BISOPROLOL KRKA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol Krka 10 mg Film-Coated Tablets EFG

bisoprolol fumarate

Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Bisoprolol Krka and what is it used for
2. What you need to know before you take Bisoprolol Krka
3. How to take Bisoprolol Krka
4. Possible side effects
5. Storing Bisoprolol Krka

1. Contents of the pack and further information

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

The active substance in Bisoprolol Krka 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 the heart rate and makes the heart more efficient at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's need for oxygen and blood supply. 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 to:

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

2. What you need to know before you take Bisoprolol Krka

Do not take Bisoprolol Krka

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

• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• severe asthma.
• severe circulatory problems in your limbs (such as Raynaud's syndrome), which can cause tingling in your fingers or toes or turn them pale or blue.
• untreated pheochromocytoma, which is a rare tumor of the adrenal gland.
• metabolic acidosis, which is 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 of heart failure that requires intravenous medication to increase the heart's pumping strength.
• low blood pressure
• certain heart conditions that cause a very slow or irregular heartbeat.
• cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and poor circulation.

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 (such as providing additional treatment or performing more frequent tests):

• diabetes.
• strict fasting.
• certain heart diseases such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina).
• kidney or liver problems.
• less severe circulatory problems in your limbs.
• mild asthma or chronic lung disease.
• history of scaly skin rash (psoriasis).
• adrenal gland tumor (pheochromocytoma).
• thyroid disorder.
• first-degree heart block (a condition in which the nerve signals to the heart are disrupted, causing the heart to skip beats or beat irregularly).

In addition, inform your doctor if you are going to undergo:

• desensitization treatment (e.g., for hay fever prevention), because Bisoprolol Krka may make you more likely to experience an allergic reaction, or make the reaction more severe.
• anesthesia (e.g., for surgery), because Bisoprolol Krka may affect how your body reacts to this situation.

Other medicines and Bisoprolol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

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

• certain medicines used to treat high blood pressure or angina pectoris or irregular heartbeat (dihydropyridine calcium channel blockers such as nifedipine, felodipine, and amlodipine).
• certain medicines used to treat irregular heartbeat or abnormal heart rhythm (Class III antiarrhythmic medicines such as amiodarone).
• beta-blockers applied locally (such as eye drops of timolol for glaucoma treatment).
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• antidiabetic medicines, including insulin.
• anesthetic agents (e.g., during surgery).
• digitalis, used to treat heart failure.
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac).
• any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensive medicines, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines for treating mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• mefloquine, used for the prevention or treatment of malaria.
• medicines for treating depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• moxisylate, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding

There is a risk that using Bisoprolol Krka during pregnancy may harm the baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take Bisoprolol Krka during pregnancy.

It is not known whether bisoprolol passes into human breast milk. 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 using machines

Your ability to drive or use machines may be affected depending on how well you tolerate the medicine. Be especially careful 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 medicine contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".

3. How to take Bisoprolol Krka

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in 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. Treatment with Bisoprolol Krka requires regular monitoring by your doctor. This is especially necessary at the start of treatment, during dose increase, and when stopping 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 medicine, your doctor may decide to reduce the dose to 5 mg or may decide to increase it to 20 mg. The dose should not exceed 20 mg per day.

Stable chronic 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, and this will usually be done as follows:

• 1.25 mg of bisoprolol once daily for one week
• 2.5 mg of bisoprolol once daily for one week
• 3.75 mg of bisoprolol once daily for one week
• 5 mg of 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 (continuing).

The recommended maximum daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you 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 tell you what to do. Normally, if you need to stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise, your condition may worsen.

Use in patients with renal and/or hepatic impairment

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

In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, it is recommended not to exceed 10 mg of bisoprolol once daily.< p>

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 decrease in heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

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

If you forget to take Bisoprolol Krka

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

If you stop taking Bisoprolol Krka

Do not stop taking Bisoprolol Krka unless your doctor tells you to. Otherwise, your condition could worsen significantly. Treatment should not be stopped abruptly, especially in patients with systolic heart failure. If you are considering stopping treatment, your doctor will normally advise you to gradually reduce the dose.

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

4. Possible side effects

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

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

• slow 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 mentioned other side effects according to their frequency of possible occurrence:

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

• fatigue, weakness, dizziness, headache
• feeling of cold or numbness in hands or feet
• low blood pressure
• stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

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

• sleep disturbances
• depression
• dizziness when standing up
• 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
• runny nose
• decreased tear production (dry eyes)
• liver inflammation that can cause yellowing of the skin or the whites of the eyes
• certain abnormal blood test results for liver function or fat levels
• allergic reactions such as itching, redness, rash. You should consult your doctor immediately if you experience more severe allergic reactions, which can include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• erectile dysfunction
• nightmares, hallucinations
• fainting.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Bisoprolol Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bisoprolol Krka

• The active ingredient is bisoprolol fumarate

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

• The other ingredients are microcrystalline cellulose, sodium starch glycolate type A, povidone K30, colloidal anhydrous 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 and Package Contents of the Product

Light yellowish-brown, slightly biconvex, film-coated tablets with beveled edges, round and scored on one side (diameter: 10.0-10.3 mm, thickness: 2.8-3.6 mm). The tablet can be divided into two equal halves.

Blister packs (Alu/Alu foil): 10, 20, 28, 30, 50, 56, 60, 84, 90, and 100 tablets in a carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

You can request more information about this medicinal product by contacting 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 under the following names:

Date of the last revision of this leaflet: December 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)