Blocard

Package leaflet: Information for the user

Blocard, 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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Blocard is and what it is used for

The active substance in Blocard 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.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Blocard is used in the treatment of stable, chronic heart failure.

2. Important information before using Blocard

When not to use Blocard:
Do not use Blocard 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 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 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 increasing cardiac contractility becomes necessary,
• if the patient has symptoms of bradycardia (slow heart rate),
• 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 disturbance 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 treatment with Blocard; the doctor may decide that special caution is required (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 disorders,
• circulatory disorders in the limbs,
• mild asthma or chronic lung disease,
• presence of psoriatic skin lesions (psoriasis), even in medical history,
• phaeochromocytoma of the adrenal medulla,
• thyroid dysfunction.

Additionally, inform your doctor if the following are planned:

• allergen immunotherapy (e.g. to prevent hay fever), as Blocard may increase the likelihood of allergic reactions or intensify such reactions;
• surgery under general anaesthesia, as Blocard may alter the body's response to administered drugs.

Children and adolescents
Blocard is not recommended for use in children and adolescents.

Blocard and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines planned for future use.
Do not take the following medicines together with Blocard 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 channel blockers 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 using any of the following medicines together with Blocard, consult your doctor, who may recommend more frequent medical checks:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine calcium channel blockers 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 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);
• cardiac glycosides (e.g. digoxin) used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, pain and swelling (e.g. ibuprofen and diclofenac);
• adrenaline (epinephrine), 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 antiepileptic drugs 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;
• ergotamine derivatives, medicines used to treat dementia and migraine headaches.

Pregnancy and breastfeeding
There is a risk that using Blocard during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Blocard can be used during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Blocard.

Driving and operating machinery
Blocard 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.

3. How to use Blocard

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Blocard. 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.
Do not chew the tablets. Tablets with a score line may be divided into two equal doses.

Adults
Your doctor will start treatment with bisoprolol at a low dose and gradually increase it – your doctor will decide how to increase the dose. The recommended starting dose is 1.25 mg once daily.
The dose is increased at intervals of two weeks or longer to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily. This is usually done as follows:

• 1.25 mg bisoprolol once daily for 2 weeks;
• 2.5 mg bisoprolol once daily for 2 weeks;
• 3.75 mg bisoprolol once daily for 2 weeks;
• 5 mg bisoprolol once daily for 2 weeks;
• 7.5 mg bisoprolol once daily for 2 weeks;
• 10 mg bisoprolol once daily for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the time interval before the next dose increase. If the 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.

Liver or kidney function disorders
Particular caution is required when increasing the dose of the medicine.

Elderly patients
Dose adjustment is not necessary.

Use in children and adolescents
Blocard is not recommended for use in children and adolescents.

Duration of treatment
Treatment with Blocard is usually long-term.
If it becomes necessary to stop treatment, your doctor will usually advise gradually reducing the dose. Otherwise, the condition may worsen.

Taking more Blocard than recommended
If you take more Blocard than you should, inform your doctor immediately. Your doctor will decide what actions need to be taken.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, a significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Blocard
Do not take a double dose to make up for a missed dose. Take the next dose as recommended the following morning.

Stopping Blocard
Never stop taking Blocard unless your doctor tells you to. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Very common (occurring in at least 1 out of 10 patients):

• bradycardia (slow heart rate)

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

• worsening of existing heart failure,
• fatigue, asthenia (weakness), dizziness, headache,
• sensation of coldness or numbness in hands or feet,
• low blood pressure,
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

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

• atrioventricular conduction disturbances,
• sleep disorders,
• depression,
• bronchospasm (difficulty breathing) in patients with bronchial asthma or chronic obstructive pulmonary disease,
• muscle weakness or muscle cramps.

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

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

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

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

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 the medicine.

5. How to store the medicine Blocard

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature. Store in the original
packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister after EXP and on the
carton after Expiry date (EXP). 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 packaging and other information

What Blocard contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of the active substance.
• The other ingredients are: microcrystalline cellulose (PH-112), maize starch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate. Coating: Opadry White OY58900: hypromellose, polyethylene glycol 400, titanium dioxide (E171).

What Blocard looks like and contents of the pack
Blocard 2.5 mg: white, heart-shaped coated tablets with a dividing line on both sides.
The tablet with a dividing line may be divided into equal doses.
Pack sizes: 20, 28, 30, 50, 56, 60, 84, 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Importer:
Medreich Plc
Warwick House, Plane Tree Crescent
Feltham TW13 7HF,
United Kingdom
Synoptis Industrial Sp. z o.o.
Rabowicka 15 Street
62-020 Swarzędz
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94, Alcalá de Henares,
28802 Madrid
Spain