Bisopromerck 10

Package leaflet: Information for the patient

Bisopromerck 5, 5 mg, film-coated tablets
Bisopromerck 10, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Bisopromerck is and what it is used for

The active substance in Bisopromerck 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.
Bisopromerck is used in the treatment of hypertension or ischemic heart disease (chest pain caused by insufficient oxygen supply to the heart).

2. Important information before using Bisopromerck

When not to use Bisopromerck
Do not use Bisopromerck 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 cardiac contractility is required,
• 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 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 Bisopromerck; your doctor may decide that special precautions are necessary (e.g. additional medications or more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart diseases (such as heart rhythm disorders or severe chest pain at rest—Prinzmetal's angina);
• milder circulatory disorders in the limbs;
• mild bronchial asthma or chronic lung disease;
• presence of psoriatic skin lesions, even in medical history;
• thyroid dysfunction;
• phaeochromocytoma of the adrenal medulla.

Additionally, inform your doctor if you are planning:

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

Children and adolescents
Use of Bisopromerck is not recommended in children and adolescents.

Bisopromerck and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use the following medicines together with Bisopromerck without specific medical advice:

• certain drugs used to treat high blood pressure, coronary heart disease, or heart rhythm disorders (calcium antagonists such as verapamil and diltiazem);
• certain drugs 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 Bisopromerck, consult your doctor; your doctor may recommend more frequent medical checks:

• certain drugs used to treat high blood pressure or coronary heart disease (dihydropyridine-type calcium antagonists such as felodipine and amlodipine);
• certain drugs used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain drugs used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
• locally applied beta-blockers (such as eye drops used to treat glaucoma);
• certain drugs used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• drugs used to treat acute heart disorders (adrenergic agonists such as isoprenaline and dobutamine);
• insulin and oral antidiabetic drugs;
• 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, relieve pain and inflammation (e.g. ibuprofen and diclofenac);
• adrenaline, a drug used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any drugs that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptic drugs or barbiturates used in general anaesthesia, and certain drugs used in psychiatric disorders with loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• drugs used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors);
• rifampicin, an antibiotic used to treat infections;
• ergotamine derivatives, drugs used to treat dementia and migraine headaches.

Pregnancy and breastfeeding
There is a risk that using Bisopromerck during pregnancy may harm the unborn child.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Bisopromerck can be taken during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Bisopromerck.

Driving and operating machinery
This medicine 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 switching medications, as well as when combining the medicine with alcohol.

3. How to take Bisopromerck

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Bisopromerck. This is particularly important at the beginning of treatment, when increasing the dose, and when discontinuing treatment.
The tablet should be taken in the morning, with food or independently of meals, swallowed with water. Do not crush or chew the tablets.

Adults
For both indications, the usual dose is one tablet of Bisopromerck 5 or 1/2 tablet of Bisopromerck 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Bisopromerck 10 mg or two tablets of Bisopromerck 5 mg (corresponding to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

Liver or kidney function impairment
In patients with mild to moderate liver or kidney dysfunction, dose adjustment is usually not required. In patients with severe renal or hepatic impairment, doses higher 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 dose adjustment is necessary.

Elderly patients
Dose adjustment is not necessary.

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

Duration of treatment
Treatment with Bisopromerck is usually long-term.
If discontinuation of treatment becomes necessary, your doctor will usually recommend gradually reducing the dose. Abruptly stopping the medication may worsen the condition.

Taking more than the recommended dose of Bisopromerck
If you take more Bisopromerck than prescribed, contact your doctor immediately. Your doctor will decide what actions are needed.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missed dose of Bisopromerck
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time the following morning.

Stopping Bisopromerck
Never stop taking Bisopromerck unless your doctor specifically advises you to do so. Otherwise, your condition may worsen.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (occurring in fewer than 1 in 10 patients)

• Fatigue*, dizziness*, headache*,
• Cold sensation or numbness in hands or feet,
• Low blood pressure,
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

* These symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1–2 weeks.

Uncommon (occurring in fewer than 1 in 100 patients)

• Atrioventricular conduction disorders, worsening of existing heart failure, bradycardia (slow heart rate),
• Sleep disturbances,
• Depression,
• Asthenia (weakness),
• Bronchospasm (breathing difficulties) in patients with bronchial asthma or chronic obstructive pulmonary disease,
• Muscle weakness or muscle cramps.

Rare (occurring in fewer than 1 in 1,000 patients)

• Hearing disturbances,
• Allergic rhinitis,
• Reduced tear secretion (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. Seek immediate medical attention if severe allergic reactions occur, which may include: swelling of the face, neck, tongue, mouth or throat, or breathing difficulties,
• Impaired potency,
• Nightmares, hallucinations,
• Fainting.

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

• Conjunctivitis (eye irritation or redness),
• Alopecia (hair loss),
• New onset or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Bisopromerck

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after EXP and on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 Bisopromerck contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• Other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, anhydrous calcium hydrogen phosphate; tablet coating: yellow iron oxide (E172), dimethicone 100, polyethylene glycol 400, titanium dioxide (E171), hypromellose, red iron oxide (E172) [only in Bisopromerck 10].

What Bisopromerck looks like and contents of the pack
Bisopromerck 5 film-coated tablets are yellowish-white, heart-shaped, with a division line.
Bisopromerck 10 film-coated tablets are pale orange/light orange, heart-shaped, with a division line.
Pack contains 30 or 100 film-coated tablets.

Marketing Authorisation Holder
Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw, Poland

Manufacturer
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany