EMCONCOR 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Emconcor 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.

Contents of the Package Leaflet:

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

1. What is Emconcor and what is it used for

The active substance in Emconcor 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, 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 and chronic stable angina.

2. What you need to know before you take Emconcor

Do not take Emconcor

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

• allergy to bisoprolol or 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 can cause tingling in the fingers and toes or turn them pale or blue,
• untreated pheochromocytoma, a rare tumor of the adrenal gland,
• metabolic acidosis, a disease 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
• worsening of heart failure that requires intravenous injection of medicines that increase the heart's contractile force,
• cardiogenic shock, a severe acute heart disease that causes a drop in blood pressure and circulatory failure,
• certain heart conditions that cause a very slow heart rate or irregular pulse (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 problems, inform your doctor before taking Emconcor:

• diabetes,
• strict fasting,
• certain heart diseases such as heart failure, arrhythmias, or severe chest pain at rest (Prinzmetal's angina),
• circulatory problems in the legs,
• asthma or chronic respiratory disease. Your doctor may need to change the dose of your asthma medicines,
• chronic obstructive pulmonary disease (COPD),
• 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 allergies), because Emconcor may make you more likely to experience an allergic reaction, or that reaction may be more severe,
• anesthesia (for example, for surgery), because Emconcor may affect how your body reacts to this situation.

Children and Adolescents

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

Using Emconcor with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

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

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

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

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

• Certain medicines used to treat high blood pressure or angina.

• Certain medicines for treating irregular or abnormal heartbeats.

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

• Certain medicines used to treat Alzheimer's disease, dementia, or glaucoma.

• Medicines used in emergency situations to treat severe circulatory disorders.

• Insulin or other diabetes medicines.

• Anesthetics (for example, during surgery).

• Medicines used to treat heart failure (digoxin).

• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation.

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

• Any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensives or certain medicines 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 whether you can take Emconcor during pregnancy.

It is not known whether Emconcor passes into human breast milk. Breastfeeding is not recommended during treatment with Emconcor.

Driving and Using Machines

Your ability to drive or use machines may be affected depending on how you tolerate the medicine. Be especially careful at the start of treatment and when changing doses or medication, and also when combined with alcohol.

Important Information about Some of the Ingredients of Emconcor

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to Take Emconcor

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Treatment with Emconcor should be started 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 or half a tablet of Emconcor 10 mg (equivalent to 5 mg of bisoprolol) once a day.

If necessary, the dose can be increased to one Emconcor 10 mg tablet or 2 Emconcor 5 mg tablets (equivalent to 10 mg of bisoprolol) once a day.

The maximum recommended dose is 20 mg once a day.

Duration of Treatment

Treatment with Emconcor is usually long-term.

Dosage in Case of Hepatic or Renal Impairment

In patients with mild to moderate hepatic or renal impairment, no dose adjustment is normally required. In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, the daily dose should not exceed 10 mg.< p>

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 slow heart rate (bradycardia), difficulty breathing (bronchospasm), severe drop in blood pressure, acute heart failure, or low blood sugar levels.

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

If You Forget to Take Emconcor

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

If You Stop Taking Emconcor

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Emconcor can cause side effects, although not everybody gets them.

These side effects are listed below according to their frequency of possible occurrence:

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

• fatigue, dizziness, headache: These side effects occur especially at the start of treatment. They are usually mild and disappear within 1-2 weeks
• feeling of cold or numbness in hands or feet
• stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation

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

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

Rare(may affect up to 1 in 1,000 people):

• increase in blood fat levels
• decrease in tear production (consider this if you wear contact lenses).
• hearing problems
• allergic rhinitis
• increase in some liver enzymes (ALAT, ASAT), liver inflammation (hepatitis)
• allergic 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)
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash
• hair loss

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting of Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emconcor

No special storage conditions are required.

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 carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Emconcor

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

• The other ingredients are:

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

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

Appearance of the Product and Contents of the Pack

Emconcor 5: Pale yellow, scored, and coriform tablets.

Packs of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Merck, S.L.

María de Molina, 40

28006, Madrid

Spain

Manufacturer:

Merck Healthcare KGaA

Frankfurter Strasse 250

D-64293 Darmstadt

Germany

or

Merck, S.L.

Merck Industrial Estate, 08100

Mollet del Vallés (Barcelona)

Spain

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 Healthcare Products (AEMPS) http://www.aemps.gob.es/