Blocard

Package Leaflet: Information for the User

Blocard, 2.5 mg, Film-Coated Tablets

Bisoprolol Fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on 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, please inform 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 pack 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 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.
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.

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 medicine (listed in section 6),
• if you have severe asthma,
• if you have severe blood circulation problems in your limbs (such as Raynaud's syndrome), which may cause tingling, pallor, or cyanosis 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 has worsened and you need to be treated with intravenous medicines that increase the heart's contractility,
• if you have symptoms of a 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 sudden, life-threatening condition where the heart is unable to pump enough blood to meet the body's needs.

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 you need to be particularly careful (for example, by taking additional medicines or having 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 problems in the limbs,
• mild asthma or chronic obstructive pulmonary disease,
• psoriasis (a skin condition), including a history of psoriasis,
• pheochromocytoma of the adrenal gland,
• thyroid function disorders.

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

• desensitization treatment (e.g., to avoid hay fever), as Blocard may increase the risk of an allergic reaction or make it worse;
• a surgical procedure under general anesthesia, as Blocard may affect the body's response to the medicines used.

Children and adolescents

Blocard is not recommended for children and adolescents.

Blocard and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take the following medicines with Blocard without special advice from your doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone); certain medicines used to treat high blood pressure, angina, or arrhythmias (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 the following medicines with Blocard, you should discuss them with your doctor, as your doctor may recommend more frequent check-ups:

• certain medicines used to treat high blood pressure or angina (dihydropyridine calcium antagonists, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class III anti-arrhythmic medicines, such as amiodarone);
• topically applied beta-blockers (such as eye drops for glaucoma);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma

(parasympathomimetics);

• medicines used to treat acute heart problems (adrenergic agonists, such as isoprenaline and dobutamine);
• insulin and oral anti-diabetic medicines;
• general anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, relieve pain and inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, 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 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 for psychiatric disorders characterized by a loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors (except for 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 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 medicine. 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 using machines

The medicine may affect your ability to drive or use machines, depending on how well you tolerate it. Be particularly careful at the beginning of treatment, when increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Blocard

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Regular check-ups are necessary while taking 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

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. This is usually 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 treatment (chronic).

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you tolerate the medicine, your doctor may recommend extending the time between dose increases. If your condition worsens or you do not tolerate the medicine, 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 decide on the appropriate course of action.

Impaired liver or kidney function

Be particularly careful 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, your condition may worsen.

Taking a higher dose of Blocard than recommended

If you have taken more Blocard than recommended, contact 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 morning, take the recommended dose.

Stopping treatment with Blocard

Never stop taking Blocard unless your doctor tells you to.
Otherwise, your condition may worsen.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Blocard can cause side effects, although not everybody gets them.
Very common(occurring in at least 1 in 10 patients):

• bradycardia (slow heart rate).

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

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

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

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

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

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider if you wear 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 ALT and AST activity) or triglyceride levels in the blood,
• 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,
• 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 medicine.

5. How to store Blocard

Keep the medicine out of the sight and reach of children.
There are no special storage instructions.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the blister pack after EXP and on the carton after the expiry date (EXP). 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Blocard contains

• The active substance is bisoprolol fumarate. Each film-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, macrogol 400, titanium dioxide (E171).

What Blocard looks like and contents of the pack

Blocard, 2.5 mg: white, heart-shaped, film-coated tablets with a score line on both sides.
The scored tablet can be divided into two equal doses.
Pack sizes: 20, 28, 30, 50, 56, 60, 84, 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Polpharma S.A.
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.
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: