Blocard

Package leaflet: Information for the user

Blocard, 5 mg, film-coated tablets
Blocard, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine because 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Blocard is and what it is used for
2. What you need to know 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. Bisoprolol at doses of 5 mg and 10 mg lowers high blood pressure.

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.
Blocard 5 mg and Blocard 10 mg are used in the treatment of hypertension or angina pectoris (chest pain caused by inadequate oxygen supply to the heart).

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 fingers or toes,
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland,
• 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 heart 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) without 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 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 heart rhythm disorders or severe chest pain at rest – Prinzmetal's angina),
• kidney or liver disorders,
• circulatory disorders 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 any of the following are planned:

• allergen immunotherapy (e.g. to prevent hay fever), because Blocard may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, because 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 you plan to take.
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 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 Blocard, consult your doctor; the doctor may recommend more frequent medical checks:

• 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 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 used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, 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 adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptics 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 have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Blocard can be taken 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
Depending on individual tolerance, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increase, or after changing medications, as well as when combining the medicine with alcohol.

3. How to use Blocard

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary while taking Blocard. This is particularly important at the beginning of treatment, during dose escalation, 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
Treatment of stable chronic heart failure
Your doctor will start treatment with bisoprolol at a low dose and gradually increase it – your doctor will decide how to adjust the dose. The recommended starting dose is 1.25 mg once daily.
The dose should be increased every 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 as maintenance (chronic) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose further. If your 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 bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.

Treatment of hypertension and angina pectoris
For both indications, the usual dose is one tablet of Blocard 5 mg or half a tablet of Blocard 10 mg (equivalent to 5 mg bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Blocard 10 mg or two tablets of Blocard 5 mg (equivalent to 10 mg bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

Impaired liver or kidney function
Treatment of hypertension and angina pectoris
In patients with mild to moderate impairment of liver or kidney function, dose adjustment is usually not necessary. In patients with severe renal impairment or severe hepatic impairment, doses higher than 10 mg bisoprolol per day should not be used.
Experience with the use of bisoprolol in patients undergoing dialysis is limited; however, there is no evidence to suggest that dose adjustment is required.

Treatment of stable chronic heart failure
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 discontinuation of treatment is necessary, your doctor will usually recommend gradually reducing the dose. Otherwise, your 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 are necessary.
Symptoms of overdose may include slowed heart rate, breathing difficulties, a significant drop in blood pressure, dizziness, or seizures (caused by reduced blood sugar levels).

If you forget to take Blocard
Do not take a double dose to make up for a missed dose. Take your next dose as scheduled the following morning.

Stopping Blocard
Never stop taking Blocard unless your doctor tells you to do so. Otherwise, your condition may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very common (affecting at least 1 in 10 patients):

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

Common (affecting fewer 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*,
• sensation of coldness or numbness in hands or feet,
• low blood pressure (especially in patients with heart failure),
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation. In patients with hypertension or angina pectoris: * these symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1–2 weeks.

Uncommon (affecting fewer than 1 in 100 patients):

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

Rare (affecting fewer than 1 in 1,000 patients):

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

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

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

5. How to store Blocard

Keep this medicine out of the sight and reach of children.
There are no special temperature requirements for storage. 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. Such measures help protect the environment.

6. Contents of the packaging 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), maize starch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate. Coating: Opadry White: OY58900: hypromellose, polyethylene glycol 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), maize starch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate. Coating: Opadry White: OY58900: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Blocard looks like and contents of the pack
Blocard 5 mg: white-yellow, film-coated heart-shaped tablets with a score line on both sides.
Blocard 10 mg: light orange, film-coated heart-shaped tablets with a score line on both sides.
Tablets with a score line can 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:
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