Corsib

Package Leaflet: Information for the Patient

Corsib, 2.5 mg, tablets

Corsib, 5 mg, tablets

Corsib, 10 mg, tablets

Bisoprolol fumarate

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

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

Table of Contents of the Leaflet:

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

1. What is Corsib and what is it used for

The active substance of Corsib 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 increases the efficiency of the heart in pumping blood throughout the body.
Corsib is used in combination with other medicines (ACE inhibitors, diuretics, and cardiac glycosides) in the treatment of stable heart failure.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Corsib is also used to treat high blood pressure (hypertension) and angina pectoris (chest pain caused by blockage of the arteries that supply the heart muscle).

2. Important information before taking Corsib

When not to take Corsib:

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
• if you have severe asthma
• if you have severe circulatory problems in your limbs (such as Raynaud's syndrome), which can cause tingling, pallor, or cyanosis of the fingers or toes
• if you have metabolic acidosis, a condition in which the acid level in the blood is too high
• if you have an untreated pheochromocytoma, a rare tumor of the adrenal gland
• if you have acute heart failure, which suddenly worsens, and (or) which may require hospital treatment
• if you have a slow heart rate, which causes problems, or low blood pressure
• if you have certain heart diseases that cause a slow or irregular heart rate
• if you have cardiogenic shock, a severe heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

Before starting to take Corsib, discuss it with your doctor or pharmacist, especially if you have any of the following conditions:

• chronic obstructive pulmonary disease or mild asthma
• diabetes
• strict fasting
• desensitization therapy (e.g., to avoid hay fever)
• certain heart diseases, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver disease
• circulatory problems in the limbs
• if you are to undergo general anesthesia
• if you have (or have had) psoriasis (a recurring disease characterized by skin peeling and dry rash)
• pheochromocytoma of the adrenal gland
• thyroid dysfunction.

Children and adolescents

Corsib is not recommended for use in children and adolescents, as there is no experience with the use of Corsib in this patient group.

Corsib with 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.
Do not take the following medicines with Corsib without special recommendation by your doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic agents, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina pectoris, or arrhythmias (calcium antagonists, such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without consulting your doctor first.Before taking the following medicines with Corsib, consult your doctor; you may need more frequent medical check-ups:
• certain medicines used to treat high blood pressure or angina pectoris (calcium channel blockers, such as felodipine and amlodipine)
• certain medicines used to treat arrhythmias (class III anti-arrhythmic agents, such as amiodarone)
• locally used beta-adrenergic blockers (such as eye drops used to treat glaucoma - increased eye pressure)
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics, such as tacrine or carbachol) or medicines used to treat acute heart disorders (such as isoprenaline and dobutamine)
• medicines used to treat diabetes, including insulin
• agents used in general anesthesia (e.g., during surgery)
• digoxin (used to treat heart failure)
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, and inflammation (such as ibuprofen and diclofenac)
• all medicines that can lower blood pressure, such as:
• antihypertensive medicines,
• certain antidepressants (such as imipramine or amitriptyline),
• certain medicines used to treat epilepsy,
• certain medicines used during anesthesia (such as phenobarbital),
• certain medicines used to treat mental disorders (such as levomepromazine)
• mefloquine, used to prevent or treat malaria
• medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Corsib with food, drink, and alcohol

Corsib is usually taken in the morning with food or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
There is a risk that bisoprolol may harm the baby during pregnancy. Your doctor will decide whether you can take Corsib during pregnancy.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and using machines

Corsib, depending on how it is tolerated by the patient, may affect the ability to drive vehicles or operate machines. Be particularly careful at the beginning of treatment, after increasing the dose, or after changing medicines, as well as when combining the medicine with alcohol.

3. How to take Corsib

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Corsib should be taken in the morning with food or without food, with a glass of water. The tablets should not be crushed or chewed.
Hypertension/angina pectoris
Adults
The doctor will start treatment with the lowest possible dose (5 mg). The doctor will carefully monitor the patient's condition at the beginning of treatment and increase the dose to achieve the dose that can be used by the patient. The recommended daily dose is 10 mg. The maximum daily dose is 20 mg.
Treatment with Corsib is usually long-term.
Patients with kidney or liver disease
In patients with mild or moderate kidney or liver disease, dose adjustment is usually not necessary. Patients with severe kidney or liver disease should not take more than 10 mg of bisoprolol per day.
Heart failure (reduced heart function)
Treatment with Corsib requires regular medical check-ups. This is especially important at the beginning of treatment and during dose adjustment. Bisoprolol treatment should be started with a low dose and gradually increased. The doctor will decide how to increase the dose and usually do it as follows:

• 1.25 mg of bisoprolol once a day for a week
• 2.5 mg of bisoprolol once a day for a week
• 3.75 mg of bisoprolol once a day for a week
• 5 mg of bisoprolol once a day for four weeks
• 7.5 mg of bisoprolol once a day for four weeks
• 10 mg of bisoprolol once a day for maintenance treatment (long-term).

The maximum recommended daily dose is 10 mg of bisoprolol. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
The tablet can be divided into equal doses.
Depending on how the patient tolerates Corsib, the doctor may also decide to extend the time between dose increases. If the patient's condition worsens or the patient does not tolerate Corsib, it may be necessary to reduce the dose again or stop treatment. If the patient needs to stop treatment completely, the doctor will usually recommend gradually reducing the dose, as otherwise, the patient's condition may worsen.

Use in children and adolescents

Corsib is not recommended for use in children and adolescents.

Use in the elderly

Generally, there is no need to adjust the dose in the elderly.

Overdose of Corsib

If you have taken more Corsib than recommended, inform your doctor immediately. The doctor will decide what actions to take.
Overdose symptoms may include: slow heart rate (bradycardia), acute bronchospasm leading to breathing difficulties, significant drop in blood pressure, acute heart failure, or low blood sugar.

Missed dose of Corsib

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

Stopping Corsib treatment

Never stop taking Corsib without consulting your doctor. Otherwise, your condition may worsen significantly.
Bisoprolol treatment should not be stopped abruptly. If you need to stop treatment, do it gradually to avoid side effects. If side effects occur, reduce the dose more slowly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Corsib can cause side effects, although not everybody gets them.
If you experience dizziness, weakness, or breathing difficulties, contact your doctor as soon as possible.
The following side effects are listed according to their frequency:

• bradycardia (slow heart rate)

Very common(may affect more than 1 in 10 people):

• feeling of coldness or numbness in hands or feet
• low blood pressure
• worsening of existing heart failure
• nausea, vomiting, diarrhea, constipation
• fatigue*, dizziness*, headache* weakness (asthenia)

Common(may affect up to 1 in 10 people):

• sleep disorders
• depression
• conduction disorders
• drop in blood pressure when standing up, causing dizziness
• breathing difficulties in patients with asthma or chronic obstructive pulmonary disease, muscle weakness, muscle cramps

Uncommon(may affect up to 1 in 100 people):

• dry eyes due to reduced tear secretion (may be problematic if you wear contact lenses)
• hearing disorders
• allergic rhinitis, stuffy nose
• hepatitis, which can cause yellowing of the skin or whites of the eyes
• increased liver enzyme levels (AST, ALT), increased triglyceride levels
• allergic reactions, such as itching, flushing, 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

Rare(may affect up to 1 in 1,000 people):

• irritation and redness of the eyes (conjunctivitis)
• development or worsening of psoriatic skin changes, psoriasis-like changes
• hair loss

* In the treatment of hypertension or angina pectoris, these symptoms occur especially at the beginning of treatment or when changing the dose. They are usually mild and often disappear within 1 to 2 weeks.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Corsib

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should 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 Corsib contains

• The active substance is bisoprolol fumarate. Corsib 2.5 mg contains 2.5 mg of bisoprolol fumarate. Corsib 5 mg contains 5 mg of bisoprolol fumarate. Corsib 10 mg contains 10 mg of bisoprolol fumarate.
• The other ingredients are microcrystalline cellulose (type 102), microcrystalline cellulose (type 101), crospovidone (type A), magnesium stearate, yellow iron oxide (E 172) (only for Corsib 2.5 mg and 10 mg), red iron oxide (E 172) (only for Corsib 10 mg).

What Corsib looks like and contents of the pack

Corsib 2.5 mg is a yellow, round, flat tablet with a dividing line on one side, 7 mm in diameter.
The tablet can be divided into equal doses.
Corsib 5 mg is a white, round, biconvex tablet with a dividing line, 7 mm in diameter.
The tablet can be divided into equal doses.
Corsib 10 mg is a dark pink, round, flat tablet with a dividing line on one side and the number "10" embossed on the other, 7 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes: 10, 20, 28, 30, 50, 60, 90, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Praga 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia

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

Slovakia:

Bisoprolol Medreg 2.5 mg
Bisoprolol Medreg 5 mg
Bisoprolol Medreg 10 mg
Czech Republic:

Bisoprolol Medreg
Poland:

Corsib
Romania:

Bisoprolol Gemax Pharma 2.5 mg comprimate
Bisoprolol Gemax Pharma 5 mg comprimate
Bisoprolol Gemax Pharma 10 mg comprimate

Date of last revision of the leaflet: 06/2024