Borez

Package Leaflet: Information for the Patient

Borez, 2.5 mg, Coated Tablets

Bisoprolol Fumarate

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

• Keep this package leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your 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 Package 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 blockers). These medications prevent excessive strain on the heart.

Bisoprolol fumarate may be used to treat:

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

In case of doubt whether any of the above conditions apply to you, consult your doctor.

Warnings and Precautions

Before starting to take Borez, discuss it with your doctor or pharmacist:

• if you have chronic lung disease (chronic obstructive pulmonary disease) or mild bronchial asthma, as concomitant administration of bronchodilators and higher doses of beta-adrenergic agonists may be necessary. Inform your doctor immediately if you experience breathing difficulties, cough, wheezing, or other symptoms while taking Borez;
• if you have 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 you are not eating solid foods (strict fasting);
• if you are being treated for allergic reactions, as bisoprolol may increase your sensitivity to substances you are allergic to and worsen the severity of allergic reactions, and adrenaline treatment may be ineffective and require increased doses;
• if you have first-degree atrioventricular block (heart conduction disorder);
• if you have Prinzmetal's angina - a type of chest pain caused by coronary artery spasm;
• if you have any circulatory disorders in the limbs, such as in the hands and feet;
• if you are scheduled for surgery or dental procedures that require anesthesia, as you should inform your doctor about all medications you are taking;
• if you have or have had psoriasis (a chronic skin disease characterized by dry, scaly skin lesions);
• if you have a pheochromocytoma (adrenal gland tumor) - before taking bisoprolol, you will receive appropriate treatment;
• if you have 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:

• insulin-treated diabetes (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.

Do not suddenly stop taking Borez, unless it is absolutely necessary.

Consult your doctor if any of the above warnings apply to you or have applied in the past.

Borez and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Some medications should not be taken at the same time as bisoprolol, while others may require changes in treatment (e.g., dose adjustment).

Inform your 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, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medications 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;
• medications 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 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 anti-diabetic medications - the effect of reducing blood sugar levels 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; do not chew or crush the tablets.

Alcohol may enhance the dizziness and fainting that can occur when taking this medication. If these symptoms occur, avoid drinking alcohol.

Pregnancy and Breastfeeding

Borez may harm your pregnancy and/or your 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, do not take bisoprolol during pregnancy.

It is not known whether bisoprolol passes into breast milk, so it is not recommended to take Borez during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.

Driving and Operating Machines

The medication, depending on how it is tolerated, may impair your ability to drive or operate machines. 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

Always take this medication exactly as your doctor or pharmacist has told you.

In case of doubt, consult your doctor or pharmacist.

Your doctor will determine the dose of Borez.

Take Borez in the morning, before, during, or after breakfast.

Swallow the recommended dose (whole tablet/whole tablets and/or half tablet) whole, with a sufficient amount of liquid; do not chew or crush the tablets.

Recommended Dose of Borez:

Heart Failure (Reduced Heart Contractility):

Adults

Before starting Borez, you 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 a digitalis glycoside (a medication used to treat heart conditions).

Your doctor will gradually increase the dose until the desired therapeutic effect is achieved:

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.

Your doctor will determine the most suitable dose for you, taking into account any possible side effects.

After administering the first dose of 1.25 mg, your doctor will monitor your blood pressure, heart rate, and any heart function disorders.

Dividing the Tablet

The tablet can be divided into equal doses.

Place the tablet on a hard, flat surface, with the dividing line facing up.

Press your thumb on the center of the tablet.

The tablet will break into two halves.

Duration of Treatment

Treatment with Borez is usually long-term.

Taking More Than the Recommended Dose of Borez

In case of accidental ingestion of too many tablets, contact your doctor or pharmacist immediately.

Bring any remaining tablets or this package leaflet with you, 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

Do not take a double dose to make up for a missed dose.

Take your usual dose as soon as you remember, and take the next dose at the usual time the next day.

Stopping Treatment with Borez

Do not stop taking Borez suddenly.

Sudden cessation of treatment may worsen symptoms.

When stopping treatment, the dose of Borez should be gradually reduced over several weeks, as advised by your doctor.

In case of any further doubts about taking this medication, consult your 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 more than 1 in 10 people):

• slow heart rate (bradycardia).

Common(may affect up to 1 in 10 people):

• fatigue, feeling of exhaustion;
• dizziness;
• headache (especially at the beginning of treatment; this side effect is usually mild and disappears 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 while walking;
• worsening of existing heart failure;
• significant decrease in blood pressure (hypotension);
• nausea, vomiting;
• diarrhea;
• constipation.

Uncommon(may affect up to 1 in 100 people):

• sleep disorders;
• depression;
• irregular heart rhythm;
• breathing difficulties may occur in patients with asthma or a history of respiratory disorders;
• muscle weakness and cramps.

Rare(may affect up to 1 in 1,000 people):

• nightmares;
• hallucinations;
• fainting;
• hearing disorders;
• nasal congestion and irritation;
• allergic reactions (itching, redness, rash). Inform your doctor immediately if you experience severe allergic reactions, which may include: facial, neck, tongue, mouth, or throat swelling, or difficulty breathing;
• dry eyes due to reduced tear secretion (be cautious if you wear 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 (impotence);
• increased blood lipid levels (triglycerides) and increased liver enzyme activity.

Very Rare(may affect up to 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 you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.

By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Borez

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry 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 expiry.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medications should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medications that are no longer needed.

This will help protect the environment.

6. Contents of the Package and Other Information

What Borez Contains

• The active substance of Borez is bisoprolol fumarate.
• Each coated tablet contains 2.5 mg of bisoprolol fumarate, equivalent to 2.12 mg of bisoprolol.
• The other ingredients of Borez are: microcrystalline cellulose, silicon dioxide, crospovidone, and glycerol dibehenate in the tablet core, and hypromellose, titanium dioxide, and macrogol 400 in the tablet coating.

What Borez Looks Like and Contents of the Package

Borez, 2.5 mg, coated tablets are white, round, biconvex 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 packaged in cardboard boxes of 30 tablets (3 blisters) or 90 tablets (9 blisters), along with 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, e-mail: [email protected]

This Medicinal Product is Authorized for Use in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Package Leaflet:10.2023