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

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Blobet ZOK and what is it 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 pack and other information

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

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

• to treat high blood pressure, also known as hypertension, to reduce the risk of complications associated with high blood pressure, such as stroke, heart attack, or sudden death,
• for the long-term treatment after a heart attack and to prevent further heart attacks,
• to treat chest pain or angina pectoris caused by stress or physical exertion in patients with coronary artery disease,
• to treat heart failure (symptomatic mild to severe chronic heart failure) - as an adjunct to other heart failure medications, to increase survival, reduce hospitalization, improve left ventricular function, alleviate the severity of heart failure (according to the NYHA classification), and improve quality of life,
• to treat heart rhythm disorders (arrhythmias), particularly rapid heart rate in patients with heart conditions (arrhythmias, including supraventricular tachycardia),
• to treat symptoms of rapid or irregular heartbeat in patients without heart conditions (palpitations),
• for migraine prophylaxis.

Blobet ZOK is used to treat high blood pressure in children and adolescents from 6 to 18 years of age.

2. Important information before taking Blobet ZOK

When not to take Blobet ZOK

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

Warnings and precautions

Before starting treatment with Blobet ZOK, discuss it with your doctor or pharmacist:

• If you are receiving intravenous verapamil.
• If you have circulatory disorders that may cause tingling, pallor, or cyanosis of the fingers and toes (taking this medication may worsen them).
• If you have severe chest pain, usually occurring at night (Prinzmetal's angina).
• If you have asthma or other chronic obstructive pulmonary diseases.
• This medication may mask small blood sugar levels (diabetes).
• If you have conduction disorders in the heart (heart block).
• If you are undergoing treatment to reduce allergic reactions. Blobet ZOK may increase sensitivity to substances you are allergic to and increase the severity of allergic reactions.
• If you have high blood pressure caused by a rare tumor in one of the adrenal glands (pheochromocytoma).
• If you are to undergo anesthesia, inform your doctor or dentist that you are taking metoprolol tablets.
• If you have increased blood acidity (metabolic acidosis).
• If you have severe kidney function disorders.
• If you are being treated with digitalis.

Blobet ZOK with other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
In particular, tell your doctor or pharmacist if you are taking any of the following medications:

• medications used to treat cardiovascular diseases (such as digitalis/digoxin, calcium antagonists, antiarrhythmic medications, sympathetic nerve blockers, hydralazine),
• monoamine oxidase inhibitors (used to treat depression),
• barbiturate derivatives (antiepileptic medication),
• inhalation anesthetics,
• antibacterial medications (rifampicin),
• medications used to treat stomach ulcers (cimetidine),
• anti-inflammatory medications (e.g., indomethacin and celecoxib),
• medications used to treat depression (antidepressants) and other mental illnesses (antipsychotics),
• medications used to treat allergies (antihistamines),
• other beta-blockers (e.g., eye drops),
• and other substances (alcohol, certain hormones),
• phenylpropanolamine (medications used for nasal mucosa).

If you are taking clonidine and Blobet ZOK at the same time and clonidine treatment is to be discontinued, Blobet ZOK should be discontinued a few days before clonidine.
If you are taking oral antidiabetic medication, your doctor may adjust the dose.

Blobet ZOK with food, drink, or alcohol

Blobet ZOK can be taken with or without food.
Consuming alcohol may increase the amount of metoprolol in the blood and affect the action of the medication. Do not drink alcohol while taking this medication.

Pregnancy and breastfeeding

Metoprolol is not recommended for pregnant or breastfeeding women. If you are pregnant or breastfeeding, or think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medication.
Beta-blocker receptors (including metoprolol) may cause fetal harm and premature birth. Taking metoprolol may cause side effects such as reduced heart rate in the fetus and newborn. If you become pregnant while taking this medication, consult your doctor as soon as possible.

Driving and using machines

If you experience dizziness or drowsiness or eye problems after starting these tablets, do not drive or operate machinery until these symptoms have resolved.

Blobet ZOK contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

3. How to take Blobet ZOK

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
The prolonged-release tablet Blobet ZOK is a dosage form that provides a uniform effect 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). Swallow them with a liquid.
The 25 mg tablets with a score line can be divided into two equal doses.
For the 50 mg, 100 mg, and 200 mg tablets, the score line is only to facilitate breaking the tablet for easier swallowing and not to divide it into equal doses.
Recommended doses are:
Hypertension
The recommended dose of Blobet ZOK for patients with mild to moderate hypertension is 50 mg once daily.
If necessary, your doctor may increase the dose to 100 mg - 200 mg once daily or combine Blobet ZOK with another medication to lower blood pressure.
It has been proven that long-term treatment with metoprolol at a dose of 100 mg to 200 mg per day can reduce the risk of complications associated with hypertension, such as stroke, heart attack, or sudden death.
Post-myocardial infarction maintenance treatment
200 mg once daily.
Long-term treatment with this dose may reduce the risk of further heart attacks and death.
Angina pectoris (chest pain)
100 mg - 200 mg once daily. Your doctor may recommend treatment in combination with other medications.
Patients with stable heart failure
The dose will be adjusted individually. The recommended initial dose is 0.5 - 1 tablet of 25 mg once daily for one to two weeks. If necessary, the dose can be doubled every other week to a maximum dose of 200 mg per day or the maximum tolerated dose.
Heart rhythm disorders (arrhythmia)
100 mg - 200 mg once daily.
Functional heart disorders with palpitations
100 mg once daily. If necessary, your doctor may increase the dose to 200 mg.
Migraine prophylaxis
100 mg - 200 mg once daily.
Patients with liver function disorders
If you have severe liver function disorders, your doctor may adjust the dose. Always follow your doctor's instructions.

Use in children and adolescents

Hypertension (high blood pressure)
Blobet ZOK should not be used in children under 6 years of age. Blobet ZOK in children and adolescents should always be used under the guidance of a doctor.
Your doctor will calculate the appropriate dose for your child. The dosage depends on the child's body weight.
The recommended initial dose is 0.5 mg/kg body weight once daily, not exceeding 50 mg.
The most suitable available tablet strength will be used. Your doctor may increase the dose to 2 mg/kg body weight once daily, depending on blood pressure values.
Doses greater than 200 mg once daily have not been studied in children and adolescents.

Taking a higher dose of Blobet ZOK than recommended

If you have taken more tablets than recommended, inform your doctor or contact the emergency department of your nearest hospital immediately. Take the medication with you so the doctor can see what medication was taken.
Overdose symptoms may include: hypotension, heart failure, bradycardia, bradyarrhythmia, conduction disorders, and bronchospasm.
High doses may increase the risk of side effects, and taking too many tablets may cause additional symptoms of poisoning; e.g., slow or irregular heart rate, shortness of breath.
Therefore, do not take higher doses of the medication than recommended by your doctor.
The mentioned symptoms may worsen if you also consume alcohol, sleeping pills, and other medications.
The first symptoms of overdose can be observed 20 minutes to 2 hours after taking the medication.
If you observe any of the above symptoms, consult your doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Blobet ZOK

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

Stopping treatment with Blobet ZOK

Do not stop taking the tablets abruptly, as this may worsen your condition.
First, consult your doctor. If treatment is to be discontinued, the dose should be gradually reduced over a period of 14 days, reducing the doses to 12.5 mg over the last 4 days.
If you have further questions about taking this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Blobet ZOK can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people)

• fatigue

Common(may affect up to 1 in 10 people)

• dizziness
• headache
• slow heart rate
• dizziness when standing up (rarely with fainting)
• feeling of cold hands and feet
• nausea
• abdominal pain
• diarrhea
• constipation
• shortness of breath during physical exertion
• palpitations

Uncommon(may affect up to 1 in 100 people)

• feeling of burning, numbness, tingling
• muscle cramps
• temporary worsening of heart failure symptoms, such as shortness of breath, fatigue, or swelling of the ankles
• sudden drop in blood pressure during a heart attack (cardiogenic shock)
• conduction disorders in the heart (mild changes in ECG)
• edema
• joint pain
• depression
• concentration disorders
• sleep disorders such as drowsiness, insomnia, or nightmares
• rash
• feeling of tension in the airways (bronchospasm)
• vomiting
• increased sweating
• weight gain

Rare(may affect up to 1 in 1,000 people)

• conduction disorders in the heart (ECG)
• irregular heartbeat
• nervousness
• anxiety disorders
• changes in liver function test results
• hair loss
• nasal mucosa inflammation
• dryness or irritation of the eyes
• dryness of the mucous membrane of the mouth
• tearing or redness of the eyes due to an allergic reaction
• impotence (inability to achieve erection) or loss of libido

Very rare(may affect up to 1 in 10,000 people)

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Blobet ZOK

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after the words "EXP". The expiry date refers to the last day of the month.
No special precautions.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. 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, ethyl cellulose, 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, film-coated tablets with dimensions of approximately 8.5 mm x 4.5 mm, with "C" embossed on one side and "69" on the other side of the score line and a score line on the other side. The tablet can be divided into equal doses.
Blobet ZOK, 50 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of approximately 12.0 mm x 6.0 mm, with "C" embossed on one side and "68" on the other side of the score line and a score line on the other side. The score line on the tablet is only to facilitate breaking it for easier swallowing and not to divide it into equal doses.
Blobet ZOK, 100 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of approximately 14.0 mm x 8.0 mm, with "C" embossed on one side and "67" on the other side of the score line and a score line on the other side. The score line on the tablet is only to facilitate breaking it for easier swallowing and not to divide it into equal doses.
Blobet ZOK, 200 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of approximately 18.5 mm x 9.5 mm, with "C" embossed on one side and "66" on the other side of the score line and a score line on the other side. The score line on the tablet is only to facilitate breaking it for easier swallowing and not to divide it into equal doses.
The medication is packaged in a blister pack of PVDC/PVC/Aluminum foil in a carton.
Pack sizes: 30, 50, 100, 250 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 medication is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Hypablo
Poland: Blobet ZOK
Estonia, Latvia, Lithuania: Blobet
Slovakia: Metoprolol Zentiva

For further information, contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z.o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00

Date of last revision of the package leaflet: