Beto 100 zk

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Beto 100 ZK (Metohexal retard), 95 mg, prolonged-release tablets
Metoprololi succinas
Beto 100 ZK and Metohexal retard 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 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What is Beto 100 ZK and what is it used for
2. Important information before taking Beto 100 ZK
3. How to take Beto 100 ZK
4. Possible side effects
5. How to store Beto 100 ZK
6. Contents of the pack and other information

1. What is Beto 100 ZK and what is it used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 100 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 100 ZK is used:

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

In children and adolescents aged 6 to 18 years:

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

2. Important information before using Beto 100 ZK

When not to use Beto 100 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 severe heart dysfunction;
• 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 an implanted cardiac pacemaker;
• if the patient has severe 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 blood pressure <90 mmHg);
• if the patient has an abnormally high level of acidity in 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 present with 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);
• systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 100 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 100 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 requires surgery under general anaesthesia. The anaesthetist must be informed about the use of Beto 100 ZK;
• the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant use of an alpha-adrenergic blocking agent is required;
• the patient has psoriasis.

Use of metoprolol may lead to positive results in anti-doping tests.
Children and adolescents
Experience with use in children under 6 years of age is limited.
Use of Beto 100 ZK is not recommended in children under 6 years of age.
Beto 100 ZK and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Beto 100 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 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 liver enzyme activity, such as rifampicin used in the treatment of 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 of fingolimod treatment.
• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein used to treat metastatic kidney cancer) with beta-blockers may lead to 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 100 ZK, food, drink and alcohol
Beto 100 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol levels may rise and decrease more slowly.
During treatment with Beto 100 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 100 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 impaired fetal development. Treatment with Beto 100 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 100 ZK passes into breast milk.
Metoprolol succinate should not be used 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 100 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 under potentially hazardous conditions. These symptoms may be particularly pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 100 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 100 ZK.

3. How to use Beto 100 ZK

This medicine should always be used exactly as directed by the physician. If in doubt, consult a doctor or pharmacist.

The following products are available on the market: 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).

The doctor will inform you how many tablets to take and when. The prescribed dose depends on the type and severity of the disease.

If the doctor has not advised otherwise, the following dosages are generally recommended:

High blood pressure (hypertension)

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

Chest pain (angina pectoris)

• 95–190 mg of metoprolol succinate once daily.
• If necessary, the doctor may additionally prescribe another medicine used in the treatment of ischemic 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, the 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 stabilize the patient’s condition with medicines typically used in heart failure therapy. The dose of Beto 100 ZK should then be individually adjusted for each patient.

• 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. The 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.
• The doctor will then 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. The 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. The 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 100 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 100 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Clinical studies have not included patients over 80 years of age, therefore the doctor will increase the dose particularly cautiously in such patients.

Beto 100 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 100 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 management.
Show the medicine packaging to the doctor so that it is clear which medicine has been taken and what treatment should be initiated.

Symptoms of overdose
Symptoms that may occur following an overdose of Beto 100 ZK include: dangerously low blood pressure, severe heart function disturbances, 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 100 ZK, and the effects of a significant overdose may persist for several days.

Treatment of overdose
The patient should be treated in a hospital, preferably 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.

Missed dose of Beto 100 ZK
Do not take a double dose to make up for a missed dose. Continue treatment as directed by the doctor.

Stopping treatment with Beto 100 ZK
Before stopping or prematurely discontinuing treatment with Beto 100 ZK, consult your doctor.
Do not stop taking Beto 100 ZK suddenly. 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 regarding 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 less than 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 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 less than 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 heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular conduction block (AV block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchoconstriction (bronchospasm)
• skin rash (psoriasiform eczema and dystrophic skin changes), increased sweating
• muscle cramps.

Rare (may affect less than 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 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 less than 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 impairment
• tissue necrosis (necrosis) in patients with severe peripheral vascular disease 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 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 blood vessel spasms in 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Beto 100 ZK

• Keep the 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.
• Do not store above 25°C.
• Translation of some information on the immediate packaging: Ch.-B./Verwendbar bis: siehe Prägung - batch number/expiry date - see embossing.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Beto 100 ZK contains
Active substance: metoprolol succinate. Each prolonged-release tablet contains 95 mg of metoprolol succinate.
Other components: sucrose, granules (sucrose, corn starch, liquid glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide.
Coating: Opadry II (lactose monohydrate, hypromellose, titanium dioxide (E 171), polyethylene glycol 4000), yellow iron oxide (E 172).

What Beto 100 ZK looks like and contents of the pack
Light yellow, elongated tablets, with a score line on both sides.
Prolonged-release tablets are packed in blisters made of PP/Aluminium foil or 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 authorisation holder or the parallel importer.

Marketing authorisation holder in Austria, country of export:
Hexal Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05, 1020 Vienna, Austria

Manufacturer:
Salutas Pharma GmbH, 39179 Barleben, Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Austria, country of export: 1-25607
Parallel import authorisation number: 34/22