK is intended for oral administration.
Tablets should be taken once daily, preferably with breakfast. Tablets may be divided into equal doses. They may be swallowed whole or divided, but should not be chewed or crushed. Tablets should be taken with water (at least half a glass).

Taking more than the recommended dose of Beto 50 ZK
Seek immediate medical advice or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the doctor will decide on the appropriate management.
Show the medicine packaging to the doctor so they know which medicine has been taken and what action should be taken.

Symptoms of overdose
Symptoms that may occur following overdose of Beto 50 ZK include:
dangerously low blood pressure, severe heart function disturbances, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple skin discoloration), and death.
The first symptoms of overdose may appear between 20 minutes and 2 hours after taking Beto 50 ZK, and the effects of a significant overdose may persist for several days.

Treatment of overdose
The patient should be treated in hospital, in an intensive care unit. Even patients who appear to be in relatively good condition after a minor metoprolol overdose should be closely observed by a doctor for at least 4 hours for signs of poisoning.

Missing a dose of Beto 50 ZK
Do not take a double dose to make up for a missed dose. Continue treatment as prescribed by your doctor.

Stopping treatment with Beto 50 ZK
Before stopping or prematurely discontinuing treatment with Beto 50 ZK, consult your doctor.
Beto 50 ZK should not be stopped abruptly, but the dose should be gradually reduced. Sudden discontinuation of beta-blockers may worsen symptoms of heart failure and increase the risk of myocardial infarction and sudden cardiac death.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, 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 position from lying down 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, diarrhoea, constipation

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

• weight gain
• depression, drowsiness, sleep disturbances, nightmares, concentration difficulties
• abnormal sensations of tingling, pricking or numbness of the skin (paraesthesia)
• transient worsening of symptoms of weakened heart muscle (with swelling of ankles and feet), first-degree atrioventricular conduction block (first-degree AV block), chest pain, poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute heart attack)
• bronchospasm (bronchoconstriction)
• skin rash (psoriasiform or dystrophic skin changes), excessive sweating
• muscle cramps

Rare (may affect up to 1 in 1,000 people):

• worsening of diabetes without characteristic symptoms (latent diabetes)
• nervousness, blurred vision, dryness or irritation of the eyes (noticeable when wearing contact lenses), conjunctivitis
• heart rhythm disorders (arrhythmia), conduction disturbances
• 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 number of blood platelets (thrombocytopenia), reduced number of white blood cells (leukopenia)

• memory loss or memory disturbances, confusion, hallucinations, personality changes (e.g. mood swings)

• ringing in the ears (tinnitus), hearing impairment

• tissue necrosis in patients with severe peripheral circulatory disorders before treatment

• taste disturbances

• hepatitis

• photosensitivity with skin rash upon exposure to light, exacerbation 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 types of lipids 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Beto 50 ZK

• Keep the medicine out of the 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 stated month.

Translation of some markings on the blister pack:
Lot/Exp: vezi lateral – Lot/Exp: see side

• Store below 25ºC, in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Beto 50 ZK contains
The active substance is metoprolol succinate. Each prolonged-release tablet contains 47.5 mg of metoprolol succinate.
Other components: sucrose, granules (sucrose, corn starch, liquid glucose); polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica.
Coating: Opadry II (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000).

What Beto 50 ZK looks like and contents of the pack
Beto 50 ZK tablets are white, elongated, with a score line on both sides.
Blister packs made of Aclar-PVC/Aluminum foil or PP/Aluminum foil in a cardboard box.
Pack size: 30 prolonged-release tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
Hexal AG
Industriestrasse 25
D-83607 Holzkirchen
Germany

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

Lek Pharmaceuticals d.d
Verovskova ulica 57
Ljubljana, 1526, Slovenia

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Romania, the country of export: 7566/2015/10
Parallel Import Licence Number: 166/20