Borez

Leaflet attached to the packaging: patient information

Borez, 5 mg, coated tablets

Borez, 10 mg, coated tablets

Bisoprolol fumarate

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Borez and what is it used for
• 2. Important information before taking Borez
• 3. How to take Borez
• 4. Possible side effects
• 5. How to store Borez
• 6. Contents of the packaging and other information

1. What is Borez and what is it used for

Borez belongs to a group of medicines called beta-adrenergic receptor antagonists (beta-adrenolytics). These medicines prevent excessive strain on the heart.
Bisoprolol fumarate may be used to treat:

• high blood pressure (hypertension),
• angina pectoris (feeling of pressure in the chest),
• heart failure, which causes shortness of breath during physical exertion or fluid retention in the body. In this case, Borez may be used as additional treatment in combination with other medicines for heart failure.

2. Important information before taking Borez

When not to take Borez

• if the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cardiogenic shock (severe heart dysfunction, characterized by rapid and barely perceptible pulse, low blood pressure, cold and moist skin, weakness, and fainting);
• if the patient has severe bronchial asthma;
• if the patient has a slow heart rate (less than 60 beats per minute) - in case of doubt, the doctor should be consulted;
• if the patient has very low blood pressure;
• if the patient has severe circulatory disorders (such as Raynaud's syndrome), which can cause tingling, pallor, or cyanosis of the fingers and toes;
• if the patient has severe heart rhythm disorders (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);
• if the patient has acute heart failure, which has occurred recently or existing heart failure is not compensated and requires hospital treatment;
• if the patient has a metabolic disorder that causes excessive acid accumulation in the blood (metabolic acidosis) - in case of doubt, the doctor should be consulted;
• if the patient has an untreated adrenal gland tumor (pheochromocytoma);

In case of doubt as to whether any of the above conditions apply to the patient, the doctor should be consulted.

Warnings and precautions

Before starting to take Borez, the doctor or pharmacist should be consulted:

• if the patient has chronic lung disease (chronic obstructive pulmonary disease) or not very severe bronchial asthma, as it may be necessary to administer bronchodilators and use higher doses of beta-adrenomimetics. The doctor should be told immediately if difficulty breathing, coughing, wheezing, or other symptoms occur while taking Borez;
• if the patient has diabetes, as the tablets may mask the symptoms of low blood sugar (e.g., rapid heart rate, unpleasant feeling of rapid or strong heart action, increased sweating);
• if the patient is not eating solid foods (strict fasting);
• if the patient is being treated for an allergic reaction (allergic reaction), as bisoprolol may increase the patient's sensitivity to substances they are allergic to and worsen the severity of allergic reactions, and adrenaline treatment may be ineffective and may require an increased dose of adrenaline;
• if the patient has first-degree atrioventricular block (heart conduction disorder);
• if the patient has Prinzmetal's angina - a chest pain caused by coronary artery spasm, which supplies blood to the heart muscle;
• if the patient has any circulatory disorders in the limbs, such as in the hands and feet;
• if the patient is scheduled for surgery or dental surgery that requires anesthesia, as the doctor should be informed about all medications being taken;
• if the patient has or has had psoriasis (a chronic skin disease characterized by dry, scaly skin lesions);
• if the patient has a pheochromocytoma (adrenal gland tumor) - before taking bisoprolol, the patient will receive appropriate treatment;
• if the patient has thyroid disease - Borez may mask the symptoms of hyperthyroidism (excessive thyroid activity).

Currently, there is no data on the treatment of heart failure with bisoprolol in patients with the following conditions and diseases:

• diabetes treated with insulin (type I),
• severe kidney dysfunction,
• severe liver dysfunction,
• certain heart diseases,
• heart attack within the last 3 months.

Treatment of heart failure with bisoprolol requires regular medical supervision. This is absolutely necessary, especially at the beginning of treatment.
Do not stop taking bisoprolol abruptly, unless absolutely necessary.
Treatment should not be stopped abruptly in patients with high blood pressure and angina pectoris with concomitant heart failure. The doctor will recommend a gradual reduction in dose, by half every week.
The doctor should be consulted if any of the warnings apply to the patient or have applied in the past.

Borez and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Certain medicines should not be taken at the same time as bisoprolol, while others may require changes in treatment (e.g., dose adjustment).
The doctor should be informed about the use of any of the following medicines in combination with Borez:

• medicines used to control blood pressure or treat heart disorders (e.g., amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, nifedipine, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medicines used to treat psychosis (mental disorders), such as barbiturates (also used to treat epilepsy), phenothiazine derivatives (also used to prevent and treat nausea and vomiting);
• antidepressants, such as tricyclic antidepressants and MAO-A inhibitors;
• medicines used for anesthesia during surgical procedures (see also "Warnings and precautions");
• certain painkillers (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• beta-blockers used topically (such as timolol in eye drops, used to treat glaucoma);
• certain medicines used to treat shock (e.g., adrenaline, dobutamine, noradrenaline);
• mefloquine, a medicine used to treat malaria. All of the above medicines, including bisoprolol, may affect blood pressure and/or heart function.
• insulin or other anti-diabetic medicines - the effect of lowering blood sugar may be enhanced, and the warning signs of low blood sugar may be masked.

Borez with food, drink, and alcohol

Borez can be taken with or without food.
The recommended dose (whole tablet/whole tablets and/or half tablet) should be swallowed whole, with a sufficient amount of liquid; the tablets should not be chewed or crushed.
Alcohol may enhance the dizziness and feeling of fainting that may occur when taking this medicine. If such symptoms occur, alcohol should be avoided.

Pregnancy and breastfeeding

Borez may be harmful to pregnancy and/or the unborn child. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the child. The medicine may also affect the development of the child. Therefore, bisoprolol should not be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, so Borez should not be taken during 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

The medicine may affect the ability to drive or operate machinery, depending on how it is tolerated. Particular care should be taken at the beginning of treatment, after a dose increase, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Borez

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The doctor will recommend the dose. Borez tablets should be taken in the morning, before, during, or after breakfast. The recommended dose (whole tablet/whole tablets and/or half tablet) should be swallowed whole, with a sufficient amount of liquid; the tablets should not be chewed or crushed.

Recommended dose of Borez:

Hypertension/angina pectoris:

Adults
The dose is determined individually.
The recommended initial dose is 5 mg once daily.
The usual dose for adults is 10 mg once daily. If necessary, the doctor may increase or decrease the dose.
The maximum dose is 20 mg once daily.
Severe liver or kidney dysfunction
In patients with severe liver or kidney dysfunction, a dose greater than 10 mg per day should not be used.
Elderly patients
Usually, there is no need to change the dose. Treatment starts with the smallest possible dose.
Use in children
The efficacy and safety of Borez in children have not been established.
Heart failure (reduced heart contraction force):
Adults
Before starting Borez, the patient will already be taking an ACE inhibitor (a medicine that dilates blood vessels, thereby lowering blood pressure), a diuretic (a medicine that increases urine production, thereby lowering blood pressure), or a digitalis glycoside (a medicine used to treat heart diseases).
The doctor will gradually increase the dose until the desired therapeutic effect is achieved:
1.25 mg once daily in the first week: if the dose is well tolerated, it will be increased to
2.5 mg once daily in the next week: if the dose is well tolerated, it will be increased to
3.75 mg once daily in the next week: if the dose is well tolerated, it will be increased to
5 mg once daily for the next 4 weeks: if the dose is well tolerated, it will be increased to
7.5 mg once daily for the next 4 weeks: if the dose is well tolerated, it will be increased to
10 mg once daily for maintenance treatment.
The maximum dose is 10 mg once daily.
Doses of 1.25 to 3.75 mg per day, used in the initial dose-increase phase, can be achieved using divisible Borez 2.5 mg tablets.
The doctor will determine the most suitable dose for the patient, taking into account any possible side effects.
After the first dose of 1.25 mg, the doctor will check the patient's blood pressure, heart rate, and any heart function disorders.
Liver or kidney dysfunction
In patients with liver or kidney dysfunction, the dose of Borez will be increased with caution.
Elderly patients
Usually, there is no need to adjust the dose.
Use in children
The efficacy and safety of Borez in children have not been established.
If the patient feels that the effect of Borez is too strong or too weak, they should consult their doctor or pharmacist.

Dividing the tablet

The tablet can be divided into equal doses. The tablet should be placed on a hard, flat surface, with the dividing line facing up. The center of the tablet should be pressed with the thumb. The tablet will break into two equal parts.

Duration of treatment

Treatment with Borez is usually long-term.

Taking a higher than recommended dose of Borez

In case of accidental ingestion of too many tablets, the doctor or pharmacist should be contacted immediately. The remaining tablets or this leaflet should be taken to the medical personnel so that they know exactly which medicine was taken. Symptoms of overdose may include dizziness, fainting, fatigue, shortness of breath, and/or wheezing. Slow heart rate, low blood pressure, acute heart failure, and low blood sugar (with symptoms such as hunger, increased sweating, and rapid heart rate) may also occur.

Missing a dose of Borez

A double dose should not be taken to make up for a missed dose. The usual dose should be taken as soon as possible after remembering the missed dose, and the next dose should be taken at the usual time the next day.

Stopping treatment with Borez

Treatment with Borez should not be stopped abruptly. Abrupt cessation of treatment may worsen symptoms. When stopping treatment, the dose of Borez should be gradually reduced over several weeks, as recommended by the doctor.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Borez can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common(may occur in at least 1 in 10 people):

• slow heart rate (this side effect occurs not very often during treatment of high blood pressure or angina pectoris).

Common(may occur in less than 1 in 10 people):

• feeling of tiredness (this side effect occurs not very often during treatment of high blood pressure or angina pectoris);
• dizziness, fatigue, headache (especially at the beginning of treatment in patients with high blood pressure and angina pectoris; these side effects are usually mild and usually disappear within 1-2 weeks);
• feeling of cold or numbness in the distal parts of the body (fingers, toes, ears, and nose); more frequent occurrence of cramping leg pain when walking;
• worsening of existing heart failure (this side effect occurs not very often during treatment of high blood pressure or angina pectoris);
• significant decrease in blood pressure (hypotension), especially in patients with heart failure;
• nausea, vomiting;
• diarrhea;
• constipation.

Uncommon(may occur in less than 1 in 100 people):

• feeling of tiredness (this side effect occurs often in the treatment of heart failure);
• sleep disorders;
• depression;
• slow heart rate (this side effect occurs very often in the treatment of heart failure);
• irregular heart rate;
• worsening of existing heart failure (this side effect occurs often in the treatment of heart failure);
• breathing difficulties may occur in patients with bronchial asthma or a history of breathing disorders;
• weakness and muscle cramps;
• hypotension in patients with angina pectoris or high blood pressure.

Rare(may occur in less than 1 in 1000 people):

• nightmares;
• hallucinations;
• fainting;
• hearing disorders;
• nasal congestion with runny nose and irritation;
• allergic reactions (itching, redness, rash). The doctor should be contacted immediately in case of more severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, and throat, or difficulty breathing;
• dry eyes due to reduced tear secretion (caution should be exercised if the patient wears contact lenses);
• hepatitis, which can cause abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the whites of the eyes and skin, as well as dark urine;
• decreased sexual potency (impotence);
• increased blood lipid levels (triglycerides) and increased liver enzyme activity. Very rare(may occur in less than 1 in 10,000 people):
• worsening of psoriasis or occurrence of dry, scaly rash similar to psoriasis;
• hair loss;
• itching or redness of the eyes (conjunctivitis).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Borez

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the blister packaging and carton after EXP. The first two digits indicate the month, and the last four digits indicate the year of expiry. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Borez contains

• The active substance of Borez is bisoprolol fumarate. Borez, 5 mg, coated tablets: Each coated tablet contains 5 mg of bisoprolol fumarate, equivalent to 4.24 mg of bisoprolol. Borez, 10 mg, coated tablets: Each coated tablet contains 10 mg of bisoprolol fumarate, equivalent to 8.49 mg of bisoprolol.
• The other ingredients of the medicine are: Silanized microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), crospovidone type B (E1202), and glycerol dibehenate in the tablet core, and hypromellose (hydroxypropylmethylcellulose, type 2910) (E464), titanium dioxide (E171), macrogol 400, and yellow iron oxide (E172) in the tablet coating.

What Borez looks like and contents of the pack

Borez, 5 mg, coated tablets are yellow, round, biconvex, coated tablets with a dividing line on one side. The dividing line is used to divide the tablet into two equal parts. The diameter of each tablet is 7.00 mm.
The tablets are available in blister packs that can be divided into single doses, made of perforated PVC/TE/PVDC/Aluminum. Each blister pack contains 10 tablets. A printed carton contains 30 tablets (3 blisters in the packaging) or 90 tablets (9 blisters in the packaging) and a patient leaflet.
Borez, 10 mg, coated tablets are brown-yellow, round, biconvex, coated tablets with a dividing line on one side. The dividing line is used to divide the tablet into two equal parts.
The diameter of each tablet is 7.00 mm.
The tablets are available in blister packs that can be divided into single doses, made of perforated PVC/TE/PVDC/Aluminum. Each blister pack contains 10 tablets. A printed carton contains 30 tablets (3 blisters in the packaging) or 90 tablets (9 blisters in the packaging) and a patient leaflet.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Poland
Phone: (42) 22-53-100

Manufacturer

ALKALOID-INT d.o.o.,
Šlandrova ulica 4,
1231 Ljubljana-Črnuče,
Slovenia
phone: +386-1-300 - 42 90
fax: +386-1- 300 - 42 91
email: info@alkaloid.si

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:10.2023