Bisohexal 10

Leaflet accompanying the packaging: patient information

BisoHEXAL 5, 5 mg, film-coated tablets

BisoHEXAL 10, 10 mg, film-coated tablets

Bisoprolol fumarate

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is BisoHEXAL and what is it used for
• 2. Important information before taking BisoHEXAL
• 3. How to take BisoHEXAL
• 4. Possible side effects
• 5. How to store BisoHEXAL
• 6. Contents of the packaging and other information

1. What is BisoHEXAL and what is it used for

BisoHEXAL contains the active substance bisoprolol. Bisoprolol is a highly selective beta-1 adrenergic blocker that does not have intrinsic sympathomimetic activity and membrane-stabilizing action. It shows only a slight affinity for beta-2 adrenergic receptors in the smooth muscles of the bronchi and blood vessels, as well as beta-2 adrenergic receptors involved in metabolic regulation. In patients with angina pectoris, beta-blockade reduces the frequency of heart contractions and thus reduces the demand for oxygen.
Acute administration of bisoprolol to patients with coronary artery disease without chronic heart failure slows down heart rate and reduces ejection volume, thereby reducing minute volume and oxygen consumption. During chronic administration, the initially increased peripheral resistance decreases.
BisoHEXAL is used to treat:
hypertension;
coronary heart disease.

2. Important information before taking BisoHEXAL

When not to take BisoHEXAL

BisoHEXAL should not be taken in the following cases:
hypersensitivity to bisoprolol or any of the other ingredients of this medicine (listed in section 6);
acute heart failure or during episodes of decompensation (uncompensated heart failure), heart failure requiring the use of intravenous inotropic agents (affecting the strength of heart muscle contractions);
cardiogenic shock;
second- or third-degree atrioventricular block (without a pacemaker);
sick sinus syndrome;
atrioventricular block;
symptomatic bradycardia;
symptomatic hypotension;
severe bronchial asthma or severe chronic obstructive pulmonary disease;
severe form of peripheral arterial occlusive disease or severe form of Raynaud's syndrome;
untreated pheochromocytoma;
metabolic acidosis.
BisoHEXAL should not be taken by children.

Warnings and precautions

Before starting to take the medicine, you should discuss it with your doctor or pharmacist in the following cases:
diagnosed first-degree atrioventricular block;
diagnosed diabetes with large fluctuations in blood sugar levels, as BisoHEXAL may mask the symptoms of hypoglycemia (reduced blood sugar levels), such as tachycardia (accelerated heart rate), palpitations, or sweating;
strict fasting;
diagnosed and treated pheochromocytoma;
Prinzmetal's angina: cases of coronary artery spasm have been observed. In patients with Prinzmetal's angina treated with bisoprolol, it is not possible to completely exclude the occurrence of angina attacks;
peripheral arterial occlusive disease (due to the possibility of exacerbating symptoms, especially at the beginning of treatment);
mild peripheral circulation disorders (such as Raynaud's disease or intermittent claudication);
diagnosed mild obstructive airway disease or bronchial asthma; in patients with obstructive airway disease, the doctor will monitor whether new symptoms occur (e.g., shortness of breath, lack of exercise tolerance, cough);
planned general anesthesia before surgery. You should inform the anesthesiologist about taking BisoHEXAL due to possible interactions with other medicines, leading to slowing and disturbances of heart rhythm (bradyarrhythmia), weakening of reflex tachycardia (accelerated heart rate), and reduced reflex compensatory ability in case of blood loss. If it is necessary to stop taking BisoHEXAL before the operation, the doctor will recommend gradually reducing its dose so that the withdrawal process is completed about 48 hours before anesthesia;
diagnosed psoriasis or psoriasis that has occurred in the patient's history;
history of severe hypersensitivity reactions;
ongoing desensitization treatment. BisoHEXAL may increase the patient's sensitivity to allergens and exacerbate anaphylactic reactions;
liver or kidney function disorders.

BisoHEXAL and other medicines

You should inform your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
BisoHEXAL should not be taken at the same time as:
calcium channel blockers of the verapamil and diltiazem type, as they have a negative effect on contractility and atrioventricular conduction. Verapamil administered intravenously to patients receiving bisoprolol may cause a strong decrease in blood pressure and atrioventricular block;
centrally acting antihypertensive agents (such as clonidine, methyldopa, moxonidine, rilmenidine) due to the possible exacerbation of heart failure. Sudden withdrawal of these agents may increase the risk of hypertension, especially if it occurs before stopping BisoHEXAL.
Care should be taken when taking the following medicines at the same time:
class I antiarrhythmic agents (such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone) and other beta-adrenergic blockers, as they may enhance the effect on atrial conduction time and increase the negative inotropic effect (reduced heart muscle contraction force);
calcium channel blockers of the dihydropyridine type (such as felodipine and amlodipine), due to the increased risk of hypotension, and in patients with heart failure, the risk of worsening contractile function of the ventricle;
class III antiarrhythmic agents (such as amiodarone) due to the possible enhancement of the effect on atrioventricular conduction time;
beta-adrenergic blockers for local use (such as eye drops for glaucoma treatment) due to the possible summation of their effect with the systemic effect of bisoprolol;
cholinomimetics due to the possible prolongation of atrioventricular conduction time and increased risk of bradycardia (slowed heart rate);
insulin and oral antidiabetic agents due to the possible enhancement of the hypoglycemic effect and possible masking of hypoglycemia symptoms;
medicines used for general anesthesia due to the possible weakening of reflex tachycardia (accelerated heart rate) and increased risk of hypotension;
digitalis glycosides due to the possible reduction in heart rate and prolongation of atrioventricular conduction time;
non-steroidal anti-inflammatory agents (NSAIDs) due to the possible weakening of the blood pressure-lowering effect of bisoprolol;
beta-adrenergic agonists (such as isoprenaline, dobutamine) due to the possible weakening of the effect of both medicines;
adrenergic agonists that activate beta- and alpha-adrenergic receptors (such as noradrenaline, adrenaline) due to the possible vasoconstrictive effect of these agents, leading to increased blood pressure and worsening of intermittent claudication;
antihypertensive agents and other medicines that lower blood pressure (such as tricyclic antidepressants, barbiturates, phenothiazine derivatives), due to the increased risk of hypotension.
The following medicines should be considered:
mefloquine may increase the risk of bradycardia;
monoamine oxidase inhibitors (except MAO-B inhibitors): they enhance the blood pressure-lowering effect of bisoprolol, but there is also a risk of a so-called hypertensive crisis;

BisoHEXAL with food and drink

BisoHEXAL should be taken in the morning on an empty stomach or during breakfast. The tablets should be swallowed without chewing, washed down with a liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Pregnancy
BisoHEXAL should not be taken during pregnancy unless it is absolutely necessary. Bisoprolol may have a harmful effect on the course of pregnancy and (or) fetal or newborn development (possible growth retardation, intrauterine death, miscarriage, or premature birth).
If treatment with bisoprolol is necessary, the doctor will monitor the course of pregnancy and fetal development, and if necessary, consider other treatment methods. The newborn should be kept under close observation. Symptoms of hypoglycemia and bradycardia in the newborn usually occur within the first 3 days after birth.
Breastfeeding
It is not known whether BisoHEXAL passes into breast milk. During treatment with BisoHEXAL, breastfeeding is not recommended.

Driving and operating machines

Treatment with bisoprolol may impair the ability to drive vehicles and operate machines, especially at the beginning of treatment, during changes in medication, and in case of concurrent alcohol consumption.

BisoHEXAL contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".
Information for patients with diabetes
One film-coated tablet contains less than 0.01 carbohydrate units.

3. How to take BisoHEXAL

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Treatment with bisoprolol starts with small doses and is gradually increased. The doctor will adjust the dose of the medicine according to heart rate and treatment efficacy.
Dosing in hypertension and coronary heart disease
The doctor determines the dose individually for each patient. In some patients, a dose of 5 mg once a day may be sufficient. If necessary, the doctor may increase the dose to 10 mg once a day. The maximum dose is 20 mg per day.
Dosing in patients with liver or kidney function disorders
In patients with mild to moderate liver or kidney function disorders, a change in dosage is usually not necessary.
In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe liver function disorders, a dose greater than 10 mg per day should not be taken.
Dosing in elderly patients
A change in dosage is not necessary.
Use in children
BisoHEXAL should not be given to children due to lack of experience with its use in this age group.
Method and duration of treatment
The medicine should be taken in the morning on an empty stomach or during breakfast.
The tablets should be swallowed without chewing, washed down with a sufficient amount of liquid.
BisoHEXAL film-coated tablets have two deep grooves, specially designed for easy division into four parts.
To divide the tablet, it should be placed on a hard surface with the grooves facing up and pressed with a finger.
There are no restrictions on the duration of treatment with bisoprolol. It depends on the indication and severity of symptoms. Treatment with bisoprolol should not be stopped abruptly. Withdrawal of the medicine, especially in patients with coronary heart disease, should be done gradually by reducing the daily doses of the medicine over 7-10 days. Sudden withdrawal of BisoHEXAL may worsen the patient's condition.

Taking a higher dose of BisoHEXAL than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.
The most common symptoms that may occur after overdose of this type of medicine are bradycardia (slowed heart rate), hypotension, bronchospasm, acute heart failure, and reduced blood sugar levels.
Treatment of overdose is usually supportive and symptomatic.
In case of bradycardia: atropine should be administered intravenously. If the reaction is not sufficient, isoprenaline or another medicine with a positive chronotropic effect (accelerating heart rate) should be administered cautiously. In certain situations, it may be necessary to insert a pacemaker through a vein.
In case of hypotension: intravenous fluids and vasoconstrictor agents should be administered.
Administration of glucagon intravenously may be beneficial.
In case of atrioventricular block (second or third degree): the patient should be carefully monitored and treated with isoprenaline in intravenous infusion or by inserting a pacemaker through a vein.
In case of worsening heart failure: diuretics, positive inotropic agents (increasing heart muscle contraction force), and vasodilators should be administered intravenously.
In case of bronchospasm: bronchodilators such as isoprenaline, beta-2 adrenergic agonists, and (or) theophylline should be used.
In case of hypoglycemia: glucose should be administered intravenously.
Limited data indicate that bisoprolol is hardly dialyzable.

Missing a dose of BisoHEXAL

You should not take a double dose to make up for a missed dose.

Stopping treatment with BisoHEXAL

You should not stop treatment without consulting your doctor. Sudden cessation of treatment may only occur in case of urgent need, on the explicit recommendation of the doctor, as it increases the risk of myocardial infarction and sudden death in patients with coronary heart disease. The medicine should be withdrawn gradually, reducing the daily doses over 7-10 days.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The observed side effects occurred with the following frequency:
Very common (may occur more often than in 1 in 10 people):
slowed heart rate (in patients with chronic heart failure)
Common (may occur less often than in 1 in 10 people):
worsening of heart failure (in patients with chronic heart failure), dizziness, headaches (especially at the beginning of treatment, usually mild and often disappearing within 1-2 weeks), nausea, vomiting, diarrhea, constipation, feeling of coldness or numbness of limbs, hypotension (especially in patients with heart failure), feeling of fatigue, exhaustion.
Uncommon (may occur less often than in 1 in 100 people):
slowed heart rate (in patients with hypertension or angina pectoris), atrioventricular conduction disorders, worsening of heart failure, bronchospasm in patients with asthma or obstructive airway disease in history, muscle weakness and cramps, sleep disorders, depression.
Rare (may occur less often than in 1 in 1,000 people):
increased triglyceride levels, increased liver enzyme activity (ALT, AST), fainting, reduced tear secretion (which should be taken into account in patients using contact lenses), hearing disorders, allergic rhinitis, hypersensitivity reactions (itching, flushing, rash), hepatitis, erectile dysfunction, nightmares, hallucinations.
Very rare (may occur less often than in 1 in 10,000 people):
conjunctivitis, alopecia, psoriasis (or exacerbation of existing psoriasis), psoriasiform rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BisoHEXAL

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What BisoHEXAL contains

The active substance of the medicine is bisoprolol fumarate.
One film-coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating:
BisoHEXAL 5
Opadry [lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000], yellow iron oxide (E 172)
BisoHEXAL 10
Opadry [lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000], yellow iron oxide (E 172), red iron oxide (E 172)

What BisoHEXAL looks like and contents of the packaging

The tablets have two deep, intersecting grooves, making it easy to divide them into four parts.
Aluminum blisters in a cardboard box contain 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków
To obtain more detailed information, you should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

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