Bisohexal 5
Poland
Table of Contents
Package leaflet: Information for the patient
BisoHEXAL 5, 5 mg, film-coated tablets
BisoHEXAL 10, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read the entire leaflet carefully before using the 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 questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- What BisoHEXAL is and what it is used for
- Important information before taking BisoHEXAL
- How to take BisoHEXAL
- Possible side effects
- How to store BisoHEXAL
- Contents of the pack and other information
1. What BisoHEXAL is and what it is used for
BisoHEXAL contains the active substance bisoprolol. Bisoprolol is a highly selective beta-
1-adrenolytic agent, which does not exhibit intrinsic sympathomimetic activity or membrane-stabilizing
effects. It has only minimal affinity for beta-2-adrenergic receptors in bronchial and vascular smooth muscle, as well as for beta-2-adrenergic receptors involved in metabolic regulation. In patients
with angina pectoris, blockade of beta receptors reduces heart rate and thus decreases oxygen demand.
Acute administration of bisoprolol in patients with coronary artery disease but without chronic heart failure slows heart rate and reduces stroke volume, thereby decreasing cardiac output and oxygen consumption. During chronic treatment, initially elevated peripheral resistance decreases.
BisoHEXAL is used in the treatment of:
arterial hypertension;
ischaemic heart disease.
2. Important information before using BisoHEXAL
When not to use BisoHEXAL
Do not use BisoHEXAL if you have:
hypersensitivity to bisoprolol or to any of the other ingredients of this medicine (listed in section 6);
acute heart failure or episodes of decompensated heart failure (uncompensated heart failure), heart failure requiring intravenous inotropic agents (affecting the force of myocardial contraction);
cardiogenic shock;
second- or third-degree atrioventricular block (without a cardiac pacemaker);
sick sinus syndrome;
sinoatrial block;
symptomatic bradycardia;
symptomatic hypotension;
severe asthma or severe chronic obstructive pulmonary disease;
severe peripheral arterial occlusive disease or severe Raynaud's syndrome;
untreated phaeochromocytoma;
metabolic acidosis.
BisoHEXAL must not be used in children.
Warnings and precautions
Before starting treatment, discuss with your doctor or pharmacist if you have:
first-degree atrioventricular block;
diagnosed diabetes with large fluctuations in blood glucose levels, as BisoHEXAL may mask symptoms of hypoglycaemia (low blood glucose), such as tachycardia (rapid heartbeat), palpitations or sweating;
strict fasting;
diagnosed and treated phaeochromocytoma;
Prinzmetal's angina: cases of coronary artery spasm have been observed. In patients with Prinzmetal's angina treated with bisoprolol, angina attacks cannot be completely excluded;
peripheral arterial occlusive disease (due to possible worsening of symptoms, especially at the beginning of treatment);
mild peripheral circulatory disorders (such as Raynaud's disease or intermittent claudication);
diagnosed mild obstructive respiratory disease or asthma; in patients with obstructive respiratory disease, your doctor will monitor for new symptoms (e.g. shortness of breath, exercise intolerance, cough);
planned general anaesthesia before surgery. Inform the anaesthetist that you are taking BisoHEXAL due to possible interactions with other medicines, which may lead to slowing and disturbances of heart rhythm (bradyarrhythmia), suppression of reflex tachycardia (increased heart rate), and reduced reflex compensatory capacity in case of blood loss. If discontinuation of BisoHEXAL is necessary before surgery, your doctor will recommend gradually reducing the dose so that the withdrawal process is completed approximately 48 hours before anaesthesia;
diagnosed psoriasis or history of psoriasis;
severe hypersensitivity reactions in medical history;
ongoing allergen desensitisation treatment. BisoHEXAL may increase the patient's sensitivity to allergens and exacerbate anaphylactic reactions;
impaired liver or kidney function.
BisoHEXAL with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of BisoHEXAL is not recommended with:
calcium channel blockers of the verapamil and diltiazem type, as they have negative effects on contractility and atrioventricular conduction. Intravenous verapamil administered to patients receiving bisoprolol may cause severe hypotension and atrioventricular block;
centrally acting antihypertensive agents (such as clonidine, methyldopa, moxonidine, rilmenidine) due to possible worsening of heart failure. Sudden withdrawal of these agents may increase the risk of hypertension, especially if it occurs before stopping BisoHEXAL.
Use with caution when taking the following medicines simultaneously:
class I antiarrhythmic agents (such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone) and other beta-blockers, as they may enhance the effect on atrial conduction time and increase negative inotropic action (reduced heart contractility);
dihydropyridine-type calcium antagonists (such as felodipine and amlodipine) due to increased risk of hypotension and, in patients with heart failure, risk of worsening ventricular systolic function;
class III antiarrhythmic agents (e.g. amiodarone) due to possible enhancement of the effect on atrioventricular conduction time;
topically applied beta-adrenergic blocking agents (e.g. eye drops for glaucoma treatment) due to possible additive effects with the systemic action of bisoprolol;
cholinomimetics due to possible prolongation of atrioventricular conduction time and increased risk of bradycardia (slowed heart rate);
insulin and oral antidiabetic agents due to possible enhancement of blood glucose-lowering effect and possible masking of hypoglycaemic symptoms;
medicines used for general anaesthesia due to possible suppression of reflex tachycardia (increased heart rate) and increased risk of hypotension;
digitalis glycosides due to possible reduction in heart rate and prolonged atrioventricular conduction time;
non-steroidal anti-inflammatory drugs (NSAIDs) due to possible attenuation of the blood pressure-lowering effect of bisoprolol;
beta-adrenomimetic agents (such as isoprenaline, dobutamine) due to possible reduction in the effectiveness of both medicines;
adrenomimetic agents activating both beta- and alpha-adrenergic receptors (e.g. noradrenaline, adrenaline) due to possible vasoconstrictive effects of these agents, leading to increased blood pressure and worsening of intermittent claudication;
antihypertensive agents and other medicines reducing blood pressure (such as tricyclic antidepressants, barbiturates, phenothiazine derivatives) due to increased risk of hypotension.
The following medicines should be used with consideration:
mefloquine may increase the risk of bradycardia;
monoamine oxidase inhibitors (except MAO-B inhibitors): enhance the blood pressure-lowering effect of bisoprolol, but also carry a risk of hypertensive crisis;
BisoHEXAL with food and drink
Take BisoHEXAL in the morning on an empty stomach or with breakfast. Swallow the tablets whole with liquid, without chewing.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
BisoHEXAL must not be used during pregnancy unless absolutely necessary in the opinion of your doctor. Bisoprolol may have harmful effects on the course of pregnancy and/or fetal or neonatal development (possible fetal growth retardation, intrauterine death, miscarriage or premature delivery).
If treatment with bisoprolol is necessary, your doctor will monitor the course of pregnancy and fetal development and, if necessary, consider alternative treatment options. The newborn should remain under close observation. Symptoms of hypoglycaemia 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. Breastfeeding is not recommended during treatment with BisoHEXAL.
Driving and operating machinery
Treatment with bisoprolol may impair the ability to drive and operate machinery, especially at the beginning of treatment, when changing medications, and when alcohol is consumed concurrently.
BisoHEXAL contains lactose and sodium
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
Information for diabetic patients
One coated tablet contains less than 0.01 carbohydrate exchange unit.
3. How to use BisoHEXAL
This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Treatment with bisoprolol should be initiated with low doses, which are then gradually and slowly increased. The physician will adjust the dosage according to heart rate and treatment effectiveness.
Dosage in arterial hypertension and ischemic heart disease
The physician determines the dose individually for each patient. In some patients, a dose of 5 mg once daily may be sufficient. If necessary, the physician may increase the dose up to 10 mg once daily. The maximum dose is 20 mg per day.
Dosage in patients with hepatic or renal impairment
In patients with mild to moderate impairment of liver or kidney function, dosage adjustment is generally not required.
In patients with severe renal failure (creatinine clearance <20 ml/min) and in patients with severe hepatic impairment, doses exceeding 10 mg per day should not be used.
Dosage in elderly patients
Dosage adjustment is not necessary.
Use in children
BisoHEXAL should not be administered to children due to lack of experience with use in this age group.
Method and duration of administration
The medicine should be taken in the morning, either fasting or with breakfast.
Tablets should be swallowed whole, without chewing, with an adequate amount of liquid.
BisoHEXAL coated tablets have two deep score lines, specially designed to allow easy division of the tablet into four parts.
To divide the tablet, place it on a hard surface with the scored side facing upwards and press with a finger.
There are no restrictions regarding the duration of bisoprolol treatment. This depends on the indication and severity of symptoms. Bisoprolol treatment should not be discontinued abruptly. Discontinuation, especially in patients with coronary heart disease, should be gradual, achieved by reducing the daily dose over 7–10 days. Sudden discontinuation of BisoHEXAL may worsen the patient's condition.
Accidental overdose of BisoHEXAL
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor or pharmacist.
The most common symptoms that may occur after overdose of drugs in this class include bradycardia (slowed heart rate), hypotension (low blood pressure), bronchospasm, acute heart failure, and decreased blood glucose levels.
Treatment of overdose is usually supportive and symptomatic.
- In case of bradycardia: administer atropine intravenously. If the response is inadequate, cautiously administer isoprenaline or another agent with positive chronotropic effect (increasing heart rate). In certain situations, insertion of an intravenous cardiac pacemaker may be necessary.
- In case of hypotension: administer intravenous fluids and vasoconstrictor agents. Intravenous glucagon may also be beneficial.
- In case of atrioventricular block (second- or third-degree): closely monitor the patient and treat with intravenous isoprenaline or insertion of an intravenous cardiac pacemaker.
- In case of worsening heart failure: administer intravenous diuretics, agents with positive inotropic effect (increasing myocardial contractility), and vasodilators.
- In case of bronchospasm: use bronchodilators such as isoprenaline, beta-2-adrenergic agonists, and/or theophylline.
- In case of hypoglycemia: administer intravenous glucose.
Limited data indicate that bisoprolol is poorly removed by hemodialysis.
Missed dose of BisoHEXAL
Do not take a double dose to make up for a missed dose.
Discontinuation of BisoHEXAL
Do not stop treatment without consulting your doctor. Sudden discontinuation should only occur in cases of absolute necessity and upon explicit physician instruction, as it increases the risk of myocardial infarction and sudden death in patients with ischemic heart disease. The drug should be discontinued gradually by reducing the daily dose over 7 to 10 days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The observed adverse effects occurred with the following frequency:
Very common (may affect more than 1 in 10 people):
slowing of heart function (in patients with chronic heart failure)
Common (may affect up to 1 in 10 people):
worsening of heart failure (in patients with chronic heart failure), dizziness, headache (especially at the beginning of treatment; usually mild and often resolve within 1–2 weeks), nausea, vomiting, diarrhoea, constipation, sensation of coldness or numbness in limbs, hypotension (especially in patients with heart failure), feeling of fatigue, exhaustion.
Uncommon (may affect up to 1 in 100 people):
slowing of heart function (in patients with hypertension or angina pectoris), atrioventricular conduction disturbances, worsening of heart failure, bronchospasm in patients with a history of bronchial asthma or obstructive respiratory disease, muscle weakness and cramps, sleep disturbances, depression.
Rare (may affect up to 1 in 1,000 people):
increased triglyceride levels, increased liver enzyme activity (AlAT, AspAT), fainting, reduced tear production (which should be considered in patients wearing contact lenses), hearing disturbances, allergic rhinitis, hypersensitivity reactions (itching, sudden redness of the skin, rash, swelling of any part of the body [angioedema]), hepatitis, erectile dysfunction, nightmares, hallucinations.
Very rare (may affect up to 1 in 10,000 people):
conjunctivitis, alopecia, psoriasis (or exacerbation of existing psoriasis), psoriasiform rash.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
By reporting adverse effects, additional information on the safety of this medicine can be collected.
5. How to store BisoHEXAL
Keep this medicine 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 stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.
6. Contents of the pack and other information
What BisoHEXAL contains
The active substance is bisoprolol fumarate.
One film-coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose,
corn starch, sodium croscarmellose, anhydrous colloidal silicon dioxide, 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 pack
The tablets have two deep, intersecting grooves, facilitating division into four parts.
Aluminum blisters in a cardboard box contain 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturers
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00