Package Leaflet: Information for the Patient

Bisoprolol Krka 10 mg Film-Coated Tablets

bisoprolol fumarate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check the package leaflet for more information.

1. Contents of the pack and other information

The active ingredient in Bisoprolol Krka is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines act by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heartbeat and makes the heart more efficient, pumping blood throughout the body. At the same time, bisoprolol reduces the demand for oxygen and blood supply to the heart. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol Krka is used for:

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

Do not take Bisoprolol Krka

Do not take Bisoprolol Krka if you have any of the following conditions:

• You are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• Severe asthma.
• Severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause tingling in the fingers of the hands and feet or make them pale or blue.
• Untreated phaeochromocytoma, a rare tumor of the adrenal gland.
• Metabolic acidosis, a condition that occurs when there is too much acid in the blood.

Do not take Bisoprolol Krka if you have any of the following heart problems:

• Acute heart failure.
• Worsening heart failure that requires intravenous medication to increase the heart's contraction force.
• Low blood pressure.
• Certain heart conditions that cause a very slow or irregular heart rate.
• Cardiogenic shock, a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol Krka. If you have any of the following conditions, consult your doctor before taking Bisoprolol Krka; your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• Diabetes.
• Strict fasting.
• Certain heart conditions such as arrhythmias or severe chest pain at rest (Prinzmetal's angina).
• Kidney or liver problems.
• Milder circulatory problems in the extremities.
• Milder asthma or chronic lung disease.
• History of scaly skin rash (psoriasis).
• Adrenal gland tumor (phaeochromocytoma).
• Thyroid disorder.
• First-degree heart block (a condition in which nerve signals to the heart are altered, causing occasional missed beats or irregular heartbeats).

Inform your doctor if you are going to:

• Undergo desensitization treatment (for example, to prevent hay fever), because Bisoprolol Krka may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe.
• Undergo anesthesia (for example, for surgery), because Bisoprolol Krka may affect how your body reacts to this situation.

Other medications and Bisoprolol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take the following medications with Bisoprolol Krka without special advice from your doctor:

• Certain medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone).
• Certain medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem).
• Certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However,do not stop taking these medicationswithout consulting your doctor first.

Consult your doctor before taking the following medications with Bisoprolol Krka; your doctor may need to monitor your condition more frequently:

• Certain medications used to treat high blood pressure or angina or irregular heartbeats (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• Certain medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medications such as amiodarone).
• Topically applied beta-blockers (such as eye drops of timolol for the treatment of glaucoma).
• Certain medications used to treat, for example, Alzheimer's disease or for the treatment of glaucoma (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine).
• Antidiabetic medications, including insulin.
• Anesthetic agents (for example, during surgery).
• Digitals used to treat heart failure.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac).
• Any medication that can lower blood pressure as a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medications used to treat mental disorders characterized by a loss of contact with reality (phenothiazines such as levomepromazine).
• Mefloquine, used to prevent or treat malaria.
• Medications used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• Moxisilat, 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 or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take Bisoprolol Krka during pregnancy.

The passage of bisoprolol into human breast milk is unknown. Therefore, breastfeeding is not recommended during treatment with Bisoprolol Krka.

Children and adolescents

Bisoprolol Krka is not recommended for use in children and adolescents.

Driving and operating machinery

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medication. Be especially cautious at the start of treatment, when the dose is increased or the medication is changed, and also in combination with alcohol.

Bisoprolol Krka contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. Monitoring by your doctor is required for treatment with Bisoprolol Krka. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of treatment.

Treatment with Bisoprolol Krka is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

The dose should be adjusted individually. The usual daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may decide to reduce the dose to 5 mg or increase it to 20 mg. The dose should not exceed 20 mg per day.

Chronic stable heart failure

Adults, including elderly patients

Treatment with bisoprolol should be initiated at a low dose and increased gradually.

Your doctor will decide how to increase the dose, and this will usually be done in the following way:

• 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 therapy (continue).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose less than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do. Normally, if you have to discontinue treatment completely, your doctor will advise you to reduce the dose gradually, as otherwise your condition may worsen.

Use in patients with renal and/or hepatic insufficiency

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic insufficiency.

In patients with severe renal insufficiency (creatinine clearance <20

Use in children and adolescents

The use of Bisoprolol Krka is not recommended in children.

If you take more Bisoprolol Krka than you should

If you have taken more Bisoprolol Krka than you should, inform your doctor immediately. Your doctor will decide what measures are necessary.

The symptoms of an overdose may include a reduced heart rate, severe difficulty breathing, a feeling of dizziness, or tremors (due to decreased blood sugar).

In case of overdose or accidental ingestion of Bisoprolol Krka, consult your doctor, pharmacist, hospital, and bring the medication with you or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bisoprolol Krka

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

If you interrupt treatment with Bisoprolol Krka

Do not stop taking Bisoprolol Krka unless your doctor tells you to. Otherwise, your condition may worsen significantly. Treatment should not be interrupted suddenly, especially in patients with systemic heart failure. If you are considering interrupting treatment, your doctor will usually advise you to gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

To prevent serious adverse reactions, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly. The most serious side effects are related to heart function:

• slowing of 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 heartbeats (may affect up to 1 in 100 people)

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

Below are other side effects listed according to their frequency of possible occurrence:

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

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

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

• sleep disturbances
• depression
• dizziness when standing
• respiratory problems in patients with asthma or chronic respiratory disease
• muscle weakness, muscle cramps.

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

• hearing problems
• nasal discharge
• decreased tear production (dry eyes)
• inflammation of the liver that may cause yellowing of the skin or eyes
• abnormal results in liver function tests or abnormal levels of fat
• allergic-like reactions such as itching, redness, skin rash.Consult your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• erectile dysfunction
• nightmares, hallucinations
• syncope.

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

• irritation and redness of the eyes (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis); rash similar to psoriasis.

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bisoprolol Krka

• The active ingredient is bisoprolol fumarate

Each film-coated tablet contains 10 mg of bisoprolol fumarate.

• The other components are microcrystalline cellulose, sodium 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), and red iron oxide (E172) in the coating.

See section 2 “Bisoprolol Krka contains sodium”.

Appearance of the product and contents of the package

Light yellowish pale, slightly biconvex, rounded, and scored on one face (diameter: 10.0-10.3 mm, thickness: 2.8-3.6 mm) film-coated tablets that can be divided into two equal halves.

Aluminum/Aluminum blisters: 10, 20, 28, 30, 50, 56, 60, 84, 90, and 100 tablets in a carton.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of thissummary of product characteristics: December 2021

Further information is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)