Sobicor

Leaflet accompanying the packaging: patient information

Sobycor, 2.5 mg, film-coated tablets

Sobycor, 5 mg, film-coated tablets

Sobycor, 10 mg, film-coated tablets

Bisoprolol fumarate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sobycor and what is it used for

The active substance of Sobycor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-adrenergic blockers. These medicines affect the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient in pumping blood throughout the body. At the same time, bisoprolol reduces the need for oxygen and blood flow to the heart. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. Sobycor is used to treat:

• high blood pressure (hypertension),
• angina pectoris,
• chronic stable heart failure. It is used in combination with other medicines given for this condition (such as angiotensin-converting enzyme inhibitors - ACE inhibitors, diuretics, and digitalis glycosides).

2. Important information before taking Sobycor

When not to take Sobycor

Do not take Sobycor if you have any of the following conditions:

• allergy to the active substance or any of the other ingredients of this medicine (listed in section 6),
• severe asthma,
• severe circulatory disorders in the limbs (such as Raynaud's syndrome) that may cause tingling, paleness, or bluish discoloration of the fingers and toes,
• untreated pheochromocytoma, a rare tumor of the adrenal gland,
• metabolic acidosis, a condition in which there is an excessive accumulation of acids in the blood.

Do not take Sobycor if you have any of the following heart conditions:

• acute heart failure,
• worsening of heart failure that requires intravenous administration of medicines that improve heart muscle contraction,
• low blood pressure,
• certain heart conditions that cause very slow or irregular heart rate,
• cardiogenic shock, a severe and acute heart disorder that results in low blood pressure and poor circulation.

Warnings and precautions

Before starting to take Sobycor, discuss it with your doctor or pharmacist. If you have any of the following conditions, inform your doctor before starting to take Sobycor; the doctor may consider that special caution is necessary (e.g., additional medication or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart conditions, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina),
• kidney or liver disease,
• mild circulatory disorders in the limbs,
• mild asthma or chronic obstructive pulmonary disease (COPD),
• psoriasis in the medical history,
• adrenal gland tumor (pheochromocytoma),
• thyroid disorders,
• first-degree atrioventricular block (a condition in which the nerve signals to the heart are impaired, which can cause skipped heartbeats or irregular heart rhythm).

Also, inform your doctor if you are planning:

• desensitization treatment (e.g., to prevent hay fever), as Sobycor may increase the risk of an allergic reaction or its severity,
• anesthesia (e.g., for surgery), as Sobycor may affect the body's response to the administered medicines.

Sobycor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Without special recommendation by the doctor, do not take the following medicines at the same time as Sobycor:

• certain medicines used to treat irregular or abnormal heart rhythm (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone),
• certain medicines used to treat high blood pressure, angina pectoris, or irregular heart rhythm (calcium channel blockers, such as verapamil or diltiazem),
• certain antihypertensive medicines, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicineswithout prior consultation with your doctor.

Before taking any of the following medicines at the same time as Sobycor, consult your doctor, as more frequent medical monitoring may be necessary:

• certain medicines used to treat high blood pressure, angina pectoris, or irregular heart rhythm (dihydropyridine calcium channel blockers, such as nifedipine, felodipine, amlodipine);
• certain medicines used to treat irregular or abnormal heart rhythm (class III anti-arrhythmic medicines, such as amiodarone);
• beta-adrenergic blockers used locally (such as timolol eye drops used to treat glaucoma);
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetic medicines, such as tacrine or carbachol) or medicines used in acute heart conditions (sympathomimetic medicines, such as isoprenaline and dobutamine);
• antidiabetic medicines, including insulin;
• anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• nonsteroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac);
• any medicines that may lower blood pressure as a desired or undesired effect, such as antihypertensive medicines, certain medicines used to treat depression (tricyclic antidepressants, such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates, such as phenobarbital), or certain medicines used to treat mental disorders that cause loss of contact with reality (phenothiazines, such as levomepromazine);
• mefloquine used to prevent or treat malaria;
• medicines used to treat depression, known as monoamine oxidase inhibitors (except for MAO-B inhibitors), such as moclobemide;
• moxisylyte used to treat circulatory disorders, such as Raynaud's syndrome.

Pregnancy and breastfeeding

There is a risk that taking Sobycor during pregnancy may harm the baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. The doctor will decide whether you can take Sobycor during pregnancy. It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended while taking Sobycor.

Children and adolescents

Sobycor is not recommended for children and adolescents.

Driving and using machines

The medicine may affect your ability to drive or use machines, depending on your individual tolerance to the treatment. Be particularly careful during the initial treatment period, when increasing the dose, or when changing the medicine, as well as in combination with alcohol.

Sobycor contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is essentially 'sodium-free'.

3. How to take Sobycor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Take the tablets in the morning, with water, with or without food. Do not chew or crush the tablets. Treatment with Sobycor requires regular medical monitoring, especially at the beginning of treatment, when increasing the dose, and when stopping treatment. Treatment with Sobycor is usually long-term.

Adults, including the elderly

The dose will be adapted individually. The usual daily dose of bisoprolol is 10 mg. Depending on the patient's response to the treatment, the doctor may reduce the dose to 5 mg or increase it to 20 mg. Do not take more than 20 mg per day.

Chronic stable heart failure

Adults, including the elderly

Treatment with bisoprolol should be started with a low dose and gradually increased. The doctor will decide how to increase the dose, usually as follows:

• 1.25 mg of bisoprolol once daily for 1 week
• 2.5 mg of bisoprolol once daily for 1 week
• 3.75 mg of bisoprolol once daily for 1 week
• 5 mg of bisoprolol once daily for 4 weeks
• 7.5 mg of bisoprolol once daily for 4 weeks
• 10 mg of bisoprolol once daily for maintenance treatment (chronic). The maximum recommended daily dose of bisoprolol is 10 mg. Depending on the patient's tolerance to the treatment, the doctor may prolong the time between dose increases. If the patient's condition worsens or the patient does not tolerate the medicine, 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 effective. The doctor will decide what to do. If treatment needs to be stopped completely, the doctor will usually recommend gradual dose reduction, otherwise, the patient's condition may worsen.

Use in patients with liver or kidney impairment

In patients with mild to moderate kidney or liver impairment, there is usually no need to adjust the dose. In patients with severe kidney impairment (creatinine clearance <20 ml min) and in patients with severe liver impairment, do not take more than 10 mg of bisoprolol per day.< p>

Use in children and adolescents

Sobycor is not recommended for children.

Taking a higher dose of Sobycor than recommended

If you have taken more than the recommended dose of Sobycor, inform your doctor immediately. The doctor will decide what to do next. Symptoms of overdose may include: slow heart rate, severe breathing difficulties, dizziness, or tremors (due to low blood sugar levels).

Missing a dose of Sobycor

Do not take a double dose to make up for a missed dose. Take the next dose the following morning.

Stopping treatment with Sobycor

Do not stop taking Sobycor without consulting your doctor. Otherwise, your condition may worsen. Especially in patients with coronary heart disease, do not stop treatment with bisoprolol abruptly. If it is considered necessary to stop treatment completely, the doctor will usually recommend gradual dose reduction. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sobycor can cause side effects, although not everybody gets them. To prevent serious side effects, consult your doctor immediately if the side effect is severe, sudden, or worsening rapidly. The most serious side effects are related to heart function:

• slow heart rate (may occur in up to 1 in 10 patients),
• worsening of heart failure (may occur in up to 1 in 10 patients),
• slow or irregular heart rate (may occur in up to 1 in 100 patients). If you experience dizziness, weakness, or breathing difficulties, contact your doctor as soon as possible.

Other side effects are listed below by frequency of occurrence. Common(may occur in up to 1 in 10 patients):

• fatigue, weakness, dizziness, headache
• feeling of coldness or numbness in the hands or feet
• low blood pressure
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

Uncommon(may occur in up to 1 in 100 patients):

• sleep disorders
• depression
• dizziness when standing up
• breathing difficulties in patients with asthma or chronic obstructive pulmonary disease (COPD)
• muscle weakness, muscle cramps.

Rare(may occur in up to 1 in 1,000 patients):

• hearing disorders
• allergic rhinitis
• reduced tear secretion (dry eyes)
• hepatitis that may cause yellowing of the skin or eyes
• abnormal results of some blood tests used to evaluate liver function or lipid levels
• allergic reactions, such as itching, redness, rash. 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.
• erectile dysfunction
• nightmares, hallucinations
• fainting.

Very rare(may occur in up to 1 in 10,000 patients):

• irritation and redness of the eye (conjunctivitis)
• hair loss
• occurrence or worsening of psoriatic rash (psoriasis); psoriatic rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sobycor

Keep this medicine out of the 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 month stated. The batch number is stated on the packaging after 'Lot'. Store in the original packaging to protect from light and moisture. There are no special storage temperature requirements. Medicines should not be disposed of via wastewater or household waste. 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 Sobycor contains

• -The active substance of Sobycor is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg, 5 mg, or 10 mg of bisoprolol fumarate.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone (K-30), colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose 2910, macrogol 400, titanium dioxide (E 171), talc, yellow iron oxide (E 172) - only in 5 mg and 10 mg film-coated tablets, red iron oxide (E 172) - only in 5 mg and 10 mg film-coated tablets. See section 2 "Sobycor contains sodium".

What Sobycor looks like and contents of the pack

2.5 mg: white to almost white, oval, slightly biconvex film-coated tablets (tablets) with a score line on one side (length: 8.3-8.7 mm, width: 5.5 mm, thickness: 2.8-3.6 mm). The tablet can be divided into equal doses. 5 mg: light yellow-brown, oval, slightly biconvex film-coated tablets (tablets) with a score line on one side (length: 8.3-8.7 mm, width: 5.5 mm, thickness: 2.8-3.6 mm). The tablet can be divided into equal doses. 10 mg: light yellow-brown, round, slightly biconvex film-coated tablets (tablets) with a beveled edge and a score line on one side (diameter: 10.0-10.3 mm, thickness: 2.8-3.6 mm). The tablet can be divided into equal doses. Packaging:10, 20, 28, 30, 50, 56, 60, 84, 90, and 100 film-coated tablets in blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warszawa Tel. 22 57 37 500 Date of last revision of the leaflet:10.12.2021