Bicardef 10 mg

Package leaflet: Information for the patient

Bicardef 5 mg
5 mg, film-coated tablets
Bisoprololi fumaras
Bicardef 10 mg
10 mg, film-coated tablets
Bisoprololi fumaras
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Bicardef is and what it is used for
2. What you need to know 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 Bicardef is and what it is used for

Bicardef contains bisoprolol (as fumarate) and is indicated in heart and circulatory system disorders. Bisoprolol affects the so-called sympathetic part of the nervous system, which among other functions regulates blood pressure and heart activity. Bisoprolol belongs to agents that predominantly influence heart function (selectively blocks cardiac beta receptors); when administered at recommended doses, it usually does not affect the gastrointestinal system, blood vessels, or bronchi (does not cause bronchoconstriction), and does not influence metabolism related to beta-receptor stimulation (does not increase blood lipid and glucose levels).

Bisoprolol reduces blood pressure, slows down heart rate at rest and during exertion, and, which is beneficial in ischemic heart disease, reduces oxygen demand by the myocardium.

Bicardef is indicated (used either as monotherapy or in combination with other appropriately selected medicines) for the treatment of arterial hypertension and ischemic heart disease (angina pectoris).

Heart failure occurs when the heart muscle is weakened and unable to pump sufficient 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 using Bicardef

When not to use Bicardef
Do not use Bicardef if the patient is allergic to bisoprolol fumarate or to any of the other ingredients of this
medication (listed in section 6).
Do not use Bicardef if any of the following conditions are present:

• acute heart failure or worsening heart failure requiring intravenous administration of drugs that improve myocardial contractility (so-called inotropic agents);
• shock caused by heart dysfunction (cardiogenic shock);
• impaired conduction of electrical impulses between the atria and ventricles of the heart (second- or third-degree atrioventricular block) without a cardiac pacemaker;
• sick sinus syndrome (so-called "sick sinus syndrome");
• sinoatrial block;
• significant slowing of the heart rate (bradycardia), with a resting heart rate below 50 beats per minute before starting treatment;
• low blood pressure (systolic blood pressure below 90 mmHg);
• severe bronchial asthma or severe chronic obstructive pulmonary disease;
• advanced peripheral arterial disease or vasoconstriction of the fingers and toes (Raynaud's syndrome);
• untreated pheochromocytoma, a rare adrenal gland tumor (see below);
• metabolic acidosis, a condition in which blood pH is abnormally low.

Warnings and precautions
Before starting treatment with Bicardef, discuss this with your doctor or pharmacist.
If any of the following conditions apply, talk to your doctor before starting Bicardef; your doctor may decide special precautions are necessary (e.g., additional medications or more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart conditions (such as heart rhythm disorders or severe chest pain at rest—Prinzmetal's angina);
• circulatory disorders in the limbs;
• bronchial asthma or chronic lung disease;
• presence of scaly skin lesions (psoriasis), even in medical history;
• thyroid dysfunction;
• pheochromocytoma.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (e.g., to prevent hay fever), because bisoprolol may increase the likelihood or severity of allergic reactions;
• surgery under general anesthesia, because bisoprolol may alter the body's response to anesthetic drugs.

Children and adolescents
Bicardef is not recommended for use in children and adolescents.

Bicardef with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take the following medicines together with Bicardef without specific medical advice:

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

Before using any of the following medicines together with Bicardef, consult your doctor; your doctor may recommend more frequent medical checks:

• certain heart medications of the dihydropyridine group (e.g., nifedipine, felodipine, amlodipine), due to the risk of hypotension and worsening heart function;
• certain antiarrhythmic drugs of class III (e.g., amiodarone), due to possible disturbances in heart function (frequent ECG monitoring required);
• certain antihypertensive drugs (e.g., prazosin, alfuzosin), due to the risk of sudden drop in blood pressure (especially careful blood pressure monitoring required);
• other drugs that may lower blood pressure, e.g., certain tricyclic antidepressants, barbiturates, and phenothiazine derivatives, due to increased risk of excessive blood pressure reduction;
• parasympathomimetic drugs (e.g., pilocarpine), due to slowing of heart rate;
• beta-sympathomimetic drugs (dobutamine, isoprenaline), due to reduced effectiveness of both simultaneously administered drugs;
• sympathomimetic drugs stimulating alpha and beta receptors, due to possible undesirable increase in blood pressure and worsening of intermittent claudication symptoms;
• other beta-blocking agents (including eye drops), due to enhanced effect of bisoprolol;
• heart medications (cardiac glycosides such as digoxin), due to possible adverse slowing of heart function;
• nonsteroidal anti-inflammatory drugs (NSAIDs), due to possible reduction of bisoprolol's antihypertensive effect;
• insulin and other glucose-lowering drugs, due to further lowering of blood glucose levels and masking of symptoms of hypoglycemia;
• certain antibiotics, e.g., rifampicin;
• ergotamine derivatives, also found in migraine medications, due to possible disturbances in blood circulation;
• drugs containing adrenaline, noradrenaline, or similar substances found in cough medicines, nasal drops, etc., because the effectiveness of both drugs may be reduced. Dose adjustments may be necessary to achieve adequate treatment of allergic conditions;
• certain local anesthetics (e.g., lidocaine), due to the risk of low blood pressure. Inform the anesthesiologist about bisoprolol use before any procedure;
• mefloquine, due to increased risk of slowed heart function;
• certain monoamine oxidase inhibitors (MAOIs), due to enhanced antihypertensive effect and increased risk of hypertensive crisis.

Bicardef with food or alcohol
The type and amount of food consumed do not alter the effect of the drug. However, following an appropriate diet and other additional recommendations from the treating physician may significantly influence treatment outcomes and quality of life.
Alcoholic beverages enhance the effect of bisoprolol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Administration of bisoprolol may be harmful to the fetus and/or newborn. Similarly, planned pregnancy in a patient treated with bisoprolol requires medical consultation.
All beta-blockers reduce placental blood flow, which may impair fetal growth, lead to intrauterine death, miscarriage, or premature delivery, and may also reduce blood glucose levels and slow the fetal heart rate.
Therefore, bisoprolol and other selective beta-1 receptor blockers may be used during pregnancy only when absolutely necessary, and only if the expected benefits to the mother outweigh the potential risks to the fetus and child. In such cases, particularly strict medical supervision is required (monitoring of placental blood flow and fetal development). If adverse effects are observed, the doctor will consider and recommend an alternative appropriate treatment for the pregnant patient.
Newborns of mothers treated with bisoprolol should be closely monitored by a physician, especially during the first three days of life.

Breastfeeding
Breastfeeding is not recommended during treatment with bisoprolol due to lack of data on safety.

Driving and operating machinery
Due to individual variability in response to the drug, bisoprolol may impair the ability to drive or operate machinery. This effect should be considered especially at the beginning of treatment, when changing medications, and in patients consuming alcohol. Therefore, patients should consult their doctor to determine whether they can drive or operate machinery.

Bicardef contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this 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, meaning the medicine is considered "sodium-free".

3. How to use Bicardef

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Oral administration.
Take the tablets in the morning, before, during, or after breakfast. Swallow whole, with a small amount of fluid.
Treatment usually starts with low doses, which are then gradually increased. In all cases, the dosage must be individually adjusted based on the doctor's assessment of the effect on heart function, blood pressure, and the patient's response to the medicine.
The duration of treatment is not limited; treatment is generally long-term and depends on the type and course of the disease.
Abrupt discontinuation of treatment is not recommended due to the risk of worsening symptoms, especially in patients with ischemic heart disease.

Hypertension
The usual recommended dose is 1 tablet of Bicardef 5 mg once daily or ½ tablet of Bicardef
10 mg once daily (corresponding to a dose of 5 mg bisoprolol fumarate once daily).
In milder forms of hypertension (diastolic pressure up to 105 mmHg), the doctor may recommend reducing the dose to ½ tablet of Bicardef 5 mg once daily (corresponding to a dose of 2.5 mg bisoprolol fumarate once daily). If necessary, the doctor may recommend increasing the dose to 2 tablets of Bicardef 5 mg once daily or 1 tablet of Bicardef 10 mg once daily (corresponding to a dose of 10 mg bisoprolol fumarate once daily).
Further dose increases are justified only in exceptional cases.
The maximum recommended dose of bisoprolol is 20 mg once daily.

Ischemic heart disease (angina pectoris)
The usual recommended dose is 1 tablet of Bicardef 5 mg once daily or ½ tablet of Bicardef
10 mg once daily (corresponding to a dose of 5 mg bisoprolol fumarate once daily).
If necessary, the doctor may recommend increasing the dose to 2 tablets of Bicardef 5 mg once daily or 1 tablet of Bicardef 10 mg once daily (corresponding to a dose of 10 mg bisoprolol fumarate once daily).
Further dose increases are justified only in exceptional cases.
The maximum recommended dose is 20 mg once daily.

Stable chronic heart failure
The doctor will start bisoprolol treatment with a low dose and gradually increase it—the doctor will decide how to adjust the dosage. The recommended starting dose is 1.25 mg once daily.
The dose should be increased every two weeks or longer intervals to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily.
The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well the medicine is tolerated, the doctor may decide to extend the interval before the next dose increase. If symptoms worsen or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue 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.

Dosing in patients with hepatic and/or renal impairment
Treatment of hypertension and angina pectoris
In patients with mild to moderate impairment of liver or kidney function, dosage adjustment is usually not necessary. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment, doses exceeding 10 mg of bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence to suggest that dosage adjustment is required.

Treatment of stable chronic heart failure
There are no data on the pharmacokinetics of bisoprolol in patients with chronic heart failure and concomitant hepatic or renal impairment. Therefore, particular caution should be exercised when increasing the dose in these patients.

Dosing in elderly patients
Dosage adjustment is not necessary.

Use in children and adolescents
Bisoprolol is not recommended for use in children and adolescents due to insufficient clinical data.
The tablet may be divided into equal doses.

Taking more Bicardef than prescribed
In case of bisoprolol overdose, contact a doctor immediately and show the medicine's packaging or patient information leaflet.
The most common symptoms of bisoprolol overdose include: slowed heart rate (bradycardia), low blood pressure, shortness of breath due to bronchospasm, acute heart failure, and low blood glucose levels (hypoglycemia).

If you miss a dose of Bicardef
Do not take a double dose to make up for a missed dose.
Take the missed dose with the next meal, following the doctor's prescribed dosing schedule (e.g., if you forgot to take the medicine in the morning, take it at noon, and take the next dose according to schedule the following day).

Stopping Bicardef treatment
Do not stop bisoprolol treatment without consulting your doctor.
Treatment should not be stopped abruptly. Stopping Bicardef may lead to a sudden worsening of health (especially in patients with ischemic heart disease). If discontinuation is necessary, the dose should be gradually reduced under medical supervision (e.g., by gradually tapering the dose over one week, or by halving the dose at weekly intervals).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if you experience severe allergic reactions,
which may include: swelling of the face, neck, tongue, mouth or throat, or
difficulty breathing.
Very common adverse reactions (occur in more than 1 in 10 patients):
bradycardia (slow heart rate) – in patients with chronic heart failure.
Common adverse reactions (occur in no more than 1 in 10 patients):
fatigue, exhaustion, dizziness, headache, sensation of coldness or numbness in limbs,
gastrointestinal disturbances (nausea, vomiting, diarrhoea or constipation), low blood pressure,
asthenia (weakness), worsening of existing heart failure – in patients with chronic
heart failure.
Applies only to patients with hypertension or angina pectoris:
Symptoms occur mainly at the beginning of treatment, are usually mild and resolve within 1–2 weeks.
Uncommon adverse reactions (occur in no more than 1 in 100
patients): sleep disturbances, depression, asthenia (weakness), cardiac disorders (excessive
slowing of heart rate – so-called bradycardia, atrioventricular conduction disturbances),
and worsening of pre-existing heart failure – in patients with hypertension or
angina pectoris, bronchospasm (difficulty breathing) in patients with bronchial asthma or
chronic obstructive pulmonary disease, muscle weakness, muscle cramps.
Rare adverse reactions (occur in no more than 1 in 1000 patients):
nightmares, hallucinations, fainting, erectile dysfunction, reduced tear secretion (important for
contact lens wearers), hearing impairment, allergic rhinitis, hepatitis,
increased liver enzyme activity (so-called AlAT, AspAT), elevated
blood triglyceride levels, skin allergic reactions (itching, redness, rash).
Very rare adverse reactions (occur in less than 1 in 10,000
patients): conjunctivitis (eye irritation or redness), hair loss, and onset or worsening of
psoriasis symptoms or appearance of psoriasis-like rash.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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:
Aleje 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 authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Bicardef 10 mg

Store at a temperature not exceeding 25°C. Keep in the original packaging to protect from light.
Keep the medicine 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bicardef contains

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

What Bicardef looks like and contents of the pack
Film-coated tablets, oval, biconvex, beige-orange in colour, with a division line, with a smooth, uniform surface.
One pack contains 30, 60 or 90 tablets.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel.: (22) 742 00 22
e-mail: [email protected]
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