Bloxazoc

Package leaflet: Information for the patient

Bloxazoc, 23.75 mg, prolonged-release tablets
Bloxazoc, 47.5 mg, prolonged-release tablets
Bloxazoc, 95 mg, prolonged-release tablets
Bloxazoc, 190 mg, prolonged-release tablets
metoprolol succinate
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• 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 Bloxazoc is and what it is used for
2. Important information before taking Bloxazoc
3. How to take Bloxazoc
4. Possible side effects
5. How to store Bloxazoc
6. Contents of the pack and other information

1. What Bloxazoc is and what it is used for

Metoprolol succinate belongs to a group of medicines called beta-blockers. Metoprolol reduces the effects of stress hormones on the heart during physical and psychological stress. This results in a slower heart function (reduction in heart rate).

Bloxazoc is used in the treatment of:

• high blood pressure (hypertension),
• chest pain caused by insufficient oxygen supply to the heart (angina pectoris),
• irregular heart rhythm (arrhythmia),
• palpitations (awareness of heart activity) due to non-organic (functional) heart disorders,
• stable heart failure (with symptoms such as shortness of breath and ankle swelling), in combination with other medicines used for heart failure.

Bloxazoc is used in prevention of:

• recurrence of myocardial infarction or further heart damage after a heart attack,
• migraine.

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

2. Important information before using Bloxazoc

When not to use Bloxazoc

• if the patient is allergic to the active substance, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has unstable heart failure and is taking medicines that increase the heart's contractility,
• if the patient has heart failure and blood pressure drops below 100 mmHg,
• if the patient has a slow heart rate (less than 45 beats per minute) or low blood pressure (hypotension),
• if the patient is in shock caused by heart disease,
• if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block) or heart rhythm disorders (sick sinus syndrome),
• if the patient has severe circulatory problems (severe peripheral arterial disease).

Warnings and precautions
Before starting treatment with Bloxazoc, discuss with a doctor or pharmacist:

• if the patient is receiving verapamil intravenously,
• if the patient has circulatory disorders that may cause tingling, cyanosis, or paleness of fingers and toes,
• if the patient has constricting chest pain, typically at night (Prinzmetal's angina),
• if the patient has asthma or another chronic obstructive pulmonary disease,
• if the patient has diabetes (low blood sugar levels may be masked by Bloxazoc),
• if the patient has heart conduction disorders (heart block),
• if the patient is being treated to reduce allergic reactions – Bloxazoc may increase sensitivity to substances the patient is allergic to and worsen the severity of allergic reactions,
• if the patient has high blood pressure due to a rare adrenal gland tumor (pheochromocytoma),
• if the patient has heart failure,
• if the patient is scheduled to receive an anesthetic, inform the doctor or dentist about metoprolol use,
• if the patient has increased blood acidity (metabolic acidosis),
• if the patient has severe kidney function impairment,
• if the patient is being treated with cardiac glycosides.

Bloxazoc and 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:

• propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, hydralazine, digitalis glycosides/digoxin (medicines used for cardiovascular diseases),
• barbituric acid derivatives (antiepileptic medicine),
• anti-inflammatory medicines (e.g. indomethacin and celecoxib),
• adrenaline (used in acute shock and severe allergic reactions),
• phenylpropanolamine (nasal decongestant),
• diphenhydramine (used in allergic conditions),
• terbinafine (used in fungal infections),
• rifampicin (antibiotic),
• other beta-blockers (e.g. eye drops),
• MAO inhibitors (medicines used in depression and Parkinson's disease),
• inhaled anesthetics (medicines used in anesthesia),
• medicines used in diabetes treatment: symptoms of low blood sugar may be masked,
• cimetidine (used in treatment of heartburn and gastroesophageal reflux),
• paroxetine, fluoxetine, and sertraline (medicines used in depression).

Bloxazoc with food and drink
Bloxazoc may be taken independently of meals.
Pregnancy and breastfeeding
Beta-blockers (including metoprolol) may reduce heart rate in the fetus and newborn. Use of Bloxazoc is not recommended during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Bloxazoc may cause fatigue and dizziness. Before driving or operating machinery, ensure these effects do not occur, especially after changing medications or when taken with alcohol.
Bloxazoc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Bloxazoc

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Bloxazoc tablets in extended-release form are a pharmaceutical formulation that ensures consistent
action throughout the day. The medicine should be taken once daily in the morning, with a glass of water.
The 23.75 mg Bloxazoc tablet may be divided into equal doses.
The break line on the 47.5 mg, 95 mg, and 190 mg Bloxazoc tablets is intended only to facilitate
breaking the tablet for easier swallowing, and does not allow for division into equal doses.
Tablets (or their halves) must not be chewed or crushed.
Tablets should be swallowed whole with water.

Typical dosages:
High blood pressure (hypertension):
47.5–95 mg of metoprolol succinate (50–100 mg of metoprolol tartrate) once daily.
Chest pain (angina pectoris):
95–190 mg of metoprolol succinate (100–200 mg of metoprolol tartrate) once daily.
Irregular heartbeat (arrhythmia):
95–190 mg of metoprolol succinate (100–200 mg of metoprolol tartrate) once daily.
Prevention of recurrent heart attack:
190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once daily.
Heart palpitations caused by heart disease:
95 mg of metoprolol succinate (100 mg of metoprolol tartrate) once daily.
Prevention of migraine:
95–190 mg of metoprolol succinate (100–200 mg of metoprolol tartrate) once daily.
Patients with stable heart failure, treated concomitantly with other medicines:
The initial dose is 11.88–23.75 mg of metoprolol succinate (12.5–25 mg of metoprolol tartrate) once daily. Your doctor may gradually increase the dose as needed, up to a maximum of 190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once daily.
Patients with impaired liver function:
If a patient has severe liver function impairment, the doctor may adjust the dose. Always follow your doctor's instructions.

Use in children and adolescents
Bloxazoc is not recommended for children under 6 years of age. Bloxazoc should always be used in children and adolescents as directed by a doctor.
The doctor will determine the appropriate dose for the child, based on body weight.
The recommended initial dose for treating high blood pressure is 0.48 mg/kg body weight of metoprolol succinate (0.5 mg/kg body weight of metoprolol tartrate) once daily (half a 23.75 mg tablet for a 25 kg child). The doctor will adjust the dose to the tablet strength closest to the required amount.
For patients not responding to a dose of 0.5 mg/kg body weight of metoprolol tartrate, the doctor may increase the dose to 0.95 mg/kg body weight of metoprolol succinate (1.0 mg/kg body weight of metoprolol tartrate), but the dose should not exceed 50 mg of metoprolol tartrate.
For patients not responding to 1.0 mg/kg body weight of metoprolol tartrate, the doctor may increase the dose to 1.9 mg/kg body weight of metoprolol succinate (2 mg/kg body weight of metoprolol tartrate) once daily (one 47.5 mg tablet for a 25 kg child). Doses higher than 190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once daily have not been studied in children and adolescents.

Taking more Bloxazoc than recommended
If you accidentally take more than the recommended dose, seek immediate medical attention at the nearest hospital emergency department or contact your doctor or pharmacist.

Missed dose of Bloxazoc
If you miss a dose, take it as soon as possible, then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping Bloxazoc
Do not stop taking Bloxazoc suddenly, as this may worsen heart failure and increase the risk of heart attack. Any dose adjustment or discontinuation of treatment must only be done after consultation with your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Very common adverse reactions (may affect at least 1 in 10 patients):

• fatigue.

Common adverse reactions (may affect less than 1 in 10 patients):

• headache, dizziness,
• cold hands and feet, slow heart rate, palpitations,
• breathlessness during intense physical exertion,
• nausea, abdominal pain, vomiting, diarrhoea, constipation.

Uncommon adverse reactions (may affect less than 1 in 100 patients):

• depression, nightmares, sleep disturbances,
• tingling/numbness sensation,
• transient worsening of heart failure symptoms,
• during myocardial infarction, significant drop in blood pressure may occur (cardiogenic shock in patients with acute myocardial infarction),
• breathlessness, worsening of bronchial disorders,
• skin hypersensitivity reactions,
• chest pain, fluid retention (oedema), weight gain.

Rare adverse reactions (may affect less than 1 in 1000 patients):

• decrease in platelet count (thrombocytopenia),
• forgetfulness, confusion, hallucinations, nervousness, anxiety,
• taste disturbances,
• visual disturbances, dryness or irritation of eyes,
• cardiac conduction disorders, heart rhythm disorders,
• changes in liver function tests,
• exacerbation of existing psoriasis or new onset of psoriasis (skin disease), photosensitivity, increased sweating, hair loss,
• impotence (inability to achieve erection),
• tinnitus.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• concentration difficulties,
• muscle cramps,
• eye inflammation,
• tissue necrosis in patients with severe circulatory disorders,
• catarrh,
• dryness of the oral mucosa,
• hepatitis,
• joint pain.

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 also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 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 the medicine.

5. How to store the medicine Bloxazoc

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bloxazoc 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: colloidal anhydrous silica, microcrystalline cellulose, hypromellose, sodium lauryl sulfate, polysorbate 80, glycerol, hydroxypropylcellulose, ethylcellulose and sodium stearyl fumarate in the tablet core; and hypromellose, titanium dioxide (E 171), talc and propylene glycol in the tablet coating. See section 2 "Bloxazoc contains sodium".

What Bloxazoc looks like and contents of the pack
23.75 mg: white to almost white, oval, biconvex film-coated tablets with a breakline on one side (dimensions: 8.5 mm x 4.5 mm). On one side of the breakline is embossed the letter C, and on the other side the number 1.
47.5 mg: white to almost white, oval, slightly biconvex film-coated tablets with a breakline on one side (dimensions: 10.5 mm x 5.5 mm). On one side of the breakline is embossed the letter C, and on the other side the number 2.
95 mg: white to almost white, oval, biconvex film-coated tablets with a breakline on one side (dimensions: 13 mm x 8 mm). On one side of the breakline is embossed the letter C, and on the other side the number 3.
190 mg: white to almost white, biconvex, capsule-shaped film-coated tablets with a breakline on both sides of the tablet (dimensions: 19 mm x 8 mm). On one side of the tablet, on one side of the breakline, the letter C is embossed, and on the other side of the breakline the number 4.
Pack sizes: 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 prolonged-release tablets in blister packs, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500