Leaflet: information for the user

Emconcor 5 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

The active ingredient in Emconcor is bisoprolol. Bisoprolol belongs to a group of medications called beta-blockers. These medications act by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows the heart rate and makes the heart more efficient, pumping blood throughout the body. At the same time, it reduces the heart's need for blood and oxygen.

Emconcor is used to treat high blood pressure (elevated blood pressure) and chronic stable angina.

Do not take Emconcor

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

• allergy to bisoprolol or any of the other components of this medication (listed in section 6),
• severe asthma,
• serious circulatory problems in the extremities (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or make them pale or blue,
• untreated phaeochromocytoma, which is a rare tumor of the adrenal gland,
• metabolic acidosis, which is a condition in which there is too much acid in the blood.

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

• acute heart failure
• exacerbation of heart failure requiring intravenous medication that increases the heart's contraction force,
• cardiogenic shock, which is a severe acute heart disease that causes low blood pressure and circulatory failure,
• determined heart conditions that produce a very slow or irregular heart rate (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• slow heart rate that causes problems,
• low blood pressure that causes problems,

Warnings and precautions

If you have any of the following, inform your doctor before taking Emconcor:

• diabetes,
• strict fasting,
• determined heart conditions such as heart failure, heart rhythm disorders, or severe chest pain at rest (Prinzmetal's angina),
• circulation problems in the legs,
• asthma or chronic respiratory disease. Your doctor may need to change your asthma medication dosage,
• respiratory obstructive disease,
• history of scaly skin rash (psoriasis),
• adrenal gland tumor (phaeochromocytoma),
• thyroid disorder.

Also, inform your doctor if you are going to:

• undergo desensitization treatment (for allergy), as Emconcor may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe,
• have anesthesia (for example, for surgery), as Emconcor may affect how your body reacts to this situation.

Children and adolescents

Emconcor is not recommended for use in children or adolescents.

Use of Emconcor with other medications

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

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

• Determined medications used to treat high blood pressure, angina, or irregular heartbeats (such as verapamil and diltiazem).

• Determined medications used to treat high blood pressure, such as clonidine, methyldopa, and moxonidine. However, do not stop taking these medications without consulting your doctor first.

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

• Determined medications used to treat high blood pressure or angina.

• Determined medications for irregular or abnormal heartbeats.

• Some eye drops for glaucoma (containing beta-blockers).

• Some medications used to treat Alzheimer's disease, dementia, or for glaucoma treatment.

• Medications used in emergency situations to treat severe circulatory diseases.

• Insulin or other medications for diabetes.

• Anesthetics (for example, during surgery).

• Medications used to treat heart failure (digoxin).

• Non-steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of arthritis, pain, or inflammation.

• Epinephrine, medication used to treat severe allergic reactions and cardiac arrest.

• Any medication that may lower blood pressure as a desired or undesired effect, such as antihypertensives or certain medications for depression.

• Mefloquine, used for the prevention or treatment of malaria.

Pregnancy and breastfeeding

There is a risk that the use of Emconcor 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 during pregnancy.

The passage of Emconcor into human breast milk is unknown. Breastfeeding is not recommended during treatment with Emconcor.

Driving and operating machinery

Your ability to drive or operate machinery may be affected depending on how you tolerate the medication. Be especially careful at the start of treatment and with changes in dosage or medication, and also in combination with alcohol.

Important information about some of the components of Emconcor

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

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

The treatment with Emconcor should be initiated gradually with low doses, which should be increased gradually. In all cases, the dose should be adjusted individually, particularly according to heart rate and therapeutic success.

Dosage

For both indications, the normal dose is one Emconcor 5 mg tablet or half of an Emconcor 10 mg tablet (equivalent to 5 mg of bisoprolol) once a day.

If necessary, the dose can be increased to one Emconcor 10 mg tablet or two Emconcor 5 mg tablets (equivalent to 10 mg of bisoprolol) once a day.

The maximum recommended dose is 20 mg once a day.

Treatment duration

The treatment with Emconcor is normally long-term.

Dosage in case of liver or kidney insufficiency

In patients with mild to moderate liver or kidney dysfunction, no dose adjustment is usually required. In patients with severe renal insufficiency (creatinine clearance <20

Dosage in the elderly

No dose adjustment is required in the elderly.

Method of administration

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet.

If you take more Emconcor than you should

If you have taken more Emconcor than you should, inform your doctor immediately. Your doctor will decide what actions are necessary.

The symptoms of an overdose include decreased heart rate (bradycardia), difficulty breathing (bronchospasm), sudden drop in blood pressure, acute heart failure, or decreased blood sugar levels.

In case of overdose or accidental ingestion, consult the Toxicological Information Service: Tel. 91.562.04.20.

If you forget to take Emconcor

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

If you interrupt the treatment with Emconcor

Never stop taking Emconcor except on the advice of your doctor. Otherwise, your condition may worsen significantly. The treatment should not be interrupted abruptly, especially in patients with ischemic heart disease. If you need to interrupt the treatment, your doctor will instruct you on how to gradually reduce the dose.

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

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

The following side effects are listed in order of their possible frequency of occurrence:

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

• fatigue, dizziness, headache: These side effects are especially common at the beginning of treatment. They are usually mild and typically resolve within 1-2 weeks
• sensation of coldness or numbness in hands or feet
• gastrointestinal problems such as nausea, vomiting, diarrhea, or constipation

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

• decreased heart rate (bradycardia)
• worsening of heart failure
• weakness
• sleep disturbances
• depression
• low blood pressure
• cardiac arrhythmias
• respiratory problems in patients with asthma or chronic respiratory disease
• muscle weakness and muscle cramps

Rare(may affect up to 1 in 1000 people):

• increased levels of blood fat
• decreased tear production (note this if you wear contact lenses)
• hearing problems
• allergic rhinorrhea
• increased levels of certain liver enzymes (ALAT, ASAT), liver inflammation (hepatitis)
• allergic-like reactions such as itching, redness, skin rash. Immediately consult your doctor 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):

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

No special conservation conditions are required.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Emconcor

• The active ingredient is bisoprolol fumarate. Each Emconcor 5 tablet contains 5 mg.

• The other components are:

Tablet core:anhydrous colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, anhydrous calcium hydrogen phosphate.

Covering:titanium dioxide (E 171), macrogol 400, dimethicone, yellow iron oxide (E 172), hypromellose.

Appearance of the product and contents of the packaging

Emconcor 5: pale yellow, scored on both sides, and cylindrical tablets.

Packaging of 60 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the Marketing Authorization:

Merck, S.L.

María de Molina, 40

28006, Madrid

Spain

Responsible for manufacturing

Merck Healthcare KGaA

Frankfurter Strasse 250

D-64293 Darmstadt

Germany

or

Merck, S.L.

Merck Industrial Estate, 08100

Mollet del Vallés (Barcelona)

Spain

Last review date of this leaflet: 11/2020

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