Blocard

Package Leaflet: Information for the User

Blocard, 5 mg, Film-Coated Tablets

Blocard, 10 mg, Film-Coated Tablets

Bisoprolol Fumarate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for your specific condition. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Blocard and What is it 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 Package and Other Information

1. What is Blocard and What is it Used For

The active substance of Blocard is bisoprolol fumarate. Bisoprolol belongs to a group of medications called beta-blockers. These medications 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. Bisoprolol in doses of 5 mg and 10 mg lowers high blood pressure.

Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.

Blocard is used to treat stable, chronic heart failure.

Blocard, 5 mg and Blocard, 10 mg are used to treat high blood pressure or angina pectoris (chest pain caused by insufficient blood supply to the heart).

2. Important Information Before Taking Blocard

When Not to Take Blocard:

Do not take Blocard in the following cases:

• if you are allergic to bisoprolol or any of the other ingredients of this medication (listed in section 6),
• if you have severe asthma,
• if you have severe blood circulation disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration of the fingers or toes,
• if you have an untreated pheochromocytoma, a rare tumor of the adrenal gland,
• if you have metabolic acidosis, a condition in which the blood pH is abnormal,
• if you have acute heart failure,
• if you have worsening heart failure and require intravenous administration of medications that increase heart contractility,
• if you have symptoms of slow heart rate,
• if you have symptoms of low blood pressure,
• if you have certain heart conditions that cause very slow or irregular heartbeats (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if you have cardiogenic shock, a severe and life-threatening heart condition that leads to low blood pressure and poor circulation.

Warnings and Precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Blocard; your doctor may decide that special caution is necessary (e.g., additional medications or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart conditions (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina),
• kidney or liver disorders,
• blood circulation disorders in the limbs,
• mild asthma or chronic obstructive pulmonary disease,
• psoriasis (a skin condition) or a history of psoriasis,
• thyroid dysfunction,
• pheochromocytoma of the adrenal gland.

In addition, you should tell your doctor if you are planning:

• desensitization therapy (e.g., to prevent hay fever), as Blocard may increase the risk of an allergic reaction or worsen such a reaction;
• undergoing surgery under general anesthesia, as Blocard may affect the body's response to anesthetics.

Children and Adolescents

Blocard is not recommended for use in children and adolescents.

Blocard and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Do not take the following medications with Blocard without special advice from your doctor:

• certain medications used to treat arrhythmias (class I antiarrhythmic agents, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medications used to treat high blood pressure, coronary artery disease, or arrhythmias (calcium channel blockers, such as verapamil and diltiazem);
• certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medications without consulting your doctor.

Before taking the following medications with Blocard, discuss them with your doctor, as your doctor may recommend more frequent monitoring:

• certain medications used to treat high blood pressure or coronary artery disease (dihydropyridine calcium channel blockers, such as felodipine and amlodipine);
• certain medications used to treat arrhythmias (class III antiarrhythmic agents, such as amiodarone);
• topically applied beta-blockers (such as eye drops for glaucoma);
• certain medications used to treat Alzheimer's disease or glaucoma (parasympathomimetics);
• medications used to treat acute heart conditions (adrenergic agents, such as isoproterenol and dobutamine);
• insulin and oral antidiabetic medications;
• general anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• nonsteroidal anti-inflammatory medications (NSAIDs) used to treat arthritis, pain, and inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a medication used to treat severe, life-threatening allergic reactions and cardiac arrest;
• all medications that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medications, certain antidepressants (tricyclic antidepressants), certain antiepileptic medications, or medications used during general anesthesia (barbiturates) and certain medications used for psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medications used to treat depression, known as monoamine oxidase inhibitors (except for MAO-B inhibitors);
• rifampicin, an antibiotic used to treat infections;
• ergotamine derivatives, medications used to treat dementia and migraine headaches.

Pregnancy and Breastfeeding

There is a risk that taking Blocard during pregnancy may harm the baby.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication. Your doctor will decide whether you can take Blocard during pregnancy.

It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Blocard.

Driving and Operating Machinery

The medication, depending on how it is tolerated, may affect your ability to drive or operate machinery.

Be particularly careful at the beginning of treatment, after increasing the dose, or when changing medications, as well as when combining the medication with alcohol.

3. How to Take Blocard

Always take this medication exactly as your doctor has told you.

If you are unsure, ask your doctor or pharmacist.

Regular medical check-ups are necessary during treatment with Blocard.

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 chew the tablets. Tablets with a score line can be divided into two equal doses.

Adults

Treatment of Stable, Chronic Heart Failure

Your doctor will start treatment with a low dose of bisoprolol, which will be gradually increased - your doctor will decide how to increase the dose.

The recommended initial dose is 1.25 mg once daily.

The dose will be 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.

Usually, this is done as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how the medication is tolerated, your doctor may recommend extending the time between dose increases.

If the condition worsens or the medication 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.

Your doctor will determine the appropriate course of action.

Treatment of High Blood Pressure and Angina Pectoris

In both indications, the usual dose is one Blocard 5 mg tablet or half a Blocard 10 mg tablet (equivalent to 5 mg of bisoprolol fumarate) once daily.

If necessary, your doctor may increase the dose to one Blocard 10 mg tablet or two Blocard 5 mg tablets (equivalent to 10 mg of bisoprolol fumarate) once daily.

The maximum recommended dose is 20 mg once daily.

Impaired Liver or Kidney Function

Treatment of High Blood Pressure and Angina Pectoris

In patients with mild to moderate liver or kidney impairment, there is usually no need to adjust the dosage.

In patients with severe kidney impairment and in patients with severe liver impairment, a dose greater 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 to suggest that the dosage needs to be adjusted.

Treatment of Stable, Chronic Heart Failure

Special caution is necessary when increasing the dose of Blocard.

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 treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose of Blocard, otherwise, the condition may worsen.

Taking a Higher Dose of Blocard Than Recommended

If you have taken a higher dose of Blocard than recommended, tell your doctor immediately.

Your doctor will decide what actions to take.

Symptoms of overdose include: slow heart rate, difficulty breathing, 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.

The next day, take the recommended dose in the morning.

Stopping Treatment with Blocard

Never stop taking Blocard without consulting your doctor.

Otherwise, the condition may worsen.

If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Blocard can cause side effects, although not everybody gets them.

Very Common(affecting at least 1 in 10 people):

• bradycardia (slow heart rate) (in patients with stable, chronic heart failure).

Common(affecting less than 1 in 10 people):

• worsening of existing heart failure (in patients with stable, chronic heart failure),
• fatigue, asthenia (weakness) (in patients with stable, chronic heart failure), dizziness, headache,
• feeling of coldness or numbness in the hands or feet,
• low blood pressure (especially in patients with heart failure),
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation. This only applies to patients with high blood pressure or angina pectoris:* these symptoms usually occur at the beginning of treatment and are usually mild and resolve within 1-2 weeks.

Uncommon(affecting less than 1 in 100 people):

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

Rare(affecting less than 1 in 1,000 people):

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider if you wear contact lenses),
• hepatitis, which can cause yellowing of the skin or eyes,
• changes in blood test results, including liver function (increased ALT and AST activity) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, or rash,
• impotence,
• nightmares, hallucinations,
• fainting.

Very Rare(affecting less than 1 in 10,000 people):

• conjunctivitis (eye irritation or redness),
• hair loss,
• onset or worsening of psoriatic skin lesions (psoriasis), psoriasis-like skin lesions.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell 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.

By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Blocard

Keep the medication out of sight and reach of children.

There are no special storage temperature requirements.

Store in the original packaging to protect from light.

Do not use this medication after the expiry date stated on the blister pack and carton after EXP.

The expiry date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medications that are no longer needed.

This will help protect the environment.

6. Contents of the Package and Other Information

What Blocard Contains

Blocard, 5 mg, Film-Coated Tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg of the active substance.
• The other ingredients are: microcrystalline cellulose (PH-112), cornstarch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate. Coating: Opadry White: OY58900: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172).

Blocard, 10 mg, Film-Coated Tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg of the active substance.
• The other ingredients are: microcrystalline cellulose (PH-112), cornstarch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate. Coating: Opadry White: OY58900: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Blocard Looks Like and Contents of the Package

Blocard, 5 mg: white-yellow film-coated tablets in the shape of a heart, with a score line on both sides.

Blocard, 10 mg: light orange film-coated tablets in the shape of a heart, with a score line on both sides.

Tablets with a score line can be divided into two equal doses.

Package sizes: 20, 28, 30, 50, 56, 60, 84, 90 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Importer:

Medreich Plc

Warwick House, Plane Tree Crescent

Feltham TW13 7HF,

United Kingdom

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94, Alcalá de Henares,

28802 Madrid

Spain

Date of Last Revision of the Package Leaflet: