Beto 200 Zk

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Beto 200 ZK (Metoprolol succinate Sandoz retard 200)

190 mg, prolonged-release tablets

Metoprolol succinate
Beto 200 ZK and Metoprolol succinate Sandoz retard 200 are different trade names for the same
drug.

Before taking the drug, the contents of the leaflet should be read carefully, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Beto 200 ZK and what is it 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 packaging and other information

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

Metoprolol succinate (selective beta-adrenergic blocker), the active substance of Beto 200 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 200 ZK is used:

• to treat high blood pressure,
• to treat chest pain,
• to treat heart rhythm disorders, including accelerated heart rate,
• for the prevention of heart attack,
• in case of unpleasant sensation of irregular and (or) strong heartbeat,
• to prevent migraine,
• to treat heart failure.

In children and adolescents from 6 to 18 years old

• to treat high blood pressure(hypertension).

2. Important information before taking Beto 200 ZK

When not to take Beto 200 ZK

• if the patient is allergic to metoprolol succinate or to any of the other ingredients of this drug (listed in section 6);
• if the patient is allergic to other beta-adrenergic blockers;
• if the patient has severe asthma or severe wheezing;
• if the patient is in shock due to severe heart problems;
• if the patient has conduction disorders in the heart (second or third degree atrioventricular block, high degree sinoatrial block) or heart rhythm disorders (sick sinus syndrome) unless the patient has a pacemaker;
• if the patient has severe circulatory disorders (severe peripheral arterial disease);
• if the patient has untreated and uncontrolled heart failure (a disease that usually causes shortness of breath and swelling of the ankles);
• if the patient has a slow heart rate (<50 beats min at rest before treatment);< li>
• if the patient has very low blood pressure (systolic blood pressure <90 mmhg);< li>
• if the patient has a more than usual acidic blood reaction (so-called metabolic acidosis);
• if the patient is taking any of the following drugs: o monoamine oxidase inhibitors (MAOIs) - drugs used to treat depression; o verapamil and diltiazem (drugs used to lower blood pressure); o antiarrhythmic drugs, such as disopyramide (drugs used to treat irregular heartbeat).

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

• they have unstable, uncontrolled heart failure (which may manifest as fluid accumulation in the lungs, poor circulation, or low blood pressure);
• they are constantly or periodically receiving drugs that increase the strength of heart contractions;
• they have a slow heart rate (less than 68 beats/min at rest before treatment);
• their systolic blood pressure is consistently less than 100 mmHg.

Warnings and precautions

Before starting to take Beto 200 ZK, the patient should discuss it with their doctor or pharmacist,
if:

• the patient has asthma, bronchitis, or lung function disorders;
• the patient has heart function disorders (e.g. slow heart rate) or circulatory disorders (taking Beto 200 ZK may worsen their course);
• the patient has diabetes;
• the patient has thyroid function disorders;
• the patient has severe liver disease;
• the patient has had a severe allergic reaction to any allergen;
• the patient has a rare form of chest pain, so-called Prinzmetal's angina;
• the patient needs to undergo surgery that requires general anesthesia. The anesthesiologist should be informed about the use of Beto 200 ZK.
• the patient has a tumor of the adrenal gland that secretes hormones (pheochromocytoma): in such a case, it is necessary to use a drug that blocks alpha-adrenergic receptors beforehand and at the same time.
• the patient has psoriasis.

Taking metoprolol may cause positive results in doping tests.

Children and adolescents

Experience with the treatment of children under 6 years old is limited.
Beto 200 ZK should not be used in children under 6 years old.

Beto 200 ZK and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking
or have recently taken, as well as any drugs they plan to take.
Beto 200 ZK interacts with many other drugs.

• Drugs 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-adrenergic blockers (also those contained in eye drops).
• Drugs that affect peripheral blood circulation (in fingers and toes), such as ergot alkaloids (which can be used to treat migraine).
• Drugs used to treat depression.
• Drugs used to treat other mental disorders.
• Antiretroviral drugs used to treat AIDS and some other diseases.
• Antihistamines (also available without a prescription, used to treat hay fever and other allergies, colds, and other conditions).
• Drugs used to prevent malaria.
• Drugs used to treat fungal infections.
• Drugs that affect liver enzyme activity, rifampicin used to treat tuberculosis.
• Drugs used to treat heart function disorders (also angina pectoris), such as amiodarone, digoxin, nitrates, and antiarrhythmic drugs.
• Other drugs that reduce heart rate: the use of fingolimod (a drug used in adults, children, and adolescents to treat relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart rate slowing effect in the first few days after starting fingolimod.
• Other drugs that lower blood pressure: the use of aldesleukin (a synthetic protein drug used to treat kidney cancer with metastases to other organs) with beta-blockers may cause enhanced blood pressure lowering effect.
• Insulin and other anti-diabetic drugs.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
• Local anesthetics containing lidocaine.
• A drug called dipyridamole, which prevents blood clots.

Beto 200 ZK with food, drink, and alcohol

Beto 200 ZK and alcoholcan mutually enhance their sedative effects. The blood alcohol concentration
may reach higher values and decrease more slowly.
During treatment with Beto 200 ZK, alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have
a child, they should consult their doctor or pharmacist before taking this drug.
Pregnancy
Beto 200 ZK can be used during pregnancy only if clearly necessary and after careful assessment by the doctor of the ratio of expected benefits to possible risks. There is evidence that metoprolol reduces blood flow in the placenta, which can lead to fetal development disorders. 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 should not be taken during pregnancy if not absolutely necessary.
Although the occurrence of side effects is unlikely when using the recommended doses, the breastfed infant should be closely monitored for possible symptoms caused by the drug (e.g. the doctor will monitor heart rate).

Driving and using machines

During treatment with Beto 200 ZK, dizzinessor fatiguemay occur. These symptoms can
affect reaction speed to the extent of impairing the ability to drive vehicles, operate machines, and work in potentially hazardous conditions. Symptoms may occur especially when consuming alcohol, as well as when switching to another drug.

Beto 200 ZK contains glucose, lactose monohydrate, and sucrose (sugar)

If the patient has previously been diagnosed with intolerance to some sugars, they should
contact their doctor before taking Beto 200 ZK.

3. How to take Beto 200 ZK

This drug should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Available on the market are: 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 how many tablets and when to take them. The prescribed dose depends on the type
of disease and its severity.

If the doctor has not prescribed otherwise, the following dosage is usually used:

High blood pressure

• Patients with mild to moderate hypertensionshould take 47.5 mgof metoprolol succinate once a day.
• If necessary, the doctor may increase the dose to 95-190 mgof metoprolol succinate once a dayor use an additional blood pressure lowering drug.

Chest pain (angina pectoris)

• 95-190 mgof metoprolol succinate once a day.
• If necessary, the doctor may use an additional drug used to treat coronary heart disease.

Heart rhythm disorders, including accelerated heart rate (arrhythmias)

• 95-190 mgof metoprolol succinate once a day.

Treatment after a heart attack

• 190 mgof metoprolol succinate once a day.

Unpleasant sensation of irregular and (or) strong heartbeat (palpitations)

• 95 mgof metoprolol succinate once a day.
• If necessary, the doctor may increase the dose to 190 mgof metoprolol succinate once a day. Prevention of migraine
• 95-190 mgof metoprolol succinate once a day.

Heart failure
Before starting treatment for heart failure, the patient's condition must be stabilized with drugs usually used to treat heart failure, and then the dose of Beto 200 ZK should be adjusted individually for the patient.

• The recommended initial dose in the first weekfor patients with heart failure(classified as heart failure grade III-IVaccording to NYHA) is 11.88 mgof metoprolol succinate once a day. The doctor may increase the dose in the second weekto 23.75 mgof metoprolol succinate once a day. The recommended initial dose in the first 2 weeksfor patients with heart failure(classified as heart failure grade IIaccording to NYHA) is 23.75 mgof metoprolol succinate once a day.
• Then the doctor will double the dose. The dose can be doubled every two weeksuntil a dose of 190 mgof metoprolol succinate once a dayis reached or the maximum dose tolerated by the patient.
• The recommended dose for long-term maintenance treatmentis 190 mgof metoprolol succinate once a dayor the maximum dose tolerated by the patient.

Use in children and adolescents
High blood pressure:
In children over 6 years old, the dose depends on body weight. The doctor will determine the dose suitable for
the patient.
Usually, the initial dose of metoprolol succinate is 0.48 mg/kg body weight once a day, but not more than 47.5 mg. The dose is adjusted to the nearest tablet strength. The doctor may increase the dose to 1.9 mg/kg body weight, depending on the blood pressure response. In children and adolescents, doses above 190 mg per day have not been studied.
Beto 200 ZK should not be used in children under 6 years old.
The duration of treatment is determined by the doctor.
If the patient feels that the effect of Beto 200 ZK is too strong or too weak, they should
contact their doctor or pharmacist.

Patients of advanced age

No studies have been conducted in patients over 80 years old, so in such patients, the doctor will be particularly cautious when increasing the dose of the drug.
Beto 200 ZK is intended for oral administration.
Tablets should be taken once a day, preferably during breakfast. Tablets can be divided into equal doses. They can be swallowed whole or divided, but should not be crushed or chewed. Tablets should be washed down with water (at least ½ glass).

Taking a higher dose of Beto 200 ZK than recommended

The patient should immediately contact their doctor or go to the emergency department of the nearest hospital. Based on the severity of the symptoms of poisoning, the doctor will decide what actions to take.
The packaging of the drug should be shown to the doctor so that it is known what drug was taken and what actions should be taken.
Symptoms of overdose
Symptoms that may occur as a result of an overdose of Beto 200 ZK may include:
dangerously low blood pressure, severe heart function disorders, breathing difficulties, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple discoloration of the skin) and death.
Treatment of overdose
The patient should be treated in a hospital, in the intensive care unit. Even patients who seem to be in good condition and have only slightly overdosed on metoprolol will be closely monitored by the doctor for at least 4 hours for signs of poisoning.

Missing a dose of Beto 200 ZK

A double dose should not be taken to make up for a missed dose, but treatment should be continued according to the doctor's instructions.

Stopping treatment with Beto 200 ZK

Before stopping or prematurely discontinuing treatment with Beto 200 ZK, the patient should
consult their doctor.
Beto 200 ZK should not be stopped abruptly, but its dose should be gradually reduced.
Sudden discontinuation of beta-blocker treatment may worsen heart failure symptoms and increase the risk of heart attack and sudden cardiac death.
In case of any further doubts related to the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everyone will experience them.

Very common (may occur more often than in 1 in 10 people):

• fatigue

Common (may occur less often than in 1 in 10 people):

• dizziness, headache
• slow heart rate (bradycardia)
• palpitations
• significant lowering of blood pressure, especially when changing body position from lying to standing, very rarely with loss of consciousness
• cold hands and feet
• breathing difficulties during exertion in predisposed patients (e.g. patients with asthma)
• nausea, abdominal pain, diarrhea, constipation

Uncommon (may occur less often than in 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disorders, nightmares, concentration disorders
• abnormal sensation of tingling, prickling, or numbness of the skin (paresthesia)
• temporary worsening of heart failure symptoms (with ankle and foot swelling), first-degree atrioventricular block, chest pain (chest pain), poor heart function as a pump (cardiogenic shock) in patients with heart attack (acute myocardial infarction)
• bronchospasm
• skin rash (urticaria-like and dystrophic skin changes), increased sweating
• muscle cramps

Rare (may occur less often than in 1 in 1000 people):

• worsening of diabetes without characteristic symptoms (latent diabetes)
• nervousness
• visual impairment, 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 occur less often than in 1 in 10,000 people):

• decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia)
• memory loss or memory disorders, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing impairment
• tissue death (necrosis) in patients with severe peripheral circulatory disorders before treatment
• taste disorders
• hepatitis
• hypersensitivity to light with skin rashes after exposure to light, worsening 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 fats, 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 side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Beto 200 ZK

• The drug should be stored in a place invisible and inaccessible to children.
• The drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Store at a temperature below 25°C.
• Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

Translation of some abbreviations on the blister pack:

Charge: en EXP: zie zijkant - Batch number and Expiry date - see side (blister pack)

6. Contents of the packaging and other information

What Beto 200 ZK contains

Active substanceis metoprolol succinate. Each prolonged-release tablet contains 190 mg of metoprolol succinate, which corresponds to 200 mg of metoprolol tartrate.
Other ingredients are:sucrose, pellets (sucrose, cornstarch, liquid glucose),
poliacrylate dispersion 30%, talc, magnesium stearate, microcrystalline cellulose, crospovidone,
silica colloidal anhydrous.
Coating Opadry II [lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000].

What Beto 200 ZK looks like and what the pack contains

Beto 200 ZK tablets are white, oblong, with a dividing line on both sides.
Blister packs of polypropylene/aluminum or PVC-aclar/aluminum, in a cardboard box.
Pack sizes: 28, 30, and 60 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V.
Veluwezoom 22
1327 AH Almere
Netherlands

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 32380

Parallel import authorization number: 708/12 Date of leaflet approval: 06.10.2022

[Information about the trademark]