Borez

Package Leaflet: Information for the Patient

Borez, 5 mg, Film-Coated Tablets

Borez, 10 mg, Film-Coated Tablets

Bisoprolol Fumarate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• The package 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 medication has been prescribed to a specific person. It should not be given to others. The medication 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 the package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Borez and what is it used for

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

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

2. Important information before taking Borez

When not to take Borez

• if the patient is allergic to bisoprolol fumarate or any other ingredient of this medication (listed in section 6);
• if the patient has cardiogenic shock (severe heart dysfunction, characterized by rapid and weak 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 that 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 pheochromocytoma (adrenal gland tumor);

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

Warnings and precautions

Before starting to take Borez, the patient should discuss the following with their doctor or pharmacist:

• if the patient has chronic pulmonary disease (chronic obstructive pulmonary disease) or mild bronchial asthma, as concomitant administration of bronchodilators and higher doses of beta-adrenomimetics may be necessary. The doctor should be informed immediately if breathing difficulties, cough, wheezing, or other symptoms occur during treatment with Borez;
• if the patient has diabetes, as the tablets may mask the symptoms of low blood sugar (e.g., rapid heartbeat, unpleasant sensation of rapid or strong heartbeat, increased sweating);
• if the patient is not eating solid food (strict fasting);
• if the patient is being treated for allergic reactions, as bisoprolol may increase the patient's sensitivity to substances they are allergic to and exacerbate the severity of allergic reactions, and adrenaline treatment may be ineffective and require increased doses;
• if the patient has first-degree atrioventricular block (heart conduction disorder);
• if the patient has Prinzmetal's angina - a type of chest pain caused by coronary artery spasm;
• 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 1),
• severe kidney dysfunction,
• severe liver dysfunction,
• certain heart diseases,
• myocardial infarction within the last 3 months.

Treatment of heart failure with bisoprolol requires regular medical monitoring. This is absolutely necessary, especially at the beginning of treatment.
Sudden discontinuation of bisoprolol treatment is not recommended, unless absolutely necessary.
Treatment should not be discontinued suddenly in patients with hypertension and angina pectoris with concomitant heart failure. The doctor will recommend gradual dose reduction, by half every week.
The patient should consult their doctor if any of the above warnings apply to them or have applied in the past.

Borez and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Certain medications should not be taken concomitantly with bisoprolol, while others may require changes in treatment (e.g., dose adjustment).
The patient should inform their doctor about taking any of the following medications concomitantly with Borez:

• medications 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 medications used to treat psychoses (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;
• medications used for anesthesia during surgical procedures (see also "Warnings and precautions");
• certain pain relievers (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• beta-blockers used topically (e.g., timolol in eye drops, used to treat glaucoma);
• certain medications used to treat shock (e.g., adrenaline, dobutamine, noradrenaline);
• mefloquine, a medication used to treat malaria. All of the above medications, including bisoprolol, may affect blood pressure and/or heart function.
• insulin or other antidiabetic medications - 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 film-coated tablets 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 fainting that can occur when taking this medication. If such symptoms occur, the patient should avoid drinking alcohol.

Pregnancy and breastfeeding

Borez may be harmful to the 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 medication 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 medication.

Driving and using machines

The medication may affect the ability to drive or operate machinery, depending on how it is tolerated. The patient should be particularly cautious at the beginning of treatment, after dose increase, or when switching medications, as well as when combining the medication with alcohol.

3. How to take Borez

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, 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, the dose should not exceed 10 mg daily.
Elderly patients
Usually, no dose adjustment is necessary. Treatment starts with the smallest possible dose.
Pediatric use
The efficacy and safety of Borez in children have not been established.
Heart Failure (reduced heart contractility):
Adults
Before starting Borez, the patient will already be taking an ACE inhibitor (a medication that dilates blood vessels, lowering blood pressure), a diuretic (a medication that increases urine production, lowering blood pressure), or digitalis glycoside (a medication used to treat heart conditions).
The doctor will gradually increase the dose to achieve the desired therapeutic effect:
1.25 mg once daily in the first week: if well tolerated, the dose will be increased to
2.5 mg once daily in the next week: if well tolerated, the dose will be increased to
3.75 mg once daily in the next week: if well tolerated, the dose will be increased to
5 mg once daily for the next 4 weeks: if well tolerated, the dose will be increased to
7.5 mg once daily for the next 4 weeks: if well tolerated, the dose 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 daily, used in the initial dose titration 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 potential side effects.
After the first dose of 1.25 mg, the doctor will monitor the patient's blood pressure, heart rate, and any cardiac disorders.
Liver or kidney dysfunction
In patients with liver or kidney dysfunction, the dose will be increased with caution.
Elderly patients
Dose adjustment is usually not necessary.
Pediatric use
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 thumb should be pressed on the center of the tablet. The tablet will break into two equal parts.

Duration of treatment

Treatment with Borez is usually long-term.

Taking a higher dose of Borez than recommended

In case of accidental ingestion of too many tablets, the patient should immediately contact their doctor or pharmacist. The patient should bring any remaining tablets or the package leaflet, so the medical staff knows exactly which medication 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 heartbeat) may also occur.

Missing a dose of Borez

A double dose should not be taken to make up for a missed dose. The patient should take their usual dose as soon as they remember, and the next dose at the usual time the following day.

Stopping treatment with Borez

Treatment with Borez should not be stopped suddenly. Sudden discontinuation of treatment may worsen symptoms. When stopping treatment, the dose should be gradually reduced over several weeks, as recommended by the doctor.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• slow heart rate (this side effect occurs less frequently during treatment of hypertension or angina pectoris).

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

• fatigue (this side effect occurs less frequently during treatment of hypertension or angina pectoris);
• dizziness, tiredness, headache (especially at the beginning of treatment in patients with hypertension and angina pectoris; these side effects are usually mild and disappear within 1-2 weeks);
• feeling of coldness 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 less frequently during treatment of hypertension or angina pectoris);
• significant decrease in blood pressure (hypotension), especially in patients with heart failure;
• nausea, vomiting;
• diarrhea;
• constipation.

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

• fatigue (this side effect occurs frequently in the treatment of heart failure);
• sleep disorders;
• depression;
• slow heart rate (this side effect occurs very frequently in the treatment of heart failure);
• irregular heart rhythm;
• worsening of existing heart failure (this side effect occurs frequently 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 hypertension.

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

• nightmares;
• hallucinations;
• fainting;
• hearing disorders;
• nasal congestion and irritation;
• allergic reactions (itching, redness, rash). The doctor should be contacted immediately in case of severe allergic reactions, which may include: facial, neck, tongue, mouth, or throat swelling, or breathing difficulties;
• dry eyes due to reduced tear secretion (caution should be exercised if the patient wears contact lenses);
• hepatitis, which may cause abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark urine;
• reduced sexual potency;
• increased blood lipid levels (triglycerides) and increased liver enzyme activity. Very rare(may affect 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 the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Borez

The medication should be stored out of sight and reach of children.
The medication should not be taken after the expiration date stated on the blister pack and carton after EXP. The first two digits indicate the month, and the last four digits indicate the year of expiration. The expiration date refers to the last day of the specified month.
The medication should not be stored at temperatures above 25°C.
The medication should be stored in its original packaging to protect it from moisture.
Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Borez contains

• The active substance of Borez is bisoprolol fumarate. Borez, 5 mg, film-coated tablets: Each film-coated tablet contains 5 mg of bisoprolol fumarate, equivalent to 4.24 mg of bisoprolol. Borez, 10 mg, film-coated tablets: Each film-coated tablet contains 10 mg of bisoprolol fumarate, equivalent to 8.49 mg of bisoprolol.
• The other ingredients of Borez are: microcrystalline cellulose (microcrystalline cellulose and silicon dioxide), crospovidone type B (E1202), and glycerol dibehenate in the tablet core, and hypromellose (hydroxypropyl methylcellulose, 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, film-coated tablets are yellow, round, biconvex film-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 of 10 tablets, which are perforated and made of PVC/TE/PVDC/Aluminum. Each carton contains 30 tablets (3 blisters) or 90 tablets (9 blisters) and a patient information leaflet.
Borez, 10 mg, film-coated tablets are brown-yellow, round, biconvex film-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 of 10 tablets, which are perforated and made of PVC/TE/PVDC/Aluminum. Each carton contains 30 tablets (3 blisters) or 90 tablets (9 blisters) and a patient information leaflet.

Marketing authorization holder

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

Manufacturer

ALKALOID-INT d.o.o.,
Šlandrova ulica 4,
1231 Ljubljana-Črnuče,
Slovenia
tel.: +386-1-300 - 42 90
fax: +386-1- 300 - 42 91
email: [email protected]

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

Date of last revision of the package leaflet:10.2023