BISOPROLOL AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Aurovitas 5mg film-coated tablets EFG

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. See section 4.

Contents of the pack

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

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

The active substance of 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 act by affecting the body's response to certain 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 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 that supply the heart muscle).

2. What you need to know before you take Bisoprolol Aurovitas

Do not take Bisoprolol Aurovitas:

• If you are allergic to bisoprolol fumarate or 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 not sure.
• If you have very low blood pressure.
• If you have cardiogenic shock, which is 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 the fingers and toes or turn them pale or blue.
• If you have heart failure that worsens suddenly and/or may require hospitalization.
• If you have excess acid in the blood, a disorder known as metabolic acidosis.
• If you have untreated pheochromocytoma, which is a rare tumor of the adrenal gland.

Consult your doctor if you are not sure 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 can mask the symptoms of low blood sugar levels.
• If you are on a solid food fast.
• If you are being treated for hypersensitivity reactions (allergies). Bisoprolol can worsen your allergy or make it more difficult to treat.
• 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 problems with circulation in your limbs.
• If you are going to be given general anesthesia during surgery, inform your doctor that you are taking bisoprolol.
• If you are taking verapamil or diltiazem, medicines used to treat heart diseases. Concomitant use is not recommended, see also "Other medicines and Bisoprolol Aurovitas".
• If you have (or have had) psoriasis (a recurring skin rash).
• If you have pheochromocytoma (a tumor of the adrenal gland). Your doctor will need to treat you before prescribing bisoprolol.
• If you have a thyroid disorder. Bisoprolol tablets can mask the symptoms of hyperthyroidism.

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

Children and adolescents

Bisoprolol Aurovitas is not recommended for use in children and adolescents.

Other medicines and Bisoprolol Aurovitas

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

Some medicines cannot be taken at the same time while others require specific changes (e.g. in dose).

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 (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medicines used to treat depression, such as imipramine, amitriptiline, moclobemide.
• Medicines used to treat mental illnesses, such as phenothiazines, such as levomepromazine.
• Anesthetic medicines used during surgery (see also "Bisoprolol Aurovitas with food, drinks and alcohol").
• Medicines used to treat epilepsy, such as barbiturates, such as phenobarbital.
• Certain 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.
• Certain medicines used to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine used to treat malaria.

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

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

Insulin or other diabetes medicines. The effect of lowering blood sugar may be enhanced. 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, breast-feeding 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 levels, and reduced heart rate in the child. It may also affect the growth of the baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

If you experience these side effects, do not drive or use machines. Be aware of the possibility of these effects, especially at the start of treatment, when the medication is changed, and with the use of alcohol.

3. How to take Bisoprolol Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the start 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 high blood pressure:

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

The maximum recommended 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 medicine.

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 medicine.

Heart failure:

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

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

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

1.25 mg once a day for one 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 a maintenance dose.

The maximum daily dose is 10 mg per day.

Depending on how well you tolerate the medicine, your doctor may also decide to prolong the time between dose increases. If your disease worsens or if you no longer tolerate this medicine, it may be necessary to reduce the dose again or interrupt treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.

Your doctor will tell you what to do.

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

Use in children and adolescents

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

Elderly patients

In general, 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, talk to 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 568 04 20, indicating the medicine and the amount ingested.

The symptoms of an overdose include dizziness, drowsiness, fatigue, shortness of breath and/or wheezing. Reduced heart rate, low blood pressure, insufficient heart activity, and low blood sugar levels (which may include a feeling of hunger, sweating, and palpitations) may also occur.

If you forget to take Bisoprolol Aurovitas

Do not take a double dose to make up for a forgotten 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 should not be stopped abruptly. If you stop taking this medicine suddenly, your disease may worsen. The dose of bisoprolol should be gradually reduced over a few weeks, your doctor will recommend how to do this.

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

4. Possible side effects

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

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

The most serious side effects are related to heart function:

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

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

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

• Fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*.
• Feeling of 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, diarrhea, or constipation.

Uncommon(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 high blood pressure or angina pectoris).

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

• Hearing problems.
• Allergic rhinitis.
• Decreased tear production (may be a problem if you wear contact lenses).
• Liver inflammation that can cause yellowing of the skin or the whites of the eyes.
• Certain blood test results for liver function or abnormal fat levels.
• Allergic reactions such as itching, redness, rash. You should consult your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, lips, or throat, or difficulty breathing.
• Erectile dysfunction.
• Nightmares, hallucinations.
• Fainting.

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

• Irritation and redness of the eyes (conjunctivitis).
• Hair loss.
• Appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Bisoprolol Aurovitas

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.

Store below 25°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Bisoprolol Aurovitas

• The active ingredient is bisoprolol fumarate. Each tablet contains 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

Appearance of the Product and Packaging Content

Bisoprolol Aurovitas 5 mg film-coated tablets are white, round, biconvex, film-coated, scored and marked with "P" on one side and "5" on the other.

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

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

Only some package 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 5 mg, film-coated tablets

Spain: Bisoprolol Aurovitas 5 mg film-coated tablets EFG

Portugal: Bisoprolol Aurovitas

Czech Republic: Bisoprolol Aurovitas 5 mg film-coated tablets

Date of the last revision of this leaflet:July 2021

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