Bisoratio

Package leaflet: Information for the patient

Bisoratio, 2.5 mg, tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Bisoratio is and what it is 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 Bisoratio is and what it is used for

The active substance in 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 heart activity and improves the heart's efficiency 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 in the treatment of 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 using Bisoratio

Do not use Bisoratio

• if the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).

Do not take Bisoratio if the patient has any of the following heart conditions:

• acute heart failure
• heart failure that has suddenly worsened and (or) requires hospital treatment, cardiogenic shock, i.e. acute, severe heart disease causing low blood pressure and circulatory failure
• certain heart diseases causing very slow or irregular heartbeat:
• second- or third-degree atrioventricular block without a cardiac pacemaker
• sick sinus syndrome
• sinoatrial block
• slow or irregular heart rhythm
• very low arterial blood pressure

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

• severe asthma or severe chronic lung disease
• severe blood circulation disorders in the limbs (peripheral arterial occlusive disease) or severe form of Raynaud's syndrome, which may cause tingling, paleness or blueness of fingers and toes
• untreated phaeochromocytoma, a rare tumour of the adrenal gland
• metabolic acidosis, a condition in which there is too much acid in the blood.

Warnings and precautions
Treatment with Bisoratio should be started with a low dose and gradually increased. Regular monitoring is required at the beginning and after completion of treatment with Bisoratio.
Treatment with Bisoratio should not be stopped suddenly unless absolutely necessary.
Especially in patients with ischaemic heart disease, this may lead to a temporary worsening of heart condition. More information is provided in section 3, "How to use Bisoratio".
Before starting treatment with Bisoratio, discuss this with your doctor or pharmacist, especially if the patient has any of the following conditions; they may recommend special management (e.g. additional treatment or more frequent monitoring):

• diabetes (bisoprolol may mask symptoms of low blood sugar such as rapid heartbeat, palpitations or sweating)
• strict diet
• allergy immunotherapy (e.g. to prevent hay fever), as using Bisoratio may increase the risk of allergic reactions or exacerbate such reactions
• certain heart diseases, such as heart rhythm disorders (first-degree atrioventricular block) or severe resting chest pain (Prinzmetal's angina)
• blood circulation disorders in the limbs. Worsening of symptoms may occur, especially at the beginning of therapy.
• history of psoriasis (psoriatic skin lesions)
• thyroid disorders (bisoprolol may mask symptoms of hyperthyroidism)
• phaeochromocytoma of the adrenal gland
• less severe asthma or chronic lung disease. The patient should inform the doctor immediately if new breathing difficulties, cough, wheezing on exertion, etc., occur during treatment with Bisoratio. In such cases, concomitant treatment with bronchodilators (medicines that widen the airways) should be initiated.

Additionally, inform your doctor if:

• anaesthesia is planned (e.g. during a surgical procedure), as Bisoratio may affect the body's response in such situations.

Children and adolescents
Bisoratio is not recommended for use in children and adolescents.
Bisoratio with other medicines
Tell your doctor or pharmacist about all medicines you have recently taken or plan to take.
Do not take the following medicines with Bisoratio without explicit medical advice:

• certain medicines used to treat heart rhythm disorders (antiarrhythmics of class I, e.g. quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina or heart rhythm disorders (calcium antagonists of the verapamil and diltiazem group)
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop treatment with these medicines without first consulting your doctor.

Consult your doctor before starting treatment with the following medicines together with Bisoratio; your doctor may recommend more frequent monitoring:

• certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone)
• certain medicines used to treat, e.g. Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol)
• locally applied beta-blockers (e.g. eye drops containing timolol used to treat glaucoma)
• antidiabetic medicines, including insulin
• anaesthetics (e.g. used during surgery)
• cardiac glycosides, used to treat heart failure
• non-steroidal anti-inflammatory drugs (NSAIDs), used to treat joint inflammation, pain or inflammatory conditions (e.g. ibuprofen or diclofenac)
• medicines used to treat acute heart disorders (sympathomimetics such as isoprenaline and dobutamine)
• norepinephrine and epinephrine, medicines used to treat acute, life-threatening allergic reactions and cardiac arrest
• any medicines that may lower blood pressure as a desired or adverse effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat psychiatric disorders characterised by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used to prevent or treat malaria
• medicines used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclomemide
• rifampicin, an antibiotic used to treat infections
• certain medicines used to treat migraine (ergotamine derivatives).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
There is a risk that using Bisoratio during pregnancy may be harmful to the unborn child. The doctor will decide whether Bisoratio should be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoratio.
Driving and using machines
The ability to drive or operate machinery may be impaired depending on how the patient tolerates the medicine. Extreme caution should be exercised at the beginning of treatment, when increasing the dose or changing medication, and also when consuming alcohol simultaneously.
Bisoratio contains lactose
Bisoratio contains milk sugar (lactose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Bisoratio

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult your physician or pharmacist again.
Treatment with Bisoratio requires regular monitoring by a physician, especially at the beginning
of treatment, during dose escalation, and when discontinuing therapy.
Take one tablet in the morning, with a small amount of water, during or independently of a meal.
Do not crush or chew the tablets.
Treatment with Bisoratio is usually long-term.
The tablet may be divided into equal doses.

Use in adult patients, including elderly patients
Treatment with bisoprolol should always be initiated at a low dose, which will then be gradually increased.
Your physician will determine how the dose should be increased, typically as follows:

• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily as maintenance therapy.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on the patient's tolerance, the physician may decide to extend the intervals between
dose increases. If the patient's condition worsens or the patient no longer tolerates the medication,
it may be necessary to reduce the dose again or discontinue treatment.
For some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your physician
will advise on the appropriate course of action.
If treatment needs to be completely discontinued, the physician will usually recommend gradually
reducing the dose, as otherwise the patient's condition may deteriorate.

Use in hepatic or renal impairment
Extreme caution should be exercised when increasing the dose.

Use in children and adolescents
Bisoratio is not recommended for use in children or adolescents.

Use of a higher than recommended dose of Bisoratio
If an excessive dose of Bisoratio is taken, seek immediate medical advice. The physician will decide
on the necessary course of action.
Symptoms of overdose may include dizziness, a sensation of "emptiness" in the head, fatigue,
shortness of breath, and/or wheezing. Bradycardia (slow heart rate), hypotension (low blood pressure),
cardiac depression, and decreased blood glucose levels (which may manifest as hunger, sweating,
tremor, and palpitations) may also occur.

Missed dose of Bisoratio
Do not take a double dose to make up for a missed dose. Take the next regular dose the following morning.

Stopping Bisoratio treatment
Never discontinue treatment with Bisoratio without consulting your physician. Otherwise,
the patient's condition may significantly worsen.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
To prevent serious reactions, contact your doctor immediately if an adverse reaction is severe,
occurs suddenly, or worsens rapidly.
If you experience dizziness, weakness, or difficulty breathing, you should contact your doctor immediately.
Most serious adverse reactions are related to heart function:

• Slowing of the 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 heartbeat (may affect up to 1 in 100 people).

Other serious adverse reactions:

• Breathing difficulties in patients with asthma or chronic lung disease (may affect up to 1 in 100 people)
• Liver inflammation, which may cause yellowing of the skin or eyes (may affect up to 1 in 1,000 people).

Other adverse reactions are listed below by frequency of occurrence:
Common (may affect up to 1 in 10 people)

• Fatigue
• Weakness
• Dizziness
• Headache
• Cold sensation or numbness in hands or feet
• Low blood pressure
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, or constipation.

Uncommon (may affect up to 1 in 100 people)

• Sleep disturbances
• Depression
• Dizziness upon standing or sitting up
• Muscle weakness
• Muscle cramps.

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

• Hearing disturbances
• Allergic rhinitis
• Dry eyes due to reduced tear production (this may be particularly troublesome if the patient wears contact lenses)
• Allergic-type reactions such as itching, redness, or rash. Immediately contact a doctor if more severe allergic reactions occur, such as swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• Decreased libido (sexual dysfunction)
• Nightmares
• Hallucinations
• Fainting. If pulse and breathing are normal and the patient regains consciousness quickly, contact a doctor. In all other cases, call emergency services and seek immediate medical help.
• Changes in certain blood test results related to liver function or lipid levels.

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

• Eye irritation or redness (conjunctivitis)
• Hair loss
• New onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

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

5. How to store Bisoratio

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use this medicine if you notice that the tablets have discoloured or show any other signs of deterioration; consult your pharmacist for advice.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Bisoratio contains

• The active substance is bisoprolol fumarate. Each Bisoratio tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate and crospovidone (Type B).

What Bisoratio looks like and contents of the pack
The tablets are white, elongated, uncoated, with a division line on both sides on the top and bottom surface,
and embossed with "BI" and "2.5" on both sides of the division line on the top of the tablet.
The tablets are packed in blisters made of µPVC/PVDC/Aluminium, placed in a cardboard box.
Pack sizes: 28, 30 or 60 tablets.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Denmark: Bisoprolol Teva
Poland: Bisoratio
For further information about this medicinal product, please contact the representative of the marketing authorisation holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.