Beto 200 zk

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Beto 200 ZK (Metoprololsuccinaat Sandoz retard 200)
190 mg, prolonged-release tablets
Metoprololi succinas
Beto 200 ZK and Metoprololsuccinaat Sandoz retard 200 are different trade names of the same
medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• 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 pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Beto 200 ZK is and what it is used for
2. Important information before taking Beto 200 ZK
3. How to take Beto 200 ZK
4. Possible side effects
5. How to store Beto 200 ZK
6. Contents of the pack and other information

1. What Beto 200 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 200 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 200 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 sensation 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 200 ZK

When not to use Beto 200 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 wheezing attacks;
• if the patient is in shock due to serious heart dysfunction;
• if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or cardiac arrhythmias (sick sinus syndrome), except in patients with an implanted cardiac pacemaker;
• 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 ankle swelling);
• if the patient has a slow heart rate (<50 beats/min at rest before treatment);
• if the patient has very low blood pressure (systolic 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 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 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 Beto 200 ZK, consult 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 (treatment with Beto 200 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 pectoris, so-called Prinzmetal's angina;
• the patient is undergoing surgery requiring general anaesthesia. Inform the anaesthetist about the use of Beto 200 ZK.
• the patient has a hormone-secreting tumour of the adrenal gland (pheochromocytoma): in such cases, prior and concomitant use of an alpha-adrenergic receptor-blocking medicine 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 200 ZK is not recommended in children under 6 years of age.
Beto 200 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 200 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 (used in the treatment of 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 the activity of liver enzymes, e.g. rifampicin used to treat tuberculosis.
• Medicines used to treat heart disorders (including angina pectoris), such as amiodarone, digoxin, nitrates, and antiarrhythmic medicines.
• Other medicines reducing 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 lowering blood pressure: concomitant use of aldesleukin (a synthetic protein medicine used to treat metastatic kidney cancer) with beta-blockers may cause a pronounced 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 200 ZK with food, drink and alcohol
Beto 200 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 200 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 baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Beto 200 ZK may be used during pregnancy only if clearly indicated and after careful assessment 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 200 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 200 ZK passes into breast milk.
Metoprolol succinate should not be taken during pregnancy unless absolutely necessary. Although adverse effects are unlikely when recommended doses are used, 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 200 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent impairing 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 200 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 200 ZK.

3. How to use Beto 200 ZK

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will inform you how many tablets to take and when. The prescribed dose depends on the type
of illness and its severity.
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 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 ischaemic heart disease.

Heart rhythm disorders, including rapid heartbeat (cardiac 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, it is necessary to stabilise the patient’s condition
with medicines usually used in heart failure therapy, followed by individual dose adjustment of Beto 200 ZK.

• The recommended initial dose in 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 in the second week to 23.75 mg of metoprolol succinate once daily. The recommended initial dose for the first 2 weeks in 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 therapy 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 200 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 200 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 200 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 ½ glass).
Taking more Beto 200 ZK than recommended
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 200 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 appear between 20 minutes and 2 hours after taking Beto 200 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 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 200 ZK
Do not take a double dose to make up for a missed dose; continue treatment as directed by your doctor.
Stopping Beto 200 ZK
Before stopping or prematurely discontinuing treatment with Beto 200 ZK, consult your doctor.
Beto 200 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 can cause adverse reactions, 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
• significant decrease in blood pressure, especially during change of 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, diarrhoea, constipation

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

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

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

• worsening of diabetes without characteristic symptoms (silent 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)
• forgetfulness or memory disorders, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing loss
• tissue necrosis in patients with severe peripheral circulatory 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 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 this leaflet, inform your doctor or pharmacist. 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 200 ZK medicine

• 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 specified month.
• Store below 25°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

Translation of some information on the immediate packaging:
Charge: en EXP: zie zijkant – Batch number and expiry date: see information embossed on the side of the blister.

6. Package contents and other information

What Beto 200 ZK contains
Active substance: metoprolol succinate. Each prolonged-release tablet contains 190 mg of metoprolol succinate.
Other ingredients: sucrose, granules (sucrose, corn starch, liquid glucose), polyacrylate dispersion 30%, talc (E 553B), magnesium stearate (E 470b), microcrystalline cellulose (E 460), crospovidone, colloidal anhydrous silica (E 551). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000.

What Beto 200 ZK looks like and contents of the pack
Beto 200 ZK tablets are white, elongated, with a score line on both sides.
Blister packs made of PP/Aluminum or PVC/Aclar/Aluminum, in a cardboard box.
Pack size: 30 prolonged-release tablets.
For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Poland
CEFEA Sp. z o.o. Sp. k.
Działkowa 56 Street
02-234 Warsaw
Poland

Marketing Authorisation number in the Netherlands, country of export: RVG 32380
Parallel import licence number: 208/18