Bicardef 5 mg

Leaflet attached to the packaging: patient information

Bicardef 5 mg

5 mg, film-coated tablets

Bisoprolol fumarate

Bicardef 10 mg

10 mg, film-coated tablets

Bisoprolol fumarate

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bicardef and what is it used for

Bicardef containing bisoprolol (in the form of fumarate) is recommended for heart and circulatory system diseases. Bisoprolol affects the so-called sympathetic part of the nervous system, which, among other things, regulates blood pressure and heart function. Bisoprolol belongs to agents that almost exclusively affect heart function (selectively blocks beta heart receptors), and its administration in recommended doses usually does not affect the functioning of the digestive system, blood vessels, and bronchi (does not cause bronchospasm) and does not affect metabolism related to beta receptor stimulation (does not increase lipid and glucose levels in the blood).
Bisoprolol lowers blood pressure, slows down the heart rate at rest and after exercise, and, which is desirable in coronary heart disease, limits oxygen consumption by the heart muscle.
The indication for the use of Bicardef (administered as the only medicine or together with other appropriately selected medicines) is arterial hypertension and coronary heart disease (angina pectoris).
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Bisoprolol is used in the treatment of stable, chronic heart failure with impaired left ventricular systolic function.

2. Important information before taking Bicardef

When not to take Bicardef

If the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
Bicardef should not be taken if the following conditions occur:
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• acute heart failure or exacerbation of heart failure requiring intravenous administration of medicines that improve heart muscle contractility (so-called inotropic agents);
• shock caused by heart function disorders (cardiogenic shock);
• conduction disorder between the atria and ventricles of the heart (second or third degree atrioventricular block) without a pacemaker;
• sick sinus syndrome (so-called sick sinus syndrome);
• atrioventricular block;
• significant slowing of heart rate (bradycardia), with heart rate below 50 beats/min before starting treatment;
• low blood pressure (systolic blood pressure below 90 mmHg);
• severe bronchial asthma or severe chronic obstructive pulmonary disease;
• late stage of peripheral arterial disease or spasm of the fingers and toes (Raynaud's syndrome);
• untreated pheochromocytoma, a rare tumor of the adrenal gland (see below);
• metabolic acidosis, a condition in which the blood pH is abnormal.

Warnings and precautions

Before starting Bicardef, you should discuss it with your doctor or pharmacist.
If any of the following conditions occur, before starting Bicardef, you should talk to your doctor; the doctor may consider that special caution is necessary (e.g., additional medication or more frequent checks):

• diabetes;
• strict fasting;
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• circulatory disorders;
• bronchial asthma or chronic pulmonary disease;
• psoriasis, including a history of psoriasis;
• thyroid function disorders;
• pheochromocytoma.

In addition, you should tell your doctor if:

• desensitization treatment is planned (e.g., to avoid hay fever), as bisoprolol may increase the likelihood of an allergic reaction or increase its severity;
• a surgical procedure under general anesthesia is planned, as bisoprolol may change the body's response to the administered medicines.

Children and adolescents

Bicardef is not recommended for children and adolescents.

Bicardef and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take the following medicines with Bicardef without special doctor's recommendation:

• certain anti-arrhythmic medicines (class I, e.g., disopyramide, quinidine, lidocaine, phenytoin, flecainide, propafenone);
• certain heart medicines (so-called calcium channel blockers, such as verapamil or diltiazem), due to possible serious heart function and blood pressure disorders;
• certain antihypertensive medicines (e.g., clonidine, methyldopa, moxonidine, rilmenidine), due to possible worsening of the patient's condition. However, you should not stop taking these medicines without consulting your doctor.

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Before taking the following medicines with Bicardef, you should discuss it with your doctor; the doctor may recommend more frequent medical check-ups:

• certain heart medicines from the dihydropyridine group (e.g., nifedipine, felodipine, amlodipine), due to the risk of hypotension and worsening of heart function;
• certain anti-arrhythmic medicines (class III, e.g., amiodarone), due to possible heart function disorders (frequent ECG monitoring is necessary);
• certain antihypertensive medicines (e.g., prazosin, alfuzosin) due to possible sudden blood pressure drop (especially careful blood pressure monitoring is necessary);
• other medicines that may lower blood pressure, e.g., certain antidepressants (tricyclic), barbiturates, and phenothiazine derivatives, due to increased risk of excessive blood pressure drop;
• parasympathomimetic medicines (e.g., pilocarpine), due to slowed heart rate;
• beta-sympathomimetic medicines (dobutamine, isoprenaline), due to weakened effect of both medicines taken simultaneously;
• sympathomimetic medicines stimulating alpha and beta receptors, due to possible undesirable increase in blood pressure and worsening of intermittent claudication symptoms;
• other beta blockers (including those administered in the form of eye drops) due to increased bisoprolol effect;
• heart medicines (digitalis glycosides), due to possible unfavorable slowing of heart function;
• non-steroidal anti-inflammatory medicines (NSAIDs), due to possible undesirable decrease in bisoprolol's antihypertensive effect;
• insulin and other medicines that lower blood glucose levels, due to further decrease in blood glucose levels and simultaneous masking of hypoglycemia symptoms;
• certain antibiotics, e.g., rifampicin;
• ergotamine derivatives, which are also part of anti-migraine medicines, due to possible circulatory disorders;
• medicines containing adrenaline, noradrenaline, and substances with similar effects, which are contained in cough medicines, nasal drops, etc., as the effect of both medicines may be weakened. To achieve the desired therapeutic effect of allergic diseases, it may be necessary to adjust their doses;
• certain local anesthetics (e.g., lidocaine), due to the risk of blood pressure drop. Before the procedure, you should inform the anesthesiologist about taking bisoprolol;
• mefloquine - due to increased risk of slowed heart function;
• certain monoamine oxidase inhibitors, due to increased antihypertensive effect and simultaneous increased risk of hypertensive crisis.

Bicardef with food or alcohol

The type and amount of food taken do not change the effect of the medicine; however, following a suitable diet and other additional doctor's recommendations regarding the course of treatment may significantly affect the treatment results and the patient's quality of life.
Alcoholic beverages increase the effect of bisoprolol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Administration of bisoprolol may be hazardous to the fetus and (or) newborn. Similarly, planned pregnancy in a patient treated with bisoprolol requires a doctor's consultation.
All beta blockers reduce blood flow through the placenta, which may disrupt fetal growth and even lead to intrauterine death, miscarriage, or premature birth, as well as lower blood glucose levels and slow down the fetal heart rate.
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Therefore, bisoprolol and other beta blockers are only allowed to be used in pregnant women in absolutely necessary cases, when the expected benefits to the mother outweigh the potential risk to the fetus and child. In such a case, careful medical supervision is necessary (monitoring of blood flow through the placenta and fetal development). If an adverse effect is detected, the doctor will consider and recommend an alternative treatment for the pregnant woman.
Newborns of mothers treated with bisoprolol should be closely monitored by a doctor, especially in the first three days of life.
Breastfeeding
Bisoprolol should not be taken during breastfeeding, due to the lack of data on its safety.

Driving and using machines

Due to individual variability in response to the medicine, bisoprolol may impair the ability to drive vehicles or operate machines. This effect should be taken into account, especially at the beginning of treatment, when changing the medicine, as well as in people who consume alcohol. Therefore, patients should consult their doctor to determine if they can drive vehicles or operate machines.

Bicardef contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.
One Bicardef 5 mg tablet contains 71 mg of lactose.
One Bicardef 10 mg tablet contains 142 mg of lactose.

Bicardef contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Bicardef

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Oral administration.
Tablets should be taken in the morning, before breakfast, during breakfast, or after a meal. Swallow whole, with a small amount of liquid.
Treatment usually starts with small doses, which are then gradually increased. In all cases, the dosage should be adjusted individually and based on the doctor's assessment of the effect on the heart, blood pressure, and the patient's response to the medicine.
The duration of treatment is not limited, and treatment is usually long-term and depends on the type and course of the disease.
It is not recommended to stop treatment abruptly, due to possible worsening of disease symptoms, especially in patients with coronary heart disease.
Hypertension
Usually, it is recommended to take 1 Bicardef 5 mg tablet once a day or ½ Bicardef 10 mg tablet once a day (which corresponds to a dose of 5 mg of bisoprolol fumarate once a day).
In milder forms of hypertension (diastolic blood pressure up to 105 mmHg), the doctor may recommend reducing the dose to ½ Bicardef 5 mg tablet once a day (which corresponds to a dose of 2.5 mg of bisoprolol fumarate once a day). If necessary, the doctor may recommend increasing the dose to 2 Bicardef 5 mg tablets once a day or 1 Bicardef 10 mg tablet once a day (which corresponds to a dose of 10 mg of bisoprolol fumarate taken once a day).
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Further dose increase is justified only in exceptional cases.
The maximum recommended dose of bisoprolol is 20 mg once a day.
Angina pectoris
Usually, it is recommended to take 1 Bicardef 5 mg tablet once a day or ½ Bicardef 10 mg tablet once a day (which corresponds to a dose of 5 mg of bisoprolol fumarate once a day).
If necessary, the doctor may recommend increasing the dose to 2 Bicardef 5 mg tablets once a day or 1 Bicardef 10 mg tablet once a day (which corresponds to a dose of 10 mg of bisoprolol fumarate taken once a day).
Further dose increase is justified only in exceptional cases.
The maximum recommended dose is 20 mg once a day.
Stable, chronic heart failure
The doctor will start treatment with bisoprolol from a low dose, which will be gradually increased - the doctor will decide how to increase the dose. The recommended initial dose is 1.25 mg once a day.
The dose is increased at intervals of two weeks or more to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once a day.
The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, the doctor may recommend extending the time interval to the next dose increase. If the disease worsens or the medicine is not tolerated, it may be necessary to reduce the dose again or stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
The doctor will determine the appropriate course of action.
Dosage in patients with liver and/or kidney impairment
Treatment of hypertension and angina pectoris
In patients with mild to moderate liver or kidney function disorders, dose modification is usually not necessary. In patients with severe kidney impairment (creatinine clearance <20 ml min) and in patients with severe liver impairment, a dose greater than 10 mg of bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence of the need to modify the dosage.
Treatment of stable, chronic heart failure
There are no data on the pharmacokinetics of bisoprolol in patients with chronic heart failure and concomitant liver or kidney function disorders. Therefore, in these patients, special caution should be exercised when increasing the dose of the medicinal product.
Dosage in the elderly
Dose modification is not necessary.

Use in children and adolescents

Bisoprolol is not recommended for children and adolescents due to the lack of sufficient clinical data.
The tablet can be divided into equal doses.

Using a higher than recommended dose of Bicardef

In case of bisoprolol overdose, you should immediately contact a doctor, showing them the medicine packaging or its leaflet.
The most common symptoms of bisoprolol overdose are: slowed heart rate (bradycardia), low blood pressure, shortness of breath due to bronchospasm, acute heart failure, and low blood glucose levels (hypoglycemia).

Missing a dose of Bicardef

You should not take a double dose to make up for a missed dose.
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You should take the dose of the medicine with the next meal, according to the doctor's recommended method of administration and dosage (e.g., if you forgot to take the medicine in the morning, take it at noon, and take the next dose according to the plan, i.e., the next day).

Stopping treatment with Bicardef

You should not stop treatment with bisoprolol without consulting your doctor.
Treatment should not be stopped abruptly. After stopping treatment with Bicardef, acute worsening of the condition (especially in patients with coronary heart disease) may occur. If it is necessary to stop treatment, the dose should be gradually reduced and according to the doctor's recommendation (e.g., by reducing the dose gradually over a week, or by reducing the dose by half at weekly intervals).
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should immediately contact a doctor in case of severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.

Very common side effects (occurring in more than 1 in 10 patients):

bradycardia (slow heart rate) - in patients with chronic heart failure.

Common side effects (occurring in less than 1 in 10 patients but more than 1 in 100 patients):

fatigue, feeling of exhaustion, dizziness, headaches, feeling of cold or numbness in the limbs, gastrointestinal disorders (nausea, vomiting, diarrhea, or constipation), low blood pressure, asthenia (weakness), worsening of existing heart failure - in patients with chronic heart failure.
This only applies to patients with hypertension or angina pectoris:
Symptoms usually occur at the beginning of treatment, are mild, and disappear within 1-2 weeks.

Uncommon side effects (occurring in less than 1 in 100 patients but more than 1 in 1000 patients):

sleep disorders, depression, asthenia (weakness), heart function disorders (excessive slowing of heart rate - so-called bradycardia, atrioventricular conduction disorders) and worsening of existing heart failure - in patients with hypertension or angina pectoris, bronchospasm (difficulty breathing) in patients with asthma or obstructive pulmonary disease, muscle weakness, muscle cramps.

Rare side effects (occurring in less than 1 in 1000 patients but more than 1 in 10,000 patients):

nightmares, hallucinations, fainting, potency disorders, decreased tear secretion (important for people wearing contact lenses), hearing impairment, allergic rhinitis, hepatitis, increased liver enzyme activity (so-called ALT, AST), elevated triglyceride levels in the blood, skin allergic reactions (itching, redness, rash).

Very rare side effects (occurring in less than 1 in 10,000 patients):

conjunctivitis (irritation or redness of the eyes), hair loss, and exacerbation of psoriasis symptoms or appearance of psoriasis-like rash.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bicardef

Store at a temperature not exceeding 25°C. Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
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 pack and other information

What Bicardef contains

• The active substance of the medicine is bisoprolol (in the form of fumarate). One tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, anhydrous colloidal silica. The composition of the Opadry II Orange 85G23568 coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol (PEG 3350), soy lecithin, aluminum lake of quinoline yellow, iron oxide red (E 172).

What Bicardef looks like and what the pack contains

Film-coated tablets, oval, biconvex, orange, with a dividing line, with a smooth uniform surface.
One pack of the medicine contains 30, 60, or 90 tablets.

Marketing authorization holder and manufacturer

PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
phone: (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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