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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• 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-blockers. Metoprolol reduces the effect of stress hormones on the heart during physical and mental exertion. This leads to a slowing of heart rate (decrease in heart frequency).
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),
• heart palpitations (awareness of heart action) due to 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 from 6 to 18 years old.

2. Important information before taking Bloxazoc

When not to take Bloxazoc:

Warnings and precautions

Before starting to take Bloxazoc, the patient should discuss it with their doctor or pharmacist:

Bloxazoc and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The following medicines may enhance the blood pressure-lowering effect of Bloxazoc:

• propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, hydralazine, digitalis glycosides/digoxin (medicines used in cardiovascular diseases),
• barbiturate derivatives (antiepileptic medicine),
• anti-inflammatory medicines (e.g., indomethacin and celecoxib),
• adrenaline (medicine used in acute shock and severe allergic reactions),
• phenylpropanolamine (medicine administered to the nasal mucosa),
• diphenhydramine (medicine used in allergic diseases),
• terbinafine (medicine used in fungal infections),
• rifampicin (antibiotic),
• other beta-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 (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 independently of meals.

Pregnancy and breastfeeding

Beta-blockers (including metoprolol) may reduce fetal heart rate and newborn heart rate. It is not recommended to take Bloxazoc during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Bloxazoc may cause fatigue and dizziness. Before driving a vehicle or operating machinery, the patient should make sure these effects do not occur, especially after changing medicines or taking them with alcohol.

3. How to take Bloxazoc

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their 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 tablet to make it easier to swallow, not to divide it into equal doses.
The tablets (or their halves) should not be chewed or crushed.
The tablets should be swallowed with water.

Usually used 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.

Heart palpitations due to heart disease:

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

Migraine prevention:

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

Patients with stable heart failure, used in combination with other medicines:

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.
The patient should always follow the doctor's instructions.

Use in children and adolescents

Bloxazoc is not recommended for children under 6 years old. Bloxazoc should always be used in children and adolescents as directed by the doctor.
The doctor will determine the dose suitable for the child. The dose depends on the child's body weight.
The recommended initial dose for high blood pressure is 0.48 mg/kg body weight of metoprolol succinate (0.5 mg/kg body weight 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 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 should not exceed a dose of 50 mg of metoprolol tartrate. In patients who do not respond 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 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, the patient should immediately go to the emergency department of the nearest hospital or inform their doctor or pharmacist.

Missing a dose of Bloxazoc

In case of a missed dose, the patient should take the medicine as soon as possible and then continue with the recommended dosing schedule.
The patient should not take a double dose to make up for the missed dose.

Stopping the use of Bloxazoc

The patient should not stop takingBloxazoc abruptly, 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 the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bloxazoc 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, heart 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,
• temporary 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):

• blood count changes (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 available data):
• concentration disorders,
• muscle cramps,
• eye inflammation,
• tissue death in patients with severe circulatory disorders,
• runny nose,
• dry mouth,
• hepatitis,
• joint pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Bloxazoc contains

• The active substance of Bloxazoc 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, 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.

What Bloxazoc looks like and contents of the packaging

23.75 mg: white to almost white, oval, biconvex, film-coated 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, film-coated 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, film-coated 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, film-coated 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 on the names of medicinal products in other EU member states, the patient 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: