BISOPROLOL TARBIS FARMA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Tarbis Farma 10 mg Film-Coated Tablets EFG

bisoprolol fumarate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Bisoprolol Tarbis Farma and what is it used for
2. What you need to know before taking 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 further information

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

The active substance in Bisoprolol Tarbis Farma is bisoprolol. Bisoprolol belongs to a group of medications called beta-blockers. These medications work by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heartbeat and makes the heart more efficient, 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 medications suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking 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 components (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 and toes or turn them pale or blue
• untreated pheochromocytoma, 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 Bisoprolol Tarbis Farma if you have any of the following heart problems:

• acute heart failure
• worsening of heart failure that requires intravenous injection of medications that increase the heart's contractile force
• slow heart rate
• low blood pressure
• certain heart conditions that cause a very slow or irregular heartbeat
• 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 starting to take 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 tumor (pheochromocytoma)
• thyroid disorder.

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

• desensitization treatment (e.g., for the prevention of hay fever), as bisoprolol may make you more likely to experience an allergic reaction or make it more severe
• anesthesia (e.g., for surgery), as 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, coughing, wheezing after exercise, etc. while using this medication.

Children and adolescents

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

Other medications and Bisoprolol Tarbis Farma

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

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

• certain medications used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• certain medications used to treat high blood pressure, angina, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem)
• certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicationswithout consulting your doctor first.

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

• certain medications used to treat high blood pressure or angina (dihydropyridine calcium antagonists such as felodipine and amlodipine)
• certain medications used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medications such as amiodarone)
• locally applied beta-blockers (such as eye drops containing timolol for the treatment of glaucoma)
• certain medications used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medications, including insulin
• anesthetic agents (e.g., during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medications (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac)
• any medication that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medications for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medications 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
• medications used to treat 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 if you can take this medication during pregnancy.

Breastfeeding

It is not known if 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 medication. 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 medication contains bisoprolol, which may produce a positive result in doping tests.

3. How to take Bisoprolol Tarbis Farma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Treatment with bisoprolol requires regular monitoring by your doctor. This is especially necessary at the start of treatment, during dose increases, 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 medication 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 is usually 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 medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, 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 advise you.

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 bisoprolol tablets than you should, inform your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Your doctor will decide what measures are necessary. The symptoms of an overdose may include a reduced heart rate, severe breathing difficulties, 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 about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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 breathing difficulties, contact your doctor as soon as possible.

Other side effects are mentioned below according to their possible frequency of 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, diarrhea, 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
• decreased tear production
• liver inflammation that can cause yellowing of the skin or the whites of the eyes
• certain abnormal blood test results for liver function or fat levels
• 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

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

5. Storage of Bisoprolol Tarbis Farma

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

Do not use this medication after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bisoprolol Tarbis Farma

The active substance is bisoprolol fumarate.

Each tablet contains 10 mg of bisoprolol fumarate.

Other components 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, white to off-white in color, approximately 8.1 mm in diameter and 3.9 ± 0.3 mm in thickness, scored and engraved with "2" and "6" on either side of the score line on one side 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 authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Bisoprolol Amarox 10 mg Filmtabletten

Netherlands: Bisoprolol Amarox 10 mg, filmomhulde tabletten

Spain: Bisoprolol Tarbis Farma 10 mg comprimidos recubiertos con película EFG

Date of the last revision of this package leaflet:February 2024

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