BISOPROLOL TARBIS FARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Tarbis Farma 2.5 mg 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 Tarbis Farma is and what it is used for
2. What you need to know before you take Bisoprolol Tarbis Farma
3. How to take Bisoprolol Tarbis Farma
4. Possible side effects
5. Storage of Bisoprolol Tarbis Farma
6. Contents of the pack and other information

1. What Bisoprolol Tarbis Farma is and what it is used for

The active substance in Bisoprolol Tarbis Farma 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 at pumping blood throughout the body.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. Bisoprolol is used to treat stable chronic heart failure.

Bisoprolol is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before you take Bisoprolol Tarbis Farma

Do not take Bisoprolol Tarbis Farma

Do not take Bisoprolol Tarbis Farma if you have any of the following conditions:

• allergy (hypersensitivity) to bisoprolol or any of the other ingredients (see section 6 "Composition of Bisoprolol Tarbis Farma")
• severe asthma
• severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling in the fingers or toes or turn them pale or blue
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• metabolic acidosis, which is a condition that occurs when there is too much acid in the blood.

Do not take Bisoprolol Tarbis Farma 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 contractions
• slow heart rate
• low blood pressure
• certain heart conditions that cause a very slow or irregular heart rate
• cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following problems, consult your doctor before taking Bisoprolol Tarbis Farma; your doctor may want to take special precautions (such as providing additional treatment or performing more frequent tests):

• diabetes
• strict fasting
• certain heart diseases such as arrhythmias or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• less severe circulatory problems in the limbs
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• adrenal gland tumour (phaeochromocytoma)
• thyroid disorder.

In addition, inform your doctor if you are going to undergo:

• desensitization treatment (e.g. for the prevention of hay fever), because bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe
• anaesthesia (e.g. for surgery), because bisoprolol may affect how your body reacts to this situation.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you start to notice breathing difficulties, cough, wheezing after exercise, etc. while using this medicine.

Children and adolescents

Bisoprolol is not recommended for use in children and adolescents.

Other medicines and Bisoprolol Tarbis Farma

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

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

• certain medicines used to treat irregular or abnormal heartbeats (Class I anti-arrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina, or irregular heartbeats (calcium antagonists 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 medicineswithout consulting your doctor first.

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

• certain medicines used to treat high blood pressure or angina (dihydropyridine calcium antagonists such as felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeats (Class III anti-arrhythmic medicines such as amiodarone)
• locally applied beta-blockers (such as eye drops containing timolol for the treatment of glaucoma)
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• anti-diabetic medicines, including insulin
• anaesthetics (e.g. during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g. ibuprofen or diclofenac)
• any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for the prevention or treatment of malaria
• medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

Pregnancy

There is a risk that the use of bisoprolol 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 this medicine during pregnancy.

Breastfeeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and using machines

Your ability to drive or use machines may be affected depending on how well you tolerate the medicine. Be especially careful at the start of treatment, when the dose is increased, or the medication is changed, and also in combination with alcohol.

Use in athletes

This medicine contains bisoprolol, which may produce a positive result in doping tests.

3. How to take Bisoprolol Tarbis Farma

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

Treatment with bisoprolol requires regular monitoring by your doctor. This is especially important at the start of treatment, during dose increase, 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 scored tablets can be divided into two equal doses.

Treatment with this medicine is usually long-term.

Adults, including the elderly

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

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

• 1.25 mg of bisoprolol once a day for one week
• 2.5 mg of bisoprolol once a day for one week
• 3.75 mg of bisoprolol once a day for one week
• 5 mg of bisoprolol once a day for four weeks
• 7.5 mg of bisoprolol once a day for four weeks
• 10 mg of bisoprolol once a day as maintenance therapy (continuing).

The maximum recommended daily dose is 10 mg of bisoprolol.

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

Your doctor will tell you what to do.

Normally, if you need to stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise, your condition may worsen.

If you take more Bisoprolol Tarbis Farma than you should

If you have taken more tablets of bisoprolol than you should, inform your doctor immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Your doctor will decide what measures are necessary. The symptoms of an overdose may include a reduction in heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

If you forget to take Bisoprolol Tarbis Farma

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

If you stop taking Bisoprolol Tarbis Farma

Never stop taking bisoprolol except on the advice of your doctor. Otherwise, your condition could worsen significantly.

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

4. Possible side effects

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

To prevent serious side effects, 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 (may affect more than 1 in 10 people)
• worsening of heart failure (may affect up to 1 in 10 people)
• slow or irregular heartbeats (may affect up to 1 in 100 people)

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:

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

• fatigue, weakness, dizziness, headache
• feeling of cold or numbness in hands or feet
• low blood pressure
• stomach or intestinal problems such as nausea, vomiting, diarrhoea, or constipation.

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

• sleep disturbances
• depression
• dizziness when standing up
• breathing problems in patients with asthma or chronic respiratory disease
• muscle weakness, muscle cramps.

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

• hearing problems
• runny nose
• reduced tear production
• liver inflammation that can cause yellowing of the skin or the whites of the eyes
• certain blood test results for liver function or fat levels that are outside the normal range
• allergic reactions such as itching, redness, skin rash. You should consult your doctor immediately if you experience more severe allergic reactions, which can 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)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es.

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

5. Storage of Bisoprolol Tarbis Farma

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 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Tarbis Farma

The active substance is bisoprolol fumarate.

Each tablet contains 2.5 mg of bisoprolol fumarate.

The other ingredients are:

Core of the tablet: Microcrystalline cellulose, calcium hydrogen phosphate, crospovidone, colloidal anhydrous silica, magnesium stearate.

Film coating: Poly(vinyl alcohol) - partially hydrolyzed (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E 172)

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, round in shape, yellow in colour, approximately 8.1 mm in diameter and 3.8 ± 0.3 mm in thickness, scored on one side with "2" and "4" on either side of the score line and "H" and "B" on either side of the score line on the other side.

The tablet can be divided into two equal doses.

Blisters containing 28, 30, 50, 60, 90, 100, and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Bisoprolol Amarox 2.5 mg film-coated tablets

Netherlands: Bisoprolol Amarox 2.5 mg, film-coated tablets

Spain: Bisoprolol Tarbis Farma 2.5 mg film-coated tablets EFG

Date of the last revision of this leaflet:February 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/