Borez

Package leaflet: Information for the patient

Borez, 2.5 mg, film-coated tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Borez is and what it is 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 Borez is and what it is used for

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

• 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 medicines intended for the treatment of 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 (a severe heart disorder characterised by rapid and weak pulse, low blood pressure, cold and clammy 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) – consult a doctor if in doubt;
• if the patient has very low blood pressure;
• if the patient has severe circulatory disorders (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of 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 that has recently occurred, or existing heart failure that is not compensated and requires hospital treatment;
• if the patient has a metabolic disorder causing excessive accumulation of acids in the blood (metabolic acidosis) – consult a doctor if in doubt;
• if the patient has untreated adrenal gland tumour (pheochromocytoma);

If in doubt whether any of the above conditions apply to the patient, consult a doctor.
Warnings and precautions
Before starting treatment with Borez, discuss with a doctor or pharmacist:

• if the patient has chronic lung disease (chronic obstructive pulmonary disease) or mild to moderate bronchial asthma, as concomitant use of bronchodilators and higher doses of beta-adrenergic agonists may be necessary. Inform the doctor immediately if breathing difficulties, cough, or wheezing occur during exercise or while taking Borez;
• if the patient has diabetes, as Borez tablets may mask symptoms of low blood sugar (e.g. rapid heartbeat, palpitations, excessive sweating);
• if the patient is not consuming regular meals (strict fasting);
• if the patient is being treated for hypersensitivity reactions (allergies), as bisoprolol may increase sensitivity to allergens and intensify allergic reactions, and adrenaline treatment may be ineffective, possibly requiring higher adrenaline doses;
• if the patient has first-degree atrioventricular block (a heart conduction disorder);
• if the patient has Prinzmetal's angina – chest pain caused by coronary artery spasm supplying blood to the heart muscle;
• if the patient has any circulatory disorders in the limbs, e.g. in hands and feet;
• if the patient is scheduled for surgery or dental procedures requiring anaesthesia – inform the doctor about all medications being taken;
• if the patient has psoriasis (a chronic skin condition characterised by dry, scaly skin lesions) currently or in the past;
• if the patient has a pheochromocytoma (adrenal gland tumour) – appropriate treatment will be given before bisoprolol administration;
• if the patient has thyroid disease – Borez may mask symptoms of hyperthyroidism (overactive thyroid).

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

• insulin-treated diabetes (type I),
• 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 essential, especially at the beginning of treatment.
Do not abruptly stop treatment with bisoprolol unless absolutely necessary.
Consult a doctor if any of the above warnings apply to the patient or applied in the past.
Borez with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for use.
Some medicines must not be used together with bisoprolol, while others may require treatment adjustments (e.g. dose modification).
Inform your doctor if you are taking any of the following medicines together 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, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medicines used to treat psychosis (mental disorders), such as barbiturates (also used in epilepsy treatment), phenothiazine derivatives (also used to prevent and treat nausea and vomiting);
• antidepressants, such as tricyclic antidepressants and MAO-A inhibitors;
• anaesthetics used during surgical procedures (see also section "Warnings and precautions");
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• topical beta-blockers (e.g. timolol eye drops used in glaucoma treatment);
• certain medicines used in shock treatment (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 antidiabetic medicines – the blood glucose-lowering effect may be enhanced, and warning symptoms of low blood sugar may be masked.

Borez with food, drink and alcohol
Borez tablets may be taken with or without food.
The recommended dose – the whole tablet(s) and (or) half tablet – should be swallowed whole with sufficient liquid; do not chew or crush the tablets.
Alcohol may worsen dizziness and drowsiness, which may occur after taking this medicine. If such symptoms occur, avoid alcohol consumption.
Pregnancy and breastfeeding
Borez may harm pregnancy and (or) the unborn child. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the newborn. The medicine may also affect the child's development. For this reason, bisoprolol should not be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk; therefore, Borez is not recommended during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on individual tolerance. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medications, as well as when combining the medicine with alcohol.

3. How to take Borez
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the number of tablets to take. Borez tablets should be taken in the morning: before, during or after breakfast. The recommended dose (the whole tablet(s) and (or) half tablet) should be swallowed whole with sufficient liquid; do not chew or crush the tablets.

Recommended dose of the medicine:
Heart failure (reduced heart contractility):
Adults
Before starting Borez treatment, 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 excretion, thereby lowering blood pressure), or a digitalis glycoside (a medicine used in 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 well tolerated, the dose will be increased to
2.5 mg once daily in the following 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 following 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.
The doctor will determine the most appropriate dose for the patient, taking into account possible adverse effects.
After the first 1.25 mg dose, the doctor will monitor the patient's blood pressure, heart rate, and any signs of heart dysfunction.
Liver or kidney dysfunction
In patients with liver or kidney dysfunction, the dose will be increased with particular caution.
Elderly patients
Dose adjustment is usually not necessary.
Use in children
The efficacy and safety of Borez in children have not been established.
If the effect of Borez seems too strong or too weak, consult your doctor or pharmacist.
Tablet splitting
The tablet may be divided into equal doses. Place the tablet on a hard, flat surface with the score line facing upwards. Press with the thumb at the centre of the tablet. The tablet will split into two halves.
Duration of treatment
Treatment with Borez is usually long-term.
Taking more Borez than recommended
If too many tablets are accidentally taken, contact a doctor or pharmacist immediately. Bring any remaining tablets or this leaflet to ensure medical staff know exactly which medicine was taken. Symptoms of overdose may include dizziness, drowsiness, fatigue, shortness of breath and (or) wheezing. A slowed heart rate, low blood pressure, acute heart failure and low blood sugar (with symptoms such as hunger, excessive sweating and palpitations) may also occur.
Missing a dose of Borez
Do not take a double dose to make up for a missed dose. Take the usual dose as soon as you remember, then take the next dose at the usual time the following day.
Stopping Borez treatment
Do not stop taking Borez suddenly. Abrupt discontinuation may worsen symptoms. When stopping treatment, the dose should be gradually reduced over several weeks, as directed by your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Very common (may affect at least 1 in 10 people):

• slow heart rate (bradycardia).

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

• fatigue, feeling of exhaustion;
• dizziness;
• headache (especially at the beginning of treatment; this adverse reaction is usually mild and typically resolves within 1-2 weeks);
• sensation of coldness or numbness in distal parts of the body (fingers, toes, ears, nose); increased occurrence of cramping leg pain during walking;
• worsening of existing heart failure;
• significant reduction in blood pressure (hypotension);
• nausea, vomiting;
• diarrhoea;
• constipation.

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

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

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

• nightmares;
• hallucinations;
• fainting;
• hearing disturbances;
• nasal mucosal inflammation with catarrh and irritation;
• allergic reactions (itching, redness, rash). Contact a doctor immediately if more severe allergic reactions occur, which may include: swelling of the face, neck, tongue, oral cavity or throat, or breathing difficulties;
• dry eyes due to reduced tear production (caution is advised if the patient wears contact lenses);
• liver inflammation, which may cause abdominal pain, loss of appetite and sometimes jaundice with yellowing of the whites of the eyes and skin, as well as dark urine;
• reduced sexual function (impotence);
• increased blood lipid levels (triglycerides) and increased liver enzyme activity.

Very rare (may affect less than 1 in 10,000 people):

• exacerbation of psoriasis or development of dry, scaly rash resembling psoriasis;
• hair loss;
• eye itching or redness (conjunctivitis).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store the medicine Borez

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following the label: 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 stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Borez contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate, equivalent to 2.12 mg of bisoprolol.
• The other ingredients are: Silicified microcrystalline cellulose (microcrystalline cellulose and colloidal anhydrous silica), crospovidone type B (E1202) and glycerol dibehenate in the tablet core, and hypromellose (substituted hydroxypropylmethylcellulose type 2910) (E464), titanium dioxide (E171), and macrogol 400 in the tablet coating.

What Borez looks like and contents of the pack
Borez 2.5 mg coated tablets are white, round, biconvex, film-coated tablets with a score line on one side.
The score line is intended to divide the tablet into two equal parts. The diameter of each tablet is 7.00 mm.
The tablets are available in perforated PVC/TE/PVDC/Aluminium blister packs divided into single doses. Each blister pack contains 10 tablets. The printed cardboard box contains 30 tablets (3 blisters per pack) or 90 tablets (9 blisters per pack) and a patient leaflet.

Marketing Authorisation 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.: +386-1-300-4290
Fax: +386-1-300-4291
e-mail: [email protected]

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