Blobet zok

Package leaflet: Information for the patient

Blobet ZOK, 25 mg, prolonged-release tablets
Blobet ZOK, 50 mg, prolonged-release tablets
Blobet ZOK, 100 mg, prolonged-release tablets
Blobet ZOK, 200 mg, prolonged-release tablets
Metoprolol succinate
Please read carefully the entire leaflet 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, please 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Blobet ZOK is and what it is used for

Blobet ZOK contains metoprolol succinate and belongs to a group of medicines called selective
beta-blockers. Beta-blockers slow down the heartbeat, reduce the force with which the heart muscle contracts,
and reduce constriction of blood vessels in the heart, brain, and throughout the body. The prolonged-release
metoprolol tablet ensures consistent effect throughout the day with once-daily dosing.
Blobet ZOK is used in adults:

• for the treatment of high blood pressure, also known as hypertension, to reduce the risk of complications associated with high blood pressure, such as stroke, myocardial infarction, or sudden death;
• for long-term treatment following myocardial infarction and prevention of recurrent myocardial infarction;
• for the treatment of chest pain or angina caused by stress or physical exertion in patients with ischemic heart disease (angina pectoris);
• for the treatment of heart failure (symptomatic mild to severe chronic heart failure) – as an add-on to other heart failure medications, to increase survival, reduce hospitalizations, improve left ventricular function, reduce the severity of heart failure (according to NYHA classification), and improve quality of life;
• for the treatment of heart conditions (arrhythmias), particularly rapid heartbeat in patients with heart disease (heart rhythm disorders, including supraventricular tachycardia);
• for the treatment of symptoms of rapid or irregular heartbeat in patients without heart disease (palpitations);
• for migraine prophylaxis.

Blobet ZOK is used in the treatment of high blood pressure in children and adolescents aged 6 to 18 years.

2. Important information before using Blobet ZOK

When not to use Blobet ZOK

• if the patient is allergic to metoprolol, another beta-blocker, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has unstable heart failure, or is being treated to increase heart contractions,
• if the patient has a slow heart rate (less than 45 beats/min) or low blood pressure (hypotension),
• if the patient is in cardiogenic shock,
• if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block) or heart rhythm disorders (sick sinus syndrome),
• if the patient has severe circulatory disorders (severe peripheral arterial disease).

Warnings and precautions
Before starting treatment with Blobet ZOK, discuss the following with your doctor or pharmacist:

• If the patient is receiving verapamil intravenously.
• If the patient has circulatory disorders that may cause tingling, paleness, or blueness of fingers in hands and feet (this medicine may worsen these symptoms).
• If the patient has severe chest pain, usually occurring at night (Prinzmetal's angina).
• If the patient suffers from asthma or other chronic obstructive lung diseases.
• This medicine may mask symptoms of low blood sugar (hypoglycemia) in diabetic patients.
• If the patient has conduction disorders in the heart (heart block).
• If the patient is undergoing treatment aimed at reducing allergic reactions. Blobet ZOK may increase sensitivity to substances the patient is allergic to and may intensify allergic reactions.
• If the patient has high blood pressure caused by a rare tumor of one of the adrenal glands (pheochromocytoma).
• If anesthesia is planned, inform the doctor or dentist about taking metoprolol tablets.
• If the patient has increased blood acidity (metabolic acidosis).
• If the patient has severe kidney function impairment.
• If the patient is being treated with digitalis.

Blobet ZOK with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of
the following medicines:

• medicines used to treat cardiovascular diseases (such as digitalis/digoxin, calcium antagonists, antiarrhythmics, ganglion-blocking agents, hydralazine),
• monoamine oxidase inhibitors (used to treat depression),
• barbituric acid derivatives (antiepileptic medicine),
• inhaled anesthetics,
• antibacterial medicines (rifampicin),
• medicines used to treat gastric ulcers (cimetidine),
• anti-inflammatory medicines (e.g. indomethacin and celecoxib),
• medicines used to treat depression (antidepressants) and other mental illnesses (antipsychotics),
• medicines used to treat allergies (antihistamines),
• other beta-blockers (e.g. eye drops),
• and other substances (alcohol, certain hormones),
• phenylpropanolamine (medicines for nasal mucous membranes).

If the patient is taking clonidine and Blobet ZOK at the same time, and clonidine treatment is to be discontinued, Blobet ZOK should be withdrawn several days before clonidine.
If the patient is taking an oral antidiabetic medicine, the doctor may need to adjust its dose.

Blobet ZOK with food, drink, or alcohol
Blobet ZOK may be taken with or without food.
Consuming alcohol may increase metoprolol levels in the blood and affect the medicine's action. Alcohol should not be consumed while taking this medicine.

Pregnancy and breastfeeding
Metoprolol is not recommended for women who are pregnant or breastfeeding. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Beta-adrenergic blockers (including metoprolol) may cause fetal harm and premature delivery. Use of metoprolol may lead to adverse effects such as reduced heart rate in the fetus and newborn. If pregnancy occurs during treatment, consult a doctor immediately.

Driving and operating machinery
If dizziness, drowsiness, or vision problems occur after starting these tablets, do not drive or operate machinery until these symptoms resolve.

Blobet ZOK contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Blobet ZOK

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The prolonged-release tablet Blobet ZOK is a dosage form designed to provide consistent action throughout the day and should be taken once daily, preferably in the morning, with a glass of water.
Do not chew or crush Blobet ZOK tablets (or their halves). They should be swallowed whole with liquid.
The 25 mg tablets with a score line may be divided into two equal doses.
For 50 mg, 100 mg, and 200 mg tablets, the score line is intended only to facilitate breaking the tablet in case of difficulty swallowing it whole, and not for dividing it into equal doses.

Recommended doses:

Hypertension
The recommended dose for patients with mild to moderate hypertension is 50 mg once daily.
If necessary, your doctor may increase the dose to 100–200 mg once daily or combine Blobet ZOK with another medicine to lower blood pressure.
Long-term treatment with metoprolol at doses of 100–200 mg daily has been shown to reduce the risk of complications associated with hypertension, such as stroke, myocardial infarction, or sudden death.

Post-myocardial infarction maintenance treatment
200 mg once daily.
Long-term treatment at this dose may reduce the risk of recurrent myocardial infarction and death.

Angina pectoris (chest pain)
100–200 mg once daily. Your doctor may recommend treatment in combination with other medicines.

Patients with stable heart failure
The dose will be individually adjusted. The recommended initial dose is 0.5–1 tablet of 25 mg once daily for one to two weeks. If necessary, the dose may be doubled every other week up to a maximum dose of 200 mg daily or the maximum tolerated dose.

Cardiac arrhythmias
100–200 mg once daily.

Functional cardiac disorders with palpitations
100 mg once daily. If necessary, your doctor may increase the dose to 200 mg.

Migraine prophylaxis
100–200 mg once daily.

Patients with impaired liver function
If the patient has severe liver function impairment, the doctor may adjust the dose. Always follow your doctor’s instructions.

Use in children and adolescents

High blood pressure (hypertension)
Blobet ZOK is not recommended for children under 6 years of age. Blobet ZOK should always be used in children and adolescents according to the doctor’s instructions.
The doctor will calculate the appropriate dose based on the child’s body weight.
The recommended initial dose is 0.5 mg/kg body weight once daily, not exceeding 50 mg.
The closest available tablet strength will be used. The doctor may increase the dose up to 2 mg/kg body weight once daily, depending on blood pressure values.
Doses higher than 200 mg once daily have not been studied in children and adolescents.

Taking more Blobet ZOK than recommended
If you take more tablets than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Bring the medicine with you so the doctor can see which medicine has been taken.
Symptoms of overdose may include: hypotension, heart failure, bradycardia, bradyarrhythmia, conduction disorders, and bronchospasm.
High doses may increase the risk of adverse effects, and taking too many tablets may lead to additional symptoms of poisoning, such as slow or irregular heartbeat, shortness of breath.
Therefore, do not take more of this medicine than prescribed by your doctor.
The mentioned symptoms may be intensified by concomitant consumption of alcohol, sleeping pills, and other medicines.
The first signs of overdose may appear 20 minutes to 2 hours after taking the medicine.
If you experience any of the above symptoms, consult your doctor, pharmacist, or go to the nearest hospital immediately.

If you miss a dose of Blobet ZOK
If you forget to take a dose, take it as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a missed tablet.

Stopping Blobet ZOK
Do not stop taking the tablets suddenly, as this may worsen your health condition.
First, consult your doctor. If treatment needs to be discontinued, the dose should be gradually reduced over a 14-day period, decreasing the dose to 12.5 mg during the last 4 days.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common (may occur in at least 1 in 10 patients)

• fatigue

Common (may occur in less than 1 in 10 patients)

• dizziness
• headache
• slowing of heart rate
• dizziness upon standing (very rarely with fainting)
• sensation of coldness in hands and feet
• nausea
• abdominal pain
• diarrhoea
• constipation
• shortness of breath during physical exertion
• palpitations

Uncommon (may occur in less than 1 in 100 patients)

• burning, numbness, or tingling sensations
• muscle cramps
• transient worsening of heart failure symptoms such as shortness of breath, fatigue, or ankle swelling
• sudden drop in blood pressure during myocardial infarction (cardiogenic shock)
• heart conduction disorders (mild changes on ECG)
• swelling (oedema)
• retrosternal pain
• depression
• difficulty concentrating
• sleep disorders such as drowsiness, insomnia, or nightmares

Rare (may occur in less than 1 in 1,000 patients)

• skin rash
• tightness in the airways (bronchospasm)
• vomiting
• excessive sweating
• weight gain
• hair loss
• nasal mucosal inflammation
• dryness or irritation of the eyes
• dryness of the oral mucosa
• tearing or redness of the eyes due to allergic reaction
• impotence (inability to achieve erection) or loss of libido

Very rare (may occur in less than 1 in 10,000 patients)

• worsening of symptoms of poor blood flow to limbs in patients with severe peripheral circulatory disorders
• joint pain
• memory loss or memory disturbances
• confusion
• hallucinations
• skin reactions due to increased sensitivity to sunlight
• exacerbation of psoriasis (a type of skin disease)
• tinnitus or hearing problems
• taste disturbances
• decreased platelet count (thrombocytopenia)
• hepatitis

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, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Blobet ZOK

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
box after the word "EXP". The expiry date refers to the last day of the stated month.
No special storage requirements.
Medicines must not be disposed of via the sewage system 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 Blobet ZOK contains

• The active substance is metoprolol succinate. Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, equivalent to 25 mg of metoprolol tartrate. Each prolonged-release tablet contains 47.5 mg of metoprolol succinate, equivalent to 50 mg of metoprolol tartrate.
  Each prolonged-release tablet contains 95 mg of metoprolol succinate, equivalent to 100 mg of metoprolol tartrate.
  Each prolonged-release tablet contains 190 mg of metoprolol succinate, equivalent to 200 mg of metoprolol tartrate.

• Other ingredients are: microcrystalline cellulose, ethylcellulose, dibutyl sebacate, hypromellose, tributyl acetylcitrate, polyvinyl acetate dispersion 30%, talc, macrogol 6000, povidone dispersion 30%, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E 171).

What Blobet ZOK looks like and contents of the pack
Blobet ZOK, 25 mg: White or almost white, oval, biconvex coated tablets, approximately 8.5 mm x 4.5 mm in size, with an embossed "C" on one side and "69" on the other side of the breakline and a breakline on the other side. The tablet may be divided into equal doses.
Blobet ZOK, 50 mg: White or almost white, oval, biconvex coated tablets, approximately 12.0 mm x 6.0 mm in size, with an embossed "C" on one side and "68" on the other side of the breakline and a breakline on the other side. The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing, not for dividing into equal doses.
Blobet ZOK, 100 mg: White or almost white, oval, biconvex coated tablets, approximately 14.0 mm x 8.0 mm in size, with an embossed "C" on one side and "67" on the other side of the breakline and a breakline on the other side. The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing, not for dividing into equal doses.
Blobet ZOK, 200 mg: White or almost white, oval, biconvex coated tablets, approximately 18.5 mm x 9.5 mm in size, with an embossed "C" on one side and "66" on the other side of the breakline and a breakline on the other side. The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing, not for dividing into equal doses.
The medicine is packed in PVDC/PVC/Aluminium foil blisters in a cardboard carton.
Pack sizes: 30, 50, 100, 250 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Hypablo
Poland: Blobet ZOK
Estonia, Latvia, Lithuania: Blobet
Slovakia: Metoprolol Zentiva

For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00