Bisoprolol Krka

PACKAGE LEAFLET
Package leaflet: Information for the patient

Bisoprololo Krka 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

Bisoprolol fumarate
Generic medicine

Read 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bisoprololo Krka is and what it is used for
2. What you need to know before taking Bisoprololo Krka
3. How to take Bisoprololo Krka
4. Possible side effects
5. How to store Bisoprololo Krka
6. Contents of the pack and other information

1. What Bisoprolol Krka is and what it is used for

The active substance in Bisoprolol Krka is bisoprolol. Bisoprolol belongs to a group of medicines known as beta-blockers. These medicines work by affecting the response of the body to certain nerve impulses, especially in the heart. As a result, bisoprolol slows the heart rate and allows the heart to pump blood more easily throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and blood supply. Heart failure occurs when the heart muscle becomes weakened and is no longer able to pump sufficient blood to meet the body's needs.
Bisoprolol Krka is used for:

• Treatment of high blood pressure (hypertension).
• Treatment of angina pectoris.
• Treatment of stable chronic heart failure. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you should know before taking Bisoprolol Krka

Do not use Bisoprolol Krka
Do not take Bisoprolol Krka if any of the following conditions apply to you:

• if you are allergic to the active substance or to any of the other ingredients (listed in section 6).
• Severe asthma.

• Severe circulatory problems in the extremities (such as Raynaud's syndrome), resulting in tingling in the fingers and toes, which may become pale or turn blue.
• Untreated phaeochromocytoma, which is a rare tumour of the adrenal gland.
• Metabolic acidosis, a condition in which there is an increase in acid levels in the blood.

Do not take Bisoprololo Krka if you suffer from any of the following heart conditions:

• Acute heart failure.
• Worsening heart failure requiring intravenous administration of medicines that increase the heart's pumping strength.
• Low blood pressure.
• Certain heart conditions causing a slow heart rate or irregular heartbeat.
• Cardiogenic shock, a severe acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprololo Krka. If you have any of the following conditions, inform your doctor before taking Bisoprololo Krka tablets; he/she may wish to proceed with caution (for example, by prescribing additional treatment or performing more frequent check-ups):

• Diabetes;
• Prolonged fasting;
• Certain heart conditions such as heart rhythm disorders or severe resting chest pain (Prinzmetal's angina);
• Kidney or liver problems;
• Mild circulatory disorders in the extremities;
• Mild asthma or chronic lung disease;
• History of skin peeling (psoriasis);
• Tumour of the adrenal gland (phaeochromocytoma);
• Thyroid disorders.
• First-degree heart block (a condition in which nerve signals to the heart are impaired, occasionally causing skipped beats or an irregular heartbeat).

Also inform your doctor if you are about to undergo:

• Desensitisation therapy (e.g. to prevent hay fever), as Bisoprololo Krka may make allergic reactions more likely or may cause such reactions to be more severe;
• Anaesthesia (e.g. for surgery), as Bisoprololo Krka may affect your body's responses in this situation.

Other medicines and Bisoprololo Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take the following medicines together with Bisoprolol Krka without specific
instructions from your doctor:

• certain medicines used to treat abnormal or irregular heartbeat (Class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat hypertension, angina pectoris, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat hypertension such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines together with Bisoprolol Krka; your
doctor may consider it necessary to monitor your condition more frequently:

• Certain medicines used to treat high blood pressure, angina pectoris, or abnormal heartbeat (dihydropyridine-type calcium antagonists such as nifedipine, felodipine, and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic drugs such as amiodarone).
• Topically applied beta-blockers (such as timolol eye drops for the treatment of glaucoma).
• Certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine).
• Antidiabetic medicines, including insulin.
• Anaesthetic agents (e.g. during surgical procedures).
• Digitalis, used to treat heart failure.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis, pain, or inflammation (e.g. ibuprofen or diclofenac).
• Any medicine that may lower blood pressure as either a desired or an undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine and amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines for the treatment of a mental illness characterised by loss of contact with reality (phenothiazines such as levomepromazine).
• Mefloquine, used for the prevention or treatment of malaria.
• Medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• Moxisylyte, which is used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding
There is a risk that the use of Bisoprolol Krka during pregnancy may harm the baby. If you are
pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with milk

maternal advice, consult your doctor or pharmacist before using this medicine. He or she will
decide whether you can take Bisoprololo Krka during pregnancy.
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not
recommended during treatment with Bisoprololo Krka.
Children and adolescents
Bisoprololo Krka is not recommended for children and adolescents.
Driving and using machines
Your ability to drive or operate machinery may be affected depending on how you tolerate the
medicine. Be especially cautious at the beginning of treatment, when the dose is increased or the medicine is changed, as well as when combined with alcohol.
Bisoprololo Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., “essentially sodium-free”.

3. How to take Bisoprolol Krka

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet.
Treatment with Bisoprolol Krka requires regular monitoring by your doctor. This is particularly important at the beginning of treatment, when increasing the dose, and when stopping treatment.
Treatment with Bisoprolol Krka is usually long-term.

Hypertension and angina pectoris
Adults including elderly patients
The dose should be individually adjusted. The usual daily dose is 10 mg of bisoprolol.
Depending on your response to the medicine, your doctor may decide to reduce the dose to 5 mg or may decide to increase it to 20 mg. The dose must not exceed 20 mg in a day.

Chronic stable heart failure
Adults including elderly patients
Treatment with bisoprolol should be started at a low dose and gradually increased.
Your doctor will decide how to increase the dose. Normally this will be done 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 of bisoprolol once daily for four weeks;
• 10 mg of bisoprolol once daily as maintenance therapy dose (ongoing). The maximum recommended daily dose is 10 mg of bisoprolol. Depending on your tolerance to the medication, your doctor may decide to extend the intervals between dose increases. If your condition worsens or if you can no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose of bisoprolol lower than 10 mg may be sufficient. Your doctor will advise you accordingly. If you need to stop treatment permanently, your doctor will normally recommend gradually reducing the dose; otherwise, your condition may worsen.

Use in patients with hepatic and/or renal impairment
In patients with mild or moderate renal or hepatic impairment, dosage adjustment is normally not required.
In patients with severe renal impairment (creatinine clearance <20 ml/min) and in patients with severe hepatic impairment, it is recommended not to exceed a daily dose of 10 mg of bisoprolol.

Use in children and adolescents
The use of Bisoprololo Krka is not recommended in children.

If you take more Bisoprololo Krka than you should
If you have taken more Bisoprololo Krka tablets than you should, inform your doctor immediately. Your doctor will decide which measures to take.
Symptoms of overdose may include: slowed heart rate, severe breathing difficulties, dizziness, or tremor (due to reduced blood glucose levels).

If you forget to take Bisoprololo Krka
Do not take a double dose to make up for the forgotten dose. Take your usual dose the following morning.

If you stop taking Bisoprololo Krka
You must not stop taking Bisoprololo Krka without first consulting your doctor. Otherwise, your condition may worsen. Especially in patients with ischemic heart disease, treatment should not be stopped abruptly. If you are considering stopping treatment, your doctor will usually advise gradually reducing the dose.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

As with all medicines, this medicine can cause side effects, although not everyone will experience them.
To prevent serious reactions, consult your doctor immediately if the side effect is severe, occurs suddenly, or worsens rapidly. The most serious side effects are related to heart function:

• Slowing of the heart rate (may affect up to 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). If you experience dizziness or feel weak, or have difficulty breathing, contact your doctor as soon as possible.

Other side effects are listed below according to their frequency:

Common (may affect up to 1 in 10 people):

• fatigue, feeling weak, dizziness, headache
• sensation of cold or tingling in hands or feet
• low blood pressure
• stomach or intestinal problems such as nausea, vomiting, diarrhoea or constipation.

Uncommon (may affect up to 1 in 100 people):

• sleep disorders
• depression
• dizziness when standing up
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.

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

• hearing problems
• allergic rhinitis
• reduced tear production (dry eyes)
• liver inflammation which may cause yellowing of the skin or whites of the eyes
• abnormalities in certain blood tests for liver function or abnormal levels of fats in the blood
• allergic-like reactions such as itching, flushing, rash
• impaired erection
• nightmares, hallucinations
• fainting.

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

• eye irritation and redness (conjunctivitis)
• hair loss

• Onset or worsening of skin desquamation (psoriasis), psoriasiform skin eruption, rash.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol Krka

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 packaging after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Krka contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate. Each film-coated tablet contains 5 mg of bisoprolol fumarate. Each film-coated tablet contains 10 mg of bisoprolol fumarate.
• The other components are microcrystalline cellulose, sodium starch glycolate type A, povidone K30, anhydrous colloidal silica and magnesium stearate (E470b) in the tablet core; and hypromellose 2910, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide (E172) – only for the 5 mg film-coated tablets and the 10 mg film-coated tablets, and red iron oxide (E172) – only for the 5 mg and the 10 mg film-coated tablets in the film coating. See section 2 “Bisoprololo Krka contains sodium”.

Description of the appearance of Bisoprololo Krka and contents of the pack

2.5 mg: film-coated tablets (tablets) of white to almost white colour, oval-shaped, slightly biconvex, engraved on one side (length: 8.3-8.7 mm, width: 5.5 mm, thickness: 3.2-3.7 mm). The tablet can be divided into equal doses.
5 mg: film-coated tablets (tablets) of light yellow to brownish colour, oval-shaped, slightly biconvex, engraved on one side (length: 8.3-8.7 mm, width: 5.5 mm, thickness: 3.2-3.7 mm). The tablet can be divided into equal doses.
10 mg: film-coated tablets (tablets) of light yellow to brownish colour, round-shaped, slightly biconvex, with bevelled edges, engraved on one side (diameter: 10.0-10.3 mm, thickness: 3.1-3.5 mm). The tablet can be divided into equal doses.
Blister (aluminium/aluminium foil): 10, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets per pack. Not all pack sizes may be marketed.
Marketing Authorization Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy
Manufacturers responsible for batch release:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorized in the European Economic Area Member States under the
following names: