Coronal 5

Leaflet accompanying the packaging: patient information

CORONAL 5, 5 mg, coated tablets

CORONAL 10, 10 mg, coated tablets

Bisoprolol fumarate

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

1. What is Coronal and what is it used for

The active substance of Coronal is bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-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. At the same time, the heart's need for blood and oxygen decreases.
Coronal is used to treat high blood pressure or coronary heart disease (chest pain caused by insufficient blood supply to the heart).

2. Important information before taking Coronal

When not to take Coronal

Do not take Coronal in the following cases:

• 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,
• if the patient has been diagnosed with severe circulatory disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration 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 has worsened and requires intravenous administration of medicines that increase heart contractility,
• if the patient has symptoms of slow heart rate,
• if the patient has symptoms of 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), in the absence of a pacemaker,
• if the patient has been diagnosed with cardiogenic shock, a severe and life-threatening heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, consult a doctor before starting Coronal; the doctor may consider that special caution is required (e.g., additional medication or more frequent check-ups):

• diabetes;
• strict fasting;
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• milder circulatory disorders in the limbs;
• mild asthma or chronic obstructive pulmonary disease;
• psoriasis (including a history of psoriasis);
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, inform your doctor if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Coronal may increase the likelihood of an allergic reaction or exacerbate it;
• a surgical procedure under general anesthesia is planned, as Coronal may alter the body's response to the administered medicines.

Children and adolescents

Coronal is not recommended for use in children and adolescents.

Coronal and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines with Coronal without special recommendation by your doctor:

• certain medicines used to treat high blood pressure, coronary heart disease, or arrhythmias (calcium antagonists, such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, and rilmenidine. However, do not stop taking these medicines without consulting your doctor.

Before taking the following medicines with Coronal, consult your doctor, as more frequent medical check-ups may be necessary:

• certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine derivatives, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class I antiarrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (class III antiarrhythmic medicines, such as amiodarone);
• locally applied beta-blockers (such as eye drops for glaucoma treatment);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart disorders (adrenergic agonists, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic medicines;
• general anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• nonsteroidal anti-inflammatory medicines (NSAIDs) used to treat joint inflammation, to relieve pain and inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a medicine used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any 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), as well as certain medicines used in psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B inhibitors);
• rifampicin, an antibiotic used to treat infections;
• ergotamine derivatives, medicines used to treat dementia and migraine headaches.

Pregnancy and breastfeeding

There is a risk that taking Coronal during pregnancy may harm the baby.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. The doctor will decide whether Coronal can be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Coronal.

Driving and using machines

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

Coronal contains sodium

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

3. How to take Coronal

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Coronal. This is especially important at the beginning of treatment, when increasing the dose, and when stopping treatment.
Take the tablet in the morning with food or on an empty stomach, with a glass of water. Do not crush or chew the tablets.

Adults

In both indications, the usual dose is one Coronal 5 tablet or half a Coronal 10 tablet (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one Coronal 10 mg tablet or two Coronal 5 mg tablets (equivalent to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

Liver or kidney impairment

In patients with mild to moderate liver or kidney impairment, there is usually no need to adjust the dosage. In patients with severe kidney or liver impairment, do not take a dose greater than 10 mg of bisoprolol per day.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that the dosage needs to be adjusted.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Coronal is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Coronal is usually long-term.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose of Coronal; otherwise, the disease may worsen.

Overdose of Coronal

If you have taken more Coronal than recommended, contact your doctor or go to the emergency department of the nearest hospital immediately. Do not drive yourself - ask someone else to drive you or call an ambulance.
Symptoms of overdose include: slow heart rate, difficulty breathing, significantly low blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Coronal

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Coronal

Never stop taking Coronal unless your doctor tells you to. Otherwise, the disease may worsen.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coronal can cause side effects, although not everybody gets them.
Common(occurring in less than 1 in 10 patients)

• fatigue*, dizziness*, headache*,
• feeling of coldness or numbness in the hands or feet,
• low blood pressure,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

* These symptoms occur mainly at the beginning of treatment. They are usually mild and disappear within 1-2 weeks.
Uncommon(occurring in less than 1 in 100 patients)

• conduction disorders, worsening of existing heart failure, bradycardia (slow heart rate),
• sleep disorders,
• depression,
• asthenia (weakness),
• bronchospasm (difficulty breathing) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness or cramps.

Rare(occurring in less than 1 in 1000 patients)

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider if the patient wears contact lenses),
• hepatitis, which can cause yellowing of the skin or eyes,
• changes in the results of some blood tests, related to liver function (increased activity of AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash,
• impotence,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• psoriasis (including exacerbation of psoriasis) or psoriasis-like skin changes.

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

5. How to store Coronal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the outer packaging and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Coronal contains

The active substance is bisoprolol fumarate.
Coronal 5: Each coated tablet contains 5 mg of bisoprolol fumarate.
Coronal 10: Each coated tablet contains 10 mg of bisoprolol fumarate.
Other ingredients are:
Coronal 5: core - microcrystalline cellulose, corn starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate; coating - hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172)
Coronal 10
core - microcrystalline cellulose, corn starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate; coating - hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172)

What Coronal looks like and contents of the pack

Coronal 5: Light yellow, biconvex, round coated tablets with a score line.
Coronal 10: Light pink, biconvex, round coated tablets with a score line.
The tablet can be divided into equal doses.
Aluminum/Aluminum or PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 30, 60, or 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, a.s., Einsteinova 24, 851 01 Bratislava, Slovak Republic

Manufacturer

S.C. Zentiva S.A., Theodor Pallady Blvd., no 50, 3 district, 032266, Bucharest, Romania