Sobycor

Package leaflet: information for the patient

Sobycor, 2.5 mg, film-coated tablets
Sobycor, 5 mg, film-coated tablets
Sobycor, 10 mg, film-coated tablets
bisoprolol fumarate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Sobycor is and what it is 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 pack and other information

1. What Sobycor is and what it is used for

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

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

2. Important information before using Sobycor

When not to use Sobycor
Do not take Sobycor if the patient has any of the following conditions:

• hypersensitivity to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• severe bronchial asthma,
• severe peripheral circulatory disorders (e.g. Raynaud's syndrome) causing tingling, pallor, or cyanosis of fingers and toes,
• untreated phaeochromocytoma, a rare tumour of the adrenal gland,
• metabolic acidosis, a condition in which there is excessive accumulation of acids in the blood.

Do not take Sobycor if the patient has any of the following heart conditions:

• acute heart failure,
• decompensated heart failure requiring intravenous administration of drugs that enhance myocardial contractility,
• low blood pressure,
• certain heart diseases causing very slow or irregular heartbeat,
• cardiogenic shock, an acute, severe impairment of heart function resulting in low blood pressure and circulatory failure.

Warnings and precautions
Talk to your doctor or pharmacist before starting Sobycor. If the patient has any of the conditions listed below, inform the doctor before starting treatment with Sobycor; the doctor may decide that special precautions are 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 peripheral circulatory disorders,
• history of psoriasis (scaly skin rash),
• phaeochromocytoma (adrenal gland tumour),
• thyroid disorders,
• first-degree heart block (a condition in which nerve signals to the heart are impaired, potentially causing missed heartbeats or irregular heart rhythm).

Additionally, inform your doctor if the patient is planning:

• allergen immunotherapy (e.g. to prevent hay fever), because Sobycor may increase the likelihood or severity of an allergic reaction,
• anaesthesia (e.g. for surgery), because Sobycor may affect the body's response to administered drugs.

Sobycor with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take the following medicines together with Sobycor without specific medical advice:

• certain medicines used to treat irregular or abnormal heart function (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone),
• certain medicines used to treat high blood pressure, angina, or irregular heart rhythm (calcium antagonists such as verapamil or diltiazem),
• certain antihypertensive medicines such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Before taking any of the following medicines together with Sobycor, consult your doctor, as more frequent medical monitoring may be required:

• certain medicines used to treat high blood pressure, angina, or abnormal heart function (dihydropyridine-type calcium antagonists such as nifedipine, felodipine, amlodipine);
• certain medicines used to treat irregular or abnormal heart function (class III antiarrhythmics such as amiodarone);
• locally administered beta-blockers (e.g. timolol eye drops used in the treatment of glaucoma);
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used in acute heart conditions (sympathomimetics such as isoprenaline and dobutamine);
• antidiabetic medicines, including insulin;
• anaesthetic medicines (e.g. during surgery);
• cardiac glycosides used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, pain, or inflammation (e.g. ibuprofen or diclofenac);
• any medicines that may lower blood pressure as either a desired or adverse effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain anticonvulsants or anaesthetics (barbiturates such as phenobarbital), or certain medicines used to treat psychiatric disorders causing loss of contact with reality (phenothiazines such as levomepromazine);
• mefloquine, used for prevention or treatment of malaria;
• antidepressants known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide;
• molsidomine, used to treat circulatory disorders such as Raynaud's syndrome.

Pregnancy and breastfeeding
There is a risk that administering Sobycor during pregnancy may be harmful to the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether the patient may take Sobycor during pregnancy.
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with Sobycor.

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

Driving and using machines
This medicine may affect the ability to drive or operate machinery, depending on the individual patient's response to treatment. Extreme caution should be exercised at the beginning of treatment, when increasing the dose, when switching medication, and when combined with alcohol.

Sobycor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Sobycor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Tablets should be taken in the morning, with water, with or without food. The tablets must not be
chewed or crushed.
Treatment with Sobycor requires regular medical monitoring. This is particularly necessary at the
beginning of treatment, during dose escalation, and when discontinuing treatment.
Treatment with Sobycor is usually long-term.

Hypertension and angina pectoris
Adults, including elderly patients
The dose should be individually adjusted. The usual daily dose of bisoprolol is 10 mg.
Depending on the patient's response to treatment, the doctor may reduce the dose to 5 mg or increase
it to 20 mg. Doses higher than 20 mg per day should not be used.

Chronic stable heart failure
Adults, including elderly patients
Treatment with bisoprolol should be initiated at a low dose and gradually increased.
Your doctor will decide how to increase the dose, usually as follows:

• 1.25 mg bisoprolol once daily for 1 week
• 2.5 mg bisoprolol once daily for 1 week
• 3.75 mg bisoprolol once daily for 1 week
• 5 mg bisoprolol once daily for 4 weeks
• 7.5 mg bisoprolol once daily for 4 weeks
• 10 mg bisoprolol once daily for long-term maintenance therapy. The maximum recommended daily dose of bisoprolol is 10 mg. Depending on the patient's tolerance to treatment, the doctor may extend the intervals 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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be effective. The doctor will determine the appropriate course of action. If treatment needs to be completely discontinued, the doctor will usually recommend gradually reducing the dose; otherwise, the patient's condition may worsen.

Use in patients with hepatic and/or renal impairment
In patients with mild to moderate renal or hepatic impairment, dose adjustment is usually not required.
In patients with severe renal impairment (creatinine clearance <20 ml/min) or severe hepatic impairment,
doses exceeding 10 mg of bisoprolol per day should not be used.

Use in children and adolescents
Sobycor is not recommended for use in children.

Taking more Sobycor than recommended
If you have taken more Sobycor than recommended, contact your doctor immediately. The doctor
will decide on further management.
Symptoms of overdose may include slow heart rate, severe breathing difficulties, dizziness, or tremor
(due to decreased 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 Sobycor
Do not stop taking Sobycor without consulting your doctor. Otherwise, your condition may worsen.
Particularly in patients with ischemic heart disease, bisoprolol treatment should not be stopped abruptly.
If complete discontinuation of treatment is being considered, the doctor will usually recommend gradually
reducing the dose.

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 gets them.
To prevent serious adverse reactions, you should consult your doctor immediately
if an adverse reaction is severe, occurs suddenly, or worsens rapidly. The most serious
adverse reactions are related to heart function:

• slowing of the heart (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 heartbeat (may occur in up to 1 in 100 patients). If you experience dizziness, weakness, or difficulty breathing, contact your doctor as quickly as possible.

Other adverse reactions are listed below according to their frequency of occurrence.
Common (may occur in up to 1 in 10 patients):

• fatigue, weakness, dizziness, headache
• sensation of coldness or numbness in hands or feet
• low blood pressure
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

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

• sleep disturbances
• depression
• dizziness upon standing
• breathing difficulties in patients with bronchial asthma or chronic lung disease
• muscle weakness, muscle cramps.

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

• hearing disturbances
• allergic rhinitis
• reduced tear production (dry eyes)
• hepatitis which may cause yellowing of the skin or whites of the eyes
• abnormal results in certain blood tests performed to assess liver function or lipid levels
• allergic-type reactions such as itching, redness, rash. You should contact your doctor immediately if more severe allergic reactions occur, 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):

• eye irritation and redness (conjunctivitis)
• hair loss
• occurrence or worsening of scaly rash (psoriasis); psoriasis-like rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, 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:
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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Sobycor

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store in the original packaging to protect from light and moisture.
There are no special storage temperature requirements for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the pack and other information

What Sobycor contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg, 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (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 coated tablets, red iron oxide (E 172) – only in 5 mg and 10 mg 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 coated tablets (tablets) with a division 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 brownish-yellow, oval, slightly biconvex coated tablets (tablets) with a division 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 brownish-yellow, round, slightly biconvex coated tablets (tablets) with bevelled edges and a division 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 coated tablets in blister packs, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500