Patient Information Leaflet

Euradal 10 mg Film-Coated Tablets

Bisoprolol Hemifumarate

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.

1.- What is Euradal and what it is used for

2.- What you need to know before starting to take Euradal

3.- How to take Euradal

4.- Possible side effects

5.- Storage of Euradal

6.- Contents of the pack and additional information.

Bisoprolol, the active ingredient in Euradal, 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 down 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.

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

Do not take Euradal

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

• allergy (hypersensitivity) to bisoprolol or to any of the other components of Euradal (listed in section 6),
• severe asthma or chronic obstructive pulmonary disease,
• serious 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,
• 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 Euradal if you have any of the following heart problems:

• uncontrolled acute heart failure with medication,
• exacerbation of heart failure that requires intravenous medication to 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 conditions, consult your doctor before taking Euradal. Your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• diabetes,
• strict fasting,
• if you are receiving certain allergy treatments (allergy desensitization, for example, for hay fever prevention),
• certain heart conditions such as arrhythmias or severe chest pain at rest (Prinzmetal's angina),
• milder circulatory problems in the extremities,
• severe persistent asthma or chronic lung disease,
• history of scaly skin rash (psoriasis),
• adrenal gland tumor (phaeochromocytoma),
• thyroid disorder.

Inform your doctor if you are going to follow:

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

Children and adolescents

The efficacy and safety of use in children have not been established. Therefore, Euradal is not recommended for use in children and adolescents (under 18 years of age).

Taking Euradal with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription.

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

• certain medicines used to treat high blood pressure, angina, or irregular heartbeat (calcium channel blockers 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 consulting your doctor first.

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

• certain medicines used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type, such as felodipine and amlodipine);
• antiarrhythmics of Class I (such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone). These medicines are used to treat irregular heartbeat or abnormal heartbeat;
• certain medicines used to treat irregular heartbeat or abnormal heartbeat (antiarrhythmics of Class III, such as amiodarone);
• topical beta-blockers (such as eye drops of timolol for glaucoma treatment);
• medicines for the nervous system used to stimulate internal organs or to treat glaucoma (parasympathomimetics) or used in emergency situations to treat severe circulatory problems (sympathomimetics);
• antidiabetic medicines, including insulin;
• anesthetics (for example, during surgery);
• digitalis, used to treat heart failure;
• nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac);
• 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, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental disorders characterized by loss of contact with reality (phenothiazines);
• mefloquine, used to prevent or treat malaria;
• medicines used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors).

Taking Euradal with food, drinks, and alcohol

You can take Euradal with or without food.

Use in athletes

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be administered during pregnancy unless it is strictly necessary.

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

Driving and operating machinery

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 in combination with alcohol.

Follow exactly the administration instructions for Euradal indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

?Dosage

For both indications, the recommended normal dose is 1 Euradal 5 mg tablet or half a Euradal 10 mg tablet (equivalent to 5 mg of bisoprolol) once a day.

If necessary, the dose can be increased to 1 Euradal 10 mg tablet or 2 Euradal 5 mg tablets (equivalent to 10 mg of bisoprolol) once a day.

The maximum recommended dose is 20 mg once a day.

?Use in liver and/or kidney insufficiency

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

?Use in children

The use of Euradal in children is not recommended.

?Use in elderly patients

No dose adjustment is required in elderly patients.

?Method of administration

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

?Duration of treatment

The treatment with Euradal is usually long-term.

If you take more Euradal than you should

If you have taken more Euradal than you should, consult your doctor or pharmacist immediately.

In case of overdose, third-degree AV block, slower pulse, and dizziness have been reported. Symptoms that may appear include: difficulty breathing, weak pulse, decreased blood pressure, dizziness, heart failure, and decreased blood sugar.

In these cases, it is necessary to discontinue treatment with bisoprolol and initiate symptomatic and supportive treatment (which may include the administration of isoprenaline, intravenous fluids, glucagon, diuretics, bronchodilators, and/or glucose, depending on the symptoms and severity of the condition being treated). In some cases, it may be necessary to implant a pacemaker.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Euradal

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

If you interrupt treatment with Euradal

Never stop taking Euradal except on the advice of your doctor. Otherwise, your condition may worsen significantly. Treatment should not be discontinued abruptly, especially in patients with ischemic heart disease. If you need to discontinue 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, Euradal can produce adverse effects, although not all people will experience them.

The following adverse effects are described according to their frequency of appearance:

?Frequent(affect at least 1 in 100 patients):

• fatigue, dizziness, headache: these adverse effects are especially present at the beginning of treatment. They are usually mild and often disappear within 1-2 weeks;
• sensation of coldness or numbness in hands or feet;
• low blood pressure;
• gastrointestinal problems such as nausea, vomiting, diarrhea, or constipation.

?Infrequent(affect at least 1 in 1,000 patients):

• decreased heart rate (bradycardia);
• worsening of heart failure;
• weakness;
• sleep disturbances;
• depression;
• cardiac rhythm problems;
• respiratory problems in patients with asthma or chronic respiratory disease;
• muscle weakness, muscle cramps.

?Rare(affect at least 1 in 10,000 patients):

• increased levels of blood fat;
• hearing problems;
• nasal discharge;
• decreased tear production;
• increased levels of certain liver enzymes (ALAT, ASAT), liver inflammation (hepatitis);
• allergic-like reactions such as itching, redness, skin rash;
• erectile dysfunction;
• nightmares, hallucinations;
• syncope.

?Very Rare(affect fewer than 1 in 10,000 patients):

• irritation and redness of the eyes (conjunctivitis);
• hair loss;
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any other adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

No special storage conditions are required.

Do not use Euradal after the expiration date shown on the packaging 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 the packaging and unused medicines at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Euradal

The active ingredient is hemifumarate of bisoprolol. Each film-coated tablet contains 10 mg of hemifumarate of bisoprolol.

The other components (excipients) are:

• Tablet core: microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate, crospovidone, dihydrogen phosphate of calcium dihydrate.
• Coating: hypromellose, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), macrogol 400.

Appearance of the product and contents of the packaging

The film-coated tablets of Euradal 10 mg are pale orange, round, biconvex, scored on one face and “10” stamped on the other face. The tablet can be divided into two equal halves. There are packaging with 30 and 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last review of this leaflet:June 2012

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