Borez

Package leaflet: Information for the patient

Borez, 5 mg, film-coated tablets
Borez, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, 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.

Table of contents:

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 help prevent excessive strain on the heart. Bisoprolol fumarate may be used in the treatment of:

• high blood pressure (hypertension),
• angina pectoris (a sensation of pressure in the chest),
• heart failure, characterized by shortness of breath during physical exertion or fluid retention in the body. In such cases, Borez may be used as an 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, 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 applies to the patient, consult a doctor.
Warnings and precautions
Before starting treatment with Borez, discuss the following with your doctor or pharmacist:

• if the patient has chronic lung disease (chronic obstructive pulmonary disease) or mild bronchial asthma, as concomitant use of bronchodilators and higher doses of beta-adrenergic agonists may be necessary. Inform your doctor immediately if breathing difficulties, cough, or wheezing during physical exertion occur while taking Borez;
• if the patient has diabetes, as the tablets may mask symptoms of low blood sugar (e.g. rapid heartbeat, uncomfortable sensation of fast or strong heart action, excessive sweating);
• if the patient is not consuming solid food (strict fasting);
• if the patient is being treated for hypersensitivity reactions (allergic reactions), because bisoprolol may increase the patient's sensitivity to substances causing allergies and may worsen the severity of allergic reactions, and treatment with adrenaline 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 spasm of the coronary arteries 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 a surgical or dental procedure requiring anaesthesia, as the doctor must be informed about all medications being taken;
• if the patient has psoriasis (a chronic skin disease characterised by dry, scaly skin lesions) currently or in the past;
• if the patient has a pheochromocytoma (adrenal gland tumour) – prior to bisoprolol administration, the patient will receive appropriate treatment;
• if the patient has a thyroid disorder – Borez may mask symptoms of hyperthyroidism (overactive thyroid).

Currently, there is no data available on the use of bisoprolol for heart failure treatment in patients with the following conditions:

• insulin-treated diabetes (type I),
• severe kidney function impairment,
• severe liver function impairment,
• certain heart diseases,
• myocardial infarction within the last 3 months.

Treatment of heart failure with bisoprolol requires regular medical monitoring. This is essential, particularly at the beginning of treatment.
Do not stop bisoprolol treatment suddenly unless absolutely necessary.
Sudden discontinuation must be avoided in patients with hypertension and angina pectoris accompanied by heart failure. The doctor will recommend gradually reducing the dose by half each week.
Consult your doctor if any of the above warnings apply to the patient or if such conditions occurred in the past.
Borez and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines must not be used together with bisoprolol, while others may require adjustments in treatment (e.g. dose modification).
Inform your doctor if any of the following medicines are being used simultaneously 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 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, indometacin, ibuprofen, naproxen);
• topical beta-blockers (such as 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 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, 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 or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Depending on individual tolerance, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increase, 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 how many tablets to take. Borez tablets should be taken in the morning: before, during or after breakfast. The recommended dose (whole tablet[s] and/or half tablet) should be swallowed whole with sufficient liquid; do not chew or crush the tablets.
Recommended dose of Borez:
Hypertension/angina pectoris:
Adults
The dose is individually determined.
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 function impairment
In patients with severe liver or kidney function impairment, doses higher than 10 mg daily should not be used.
Elderly patients
Dose adjustment is usually not necessary. Treatment should start with the lowest possible dose.
Use in children
The efficacy and safety of Borez in children have not been established.
Heart failure (reduced heart contractility):
Adults
Before starting Borez, the patient should already be receiving an ACE inhibitor (a medicine that dilates blood vessels, thereby lowering blood pressure), a diuretic (a medicine that increases urine output, 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.
Doses from 1.25 to 3.75 mg daily, used during the initial dose titration phase, can be achieved using Borez 2.5 mg divisible tablets.
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 function disturbances.
Liver or kidney function impairment
Dose escalation should be performed with particular caution in patients with liver or kidney function impairment.
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
Tablets may be divided into equal doses. Place the tablet on a hard, flat surface with the score line facing upwards. Press thumbs 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 so that medical personnel know exactly which medicine was taken. Symptoms of overdose may include dizziness, drowsiness, fatigue, shortness of breath and/or wheezing. Bradycardia (slow heart rate), low blood pressure, acute heart failure and low blood glucose (symptoms: hunger, excessive sweating, palpitations) may also occur.
Missed 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, and take the next dose at the usual time the following day.
Stopping Borez treatment
Do not stop Borez treatment suddenly. Abrupt discontinuation may worsen symptoms. The dose should be gradually reduced over several weeks according to the doctor's instructions.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• slow heart rate (this adverse effect occurs uncommonly during treatment for hypertension or angina pectoris).

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

• feeling of exhaustion (this adverse effect occurs uncommonly during treatment for hypertension or angina pectoris);
• dizziness, fatigue, headache (especially at the beginning of treatment in patients with hypertension and angina pectoris; these adverse effects are usually mild and generally resolve within 1–2 weeks);
• sensation of coldness or numbness in distal parts of the body (fingers, toes, ears, and nose); increased occurrence of cramping leg pain during walking;
• worsening of existing heart failure (this adverse effect occurs uncommonly during treatment for hypertension or angina pectoris);
• significant decrease in blood pressure (arterial hypotension), especially in patients with heart failure;
• nausea, vomiting;
• diarrhoea;
• constipation.

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

• feeling of exhaustion (this adverse effect occurs commonly during treatment for heart failure);
• sleep disturbances;
• depression;
• slow heart rate (this adverse effect occurs very commonly during treatment for heart failure);
• irregular heart rhythm;
• worsening of existing heart failure (this adverse effect occurs commonly during treatment for heart failure);
• breathing difficulties, which may occur in patients with bronchial asthma or history of respiratory disorders;
• weakness and muscle cramps;
• hypotension in patients with angina pectoris or hypertension.

Rarely (may affect less than 1 in 1,000 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, mouth or throat, or breathing difficulties;
• dry eyes due to reduced tear production (caution is advised if the patient wears contact lenses);
• hepatitis, which may cause abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the whites of the eyes and skin, and dark urine;
• decreased sexual function (impotence);
• increased blood lipid levels (triglycerides) and increased liver enzyme activity.

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

• worsening of psoriasis or development of dry, scaly rash resembling psoriasis;
• hair loss;
• itching or redness of the eyes (conjunctivitis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Borez

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer carton following 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Borez contains

• The active substance 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 are: Microcrystalline cellulose with silica (microcrystalline cellulose and colloidal anhydrous silica), crospovidone type B (E1202), and glycerol dibehenate in the tablet core; hypromellose (substituted 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, film-coated tablets are yellow, 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 unit dose blister packs. 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.
Borez 10 mg, film-coated tablets are brown-yellow, 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 unit dose blister packs. 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: