BISORATIO 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Bisoratio 5; 5 mg, tablets
   1. Bisoratio 10; 10 mg, tablets
   2. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   3. Table of Contents of the Leaflet
3. What is Bisoratio and what is it used for
4. Important information before taking Bisoratio
   1. When not to take Bisoratio
   2. Warnings and precautions
   3. Children and adolescents
   4. Bisoratio and other medicines
   5. Bisoratio with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Bisoratio
   1. Adults
   2. Impaired liver or kidney function
   3. Elderly patients
   4. Use in children and adolescents
   5. Duration of treatment
   6. Impaired liver and kidney function
   7. Elderly patients
   8. Use in children and adolescents
   9. Overdose of Bisoratio
   10. Missed dose of Bisoratio
   11. Stopping treatment with Bisoratio
6. Possible side effects
   1. Reporting side effects
7. How to store Bisoratio
8. Contents of the pack and other information
   1. What Bisoratio contains
   2. What Bisoratio looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Bisoratio 5; 5 mg, tablets

Bisoprolol fumarate

Bisoratio 10; 10 mg, tablets

Bisoprolol fumarate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Bisoratio and what is it used for

The active substance of Bisoratio 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 heart's efficiency in pumping blood throughout the body. Bisoprolol at doses of 5 mg and 10 mg lowers high blood pressure.

Bisoratio is used to treat:

• high blood pressure;
• angina pectoris (chest pain caused by insufficient blood supply to the heart);
• chronic stable heart failure of moderate to severe severity with restricted systolic ventricular function (ejection fraction ≤35% in echocardiographic assessment) in combination with ACE inhibitors, diuretics, and - if necessary - cardiac glycosides.

2. Important information before taking Bisoratio

When not to take Bisoratio

Do not take Bisoratio in the following cases:

Warnings and precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Bisoratio; 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 circulatory problems in the limbs;
• mild asthma or chronic pulmonary disease;
• psoriasis (a skin condition) or a history of psoriasis;
• thyroid function disorders;
• pheochromocytoma of the adrenal gland;
• first-degree atrioventricular block.

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

• desensitization treatment (e.g., to prevent hay fever), as Bisoratio may increase the risk of an allergic reaction or worsen such a reaction;
• a surgical procedure under general anesthesia, as Bisoratio may affect the body's response to the anesthetics.

Treatment of chronic stable heart failure with bisoprolol must be started with a dose-titration phase.

Initiation and cessation of treatment for chronic stable heart failure with bisoprolol require regular monitoring.

There is limited experience with the use of bisoprolol in patients with heart failure and concomitant conditions, such as:

• NYHA class II heart failure;
• insulin-dependent diabetes (type I);
• severe renal impairment (serum creatinine ≥300 µmol/l or ≥3.4 mg/dl);
• severe hepatic impairment;
• patients over 80 years of age;
• restrictive cardiomyopathy;
• congenital heart defects;
• hemodynamically significant valvular defects;
• myocardial infarction within the last 3 months.

During treatment with bisoprolol, your doctor should recommend regular check-ups to monitor the function of the circulatory system, especially in elderly patients.

Treatment with bisoprolol should not be stopped abruptly, especially in patients with angina pectoris, as this may lead to an increased risk of myocardial infarction and sudden death.

Children and adolescents

Bisoratio is not recommended for use in children and adolescents.

Bisoratio and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

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

• certain medicines used to treat high blood pressure, angina pectoris, 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.
• certain medicines used to treat high blood pressure or angina pectoris (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class I antiarrhythmic agents, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (class III antiarrhythmic agents, such as amiodarone);
• locally 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 agents, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic agents;
• anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory agents (NSAIDs) used to treat arthritis, pain, and 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 agents, certain antidepressants (tricyclic antidepressants), certain antiepileptic agents, or anesthetics (barbiturates) and certain antipsychotic agents (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, used to treat dementia and migraine headaches.

Bisoratio with food and drink

The tablets can be taken with food. They should be swallowed with a small amount of liquid, without chewing.

Pregnancy and breastfeeding

There is a risk that taking Bisoratio 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 Bisoratio during pregnancy.

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

Driving and using machines

The medicine may affect your ability to drive or use machines. Be particularly careful at the start of treatment, when increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

Bisoratio contains lactose monohydrate.

Each Bisoratio 5 tablet contains 135.7 mg of lactose monohydrate.

Each Bisoratio 10 tablet contains 130.4 mg of lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Bisoratio

Always take this medicine 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 Bisoratio. This is especially important at the start of treatment, when increasing the dose, and when stopping treatment.

Adults

For high blood pressure and angina pectoris, the usual dose is one Bisoratio 5 tablet or half a Bisoratio 10 tablet (equivalent to 5 mg of bisoprolol fumarate) once daily. If necessary, your doctor may increase the dose to one Bisoratio 10 mg tablet or two Bisoratio 5 mg tablets (equivalent to 10 mg of bisoprolol fumarate) once daily.

The maximum daily dose is 20 mg.

In any case, the smallest effective dose should be used.

Impaired liver or kidney function

In patients with mild to moderate liver or kidney impairment, dose adjustment is usually not necessary. In patients with severe renal or hepatic 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 dose adjustment is necessary.

Elderly patients

Dose adjustment is not necessary. It is recommended to start treatment with the lowest possible dose.

Use in children and adolescents

Bisoratio is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Bisoratio is usually long-term.

Do not stop taking Bisoratio abruptly. If it is necessary to stop treatment, the dose should be gradually reduced (e.g., by halving the dose every week).

How to take the medicine

The tablets should be taken every morning on an empty stomach or during breakfast; they should not be chewed and should be swallowed with a sufficient amount of liquid.

Stable chronic heart failure

The medicine is used in patients with diagnosed stable chronic heart failure who have not had acute heart failure in the last six weeks and whose treatment for the underlying condition has not been changed in the last two weeks.

Before starting treatment with bisoprolol, patients should be treated with an ACE inhibitor at an optimal dose (or another vasodilator in case of intolerance to ACE inhibitors), a diuretic, and - if necessary - a cardiac glycoside.

Recommendation:

The treating physician should have experience in the treatment of chronic heart failure.

Dose-titration phase

Treatment of chronic stable heart failure with bisoprolol requires a dose-titration phase.

Treatment should be started with a low dose, which should then be gradually increased according to the scheme below. The doses necessary for the initial phase of treatment (1.25 mg, 3.75 mg) cannot be achieved with this medicinal product.

• 1.25 mg once daily for 1 week (for this dosing, products with a different active substance content are available). If this dose is well tolerated, it should be increased to:
• 2.5 mg once daily for 1 week. If this dose is well tolerated, it should be increased to:
• 3.75 mg once daily for 1 week (for this dosing, products with a different active substance content are available). If this dose is well tolerated, it should be increased to:
• 5 mg once daily for 4 weeks. If this dose is well tolerated, it should be increased to:
• 7.5 mg once daily for 4 weeks. If this dose is well tolerated, it should be increased to:
• 10 mg once daily (maintenance dose). After the first administration of the 1.25 mg dose, the patient should be monitored for 4 hours; particular attention should be paid to blood pressure, heart rate, conduction disorders, and signs of worsening heart failure.

The maximum recommended dose of bisoprolol is 10 mg once daily.

The occurrence of side effects may make it impossible to treat all patients with the maximum recommended doses. If necessary, the dose already achieved may be gradually reduced. If necessary, treatment can be stopped and restarted.

If, during the dose-titration phase, signs of worsening heart failure or intolerance occur, it is recommended to first reduce the dose of bisoprolol or, if necessary, stop its administration (especially in the case of severe hypotension, worsening of heart failure with acute pulmonary edema, cardiogenic shock, symptomatic bradycardia, or atrioventricular block).

Treatment of stable chronic heart failure with bisoprolol is usually long-term.

Do not stop taking bisoprolol abruptly, as this may lead to a transient worsening of heart failure. If it is necessary to stop treatment, the dose of the medicine should be gradually reduced (e.g., by halving the dose every week).

The tablets should be taken in the morning. They can be taken with food. They should be swallowed with a small amount of liquid, without chewing.

Impaired liver and kidney function

There are no data on the pharmacokinetics of bisoprolol in patients with chronic heart failure and renal or hepatic impairment. In these patients, the dose should be titrated with particular caution.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

There are no results from studies with the use of the medicine in this age group, so the use of the medicine is not recommended.

Overdose of Bisoratio

If you have taken more Bisoratio than prescribed, tell 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).

Missed dose of Bisoratio

Do not take a double dose to make up for a missed dose. The next morning, take the prescribed dose.

Stopping treatment with Bisoratio

Never stop taking Bisoratio unless your doctor advises you to do so. Otherwise, your condition may worsen.

Do not stop taking bisoprolol abruptly, as this may lead to a transient worsening of heart failure. If it is necessary to stop treatment, the dose of the medicine should be gradually reduced (e.g., by halving the dose every week).

If you have any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common(occurring in more than 1 in 10 patients):

• bradycardia (in patients with chronic heart failure).

Common(occurring in less than 1 in 10 patients)

• fatigue*, dizziness*, headaches*;
• feeling of coldness or numbness in the hands or feet;
• hypotension, especially in patients with heart failure;
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, constipation;
• worsening of existing heart failure (in patients with chronic heart failure).

* These symptoms occur mainly at the start of treatment and are usually 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;
• orthostatic hypotension.

Rare(occurring in less than 1 in 1000 patients)

• hearing disorders;
• allergic rhinitis;
• reduced tear secretion (should be considered if the patient wears contact lenses);
• hepatitis, which can 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, and angioedema. You should immediately consult your doctor if you experience severe allergic reactions, which may include: facial, neck, tongue, mouth, or throat swelling, 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-like lesions.

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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 the medicine.

5. How to store Bisoratio

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

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

Do not use this medicine after the expiry date stated on the packaging.

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

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 Bisoratio contains

• The active substance of Bisoratio is bisoprolol fumarate.
• Each tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone.

Bisoratio 5 tablets also contain the colorant PB 22812 (lactose monohydrate, yellow iron oxide (E 172)).

Bisoratio 10 tablets also contain the colorant PB 27215 (lactose monohydrate, yellow iron oxide (E 172), red iron oxide (E 172)).

What Bisoratio looks like and contents of the pack

Bisoratio tablets are round, biconvex with a score line on one side.

The tablet can be divided into equal doses.

The packaging contains 30 or 60 tablets.

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Tel: (22) 345 93 00

Manufacturer

Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Date of last revision of the leaflet: