Bloxazoc

Leaflet attached to the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bloxazoc and what is it 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 packaging and other information

1. What is Bloxazoc and what is it used for

Metoprolol succinate belongs to a group of medicines called beta-adrenergic blockers. Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion. This leads to a slowing of heart rate (reduced 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 caused by non-organic (functional) heart disorders,
• stable heart failure (with symptoms such as shortness of breath and swelling of the ankles), in combination with other heart failure medications.

Bloxazoc is used in the prevention of:

• another heart attack or heart damage after a heart attack,
• migraine.

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

2. Important information before taking Bloxazoc

When not to take Bloxazoc

• if the patient is allergic to the active substance, other beta-adrenergic blockers, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has unstable heart failure and is taking medications that increase heart contractility,
• if the patient has heart failure and their blood pressure is 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 due to heart disease,
• if the patient has conduction disorders (second- or third-degree atrioventricular block) or rhythm disorders (sick sinus syndrome),
• if the patient has severe circulatory disorders (severe peripheral arterial disease).

Warnings and precautions

Before starting to take Bloxazoc, you should discuss it with your doctor or pharmacist:

• if you are taking verapamil intravenously,
• if you have circulatory disorders that may cause tingling, discoloration, or pallor of the fingers and toes,
• if you have chest pain at night (Prinzmetal's angina),
• if you have asthma or other chronic obstructive pulmonary disease,
• if you have diabetes (low blood sugar may be masked by Bloxazoc),
• if you have conduction disorders (heart block),
• if you are being treated to reduce allergic reactions - Bloxazoc may increase sensitivity to substances you are allergic to and worsen the severity of allergic reactions,
• if you have high blood pressure due to a rare adrenal gland tumor (pheochromocytoma),
• if you have heart failure,
• if you are scheduled to receive an anesthetic, you should inform your doctor or dentist that you are taking metoprolol,
• if you have increased blood acidity (metabolic acidosis),
• if you have severe kidney function disorders,
• if you are being treated with digitalis glycosides.

Bloxazoc and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, hydralazine, digitalis glycosides/digoxin (medicines used in cardiovascular diseases),
• barbiturate derivatives (antiepileptic medication),
• anti-inflammatory medicines (e.g., indomethacin and celecoxib),
• adrenaline (a medicine used in acute shock and severe allergic reactions),
• phenylpropanolamine (a medicine given on the nasal mucosa),
• diphenhydramine (a medicine used in allergic diseases),
• terbinafine (a medicine used in fungal infections),
• rifampicin (an antibiotic),
• other beta-adrenergic blockers (e.g., eye drops),
• monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease),
• inhalation anesthetics (medicines used in anesthesia),
• medicines used to treat diabetes: symptoms of low blood sugar may be masked,
• cimetidine (a medicine used to treat heartburn and acid reflux),
• paroxetine, fluoxetine, and sertraline (medicines used in depression).

Bloxazoc with food and drink

Bloxazoc can be taken with or without food.

Pregnancy and breastfeeding

Beta-adrenergic blockers (including metoprolol) may reduce the heart rate of the fetus and newborn. It is not recommended to take Bloxazoc during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Bloxazoc may cause fatigue and dizziness. Before driving a car or operating machinery, you should make sure that these effects do not occur, especially when changing medications or taking them with alcohol.

Bloxazoc contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take 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 prolonged-release tablets have a pharmaceutical form that ensures a uniform effect throughout the day. The medicine should be taken once a day, in the morning, with a glass of water.
The 23.75 mg tablet can be divided into equal doses.
The dividing line on the 47.5 mg, 95 mg, and 190 mg tablets is only to facilitate breaking the tablets, not to divide them into equal doses.
The tablets (or their halves) should not be chewed or crushed.
The tablets should be swallowed with water.

Usual doses:

High blood pressure (hypertension):

47.5-95 mg of metoprolol succinate (50-100 mg of metoprolol tartrate) once a day.

Chest pain (angina pectoris):

95-190 mg of metoprolol succinate (100-200 mg of metoprolol tartrate) once a day.

Irregular heart rhythm (arrhythmia):

95-190 mg of metoprolol succinate (100-200 mg of metoprolol tartrate) once a day.

Prevention of another heart attack:

190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once a day.

Palpitations caused by heart disease:

95 mg of metoprolol succinate (100 mg of metoprolol tartrate) once a day.

Prevention of migraine:

95-190 mg of metoprolol succinate (100-200 mg of metoprolol tartrate) once a day.

Patients with stable heart failure, taking other medications:

The initial dose is 11.88-23.75 mg of metoprolol succinate (12.5-25 mg of metoprolol tartrate) once a day. The doctor may gradually increase the dose as needed, up to a maximum of 190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once a day.

Patients with liver function disorders:

If the patient has severeliver function disorders, the doctor may adjust the dose.
You should always follow the doctor's instructions.

Use in children and adolescents

Bloxazoc is not recommended for children under 6 years of age. Bloxazoc should always be taken by children and adolescents as directed by their doctor.
The doctor will determine the dose of the medicine suitable for the child. The dose depends on the child's body weight.
The recommended initial dose for the treatment of high blood pressure is 0.48 mg/kg of metoprolol succinate (0.5 mg/kg of metoprolol tartrate) once a day (half a 23.75 mg tablet for a child weighing 25 kg). The doctor will adjust the dose to the nearest available tablet strength. In patients who do not respond to a dose of 0.5 mg/kg of metoprolol tartrate, the doctor may increase the dose to 0.95 mg/kg of metoprolol succinate (1.0 mg/kg of metoprolol tartrate), but the dose should not exceed 50 mg of metoprolol tartrate. In patients who do not respond to 1.0 mg/kg of metoprolol tartrate, the doctor may increase the dose to 1.9 mg/kg of metoprolol succinate (2 mg/kg of metoprolol tartrate) once a day (one 47.5 mg tablet for a child weighing 25 kg). Doses greater than 190 mg of metoprolol succinate (200 mg of metoprolol tartrate) once a day have not been studied in children and adolescents.

Taking a higher dose of Bloxazoc than recommended

In case of accidental ingestion of a higher dose than recommended, you should immediately go to the emergency department of the nearest hospital or inform your doctor or pharmacist.

Missing a dose of Bloxazoc

If you miss a dose, you should take the medicine as soon as possible, and then continue with the recommended dosing schedule.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Bloxazoc

You should not suddenly stoptaking Bloxazoc, as this may worsen heart failure and increase the risk of a heart attack. Changing the dose or stopping treatment is only possible after consulting a doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

• fatigue.

Common side effects(may affect less than 1 in 10 people):

• -headache, dizziness,
• cold hands and feet, slow heart rate, palpitations,
• shortness of breath during intense physical exertion,
• nausea, abdominal pain, vomiting, diarrhea, constipation.

Uncommon side effects(may affect less than 1 in 100 people):

• depression, nightmares, sleep disorders,
• tingling/numbness,
• transient worsening of heart failure symptoms,
• during a heart attack, there may be a significant decrease in blood pressure (cardiogenic shock in patients with acute myocardial infarction),
• shortness of breath, worsening of bronchial disorders,
• skin hypersensitivity reactions,
• chest pain, fluid retention (edema), weight gain.

Rare side effects(may affect less than 1 in 1000 people):

• decreased platelet count (thrombocytopenia),
• forgetfulness, confusion, hallucinations, nervousness, anxiety,
• taste disorders,
• vision disorders, dryness or irritation of the eyes,
• heart conduction disorders, heart rhythm disorders,
• changes in liver function tests,
• worsening of existing psoriasis or development of psoriasis (skin disease), hypersensitivity to light, increased sweating, hair loss,
• impotence (erectile dysfunction),
• ringing in the ears.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• concentration disorders,
• muscle cramps,
• eye inflammation,
• tissue death in patients with severe circulatory disorders,
• runny nose,
• dryness of the oral mucosa,
• hepatitis,
• joint pain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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
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 Bloxazoc

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bloxazoc contains

• The active substance of the medicine is metoprolol succinate. Each prolonged-release tablet contains 23.75 mg of metoprolol succinate, which corresponds to 25 mg of metoprolol tartrate. Each prolonged-release tablet contains 47.5 mg of metoprolol succinate, which corresponds to 50 mg of metoprolol tartrate. Each prolonged-release tablet contains 95 mg of metoprolol succinate, which corresponds to 100 mg of metoprolol tartrate. Each prolonged-release tablet contains 190 mg of metoprolol succinate, which corresponds to 200 mg of metoprolol tartrate.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, hypromellose, sodium lauryl sulfate, polysorbate 80, glycerol, hydroxypropyl cellulose, ethyl cellulose, 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 tablets with a dividing line on one side of the tablet (dimensions: 8.5 mm x 4.5 mm). On one side of the dividing line, the letter "C" is embossed, and on the other side, the number "1".
47.5 mg: white to almost white, oval, slightly biconvex tablets with a dividing line on one side of the tablet (dimensions: 10.5 mm x 5.5 mm). On one side of the dividing line, the letter "C" is embossed, and on the other side, the number "2".
95 mg: white to almost white, oval, biconvex tablets with a dividing line on one side of the tablet (dimensions: 13 mm x 8 mm). On one side of the dividing line, the letter "C" is embossed, and on the other side, the number "3".
190 mg: white to almost white, biconvex tablets in the shape of a capsule, with a dividing line on both sides of the tablet (dimensions: 19 mm x 8 mm). On one side of the tablet, on one side of the dividing line, the letter "C" is embossed, and on the other side of the dividing line, the number "4".
Packaging:10, 14, 28, 30, 50, 56, 60, 84, 90, 98, and 100 prolonged-release tablets, in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information about the names of medicinal products in other European Economic Area member states, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: