Corectin

Patient Information Leaflet

CORECTIN
2.5 mg, film-coated tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Corectin is and what it is used for
2. What you need to know before you take Corectin
3. How to take Corectin
4. Possible side effects
5. How to store Corectin
6. Contents of the pack and other information

1. What Corectin is and what it is used for

The active substance in Corectin is bisoprolol fumarate. 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 the heart rate and improves the heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Corectin is used in the treatment of stable chronic heart failure.

2. Important information before using Corectin

When NOT TO USE 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 bronchial asthma or chronic obstructive pulmonary disease (COPD),
• if the patient has serious circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness of the fingers or toes,
• if the patient has untreated pheochromocytoma, a rare adrenal gland tumour,
• if the patient has metabolic acidosis, a condition in which blood pH is abnormally low,
• if the patient has acute heart failure,
• if the patient's heart failure worsens and intravenous administration of drugs that increase heart contractility becomes necessary,
• if the patient has bradycardia (slow heart rate),
• if the patient has low blood pressure,
• if the patient has certain heart diseases causing very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• if the patient has cardiogenic shock, an acute, life-threatening condition involving impaired heart function leading to low blood pressure and circulatory failure,
• if the patient is concurrently taking floctafénine or sultopride (see section "Corectin and other medicines").

If there is any doubt whether any of the above conditions applies to the patient, consult a doctor.

Warnings and precautions

Before starting treatment with Corectin, consult a doctor or pharmacist if the patient has any of the following conditions. Special caution may be required (e.g. additional medications or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart diseases (such as arrhythmias or severe chest pain at rest – Prinzmetal's angina),
• impaired kidney or liver function,
• mild form of peripheral circulation disorder,
• mild form of bronchial asthma or chronic lung disease,
• history of psoriasis (skin scaling),
• adrenal tumour (pheochromocytoma),
• thyroid disease.

Additionally, inform the doctor if the following are planned:

• allergen immunotherapy (e.g. to prevent hay fever), as Corectin may increase the likelihood or severity of allergic reactions;
• general anaesthesia (e.g. for surgery), as Corectin may alter the body's response to anaesthetic drugs.

This medicine contains an active substance that may yield a positive result in anti-doping tests in athletes.

Children and adolescents

Use is not recommended due to lack of experience with bisoprolol in children and adolescents.

Corectin and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Do not take the following medicines during treatment with Corectin:

• floctafénine (used for pain and joint inflammation),
• sultopride (used to treat serious psychiatric disorders).

Do not take the following medicines simultaneously with Corectin without specific medical advice:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone),
• certain medicines used to treat high blood pressure, coronary artery disease, or heart rhythm disorders (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.

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

• 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 heart rhythm disorders (class III antiarrhythmics such as amiodarone),
• locally applied beta-blockers (e.g. eye drops used to treat glaucoma),
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics),
• medicines used to treat acute heart conditions (adrenergic agonists such as isoprenaline and dobutamine),
• insulin and oral antidiabetic medicines – when used concomitantly with bisoprolol, symptoms of low blood sugar may be masked,
• agents used in general anaesthesia (e.g. during surgery),
• cardiac glycosides used to treat heart failure,
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, relieve 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 adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptics or barbiturates used during general anaesthesia, and certain medicines used in psychiatric disorders involving loss of contact with reality (phenothiazine derivatives),
• mefloquine, used for prevention and treatment of malaria,
• medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs), except MAO-B inhibitors,
• rifampicin, an antibiotic used to treat infections,
• baclofen – a muscle relaxant,
• ergotamine derivatives, medicines used to treat dementia and migraine headaches.

Corectin with food, drink or alcohol

Alcohol may worsen dizziness and the sensation of "emptiness" in the head caused by Corectin.
Alcohol consumption should be avoided during treatment with bisoprolol.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Corectin may harm pregnancy and/or the foetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slowed heart rate in the foetus or newborn. The medicine may also affect foetal or neonatal development.
Therefore, Corectin should not be used during pregnancy unless strictly prescribed by a doctor.

Breastfeeding

It is unknown whether bisoprolol passes into human breast milk; therefore, breastfeeding should not be performed during treatment with Corectin.

Driving and operating machinery

The medicine may cause fatigue, drowsiness, or dizziness. If such adverse effects occur, the patient should not drive or operate machinery. Be aware of the possibility of such effects, especially at the beginning of treatment, during dose changes of this or other medicines, and when consuming alcohol concurrently.

3. How to use Corectin

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Corectin. This is particularly important
at the beginning of treatment, when increasing the dose, and when discontinuing treatment.
Dosage
Adults
Your doctor will start treatment with bisoprolol at a low dose and gradually increase it – the doctor
will decide how to adjust the dose. The recommended initial dose is 1.25 mg once daily.
The dose should be increased every two weeks or at longer intervals 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, your doctor may decide to extend the interval before the
next dose increase. If your condition worsens or if the medicine is not well tolerated, 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 sufficient.
Your doctor will determine the appropriate course of action.
If treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose.
Otherwise, your condition may worsen.
Treatment with Corectin is usually long-term.
Liver or kidney impairment
Your doctor will exercise special caution when increasing the dose of the medicine.
Elderly patients
Dose adjustment is not necessary.
Use in children and adolescents
Corectin is not recommended for use in children and adolescents.
Method of administration

• Take the tablets once daily in the morning, on an empty stomach or with food.
• Swallow the tablets with water.
• The tablet may be divided into equal doses.

Taking more Corectin than prescribed
If you take more than the prescribed dose, contact your doctor immediately or go to the emergency
department of the nearest hospital. Bring any remaining tablets or this leaflet with you so that medical
staff know which medicine has been taken.
Symptoms of overdose include: dizziness, a feeling of "emptiness" in the head, fatigue, difficulty
breathing. There may also be a slowing of heart function, low blood pressure, heart failure, and
reduced blood glucose levels (which may cause feelings of hunger, sweating, palpitations, and
tremor).
Missed dose of Corectin
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the tablet within the next 12 hours. If more than 12 hours have passed, do
not take the missed dose; instead, take the next dose at the usual time.
Stopping treatment with Corectin
Treatment with Corectin MUST NOT be stopped suddenly, especially in patients with angina or
after a heart attack. Abruptly stopping treatment may worsen your health condition or cause a
rebound increase in blood pressure. To avoid this, the dose must be gradually reduced over several
weeks, as directed by your doctor.
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 will experience 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* (* particularly at the beginning of treatment – these symptoms are usually mild and often resolve within 1–2 weeks),
• sensation of coldness or numbness in the upper and/or lower limbs,
• pain, pallor, or blueness of hands and/or feet – Raynaud's phenomenon,
• increased occurrence of leg cramps during walking – in patients with intermittent claudication,
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea, or constipation.

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

• atrioventricular conduction disturbances,
• sleep disorders,
• depression,
• hypotension, especially during changes in posture from lying to standing or upon sudden standing (orthostatic hypotension),
• bronchospasm (difficulty breathing) – in patients with bronchial asthma or chronic obstructive pulmonary disease,
• muscle weakness, painful muscle cramps.

Rare (occurring in less than 1 in 1000 patients):

• low blood sugar levels – a condition which may manifest, among others, as increased heart rate or palpitations, excessive sweating (note – Corectin may prevent the perception of these symptoms (so-called symptom masking)),
• nightmares,
• hallucinations,
• fainting,
• dry eyes due to reduced tear secretion (may be bothersome if the patient wears contact lenses),
• hearing disturbances,
• allergic rhinitis,
• hepatitis causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of eyes and skin, and dark urine,
• allergic reactions (itching, rash, sudden facial flushing),
• reduced sexual function,
• changes in blood test results (increased blood triglyceride levels, increased liver enzyme activity).

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

• conjunctivitis (eye irritation and redness),
• occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions,
• hair loss (alopecia).

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 provide more information on the safety of this medicine.

5. How to store Corectin

Do not store above 30°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Corectin contains

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

coating composition AquaPolish white 010.12C: hypromellose, polyethylene glycol 6000, polysorbate 20, talc, calcium carbonate, titanium dioxide.

What Corectin looks like and contents of the pack
White, round, biconvex coated tablets with a dividing line on one side and a circular embossing on the other side.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Pack sizes contain 10, 28, 30, 56, 60, 90 or 120 coated tablets.
Not all pack sizes may be marketed.

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