Bisoprolol Aurovitas 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol Aurovitas 2.5 mg film-coated tablets EFG

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 must not be given to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

1. What Bisoprolol Aurovitas is and what it is used for
2. What you need to know before taking Bisoprolol Aurovitas
3. How to take Bisoprolol Aurovitas
4. Possible adverse effects
5. How to store Bisoprolol Aurovitas
6. Contents of the pack and other information

1. What Bisoprolol Aurovitas is and what it is used for

The active substance in this medicine is bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart from excessive activity. These medicines work by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol fumarate slows the heartbeat and makes the heart more efficient at pumping blood throughout the body.

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

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

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

2. What you need to know before taking Bisoprolol Aurovitas

Do not take Bisoprolol Aurovitas:

• If you are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (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, which is a serious and acute heart condition causing low blood pressure and circulatory failure.
• If you have severe circulatory problems (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make them pale or blue.
• If you have heart failure that suddenly worsens and/or may require hospitalization.
• If you have excess acid in the blood, a disorder known as metabolic acidosis.
• If you have untreated phaeochromocytoma, which is a rare tumor of the adrenal gland.

Consult your doctor if you are unsure about any of the 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 levels.
• If you are fasting from solid food.
• If you are undergoing treatment for hypersensitivity reactions (allergy). Bisoprolol may worsen your allergy or make it more difficult to treat.
• If you have certain heart conditions such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina).
• If you have liver or kidney problems.
• If you have circulation problems in your limbs.
• If you are due to receive general anesthesia during surgery, inform your doctor that you are taking bisoprolol.
• If you are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended; see also “Other medicines and Bisoprolol Aurovitas”.
• If you have (or have had) psoriasis (a recurrent skin rash).
• If you have phaeochromocytoma (a tumor of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol.
• If you have a thyroid disorder. Bisoprolol tablets may mask symptoms of an overactive thyroid.

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

Children and adolescents

The administration of Bisoprolol Aurovitas is not recommended in children and adolescents.

Other medicines and Bisoprolol Aurovitas Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines cannot be taken at the same time, while others may require specific adjustments (e.g., in dosage).

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

• Medicines used to control blood pressure or medicines for heart problems (e.g., amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medicines used to treat depression, for example imipramine, amitriptyline, moclobemide.
• Medicines for treating mental illnesses, for example phenothiazines such as levomepromazine.
• Anaesthetic medicines used during surgery (see also “Take special care with Bisoprolol Aurovitas”).
• Medicines used to treat epilepsy, for example barbiturates such as phenobarbital.
• Some anti-inflammatory medicines (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines used for asthma or nasal congestion.
• Medicines used for certain eye disorders such as glaucoma (increased eye pressure) or used to dilate the pupils.
• Some medicines used to treat clinical shock (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine used to treat malaria.

All of these medicines, as well as bisoprolol, can affect blood pressure and/or heart function.

It is also especially important that you speak with your doctor if you are using:

Insulin or other medicines for diabetes. The blood glucose-lowering effect may be enhanced. Symptoms of low blood sugar may be masked.

Bisoprolol Aurovitas with food, drinks and alcohol

Bisoprolol Aurovitas may 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 an increased risk of premature birth, miscarriage, low blood sugar levels, and reduced heart rate in the baby. The baby's growth may also be affected.

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

Driving and using machines

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

If you experience these side effects, do not drive or operate machinery. Be aware of the possibility of such effects, especially at the beginning of treatment, when the medication is adjusted, and when used together with alcohol.

3. How to take Bisoprolol Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment with bisoprolol 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. 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 find the most appropriate dose for you.

The maximum recommended dose is 20 mg once daily.

Patients with kidney problems:

Patients with severe renal disease must not exceed 10 mg of bisoprolol per day. Please consult your doctor before starting to use this medicine.

Patients with liver disease:

Patients with hepatic disease must not exceed 10 mg of bisoprolol per day. Please consult your doctor before starting to use this medicine.

Heart failure:

Before starting to use bisoprolol fumarate, you should have already been treated with other heart failure medications, including an ACE inhibitor, diuretics, and cardiac glycosides (as an additional option).

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

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

1.25 mg once daily for one week. If well tolerated, the dose may be increased to:

2.5 mg once daily for the following week. If well tolerated, the dose may be increased to:

3.75 mg once daily for the following week. If well tolerated, the dose may be increased to:

5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to:

7.5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to:

10 mg once daily as maintenance dose.

The maximum daily dose is 10 mg per day.

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 this 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 advise you what to do.

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

Use in children and adolescents

Bisoprolol is not recommended for use in children or adolescents.

Elderly patients

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

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

Duration of treatment

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 568 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose include dizziness, lightheadedness, fatigue, shortness of breath and/or gasping. There may also be a slowed heart rate, low blood pressure, inadequate heart function, and low blood sugar (which may include hunger, sweating, and palpitations).

If you forget to take Bisoprolol Aurovitas

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

If you stop taking Bisoprolol Aurovitas

Treatment with bisoprolol must not be stopped abruptly. If you stop taking this medicine suddenly, your condition may worsen. The dose of bisoprolol should be gradually reduced over several weeks; your doctor will advise you how to do this.

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

4. Possible adverse effects

Like all medicines, this medicine can 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 (affects more than 1 in 10 patients with chronic heart failure and less than 1 in 100 patients 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 patients with hypertension or angina pectoris).
• Irregular heartbeats (affects less than 1 in 100 patients).
• Worsening of symptoms of blockage in the main blood vessels of 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.

Other adverse effects, listed below by their possible frequency of occurrence:

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

• Fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*.
• Feeling cold or numbness in hands or feet.
• Low blood pressure, especially in patients with chronic heart failure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea or constipation.

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

• Sleep disturbances.
• Depression.
• Breathing 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):

• Hearing problems.
• Allergic nasal discharge.
• Reduced tear production (may be an issue if you wear contact lenses).
• Inflammation of the liver, which may cause yellowing of the skin or whites of the eyes.
• Certain abnormal blood test results for liver function or fat levels.
• Allergy-like reactions such as itching, redness, or 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 problems.
• 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.

*When treating high blood pressure or angina, these symptoms may occur especially at the beginning of treatment or if your dose changes. Usually, they are mild symptoms that often disappear within 1–2 weeks.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Aurovitas

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

• The other components (excipients) are:

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

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

Appearance of the product and contents of the container

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

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:

Belgium: Bisoprolol AB 2.5 mg, filmomhulde tabletten

Spain: Bisoprolol Aurovitas 2.5 mg film-coated tablets EFG

Portugal: Bisoprolol Aurovitas

Czech Republic: Bisoprolol Aurovitas 2.5 mg potahované tablety

Date of the most recent review of this leaflet: July 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)