Leaflet: information for the user

Bisoprolol Aurovitas 2.5mg film-coated tablets EFG

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. See section 4.

1. What isBisoprolol Aurovitasand what it is used for

2. What you need to know before you start takingBisoprolol Aurovitas

3. How to takeBisoprolol Aurovitas

4. Possible side effects

5. Storage ofBisoprolol Aurovitas

6. Contents of the pack and additional information

The active ingredient of this medication is bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medications called beta-blockers. Beta-blockers protect the heart from excessive activity. These medications act by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol fumarate slows down the heartbeat and makes the heart more efficient, pumping blood throughout the body.

Heart failure occurs when the cardiac muscle is weak or unable to pump enough blood to meet the body's needs.

Bisoprolol is used in combination with other medications to treat chronic stable heart failure.

Bisoprolol is also used to treat high blood pressure (hypertension) and angina pectoris (chest pain caused by blockages in the arteries that supply the cardiac muscle).

Do not take Bisoprolol Aurovitas:

• If you are allergic to bisoprolol fumarate or to any of the other components of this medication (listed in section 6).
• If you have severe asthma or severe chronic lung disease.
• If you have a slow or irregular heartbeat. Consult your doctor if you are unsure.
• If you have very low blood pressure.
• If you have cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.
• If you have severe circulatory problems (such as Raynaud's syndrome) that can cause tingling in your hands and feet or make them pale or blue.
• If you have heart failure that worsens suddenly and/or may require hospitalization.
• If you have metabolic acidosis, a condition known as excessive acid in the blood.
• If you have untreated phaeochromocytoma, a rare tumor of the adrenal gland.

Consult your doctor if you are unsure about anything mentioned above: your doctor will advise you.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Bisoprolol Aurovitas.
• If you have asthma or chronic lung disease.
• If you have diabetes. Bisoprolol may mask the symptoms of low blood sugar.
• If you are fasting from solid food.
• If you are undergoing hypersensitivity reactions (allergy) treatment. Bisoprolol may worsen your allergy or make it difficult to treat frequently.
• If you have certain heart diseases such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina).
• If you have any liver or kidney problems.
• If you have any circulation problems in your extremities.
• If you are to receive general anesthesia during a surgical procedure, inform your doctor that you are taking bisoprolol.
• If you are taking verapamil or diltiazem, medications for heart disease. Concomitant use is not recommended, see also “Other medications and Bisoprolol Aurovitas”.
• If you have (or have had) psoriasis (a recurring skin eruption).
• If you have phaeochromocytoma (an adrenal gland tumor). Your doctor will need to treat it before prescribing bisoprolol.
• If you have a thyroid disorder. Bisoprolol tablets may mask the symptoms of hyperthyroidism.

Consult your doctor if any of the above warnings apply to you, or if they have applied to you previously.

Children and adolescents

Bisoprolol Aurovitas is not recommended for children or adolescents.

Other medications and Bisoprolol AurovitasInform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications cannot be taken at the same time, while others require specific changes (for example, in dosage).

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

• Medications used to control blood pressure or medications for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medications used to treat depression, for example imipramine, amitriptyline, moclobemide.
• Medications for mental health disorders, for example phenothiazines such as levomepromazine.
• Medications used for anesthesia during surgery (see also “Be especially careful with Bisoprolol Aurovitas”).
• Medications used to treat epilepsy, for example barbiturates such as phenobarbital.
• Some anti-inflammatory medications (for example acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medications used for asthma or for nasal congestion.
• Medications used for some eye disorders such as glaucoma (increased intraocular pressure) or used to dilate the pupils.
• Some medications used to treat clinical shock (for example adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication used to treat malaria.

All these medications, as well as bisoprolol, may affect blood pressure and/or cardiac function.

It is also especially important to talk to your doctor if you are using:

Insulin or other diabetes medications. The effect of low blood sugar may be potentiated. The symptoms of low blood sugar may be masked.

Bisoprolol Aurovitas with food, drinks, and alcohol

Bisoprolol Aurovitas can be taken with or without food and should be swallowed with a full glass of water.

Pregnancy, breastfeeding, and fertility

Do not take bisoprolol if you are pregnant or planning to become pregnant. Bisoprolol Aurovitas may be harmful to pregnancy and/or the fetus. There is a higher risk of premature birth, spontaneous abortion, low blood sugar, and reduced heart rate in the child. It may also affect the baby's growth.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

These tablets may make you feel tired, drowsy, or dizzy.

If you experience these adverse effects, do not drive or operate machinery. Be aware of the possibility of these effects, especially at the beginning of treatment, when the medication is changed, and with the use of alcohol.

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

Monitoring by your doctor is required for treatment with bisoprolol. This is particularly necessary at the beginning of treatment, during dose increase, and when treatment is interrupted.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The tablet can be divided into equal doses.

Adults:

Chest pain and hypertension:

Your doctor should start treatment with the lowest possible dose (5 mg). Your doctor will closely monitor you at the beginning of treatment. Your doctor will increase your dose to obtain the most suitable dose for you.

The maximum recommended daily dose is 20 mg once a day.

Patients with kidney problems:

Patients with severe kidney disease should not exceed 10 mg of bisoprolol per day. Please consult your doctor before starting to use this medication.

Patients with liver disease:

Patients with liver disease should not exceed 10 mg of bisoprolol per day. Please consult your doctor before starting to use this medication.

Heart failure:

Before starting to use bisoprolol fumarate, you should have taken other medications for heart failure, including some beta-blockers, diuretics, and cardiac glycosides (as an added possibility).

Treatment with bisoprolol should start with a low dose and be gradually increased.

Your doctor will decide how to increase the dose, which will usually be done as follows:

1.25 mg once a day for a week. If well tolerated, the dose can be increased to:

2.5 mg once a day for the next week. If well tolerated, the dose can be increased to:

3.75 mg once a day for the next week. If well tolerated, the dose can be increased to:

5 mg once a day for the next 4 weeks. If well tolerated, the dose can be increased to:

7.5 mg once a day for the next 4 weeks. If well tolerated, the dose can be increased to:

10 mg once a day as maintenance dose.

The maximum daily dose is 10 mg per day.

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 if you no longer tolerate this medication, it may be necessary to reduce the dose again or interrupt treatment. In some patients, a maintenance dose below 10 mg of bisoprolol may be sufficient.

Your doctor will tell you what to do.

If you need to interrupt treatment completely, your doctor will usually recommend reducing the dose gradually, as otherwise your condition may worsen.

Use in children and adolescents:

The use of bisoprolol is not recommended in children or adolescents.

Older adults:

Generally, no dose adjustment is required. It is recommended to start with the lowest possible dose.

If you consider that the effect of bisoprolol is too strong or too weak, inform your doctor or pharmacist.

Treatment duration:

Treatment with bisoprolol is usually long-term.

The tablet can be divided into equal doses.

If you take more Bisoprolol Aurovitas than you should:

If you have taken more bisoprolol than you should, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 568 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose include drowsiness, dizziness, fatigue, shortness of breath, and/or rapid breathing. Bradycardia, hypotension, reduced cardiac activity, and low blood glucose levels (which may include hunger, sweating, and palpitations) may also occur.

If you forget to take Bisoprolol Aurovitas:

Do not take a double dose to compensate for the missed dose. Take the next dose as soon as you remember and then continue with your usual daily dose the next day.

If you interrupt treatment with Bisoprolol Aurovitas:

Treatment with bisoprolol should not be interrupted abruptly. If you interrupt the use of this medication suddenly, your condition may worsen. The dose of bisoprolol should be gradually reduced over a few weeks, and your doctor will recommend how to do it.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

The most serious side effects are related to heart function:

• Slowing of heart rate (affects more than 1 in 10 patients with chronic heart failure and less than 1 in 100 with hypertension or angina pectoris).
• Worsening of heart failure (affects more than 1 in 100 patients with chronic heart failure and less than 1 in 100 with hypertension or angina pectoris).
• Irregular heartbeats (affects less than 1 in 100 patients).
• Worsening of symptoms of blockage of the main blood vessels in the legs, especially at the beginning of treatment (frequency not established). If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

The following side effects are mentioned below according to their frequency of possible occurrence:

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

• Tiredness*, weakness (in patients with chronic heart failure), dizziness*, headache*.
• Sensation of coldness or numbness in hands or feet.
• Low blood pressure, especially in patients with chronic heart failure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

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

• Sleep disturbances.
• Depression.
• Respiratory problems in patients with asthma or chronic respiratory disease
• Muscle weakness and muscle cramps.
• Weakness (in patients with hypertension or angina pectoris).

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

• Problems with hearing.
• Allergic rhinorrhea.
• Decreased tear production (may be a problem if you wear contact lenses).
• Inflammation of the liver that can cause yellowing of the skin or the white of the eyes.
• Determined results of blood tests for liver function or abnormal levels of fat.
• Allergic reactions similar to those of type I, 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.
• Problems with erection.
• Nightmares, hallucinations.
• Blackouts.

Very rare(may affect up to 1 in 10,000 people):

• Irritation and redness of the eyes (conjunctivitis).
• Loss of hair.
• Appearance or worsening of scaly skin rash (psoriasis); rash similar to psoriasis.

*In the case of treatment for high blood pressure or angina, these symptoms may appear especially at the beginning of treatment, or if your dose changes. They are usually mild symptoms that often disappear within 1-2 weeks.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 25°C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGREpoint of your pharmacy.In case of doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Bisoprolol Aurovitas Composition

• The active ingredient is bisoprolol fumarate. Each tablet contains 2.5 mg of bisoprolol fumarate.

• The other components (excipients) are:

Core:microcrystalline cellulose, calcium hydrogen phosphate, anhydrous colloidal silica, crospovidone (type A), magnesium stearate.

Coating:hypromellose 6cP (E464), titanium dioxide (E171), macrogol 400

Product Appearance and Packaging Contents

Bisoprolol Aurovitas 2.5 mg film-coated tablets are white, round, biconvex, film-coated, scored, and marked with “P” on one face and “2” on the other.

Bisoprolol Aurovitas film-coated tablets are available in blister packs.

Packaging sizes:14, 20, 28, 30, 56, 60, and 100 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19, Venda Nova

2700-487 Amadora,

Portugal.

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Bélgica:Bisoprolol AB 2.5 mg, filmomhulde tabletten

España:Bisoprolol Aurovitas 2.5 mg comprimidos recubiertos con película EFG

Portugal:Bisoprolol Aurovitas

República Checa:Bisoprolol Aurovitas 2.5 mg potahované tablety

Last review date of this leaflet:July 2021

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