Bisoratio

Package Leaflet: Information for the Patient

Bisoratio, 2.5 mg, 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. 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. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting 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.
Heart failure occurs when the heart muscle is weakened and cannot pump enough blood to meet the body's needs. Bisoratio is used to treat stable chronic heart failure. It is given in combination with other medicines used for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. Important information before taking Bisoratio

When not to take Bisoratio

Do not take Bisoratio if any of the following conditions apply to you:

• allergy to bisoprolol fumarate or any other ingredient of this medicine (listed in section 6)
• severe asthma or severe chronic lung disease
• severe blood circulation disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration of the fingers and toes
• untreated pheochromocytoma, a rare tumor of the adrenal gland
• metabolic acidosis, a condition where there is too much acid in the blood.

Do not take Bisoratio if you have any of the following heart conditions:

• heart failure that has suddenly worsened and/or requires hospital treatment
• slow or irregular heart rate
• very low blood pressure.

Warnings and precautions

Before starting to take Bisoratio, discuss it with your doctor, pharmacist, or nurse, especially if you have any of the following conditions; they may recommend special precautions (e.g., additional treatment or more frequent checks):

• diabetes (bisoprolol may mask the symptoms of low blood sugar)
• strict diet
• certain heart diseases, such as arrhythmias or severe resting angina (Prinzmetal's angina)
• kidney or liver disorders
• blood circulation disorders in the limbs
• asthma or chronic lung disease
• psoriasis (in history)
• pheochromocytoma of the adrenal gland
• thyroid disorders (bisoprolol may mask the symptoms of hyperthyroidism).

Additionally, inform your doctor if:

• desensitization treatment is planned (e.g., to prevent hay fever), as taking Bisoratio may increase the risk of an allergic reaction or worsen it
• anesthesia is planned (e.g., during surgery), as Bisoratio may affect the body's response in such a situation.

Bisoratio and other medicines

Tell your doctor or pharmacist about all the medicines you have taken recently and any medicines you plan to take.
Do not take the following medicines with Bisoratio without your doctor's explicit recommendation:

• certain medicines used to treat arrhythmias (such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina, or arrhythmias (calcium channel blockers of the verapamil and diltiazem group)
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmendine. However, do not stop taking these medicineswithout consulting your doctor first.

Consult your doctor before taking the following medicines with Bisoratio; your doctor may recommend more frequent monitoring of your condition:

• certain medicines used to treat high blood pressure or angina (such as felodipine and amlodipine)
• certain medicines used to treat arrhythmias (such as amiodarone)
• eye drops containing timolol (and similar substances) used to treat glaucoma
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (such as tacrine or carbachol) or medicines used to treat sudden heart disorders (such as isoprenaline and dobutamine)
• antidiabetic medicines, including insulin
• anesthetics (e.g., used during surgery)
• digoxin, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs), used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac)
• any medicines that may lower blood pressure, such as antihypertensive medicines, certain medicines used to treat depression (such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (such as phenobarbital), or certain medicines used to treat mental illnesses (such as levomepromazine)
• mefloquine used to prevent or treat malaria
• medicines used to treat depression, known as monoamine oxidase inhibitors (except for MAO-B inhibitors), such as moclobemide
• certain medicines used to treat migraines (ergotamine derivatives).

Pregnancy and breastfeeding

Taking Bisoratio during pregnancy may be harmful to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoratio.

Driving and using machines

Your ability to drive or operate machines may be impaired depending on how you tolerate the medicine. Be particularly careful at the beginning of treatment, when increasing the dose, or when changing the medicine, as well as when consuming alcohol.

Bisoratio contains lactose

Bisoratio contains lactose (a sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Bisoratio

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.
Taking Bisoratio requires regular monitoring by your doctor, especially at the beginning of treatment and when increasing the dose.
Take one tablet in the morning, with a small amount of water, with or without food. Do not crush or chew the tablets.
Treatment with Bisoratio is usually long-term.
The tablet can be divided into equal doses.

Use in adults, including the elderly

Treatment with bisoprolol must be started with a low dose, which will be gradually increased.
Your doctor will decide how to increase the dose, usually as follows:

• 1.25 mg of bisoprolol once a day for one week
• 2.5 mg of bisoprolol once a day for one week
• 3.75 mg of bisoprolol once a day for one week
• 5 mg of bisoprolol once a day for four weeks
• 7.5 mg of bisoprolol once a day for four weeks
• 10 mg of bisoprolol once a day as maintenance treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to extend the intervals between dose increases. If your condition worsens or you can no longer tolerate the medicine, it may be necessary to reduce the dose again or stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
Your doctor will inform you about the procedure.
If treatment needs to be completely stopped, your doctor will usually recommend gradual dose reduction, as otherwise, your condition may worsen.

Use in children

Bisoratio is not recommended for use in children.

Taking a higher dose of Bisoratio than recommended

If you have taken more Bisoratio than recommended, contact your doctor immediately. Your doctor will decide what action is necessary.
Symptoms of overdose may include dizziness, feeling of emptiness in the head, fatigue, shortness of breath, and/or wheezing. Also, heart rate may slow down, blood pressure may decrease, heart failure may worsen, and blood sugar levels may decrease (which may cause hunger, sweating, and palpitations).

Missing a dose of Bisoratio

Do not take a double dose to make up for a missed dose. Take your usual dose the next morning.

Stopping treatment with Bisoratio

Never stop treatment with Bisoratio without consulting your doctor. Otherwise, your condition may significantly worsen.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bisoratio can cause side effects, although not everybody gets them.
To prevent serious reactions, contact your doctor immediately if a side effect is severe, sudden, or worsens rapidly.
Most serious side effects are related to heart function:

• slow heart rate (may affect more than 1 in 10 people)
• worsening of heart failure (may affect up to 1 in 10 people)
• slow or irregular heart rate (may affect up to 1 in 100 people).

If you experience dizziness, weakness, or difficulty breathing, contact your doctor immediately.
Other side effects are listed below by frequency:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• sleep disorders
• depression
• breathing difficulties in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.

Rare (may affect up to 1 in 1,000 people)

• hearing disorders
• allergic rhinitis
• dry eyes due to reduced tear secretion (which can be very troublesome if you wear contact lenses)
• liver inflammation, which can cause yellowing of the skin or eyes
• allergic reactions, such as itching, redness, rash
• decreased sex drive (impotence)
• nightmares, hallucinations
• fainting
• changes in some blood test results related to liver function or lipid levels.

Very rare (may affect up to 1 in 10,000 people)

• irritation or redness of the eyes (conjunctivitis)
• hair loss
• appearance or worsening of psoriatic skin rash; psoriasis-like rash.

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 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, 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 Bisoratio

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Do not store bisoprolol tablets above 30°C.
Do not use this medicine if you notice that the tablets have discolored or show any other signs of deterioration, and consult your pharmacist for advice.
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 is bisoprolol fumarate. Each Bisoratio tablet of 2.5 mg strength contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, and crospovidone (Type B).

What Bisoratio looks like and contents of the pack

The tablets are white, oblong, uncoated, with a score line on both sides on the top and bottom, with the inscription "BI" and "2.5" on both sides of the score line on the top of the tablet.
The tablets are packaged in PVC/PVDC/Aluminum blisters placed in a cardboard box.
Pack sizes: 28, 30, or 60 tablets.

Marketing authorization holder:

Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður
Iceland

Manufacturer:

Niche Generics Limited
Unit 5, 151 Baldoyle Industrial Estate
Dublin 13
Ireland
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark:
Bisoprolol Teva
Poland:
Bisoratio

For more information about this medicine, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:July 2023