Bisopromerck 10

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 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 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 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. Bisoprolol, in 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 of the other ingredients of this medicine (listed in section 6),
• if you have severe asthma,
• if you have serious blood circulation problems in your limbs (such as Raynaud's syndrome) that may cause tingling, pale or blue 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 given medicines that increase the heart's contractions intravenously,
• 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 serious, 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 Bisopromerck; 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);
• mild blood circulation problems in the limbs;
• mild asthma or chronic lung disease;
• psoriasis (a skin condition) or a history of psoriasis;
• thyroid dysfunction;
• pheochromocytoma of the adrenal gland.

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

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

Children and Adolescents

Bisopromerck is not recommended for use in children and adolescents.

Bisopromerck and Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

Do not take the following medicines with Bisopromerck without special advice from your doctor:

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

Before taking the following medicines with Bisopromerck, 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 coronary heart disease (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (anti-arrhythmic medicines of class I, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (anti-arrhythmic medicines of class III, such as amiodarone);
• locally used 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 reduce inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a medicine used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any 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), and 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, known as monoamine oxidase inhibitors (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 taking Bisopromerck 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 Bisopromerck during pregnancy.

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

Driving and Using Machines

The medicine may affect your ability to drive or use machines.

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 Bisopromerck

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

If you are not sure, ask your doctor or pharmacist.

Regular medical check-ups are necessary while taking 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 or without food, with a glass of water.

Do not crush or chew the tablets.

Adults

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

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 a day.

The maximum recommended dose is 20 mg once a day.

Liver or Kidney Impairment

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

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

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

Elderly Patients

No dose adjustment is 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 treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose of Bisopromerck; otherwise, the disease may worsen.

Overdose of Bisopromerck

If you have taken more Bisopromerck than you should, 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 Bisopromerck

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

The next morning, take the prescribed dose as usual.

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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Frequent(occurring in less than 1 in 10 patients)

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

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

Uncommon(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.

Rare(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 some blood tests, related to liver function (increased activity of AlAT and AspAT) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, rash. You should immediately contact your doctor if you experience severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing,
• 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Jerozolimskie Avenue 181C, 02-222 Warsaw

Phone: +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 Bisopromerck

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures 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 anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous; tablet coating: yellow iron oxide (E172), dimeticone 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.

Jerozolimskie Avenue 142B

02-305 Warsaw, Poland

Manufacturer

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt, Germany

Date of Last Revision of the Leaflet: March 2022