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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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 medications called beta-adrenergic blockers. These medications 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 heart's efficiency in pumping blood throughout the body.
Corsib is used in combination with other medications (ACE inhibitors, diuretics, and cardiac glycosides) to treat 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 coronary arteries).

2. Important information before taking Corsib

When not to take Corsib:

Warnings and precautions

Before starting to take Corsib, the patient should discuss it with their doctor or pharmacist, especially if they have any of the following conditions:

• chronic bronchitis or mild asthma
• diabetes
• strict fasting
• desensitization treatment (e.g., to avoid hay fever)
• certain heart diseases, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver disorders
• circulatory disorders in the limbs
• if the patient is to undergo general anesthesia
• 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 and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The following medications should not be taken with Corsib without special recommendation by the doctor:

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

Corsib with food, drink, and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
There is a risk that taking bisoprolol during pregnancy may harm the fetus. The doctor will decide whether Corsib can be taken 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 or operate machinery. The patient should be particularly careful at the beginning of treatment, after increasing the dose, or when changing medications, as well as when combining the medication with alcohol.

3. How to take Corsib

This medication should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist.
Corsib should be taken in the morning with 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 maximum tolerated dose. 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 disorders
In patients with mild or moderate kidney or liver disorders, dose adjustment is usually not necessary. Patients with severe kidney or liver disorders 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, usually 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 they do not tolerate Corsib, it may be necessary to reduce the dose again or stop treatment. If the patient must stop treatment completely, the doctor will usually recommend gradual dose reduction, 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

In case of taking a higher dose of Corsib than recommended, the patient should immediately inform their doctor. 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

The patient should not take a double dose to make up for a missed dose. They should take their usual dose the next morning.

Stopping Corsib treatment

The patient should never stop taking Corsib without consulting their doctor first. Otherwise, their condition may worsen significantly.
Bisoprolol treatment should not be stopped abruptly. If the patient must stop treatment, it should be done gradually to avoid side effects. If side effects occur, the dose should be reduced more slowly.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Corsib can cause side effects, although not everybody gets them.
In case of dizziness, weakness, or breathing difficulties, the patient should contact their doctor as soon as possible.
The following side effects are listed according to their frequency:

• bradycardia (slow heart rate)

Common(may affect up to 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)

Uncommon(may affect up to 1 in 100 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 (COPD), muscle weakness, muscle cramps

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

• dry eyes due to reduced tear secretion (may be problematic if the patient wears 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. The patient should contact their doctor immediately if they 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 affect up to 1 in 10,000 people):

• irritation and redness of the eyes (conjunctivitis)
• development or worsening of psoriatic skin lesions, psoriasis-like lesions
• 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 the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety, 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
Reporting side effects can help gather more information on the safety of the medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Corsib

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after: EXP.
The expiration date refers to the last day of the month stated.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Corsib contains

• The active substance of Corsib 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.
• 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 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

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

This medication 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 tablets
Bisoprolol Gemax Pharma 5 mg tablets
Bisoprolol Gemax Pharma 10 mg tablets

Date of last revision of the leaflet: 06/2024