Beto 25 zk

Package leaflet: Information for the patient

Caution! Keep the leaflet. Information on the immediate packaging in a foreign language.
Beto 25 ZK (MetoHEXAL Succ 23.75 mg)
23.75 mg, prolonged-release tablets
Metoprolol succinate
Beto 25 ZK and MetoHEXAL Succ 23.75 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 doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Beto 25 ZK is and what it is used for
2. Important information before taking Beto 25 ZK
3. How to take Beto 25 ZK
4. Possible side effects
5. How to store Beto 25 ZK
6. Contents of the pack and other information

1. What Beto 25 ZK is and what it is used for

Metoprolol succinate (a selective beta-adrenolytic agent), the active substance in Beto 25 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 25 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 prophylaxis following the acute phase of myocardial infarction,
• in cases of unpleasant sensations 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 25 ZK

When not to use Beto 25 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 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 permanently 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 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 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).

In patients with chronic heart failure, metoprolol must not be used if:

• they have unstable, decompensated 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 treatment with Beto 25 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 25 ZK may worsen these conditions;
• the patient has diabetes;
• the patient has thyroid disorders;
• the patient has severe liver dysfunction;
• the patient has ever experienced a severe allergic reaction to any allergen;
• the patient has a rare form of angina known as Prinzmetal's angina;
• the patient is scheduled for surgery requiring general anaesthesia. The anaesthesiologist must be informed about the use of Beto 25 ZK.
• the patient has a hormone-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant treatment with an alpha-adrenergic blocking agent is required;
• the patient has psoriasis.

Use of metoprolol may lead to positive results in doping tests.
Children and adolescents
Experience with treatment in children under 6 years of age is limited.
Use of Beto 25 ZK is not recommended in children under 6 years of age.
Beto 25 ZK and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Beto 25 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 in the treatment of 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 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 for the treatment of relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart rate-lowering effect during the first days after initiating fingolimod.
• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein 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 (NSAIDs), used to treat pain and inflammation.
• Local anaesthetics containing lidocaine.
• A medicine called dipyridamole, used to prevent blood clots.

Beto 25 ZK with food, drink and alcohol
Beto 25 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol concentration may reach higher levels and decrease more slowly.
During treatment with Beto 25 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Beto 25 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 25 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 25 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 25 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that impairs the ability to drive vehicles, 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 25 ZK contains glucose, lactose and sucrose (sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking Beto 25 ZK.

3. How to use Beto 25 ZK

This medicine should always be used 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 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, the 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, 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.

Weakened heart muscle (heart failure)
Before starting treatment for weakened heart muscle, it is necessary to stabilize the patient’s condition with medicines commonly used in heart failure therapy, followed by individual dose adjustment of Beto 25 ZK.

• The recommended initial dose during 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. 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 for patients with weakened heart muscle (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 25 ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto 25 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 the doctor will increase the dose particularly cautiously in such patients.

Beto 25 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 than the recommended dose of Beto 25 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 that it is clear which medicine has been taken and what action should be taken.

Symptoms of overdose
Symptoms that may occur following overdose of Beto 25 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 appear between 20 minutes and 2 hours after taking Beto 25 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 relatively good condition after a minor metoprolol overdose should be closely observed by a doctor for at least 4 hours to monitor for signs of poisoning.

Missed dose of Beto 25 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 25 ZK
Before stopping or prematurely discontinuing treatment with Beto 25 ZK, consult your doctor.
Do not stop taking Beto 25 ZK abruptly, but gradually reduce the dose. Abrupt 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 effects

Like all medicines, this medicinal product may cause adverse effects, although not everybody 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 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 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 block (first-degree AV block), chest pain (chest pain), poor heart pump function (cardiogenic shock) in patients with heart attack (acute myocardial infarction)
• bronchospasm (airway constriction)
• 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 when wearing contact lenses), 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 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 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 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for 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 provide more information on the safety of the medicine.

5. How to store the medicine Beto 25 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.
• Medicines must not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
• Translation of some abbreviations appearing on the immediate packaging: Ch.-B./verwendbar bis: see imprint

6. Contents of the pack and other information

What Beto 25 ZK contains
Active substance:
Metoprolol succinate.
Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, equivalent to
25 mg of metoprolol tartrate.

Other ingredients:
Sucrose, granules (sucrose, corn starch, glucose), polyacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose (E 460), crospovidone, colloidal anhydrous silica.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Beto 25 ZK looks like and contents of the pack
Beto 25 ZK tablets are white, elongated, with a score line on both sides.
Blister packs made of PVC/Aclar-Aluminium or PP/Aluminium, contained in a cardboard box.
Pack sizes: 30 or 60 prolonged-release tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

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

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

German Marketing Authorisation Number (country of export): 61494.00.00
Parallel Import Authorisation Number: 604/15