Coronal 5

Package leaflet: Information for the patient

CORONAL 5, 5 mg, film-coated tablets
CORONAL 10, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Coronal is and what it is 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 pack and other information

1. What Coronal is and what it is used for

The active substance in 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 heart activity and thereby improves the heart's efficiency in pumping blood throughout the body. At the same time, the heart's demand for blood and oxygen decreases.
Coronal is used in the treatment of high blood pressure or ischemic heart disease (chest pain caused by inadequate oxygen supply to the heart).

2. Important information before using Coronal

When not to take Coronal
Do not take Coronal in the following cases:

• if the patient is allergic to bisoprolol or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe asthma,
• if the patient has serious circulation problems 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 phaeochromocytoma, a rare tumour of the adrenal glands,
• 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 intravenous administration of drugs that increase heart contractility is required,
• if the patient has symptoms of a very slow heartbeat,
• if the patient has symptoms of 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), in the absence of a pacemaker,
• if the patient has cardiogenic shock, an acute, life-threatening disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, talk to your doctor before starting Coronal; your doctor may decide that special caution is needed (for example, additional medicines or more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart diseases (such as heart rhythm disorders or severe chest pain at rest—Prinzmetal's angina);
• milder circulation problems in the limbs;
• mild bronchial asthma or chronic lung disease;
• presence of scaly skin lesions (psoriasis), even in medical history;
• thyroid dysfunction;
• phaeochromocytoma of the adrenal medulla.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), because Coronal may increase the likelihood of an allergic reaction or worsen such a reaction;
• surgery under general anaesthesia, because Coronal may alter the body's response to administered drugs.

Children and adolescents
Use of Coronal is not recommended in children and adolescents.

Coronal and other medicines
Tell 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 together with Coronal without specific instruction from your doctor:

• 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 Coronal, talk to your doctor, as more frequent medical monitoring may be necessary:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine-type calcium antagonists such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
• locally applied beta-blockers (such as eye drops used to treat glaucoma);
• certain medicines used to treat conditions such as 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;
• agents used in general anaesthesia (e.g. during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory drugs (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 adverse effect, such as antihypertensive medicines, certain tricyclic antidepressants, certain antiepileptic medicines or barbiturates used during general anaesthesia, and certain medicines used for psychiatric disorders involving loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• medicines used to treat depression called monoamine oxidase inhibitors (excluding 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 using Coronal during pregnancy may harm the unborn child.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you may take Coronal during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Coronal.

Driving and operating machinery
Coronal may impair the ability to drive or operate machinery, depending on individual response. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medications, 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; therefore, this medicine is considered "sodium-free".

3. How to use Coronal

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Regular medical check-ups are necessary while taking Coronal. This is particularly important at
the beginning of treatment, when increasing the dose, and when stopping treatment.
The tablet should be taken in the morning with food or independently of meals, with water. The
tablets must not be crushed or chewed.
Adults
For both indications, the usual dose is one tablet of Coronal 5 or 1/2 tablet of Coronal 10 (i.e.
equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, the doctor may increase the dose to one tablet of Coronal 10 mg or two tablets of
Coronal 5 mg (corresponding to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.
Liver or kidney function impairment
In patients with mild to moderate impairment of liver or kidney function, dosage adjustment is
usually not required. In patients with severe renal or hepatic insufficiency, doses higher than 10
mg of bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no
evidence indicating the need for dosage adjustment.
Elderly patients
Dosage 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, the doctor will usually recommend gradually reducing
the dose. Otherwise, the condition may worsen.
Taking more Coronal than recommended
If you take more Coronal than prescribed, contact your doctor immediately or go to the
emergency department of the nearest hospital. Do not drive yourself—ask someone else to drive
or call an ambulance.
Symptoms of overdose include: slowed heart rate, breathing difficulties, significant drop in
blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missed dose of Coronal
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up
for a missed dose.
Stopping Coronal treatment
Never stop taking Coronal unless instructed by your doctor. Otherwise, your condition may
worsen.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Common (occurring in fewer than 1 in 10 patients)

• fatigue*, dizziness*, headache*,
• sensation of cold or numbness in hands or feet,
• low blood pressure,
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

* These symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1–2 weeks.

Uncommon (occurring in fewer than 1 in 100 patients)

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

Rare (occurring in fewer than 1 in 1,000 patients)

• hearing disturbances,
• allergic rhinitis,
• reduced tear production (should be considered if the patient uses contact lenses),
• hepatitis, which may cause yellowing of the skin or eyes,
• changes in the results of certain blood tests related to liver function (increased AlAT and AspAT activity) or serum triglyceride (fat) levels,
• allergic reactions such as itching, facial flushing, rash,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

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

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Coronal 10

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What the medicine Coronal contains
The active substance is bisoprolol fumarate.
Coronal 5: Each film-coated tablet contains 5 mg of bisoprolol fumarate.
Coronal 10: Each film-coated tablet contains 10 mg of bisoprolol fumarate.

Other ingredients:
Coronal 5:
Core – microcrystalline cellulose, maize starch, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate;
Coating – hypromellose, polyethylene glycol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

Coronal 10:
Core – microcrystalline cellulose, maize starch, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate;
Coating – hypromellose, polyethylene glycol 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 film-coated tablets with a score line.
Coronal 10: Light pink, biconvex, round film-coated tablets with a score line.
The tablet can be divided into equal doses.

Packaged in aluminium/aluminium or PVC/PE/PVDC/aluminium blisters, contained in a cardboard box.
Pack sizes: 30, 60 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel. +48 22 375 92 00