Corectin

Package Leaflet: Information for the User

CORECTIN

2.5 mg, coated 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.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Corectin and what is it used for
• 2. Important information before taking Corectin
• 3. How to take Corectin
• 4. Possible side effects
• 5. How to store Corectin
• 6. Package contents and other information

1. What is Corectin and what is it used for

The active substance of Corectin is bisoprolol fumarate. 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 heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Corectin is used to treat stable, chronic heart failure.

2. Important information before taking Corectin

When NOT to take Corectin:

• if the patient is allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe asthma or chronic obstructive pulmonary disease,
• if the patient has severe circulatory disorders (such as Raynaud's syndrome) that may cause tingling, pallor, or cyanosis of the fingers or toes,
• if the patient has an untreated pheochromocytoma, a rare tumor of the adrenal gland,
• if the patient has metabolic acidosis, a condition in which the blood pH is abnormal,
• if the patient has acute heart failure,
• if the patient's heart failure worsens and requires intravenous administration of medicines that increase heart contractility,
• if the patient has a slow heart rate,
• if the patient has low blood pressure,
• if the patient has certain heart diseases that cause very slow or irregular heartbeats (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• if the patient has cardiogenic shock, a severe and life-threatening heart disorder that leads to low blood pressure and circulatory failure,
• if the patient is taking floctafenine or sultopride (see "Corectin and other medicines").

In case of doubt as to whether any of the above disorders apply to the patient, they should consult a doctor.

Warnings and precautions

Before starting treatment with Corectin, the patient should discuss it with their doctor or pharmacist if they have any of the following conditions. Special caution may be necessary (e.g., additional medication or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina),
• kidney or liver dysfunction,
• mild circulatory disorders in the limbs,
• mild asthma or chronic obstructive pulmonary disease,
• psoriatic skin lesions in the medical history (psoriasis),
• adrenal gland tumor (pheochromocytoma),
• thyroid disease.

In addition, the patient should tell their doctor if they are planning:

• desensitization treatment (e.g., to avoid hay fever), as Corectin may increase the risk of an allergic reaction or worsen such a reaction;
• general anesthesia (e.g., for surgery), as Corectin may alter the body's response to the administered medicines.

The medicine contains an active substance that gives a positive result in doping tests for athletes.

Children and adolescents

It is not recommended to use Corectin due to the lack of experience with bisoprolol in children and adolescents.

Corectin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Do not take the following medicines while taking Corectin:

• floctafenine (used for pain and joint inflammation),
• sultopride (used to treat severe mental disorders).

Do not take the following medicines with Corectin without special recommendation by the doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone),
• certain medicines used to treat high blood pressure, coronary artery disease, 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 a doctor.

Before taking the following medicines with Corectin, the patient should consult their doctor, as more frequent medical check-ups may be necessary:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine calcium antagonists, such as felodipine and amlodipine),
• certain medicines used to treat arrhythmias (class III anti-arrhythmic medicines, such as amiodarone),
• locally used beta-adrenergic blockers (such as eye drops for glaucoma treatment),
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics),
• medicines used to treat acute heart disorders (adrenergic agonists, such as isoprenaline and dobutamine),
• insulin and oral anti-diabetic medicines - when used with bisoprolol, the symptoms of low blood sugar may be masked,
• general anesthetics (e.g., during surgery),
• digitalis glycosides used to treat heart failure,
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat joint inflammation, pain, and inflammation (e.g., ibuprofen and diclofenac),
• adrenaline, a medicine used to treat severe, life-threatening allergic reactions and cardiac arrest,
• all medicines that may lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines, or medicines used during general anesthesia (barbiturates), and certain medicines used for psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives),
• mefloquine, used to prevent and treat malaria,
• medicines used to treat depression, known as monoamine oxidase inhibitors (except for MAO-B inhibitors),
• rifampicin, an antibiotic used to treat infections,
• baclofen, a muscle relaxant,
• ergotamine derivatives, medicines used to treat dementia and migraines.

Corectin with food, drink, or alcohol

Alcohol may increase the dizziness and feeling of "emptiness" in the head caused by Corectin.
Alcohol should be avoided while taking bisoprolol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Corectin may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the fetus or newborn. The medicine may also affect fetal or newborn development.
Therefore, Corectin should not be taken during pregnancy unless absolutely necessary, as recommended by the doctor.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, and therefore, breastfeeding should be avoided while taking Corectin.

Driving and using machines

The medicine may cause fatigue, drowsiness, or dizziness. If such effects occur, the patient should not drive vehicles or operate machines. They should be aware of the possibility of such effects, especially at the beginning of treatment, when changing the dose of the medicine or other medicines, and when drinking alcohol.

3. How to take Corectin

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Regular medical check-ups are necessary while taking Corectin. This is especially important at the beginning of treatment, during dose increases, and when stopping treatment.

Dosage Adults

The doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - the doctor will decide how to increase the dose. The recommended initial dose is 1.25 mg once daily.
The dose is increased at intervals of at least 2 weeks 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 the medicine is tolerated, the doctor may recommend extending the time between dose increases. If the disease worsens or the medicine is not tolerated, 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 sufficient.
The doctor will determine the appropriate course of action.
If treatment needs to be stopped, the doctor will usually recommend gradually reducing the dose of the medicine, otherwise, the disease may worsen.
Corectin treatment is usually long-term.
Liver or kidney failure
The doctor will exercise special caution when increasing the dose of the medicine.
Elderly patients
Dose adjustment is not necessary.
Use in children and adolescents
It is not recommended to use Corectin in children and adolescents.

Method of administration

• Tablets should be taken once daily, in the morning, on an empty stomach or with food.
• Tablets should be swallowed with water.
• The tablet can be divided into equal doses.

Overdose of Corectin

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. They should bring the remaining tablets or this leaflet, so the medical staff knows which medicine was taken.
Symptoms of overdose include dizziness, feeling of "emptiness" in the head, fatigue, and breathing difficulties. It may also lead to slow heart rate, low blood pressure, heart failure, and low blood sugar levels (which may cause hunger, sweating, palpitations, and tremors).

Missed dose of Corectin

A double dose should not be taken to make up for a missed dose.
If a dose is missed, the patient should take a tablet within the next 12 hours. If more than 12 hours have passed, they should not take the missed dose, but take the next dose at the usual time.

Stopping Corectin treatment

Corectin treatment should NOT be stopped abruptly, especially in patients with angina pectoris or after a heart attack. Sudden stopping of treatment may worsen the patient's condition or increase blood pressure again. To avoid this, the dose of the medicine should be gradually reduced over several weeks, as recommended by the doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Corectin can cause side effects, although not everybody gets them.
Very common(occurring in at least 1 in 10 patients):

• bradycardia (slow heart rate).

Common(occurring in less than 1 in 10 patients):

• worsening of existing heart failure,
• weakness, fatigue*, dizziness*, headache* (*especially at the beginning of treatment - these symptoms are usually mild and often disappear within 1-2 weeks),
• feeling of cold or numbness in the upper and/or lower limbs,
• pain, pallor, or cyanosis of the hands and/or feet - Raynaud's phenomenon,
• more frequent occurrence of leg cramps while walking - in patients with intermittent claudication,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

Uncommon(occurring in less than 1 in 100 patients):

• conduction disorders,
• sleep disorders,
• depression,
• low blood pressure, especially when changing body position from lying to standing or when getting up quickly (orthostatic hypotension),
• bronchospasm (breathing difficulties) - in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness, painful muscle cramps.

Rare(occurring in less than 1 in 1,000 patients):

• low blood sugar - a condition that may cause rapid heart rate or palpitations, increased sweating (note - Corectin may mask the symptoms of low blood sugar),
• nightmares,
• hallucinations,
• fainting,
• dryness of the conjunctiva caused by reduced tear secretion (may be troublesome if the patient wears contact lenses),
• hearing disorders,
• allergic rhinitis,
• hepatitis, which may cause abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, and dark urine,
• allergic reactions (itching, rash, sudden flushing of the face),
• decreased sexual potency,
• changes in blood test results (increased triglyceride levels in the blood, increased liver enzyme activity).

Very rare(occurring in less than 1 in 10,000 patients):

• conjunctivitis (irritation and redness of the eyes),
• psoriatic skin lesions or psoriasis-like lesions,
• hair loss (alopecia).

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be gathered on the safety of the medicine.

5. How to store Corectin

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Corectin contains

• The active substance of Corectin is bisoprolol fumarate. One coated tablet contains 2.5 mg of bisoprolol fumarate.
• Other ingredients are: tablet core:microcrystalline cellulose, maize starch, crospovidone, type A, colloidal anhydrous silica, magnesium stearate;

coating AquaPolish white 010.12C:hypromellose, Macrogol 6000, Polysorbate 20, talc, calcium carbonate, titanium dioxide.

What Corectin looks like and what the package contains

White, round, biconvex coated tablets with a score line on one side and a round embossing on the other side.
Tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
The package contains 10, 28, 30, 56, 60, 90, or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
e-mail: [email protected]

Date of last revision of the leaflet: