EMCONCOR COR 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Emconcor Cor 2.5 mg Film-Coated Tablets

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 Package Leaflet:

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

1. What is Emconcor Cor and what is it used for

The active substance in Emconcor Cor 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.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. Emconcor Cor is used to treat stable chronic heart failure.

Bisoprolol 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 Emconcor Cor

Do not take Emconcor Cor

Do not take Emconcor Cor if you have any of the following conditions:

• allergy (hypersensitivity) to bisoprolol or any of the other ingredients (see section 6 "Composition of Emconcor Cor")
• severe asthma
• severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or turn them pale or blue
• untreated phaeochromocytoma, 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 Emconcor Cor 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 contractile force
• slow heart rate
• low blood pressure
• certain heart conditions that cause a very slow or irregular heart rate
• cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following problems, consult your doctor before starting to take Emconcor Cor; 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 the limbs
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• adrenal gland tumor (phaeochromocytoma)
• thyroid disorder.

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

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

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you start to notice breathing difficulties, coughing, wheezing after exercise, etc. while using Emconcor Cor.

Children and adolescents

Emconcor Cor is not recommended for use in children and adolescents.

Taking Emconcor Cor with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicines.

Do not take the following medicines with Emconcor Cor without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heart rhythm (Class I anti-arrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina, or irregular heart rhythm (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 medicineswithout consulting your doctor first.

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

• certain medicines used to treat high blood pressure or angina (dihydropyridine calcium antagonists such as felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heart rhythm (Class III anti-arrhythmic medicines such as amiodarone)
• locally applied beta-blockers (such as timolol eye drops for the treatment of glaucoma)
• certain medicines used to treat, for example, 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)
• anti-diabetic 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 mental illnesses characterized 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.

Pregnancy and breastfeeding

Pregnancy

There is a risk that the use of Emconcor Cor during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide if you can take Emconcor Cor during pregnancy.

Breastfeeding

It is not known if bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with Emconcor Cor.

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.

3. How to take Emconcor Cor

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Treatment with Emconcor Cor requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when stopping treatment.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The scored tablets can be divided into two equal doses.

Treatment with Emconcor Cor is usually long-term.

Adults, including the elderly

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.

If you take more Emconcor Cor than you should

If you have taken more Emconcor Cor tablets 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 breathing difficulties, dizziness, or tremors (due to low blood sugar).

If you forget to take Emconcor Cor

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

If you stop taking Emconcor Cor

Never stop taking Emconcor Cor except on the advice of your doctor. Otherwise, your condition could worsen significantly.

If you have any further questions on 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 more than 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 breathing difficulties, contact your doctor as soon as possible.

Other side effects are mentioned below according to their frequency of possible occurrence:

Frequent(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
• 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
• decreased tear production
• 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, skin 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); psoriasis-like rash.

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emconcor Cor

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 blister and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emconcor Cor

The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.

The other ingredients are:

• Core of the tablet: anhydrous colloidal silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium phosphate (anhydrous).
• Film coating: dimeticone, macrogol 400, titanium dioxide (E171), hypromellose.

Appearance of the product and contents of the pack

Emconcor Cor 2.5 mg film-coated tablets are white and coriform with a score line on both sides.

Each pack contains 20, 28, 30, 50, 56, 60, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Manufacturer

Merck Healthcare KGaA

Frankfurter Strasse, 250 (Darmstadt) - D-64293 - Germany

or

Merck, S.L.

Merck Industrial Park, 08100 Mollet del Vallés (Barcelona), Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Concor COR

Croatia: Concor COR

Finland: Emconcor CHF

France: Cardensiel

Germany: Concor COR

Ireland: Cardicor

Italy: Sequacor

Luxembourg: Concor Cor

Netherlands: Emcor Deco

Portugal: Concor IC

Spain: Emconcor Cor

Sweden: Emconcor CHF

United Kingdom: Cardicor

Date of last revision of this leaflet: 11/2020

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