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 medicine, 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 medicine has been prescribed for you only. 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, please 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 medicines called selective beta-blockers. Beta-blockers slow down the heart rate, reduce the force of contraction of the heart muscle, 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 heart 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), especially rapid heart rate in patients with heart rhythm disorders (arrhythmias, including supraventricular tachycardia),
• to treat symptoms of rapid or irregular heartbeat in patients without heart disease (palpitations),
• for migraine prophylaxis.

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

2. Important information before taking Blobet ZOK

When not to take Blobet ZOK

• if you are allergic to metoprolol, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6),
• if you have unstable heart failure and 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 shock due to heart problems,
• 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 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 medicine 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 medicine 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 medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used to treat cardiovascular diseases (such as digitalis, calcium antagonists, anti-arrhythmic medicines, alpha-blockers, hydralazine),
• monoamine oxidase inhibitors (used to treat depression),
• barbiturate derivatives (anti-epileptic medicine),
• inhalation anesthetics,
• antibiotics (rifampicin),
• medicines used to treat stomach 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 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 an oral anti-diabetic medicine, 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 medicine. You should not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

Metoprolol is not recommended for women who are pregnant or breastfeeding. If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Beta-blocker receptors (including metoprolol) may cause fetal damage and premature birth. Taking metoprolol may cause side effects such as reduced heart rate in the fetus and newborn.

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, you should contact your doctor before taking this medicine.

3. How to take Blobet ZOK

Always take this medicine exactly as your doctor has told you. If you are not sure, 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.

Blobet ZOK tablets (or their halves) should not be chewed or crushed. They should be swallowed with a liquid.

The 25 mg tablets with a dividing line can be divided into two equal doses.

For the 50 mg, 100 mg, and 200 mg tablets, the dividing line is only to facilitate breaking the tablet to make it easier to swallow 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 medicine 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.

Maintenance treatment after a heart attack

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 medicines.

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 (arrhythmias)

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 is not recommended for children under 6 years of age. Blobet ZOK should be used in children and adolescents under the guidance of a doctor.

The doctor will calculate the appropriate dose for the 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, you should immediately inform your doctor or contact the emergency department of the nearest hospital. You should take the medicine with you so that the doctor can see what 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 side effects, and taking too many tablets may cause additional symptoms of poisoning, such as slow or irregular heartbeat, shortness of breath.

Therefore, you should not take higher doses of the medicine than recommended by your doctor.

The mentioned symptoms may worsen if you also consume alcohol, sleeping pills, and other medicines.

The first symptoms of overdose can be observed 20 minutes to 2 hours after taking the medicine.

If you observe any of the above symptoms, you should consult your doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Blobet ZOK

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

Stopping treatment with Blobet ZOK

You should not suddenly stop taking the tablets, as this may worsen your condition.

First, consult your doctor. In case of treatment discontinuation, 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 any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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)

• tingling, numbness, prickling sensation
• muscle cramps
• transient 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
• rhinitis
• dryness or irritation of the eyes
• dryness of the mucous membrane of the mouth
• tearing or redness of the eyes due to allergic reactions
• impotence (inability to achieve an erection) or loss of libido

Very rare(may affect less than 1 in 10,000 people)

• worsening of symptoms of poor blood flow to the limbs in patients with severe peripheral arterial disease
• joint pain
• memory loss or memory 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, please inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug 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 medicine.

5. How to store Blobet ZOK

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after the words "EXP". The expiry date refers to the last day of the month.

No special precautions for disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 about 8.5 mm x 4.5 mm, with "C" embossed on one side and "69" on the other side of the dividing line and a dividing line on the other side. The tablet can be divided into two equal doses.

Blobet ZOK, 50 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of about 12.0 mm x 6.0 mm, with "C" embossed on one side and "68" on the other side of the dividing line and a dividing line on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Blobet ZOK, 100 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of about 14.0 mm x 8.0 mm, with "C" embossed on one side and "67" on the other side of the dividing line and a dividing line on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Blobet ZOK, 200 mg: White or almost white, oval, biconvex, film-coated tablets with dimensions of about 18.5 mm x 9.5 mm, with "C" embossed on one side and "66" on the other side of the dividing line and a dividing line on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

The medicine is packaged in a blister pack of PVDC/PVC/Aluminum foil in a carton.

Package sizes: 30, 50, 100, 250 prolonged-release tablets.

Not all package 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 medicine 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, please 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: