Emconcor Cor 5 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Emconcor Cor 5mg film-coated tablets

Bisoprolol fumarate

Read the 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 others, 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 Emconcor Cor is and what it is used for
2. What you need to know before taking Emconcor Cor
3. How to take Emconcor Cor
4. Possible adverse effects
5. How to store Emconcor Cor
6. Contents of the pack and other information

1. What Emconcor Cor is and what it is 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 effective 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 appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before starting to 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 to any of the other components (see section 6 “Composition of Emconcor Cor”)
• 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 pheochromocytoma, which is a rare tumor of the adrenal gland
• metabolic acidosis, 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 heart failure requiring intravenous administration of medications that increase the force of heart contraction
• slow heart rate
• low blood pressure
• certain heart conditions causing very slow heart rate or irregular pulse
• cardiogenic shock, a severe and acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following conditions, consult your doctor before starting Emconcor Cor; 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
• chronic lung disease or milder asthma
• history of scaly skin rash (psoriasis)
• tumor of the adrenal gland (pheochromocytoma)
• thyroid disorder.

Additionally, inform your doctor if you are undergoing:

• desensitization treatment (for example, to prevent hay fever), because Emconcor Cor may make allergic reactions more likely or more severe
• anesthesia (for example, for surgery), because Emconcor Cor may affect how your body responds to this situation.

If you have chronic lung disease or milder asthma, inform your doctor immediately if you begin to experience breathing difficulties, coughing, wheezing after exercise, etc., while using Emconcor Cor.

Children and adolescents

The use of Emconcor Cor is not recommended in children and adolescents.

Taking Emconcor Cor with other medicines

Inform 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 Emconcor Cor without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeat (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 Emconcor Cor; your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as 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
• anesthetic 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 a desired or undesired effect, such as antihypertensives, 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 the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

It is unknown whether 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 operate machinery may be affected depending on how well you tolerate the medicine. Be especially cautious at the beginning of treatment, when the dose is increased or the medication is changed, and also when combined with alcohol.

3. How to take Emconcor Cor

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Treatment with Emconcor Cor requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose escalation, 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. Scored tablets may be divided into two equal doses.

Treatment with Emconcor Cor is usually long-term.

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 therapy (ongoing).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 tell you what to do.

Normally, if you need to stop 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.

Symptoms of overdose may include a reduced heart rate, severe breathing difficulty, dizziness, or tremors (due to decreased 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may 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 the 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 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
• feeling cold 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
• 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, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report adverse effects directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the blister pack and the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. 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 5 mg.

The other components are:

• Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous).
• Film coating: yellow iron oxide (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Appearance of the product and contents of the pack

Emconcor Cor 5 mg film-coated tablets are yellowish-white, heart-shaped tablets with a score line on both sides.

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

Only certain 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.

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

This medicine is authorized in the European Economic Area member states 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 the most recent review of this leaflet: 11/2020

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