Beto 50 zk

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the outer packaging 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 medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 agent), the active substance in Beto 50 ZK, blocks
certain beta-adrenergic receptors in the body, primarily 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 cardiac arrhythmias, including rapid heart rate,
• for prophylaxis following the acute phase of myocardial infarction,
• in cases of unpleasant sensations due to 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 medicines;
• if the patient has severe asthma or severe wheezing attacks;
• if the patient is in shock due to serious heart problems;
• if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or 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 disease 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 an abnormally acidic blood condition (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 reduce 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 recently received medicines that increase heart contractility;
• they have a slow heart rate (less than 68 beats/min at rest before treatment);
• their systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting to take Beto 50 ZK, discuss this with your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders;
• the patient has heart (e.g. slow heart rate) or circulatory disorders (taking 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 scheduled for surgery requiring general anaesthesia. The anaesthetist must be informed about the use of Beto 50 ZK.
• the patient has a hormone-secreting tumour of the adrenal gland (phaeochromocytoma): in such a case, prior and concomitant treatment with an alpha-adrenergic receptor blocker is necessary;
• 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. 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 such as verapamil, diltiazem or nifedipine).
• Other beta-blocking medicines (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.
• Antihistamine medicines (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, such as 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-lowering 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 lead to an enhanced blood pressure-lowering effect.
• Insulin and other antidiabetic medicines.
• Non-steroidal anti-inflammatory drugs (so-called NSAIDs), used to treat pain and inflammation.
• Local anaesthetics containing lidocaine.
• The 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 her 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 placental blood flow, which may lead to fetal developmental disorders. Treatment with Beto 50 ZK should be discontinued 48 to 72 hours before the expected delivery date. 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 carefully monitored 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 impair reaction speed to an extent that may interfere with the ability to drive, operate machinery or work under potentially hazardous conditions. These symptoms may be particularly pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 50 ZK contains liquid 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 used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take and when. The prescribed dose depends on the type and severity of the condition.

If your doctor has not advised otherwise, 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 medicine to lower blood pressure.

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 ischaemic heart disease.

Heart rhythm disorders, including rapid heartbeat (cardiac arrhythmias)

• 95–190 mg of metoprolol succinate once daily.

Treatment after heart attack

• 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.

Weakened heart muscle (heart failure)

Before starting treatment for weakened heart muscle, the patient’s condition must first be stabilised with medicines usually used in the treatment of heart failure. The dose of Beto 50 ZK is then individually adjusted for each patient.

• The recommended initial dose in the first week for patients with weakened heart muscle (classified as NYHA class III–IV heart failure) is 11.88 mg of metoprolol succinate once daily. Your doctor may increase the dose in the second week to 23.75 mg of metoprolol succinate once daily.
• The recommended initial dose for the first 2 weeks for patients with weakened heart muscle (classified as NYHA class II heart failure) is 23.75 mg of metoprolol succinate once daily.
• Your doctor will then double the dose. The dose may be doubled every two weeks until a dose of 190 mg of metoprolol succinate once daily is reached, or until the highest dose tolerated by the patient is achieved.
• 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 per day have not been studied in children and adolescents.
Beto 50 ZK is not recommended for use in children under 6 years of age.
The duration of treatment will be determined by your 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, therefore your doctor will increase the dose with particular caution 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 Beto 50 ZK than prescribed

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 course of action.
Show the medicine packaging to the doctor so they know which medicine has been taken and what treatment is required.

Symptoms of overdose

Symptoms that may occur following an overdose of Beto 50 ZK include:
dangerously low blood pressure, severe disturbances in heart function, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or violet 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 last 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 good condition after a minor overdose of metoprolol should be closely observed by a doctor for at least 4 hours for any signs of poisoning.

Missed 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 discontinuing treatment with Beto 50 ZK, consult your doctor.
Do not stop taking Beto 50 ZK suddenly, but gradually reduce the dose. Abrupt discontinuation of beta-blockers may worsen 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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 down to standing up, 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 disorders, nightmares, concentration disturbances
• abnormal sensations of tingling, pricking or numbness of the skin (paraesthesia)
• transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular conduction block (AV block), chest pain, impaired heart pump function (cardiogenic shock) in patients with myocardial infarction (acute heart attack)
• bronchospasm (bronchoconstriction)
• skin rash (psoriasiform and 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 during contact lens use), 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 number of platelets (thrombocytopenia), reduced number of white blood cells (leukopenia)
• forgetfulness or memory disturbances, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing loss
• tissue necrosis in patients with severe peripheral circulation disorders prior to treatment
• taste disturbances
• hepatitis
• photosensitivity with skin rash after exposure to light, exacerbation of psoriasis symptoms, development of psoriasis
• joint pain, muscle weakness

Frequency not known (frequency cannot be estimated from 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 vasoconstriction of the fingers and toes (Raynaud's phenomenon)

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Beto 50 ZK

• Keep this medicine 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 stated month.
• Store below 25°C in the original packaging.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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, equivalent to
50 mg of metoprolol tartrate.
The other ingredients are: sucrose, corn starch, liquid glucose, polyacrylate dispersion 30%,
talc, magnesium stearate, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.
What Beto 50 ZK looks like and contents of the pack
White, elongated tablets with a score line on both sides.
Prolonged-release tablets are packed in blisters made of PP/Aluminium foil or PVC/aclar/Aluminium foil, and placed in a cardboard box.
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Romania, 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.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
CANPOLAND JOINT STOCK COMPANY
Beskidzka 190 Street
91-610 Łódź
Numbers of marketing authorization in Romania, country of export: 7566/2015/10
7566/2015/02
7566/2015/04
7566/2015/05
7566/2015/08
7566/2015/11
7566/2015/12
Number of parallel import authorization: 159/22