Bisoprolol Krka 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bisoprolol Krka 5 mg Film-coated Tablets EFG

bisoprolol fumarate

Read this entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Bisoprolol Krka is and what it is used for
2. What you need to know before taking Bisoprolol Krka
3. How to take Bisoprolol Krka
4. Possible adverse effects
5. How to store Bisoprolol 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 called beta-blockers. These medicines work by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows the heartbeat and makes the heart more efficient at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and its 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 appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking Bisoprolol Krka

Do not take Bisoprolol Krka

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

• are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• severe asthma.
• severe circulatory problems in the limbs (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make them pale or blue.
• untreated phaeochromocytoma, which is a rare tumour 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 requiring intravenous injection of medicines that increase the force of the heart's contraction.
• low blood pressure.
• certain heart conditions causing a very slow heart rate or irregular pulse.
• cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions

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

• diabetes.
• strict fasting.
• certain heart diseases such as heart rhythm disorders, or severe chest pain at rest (Prinzmetal's angina).
• kidney or liver problems.
• less severe circulatory problems in your limbs.
• less severe asthma or chronic lung disease.
• history of scaly skin rash (psoriasis).
• tumour of the adrenal gland (phaeochromocytoma).
• thyroid disorder.
• first-degree heart block (a condition in which nerve signals to the heart are disturbed, possibly causing occasional missed beats or irregular heartbeat).

In addition, inform your doctor if you are undergoing:

• desensitisation treatment (for example, to prevent hay fever), because Bisoprolol Krka may make it more likely that you experience an allergic reaction, or that such a reaction may be more severe.
• anaesthesia (for example, for surgery), because Bisoprolol Krka may affect how your body responds to this situation.

Other medicines and Bisoprolol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 or abnormal heartbeats (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone).
• certain medicines used to treat high blood pressure, angina, or irregular heartbeat (calcium antagonists 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 medicines without first consulting your doctor.

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, angina, or abnormal heartbeat (calcium antagonists of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone).
• locally applied beta-blockers (such as timolol eye drops for the treatment of glaucoma).
• certain medicines used, for example, for Alzheimer's disease or for the treatment of 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.
• anaesthetic agents (for example, during surgery).
• digitalis, used to treat heart failure.
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac).
• any medicine that may lower blood pressure as either a desired or unwanted effect, such as antihypertensives, certain medicines for depression (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 mental illnesses 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.
• moxisylylate, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breast-feeding

There is a risk that using Bisoprolol Krka during pregnancy may harm the baby. If you are pregnant or breast-feeding, 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, breast-feeding 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 machinery 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 when medication is changed, and also when taking alcohol.

Bisoprolol Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; essentially, "sodium-free".

3. How to take Bisoprolol Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If you are 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 particularly necessary at the beginning of treatment, during dose escalation, and when stopping treatment.

Treatment with Bisoprolol Krka is usually long-term.

High blood pressure and angina pectoris

Adults, including elderly patients

The dose should be individually adjusted. 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 must 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 gradually increased.

Your doctor will decide how to increase the dose, and this will normally 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 (ongoing) therapy.

The maximum recommended 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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will advise you what to do. Normally, if treatment has to be completely discontinued, 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

Dose adjustment is normally not 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.

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.

Symptoms of overdose may include a reduced 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, or hospital immediately, and bring the medicine with you or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Krka

Do not take a double dose to make up for missed 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 must not be stopped suddenly, especially in patients with systemic heart failure. If you are considering stopping treatment, your doctor will usually 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

To prevent serious reactions, speak to a doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly. The most serious adverse 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.

Other adverse effects, listed below according to their possible frequency of occurrence:

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

• tiredness, weakness, dizziness, headache
• cold sensation or numbness 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 disturbances
• depression
• dizziness upon standing
• breathing 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
• reduced tear production (dry eyes)
• liver inflammation that may cause yellowing of the skin or whites of the eyes
• certain abnormal blood test results for liver function or fat levels
• allergic-type reactions such as itching, redness, skin rash. You should 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
• fainting.

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

• eye irritation and redness (conjunctivitis)
• hair loss
• onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Krka

• The active substance is bisoprolol fumarate.

Each film-coated tablet contains 5 mg of bisoprolol fumarate.

• The other components 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 of the product and pack contents

Film-coated tablets, slightly biconvex, pale yellowish-brown, oval-shaped, and scored on one side (length: 8.3–8.7 mm, width: 5.5 mm, thickness: 2.8–3.6 mm). The tablet may be divided into two equal parts.

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

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 European Economic Area (EEA) Member States under the following names:

Date of the most recent review of this leaflet: December 2021

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