Leaflet: information for the user

Emconcor Cor 2.5mg 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Emconcor Cor

3.How to take Emconcor Cor

4.Possible side effects

5.Storage of Emconcor Cor

6.Contents of the pack and additional information

The active ingredient in Emconcor Cor is bisoprolol. Bisoprolol belongs to a group of medications called beta-blockers. These medications 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.

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 chronic stable heart failure.

Bisoprolol is used in combination with other suitable medications for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

Do not take Emconcor Cor

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

• allergy (hypersensitivity) to bisoprolol or to any of the other components (see section 6 “Composition of Emconcor Cor“)
• severe asthma
• severe circulatory problems in the extremities (such as Raynaud's syndrome), which may cause numbness in the fingers of the hands and feet or make them pale or blue
• un-treated 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 one of the following heart problems:

• acute heart failure
• exacerbation of heart failure that requires intravenous injection of medications that increase the heart's contraction force
• slow heart rate
• low blood pressure
• certain heart conditions that produce a very slow heart rate or irregular pulse
• cardiogenic shock, which is a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.

Warnings and precautions

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

Also, inform your doctor if you are going to:

• undergo desensitization treatment (for example, for hay fever prevention), because Emconcor Cor may make it more likely that you will experience an allergic reaction, or that such a reaction may be more severe
• anesthesia (for example, 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 children or adolescents.

Emconcor Cor with other medications

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

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

• determinados medicamentos utilizados para tratar el latido cardiaco irregular o anormal (medicamentos antiarrítmicos de Clase I como la quinidina, disopiramida, lidocaína, fenitoína; flecainida, propafenona)
• determinados medicamentos utilizados para tratar la presión arterial alta, angina de pecho o latido cardiaco irregular (antagonistas del calcio como verapamilo y diltiazem)
• determinados medicamentos utilizados para tratar la presión arterial alta tales como la clonidina, metildopa, moxonodina, rilmenidina. Sin embargo,do not stop taking these medicationswithout consulting your doctor first.

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

• determinados medicamentos utilizados para tratar la presión arterial alta o angina de pecho (antagonistas del calcio del tipo de la dihidropiridina como el felodipino y el amlodipino)
• determinados medicamentos utilizados para tratar el latido cardiaco irregular o anormal (medicamentos antiarrítmicos de Clase III como la amiodarona)
• beta-bloqueantes aplicados localmente (como gotas oculares de timolol para el tratamiento del glaucoma)
• determinados medicamentos utilizados para tratar, por ejemplo, la enfermedad de Alzheimer o para el tratamiento del glaucoma (parasimpaticomiméticos como la tacrina o el carbacol) o medicamentos que se utilizan para tratar problemas cardiacos agudos (simpaticomiméticos como la isoprenalina y dobutamina)
• medicamentos antidiabéticos incluyendo la insulina
• agentes anestésicos (por ejemplo durante la cirugía)
• digitálicos, utilizados para tratar la insuficiencia cardiaca
• antiinflamatorios no esteroideos (AINEs) utilizados para el tratamiento de la artritis, el dolor o la inflamación (por ejemplo, ibuprofeno o diclofenaco)
• cualquier medicamento que pueda disminuir la presión arterial como efecto deseado o no deseado, como los antihipertensivos, determinados medicamentos para la depresión (antidepresivos tricíclicos como imipramina o amitriptilina), determinados medicamentos utilizados para tratar la epilepsia o durante la anestesia (barbitúricos como el fenobarbital), o determinados medicamentos para tratar enfermedades mentales caracterizadas por la pérdida de contacto con la realidad (fenotiazinas como la levomepromazina)
• mefloquina, utilizada para la prevención o el tratamiento de la malaria
• medicamentos para el tratamiento de la depresión llamados inhibidores de la monoaminooxidasa (excepto los inhibidores de MAO-B) como la moclobemida.

Pregnancy and lactation

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.

Lactation

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

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.

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

The treatment with Emconcor Cor requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase and at the end of 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.

The treatment with Emconcor Cor is usually long-term.

Adults, including elderly

The 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 be done normally as follows:

• 1.25mg of bisoprolol once a day for one week
• 2.5mg of bisoprolol once a day for one week
• 3.75mg of bisoprolol once a day for one week
• 5mg of bisoprolol once a day for four weeks
• 7.5mg of bisoprolol once a day for four weeks
• 10mg of bisoprolol once a day as maintenance therapy (continue).

The maximum recommended daily dose is 10mg 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 10mg 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.

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 reduced heart rate, severe difficulty breathing, dizziness, or tremors (due to decreased blood sugar).

If you forgot to take Emconcor Cor

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

If you discontinue treatment with Emconcor Cor

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

To prevent serious adverse reactions, talk to your doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

The most serious side effects are related to heart function:

• Slowed heart rate (may affect more than 1 in 10 people)
• Worsening 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 possible frequency of 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
• inflammation of the liver that may cause yellowing of the skin or the white part of the eyes
• abnormal results of blood tests for liver function 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 side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.You can also report side effects directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Emconcor Cor

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

The other components are:

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Responsible for manufacturing

Merck Healthcare KGaA

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

or

Merck, S.L.

Polígono Merck, 08100 Mollet del Vallés (Barcelona), Spain

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

Austria:Concor COR

Croatia:Concor COR

Finland:Emconcor CHF

France:Cardensiel

Germany:Concor COR

IrelandCardicor

Italy:Sequacor

Luxembourg:Concor Cor

Netherlands:Emcor Deco

Portugal:Concor IC

Spain:Emconcor Cor

Sweden:Emconcor CHF

United Kingdom:Cardicor

Last review date of this leaflet: 11/2020

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