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, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not give it to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the 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 heart's efficiency 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:

You should not take Blocard in the following cases:

• if you are allergic to bisoprolol or any other ingredient 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 blue 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 where the blood pH is abnormal,
• if you have acute heart failure,
• if your heart failure worsens and you need intravenous medications to 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 check-ups):

• 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 (including a history of psoriasis),
• thyroid function disorders,
• pheochromocytoma of the adrenal gland.

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

• desensitization therapy (e.g., to avoid 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 children and adolescents.

Blocard and Other Medications:

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

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

• certain medications used to treat arrhythmias (class I anti-arrhythmic medications, 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, you should not stop taking these medications without consulting your doctor.

Before taking the following medications with Blocard, you should discuss them with your doctor, as your doctor may recommend more frequent check-ups:

• 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 anti-arrhythmic medications, 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 agonists, such as isoproterenol and dobutamine);
• insulin and oral anti-diabetic medications;
• anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal 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 anti-epileptic 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, you should consult your doctor or pharmacist 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 Machines:

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

You should 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

This medication should always be taken as directed by your doctor.

In case of doubts, you should consult your doctor or pharmacist.

During treatment with Blocard, regular check-ups are necessary.

This is especially important at the beginning of treatment, during dose increases, and when stopping treatment.

The tablet should be taken in the morning with food or independently of food, washed down with water.

The tablets should not be chewed.

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 bisoprolol at a low dose, 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 is increased at intervals of at least two weeks to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily.

This usually happens 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 treatment (chronic).

The maximum recommended daily dose is 10 mg bisoprolol.

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

If your condition worsens or the medication is not tolerated, it may be necessary to reduce the dose again or stop treatment.

For some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient.

Your doctor will determine the appropriate course of action.

Treatment of High Blood Pressure and Angina Pectoris

In both cases, the usual dose is one Blocard 5 mg tablet or half a Blocard 10 mg tablet (equivalent to 5 mg 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 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 modify the dosage.

In patients with severe kidney impairment and severe liver impairment, the dose should not exceed 10 mg bisoprolol per day.

Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that the dosage needs to be modified.

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 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 More Than the Recommended Dose of Blocard:

If you take more Blocard than recommended, you should immediately inform your doctor.

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:

You should not take a double dose to make up for a missed dose.

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

Stopping Treatment with Blocard:

You should never stop taking Blocard without consulting your doctor.

Otherwise, your condition may worsen.

If you have any further doubts about taking this medication, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Blocard can cause side effects, although not everyone will experience them.

Very Common(occurring in at least 1 in 10 patients):

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

Common(occurring less frequently than 1 in 10 patients):

• 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 occur mainly at the beginning of treatment. They are usually mild and disappear within 1-2 weeks.

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

• 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(occurring less frequently than 1 in 1,000 patients):

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

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

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

Reporting Side Effects

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

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

5. How to Store Blocard

The medication should be stored out of sight and reach of children.

There are no special storage temperature recommendations.

Store in the original packaging to protect from light.

Do not use this medication after the expiration date stated on the blister pack after the EXP and on the carton after the Expiration Date (EXP).

The expiration date refers to the last day of the specified month.

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

You should 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 of Blocard 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 of Blocard 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.

A tablet 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 available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Zakłady Farmaceutyczne 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 Leaflet: