Bisopromerck 5

Package Leaflet: Information for the Patient

Bisopromerck 5, 5 mg, Film-Coated Tablets

Bisopromerck 10, 10 mg, Film-Coated Tablets

Bisoprolol Fumarate

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

• Keep this Package Leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 Package Leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Bisopromerck and what is it used for
• 2. Important information 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 is Bisopromerck and what is it used for

The active substance of Bisopromerck 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 at doses of 5 mg and 10 mg lowers high blood pressure.

Bisopromerck is used to treat high blood pressure or coronary heart disease (chest pain caused by insufficient blood supply to the heart).

2. Important information before taking Bisopromerck

When not to take Bisopromerck

Do not take Bisopromerck 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 circulatory problems in your limbs (such as Raynaud's syndrome) that 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 in which the blood pH is abnormal),
• if you have acute heart failure,
• if your heart failure has worsened and you need to take medications that increase the contractility of the heart intravenously,
• 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, life-threatening disorder of heart function leading to low blood pressure and circulatory failure).

Warnings and precautions

If any of the following conditions occur, consult your doctor before taking Bisopromerck; your doctor may decide that special caution is required (e.g., additional medications or more frequent medical check-ups):

• diabetes;
• strict fasting;
• certain heart conditions (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• mild circulatory disorders in the limbs;
• mild bronchial asthma or chronic pulmonary disease;
• psoriatic skin lesions (psoriasis), including a history of such lesions;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, inform your doctor if:

• desensitization therapy is planned (e.g., to avoid hay fever), as Bisopromerck may increase the likelihood of an allergic reaction or worsen such a reaction;
• a surgical procedure under general anesthesia is planned, as Bisopromerck may alter the body's response to medications administered during surgery.

Children and adolescents

Bisopromerck is not recommended for children and adolescents.

Bisopromerck and other medications

Inform 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 Bisopromerck without special recommendation by your doctor:

• certain medications used to treat high blood pressure, coronary heart disease, or arrhythmias (calcium antagonists, such as verapamil and diltiazem);
• certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, and rilmenidine. However, do not stop taking these medications without consulting your doctor.

Before taking the following medications with Bisopromerck, consult your doctor; your doctor may recommend more frequent medical check-ups:

• certain medications used to treat high blood pressure or coronary heart disease (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine);
• certain medications used to treat arrhythmias (class I antiarrhythmic medications, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medications used to treat arrhythmias (class III antiarrhythmic medications, such as amiodarone);
• locally applied beta-blockers (such as eye drops for glaucoma treatment);
• certain medications used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• medications used to treat acute heart disorders (adrenergic agonists, 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 joint inflammation, pain, and inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a medication used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any medications that may 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), as well as 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 Bisopromerck during pregnancy may harm the fetus.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication. Your doctor will decide whether you can take Bisopromerck during pregnancy.

It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Bisopromerck.

Driving and using machines

The medication, depending on how it is tolerated, may impair the ability to drive vehicles or operate machines.

Be particularly cautious 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 Bisopromerck

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

If you are unsure, consult your doctor or pharmacist.

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

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 crush or chew the tablets.

Adults

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

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

The maximum recommended dose is 20 mg once daily.

Impaired liver or kidney function

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

In patients with severe kidney or liver impairment, do not exceed a dose of 10 mg of bisoprolol per day.

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

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Bisopromerck is not recommended for children and adolescents.

Duration of treatment

Treatment with Bisopromerck is usually long-term.

If treatment needs to be discontinued, your doctor will usually recommend gradual reduction of the dose; otherwise, the disease may worsen.

Overdose of Bisopromerck

If you have taken more Bisopromerck than prescribed, inform your doctor immediately.

Your doctor will decide what actions to take.

Symptoms of overdose include: slow heart rate, difficulty breathing, significant decrease in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missed dose of Bisopromerck

Do not take a double dose to make up for a missed dose.

The next morning, take the prescribed dose.

Stopping treatment with Bisopromerck

Never stop taking Bisopromerck unless your doctor tells you to.

Otherwise, the disease may worsen.

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

4. Possible side effects

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

Frequently(occurring in less than 1 in 10 patients)

• fatigue*, dizziness*, headache*,
• feeling of coldness or numbness in the hands or feet,
• low blood pressure,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

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

Less frequently(occurring in less than 1 in 100 patients)

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

Rarely(occurring in less than 1 in 1000 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 activity of AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash. If you experience severe allergic reactions, including: facial swelling, neck, tongue, mouth, or throat swelling, or difficulty breathing, contact your doctor immediately,
• impotence,
• nightmares, hallucinations,
• fainting. Very rarely(occurring in less than 1 in 10,000 patients)
• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• onset or exacerbation of psoriatic skin lesions (psoriasis), psoriasis-like lesions.

Reporting side effects

If you experience any side effects, including any not listed in this Package Leaflet, 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 Bisopromerck

Keep this medication out of the sight and reach of children.

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.

Do not store above 30°C.

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 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.
• The other ingredients are: tablet core: colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, anhydrous calcium hydrogen phosphate; tablet coating: yellow iron oxide (E172), dimethicone 100, macrogol 400, titanium dioxide (E171), hypromellose, red iron oxide (E172) [only Bisopromerck 10].

What Bisopromerck looks like and contents of the pack

Bisopromerck 5 film-coated tablets are yellowish-white, heart-shaped, with a score line.

Bisopromerck 10 film-coated tablets are pale orange/light orange, heart-shaped, with a score line.

The pack contains 30 or 100 film-coated tablets.

Marketing authorization holder

Merck Sp. z o.o.

Al. Jerozolimskie 142B

02-305 Warsaw, Poland

Manufacturer

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt, Germany

Date of last revision of the Package Leaflet: March 2022