Beto 25 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Beto 25 ZK (Metoprololsuccinaat Sandoz retard 25), 23.75 mg, prolonged-release tablets
Metoprololi succinas
Beto 25 ZK and Metoprololsuccinaat Sandoz retard 25 are different trade names for the same
medicinal product.
Please read the leaflet carefully before using 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, 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.
Contents of the 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 package and other information

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

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 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 heart rate,
• in the prevention following the acute phase of myocardial infarction (heart attack),
• 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 ZK

When not to use Beto 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 heart rhythm disorders (sick sinus syndrome), except in patients with a cardiac pacemaker implanted;
• if the patient has severe circulatory problems (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 acidic 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 heart rhythms).

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 continuously or intermittently receiving 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 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), as treatment with Beto 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, so-called Prinzmetal's angina;
• the patient is undergoing surgery requiring general anaesthesia. The anaesthesiologist must be informed about the use of Beto ZK.
• the patient has a hormone-secreting tumour of the adrenal medulla (pheochromocytoma): in such cases, prior and concomitant use of 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 ZK is not recommended in children under 6 years of age.
Interaction of Beto ZK with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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-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.
• 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, e.g. rifampicin used to treat tuberculosis.
• Medicines used to treat heart disorders (including angina), 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 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.
• A medicine called dipyridamole, used to prevent blood clots.

Beto ZK with food, drink and alcohol
Beto ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto ZK, alcohol consumption should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 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 fetal developmental disorders. Treatment with Beto 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 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 closely monitored for possible drug-related symptoms (e.g. the doctor will monitor heart function).
Driving and operating machinery
During treatment with Beto ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent impairing the ability to drive, operate machinery or work in potentially hazardous conditions. These symptoms may be especially pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto ZK contains glucose, 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 ZK.

3. How to use Beto 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 and severity of the condition.

Unless otherwise advised 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 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 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 commonly used to treat heart failure. The dose of Beto ZK is then individually adjusted for each patient.

• The recommended starting 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 starting 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.
• 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 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 higher than 190 mg daily have not been studied in children and adolescents.
Beto ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by your doctor.
If you feel that the effect of Beto ZK is too strong or too weak, contact 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 ZK is intended for oral administration.
Take the tablets 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 ZK than prescribed
Seek immediate medical advice from your doctor 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 package 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 ZK include dangerously low blood pressure, severe heart dysfunction, 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 ZK, and the effects of a significant overdose may last for several days.

Treatment of overdose
The patient should be treated in a hospital, in an intensive care unit. Even patients who appear stable 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 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 ZK
Before stopping or discontinuing treatment with Beto ZK, consult your doctor.
Do not stop taking Beto ZK suddenly, but gradually reduce the dose. Abrupt discontinuation of beta-blockers may worsen heart failure symptoms 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 they do not occur in everyone.

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 drop 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 disturbances, nightmares, difficulty concentrating
• abnormal sensations of tingling, pricking or numbness of the skin (paresthesia)
• transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular conduction block (first-degree atrioventricular block), chest pain (chest pain), poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchoconstriction)
• 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 (latent diabetes)
• nervousness
• blurred vision, dryness or irritation of the eyes (noticeable during use of 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 disturbances, 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 appearing after 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 blood vessels in 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, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 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 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Beto ZK contains
Active substance: metoprolol succinate.
Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, which corresponds to 25 mg of metoprolol tartrate.
Other ingredients: 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 ZK looks like and contents of the pack
Beto 25 ZK
White, elongated tablets with a score line on both sides.
The prolonged-release tablets are packed in blisters made of PP/Aluminium foil or PVC/aclar/Aluminium foil, and placed in a cardboard box.
Blisters:
Pack sizes: 30 and 60 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder 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

Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czesky Těšín
Czech Republic

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryn Pharmaceutical Laboratory 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

Marketing Authorisation Number in the Netherlands, country of export: RVG 32376
Parallel Import Licence Number: 90/22
[Trademark information]