BISOPROLOL TEVA 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Teva 2.5 mg Tablets EFG

bisoprolol fumarate

Contents of the Package Leaflet

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

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

Bisoprolol Teva contains the active substance bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Bisoprolol prevents irregular heartbeats (arrhythmia) during stress and decreases the cardiovascular workload. Bisoprolol also dilates blood vessels and thus facilitates blood flow.

Bisoprolol is used to:

• Treat high blood pressure (hypertension).
• Treat coronary heart disease and chest pain (angina pectoris) caused by lack of oxygen in the heart muscle.
• Treat heart failure in combination with other medicines. Heart failure is the inability of the heart to pump enough blood to meet the body's needs, causing swelling (edema) of the limbs and difficulty breathing.

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

Do not take Bisoprolol Teva

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
• if you have heart failure that has recently occurred or worsened, or if you are receiving treatment for circulatory shock due to acute heart failure by intravenous infusion to help your heart work,
• if you have very low blood pressure or a slow heart rate due to severe heart dysfunction (also called cardiogenic shock),
• if you have heart rhythm disorders, such as sick sinus syndrome, sinoatrial block or second or third degree atrioventricular block,
• if you have a slow heart rate,
• if you have very low blood pressure,
• if you have an untreated tumor that can increase blood pressure (also called pheochromocytoma),
• if you have severe asthma,
• if you have severe blood circulation problems in the limbs, such as intermittent claudication (easily provoked pain in the legs when walking) or Raynaud's syndrome (pale, blue, and finally reddish color in the fingers of the hands or toes associated with pain),
• if you have metabolic acidosis, which is an imbalance of acid-base balance, such as in diabetic patients when blood glucose levels rise too high.

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine, they may want to take special precautions (e.g., provide additional treatment or perform more frequent tests):

• if you have asymptomatic and well-treated heart failure,
• kidney or liver problems,
• if you have problems with your heart valves or have a congenital heart condition.
• if you have had a heart attack in the last three months,
• if you have chronic obstructive pulmonary disease or less severe asthma (if you use bronchodilators, you may need to adjust the doses and monitor your lung function),
• if you are going to undergo surgery or another procedure under sedation or spinal anesthesia (you should inform the anesthesiologist that you are taking bisoprolol),
• if you have diabetes mellitus and your blood glucose levels vary greatly, bisoprolol may mask the symptoms of hypoglycemia and slow the recovery of blood glucose levels,
• if you are on a strict diet,
• if you have hyperthyroidism, bisoprolol may mask the symptoms of hyperthyroidism,
• if you are receiving desensitization treatment, bisoprolol may enhance allergic reactions and more medication may be needed to treat the allergic reaction.
• if you have a mild conduction disorder of the heart (first-degree atrioventricular block),
• if you have chest pain caused by coronary artery spasms (also called Prinzmetal's angina),
• if you wear contact lenses, (bisoprolol may reduce tear production and cause dry eyes),
• history of scaly skin eruption (psoriasis).

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

Children and adolescents

This medicine is not recommended for use in children or adolescents.

Other medicines and Bisoprolol Teva

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

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

• Quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone (used to treat irregular heartbeat or abnormal rhythm)
• Verapamil, diltiazem (used to treat irregular heartbeat and high blood pressure)
• Clonidine, methyldopa, guanfacine, moxonidine, and rilmenidine (for high blood pressure and some neurological diseases)

However, do not stop taking these medicineswithout consulting your doctor first.

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

• nifedipine, felodipine, and amlodipine (used to treat high blood pressure or angina or abnormal heartbeat),
• amiodarone (used to treat irregular heartbeat or abnormal rhythm),
• beta-blockers, including beta-blockers contained in eye drops such as timolol for glaucoma treatment,
• digitalis, used to treat heart failure,
• donepezil or tacrine (for dementia),
• neostigmine or pyridostigmine (for myasthenia gravis, a disease that causes muscle weakness),
• physostigmine for high eye pressure, glaucoma,
• ergot alkaloids (for migraine or high blood pressure),
• other antihypertensive medicines,
• other medicines that may lower blood pressure, such as tricyclic antidepressants (e.g., imipramine or amitriptyline), phenothiazines (e.g., levomepromazine for psychosis) or barbiturates (e.g., phenobarbital for epilepsy),
• adrenaline for allergic reactions,
• baclofen and tizanidine (muscle relaxants),
• amifostine (a protective substance during certain cancer treatments),
• mefloquine (for malaria),
• rifampicin (an antibiotic),
• insulins and other preparations for diabetes mellitus,
• anesthetic agents (used during surgery),
• cortisone orally or intravenously,
• monoamine oxidase inhibitors, i.e., MAOIs (except MAO-B inhibitors) such as moclobemide or phenelzine (for depression).

Non-steroidal anti-inflammatory medicines such as acetylsalicylic acid, diclofenac, ibuprofen, ketoprofen, naproxen, celecoxib, or etoricoxib (especially if used long-term or regularly) may reduce the effectiveness of bisoprolol in treating hypertension. However, small daily doses of acetylsalicylic acid, e.g., 100 mg, can be used safely in combination with bisoprolol to prevent blood clots.

Pregnancy and breastfeeding

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

Bisoprolol should not be used during pregnancy unless clearly necessary. If you are pregnant or planning to become pregnant during treatment with bisoprolol, inform your doctor so that they can advise you on appropriate treatment.

It is not known whether bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during use of this medicine.

Driving and using machines

Bisoprolol has a minimal or non-existent impact on the ability to drive. Adverse effects related to a drop in blood pressure may include dizziness, headache, fatigue, or other adverse effects (see section 4) that may affect the ability to drive or operate machines. If you experience these adverse effects, do not drive vehicles and/or operate machines that require your full attention. In particular, attention is required at the start of treatment and after increasing the dose. Bisoprolol normally does not affect the ability to drive if the treatment is well balanced.

Bisoprolol Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Bisoprolol Teva

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

The recommended dose is

Adults:

For treating hypertension and angina pectoris

• The initial dose is 5 mg once daily.
• Your doctor may increase in small increments (usually every few weeks) to 10 mg or up to 20 mg as needed.

For treating stable chronic heart failure

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 daily for one week.
• 2.5 mg of bisoprolol once daily for one week.
• 3.75 mg of bisoprolol once daily for one week.
• 5 mg of bisoprolol once daily for four weeks.
• 7.5 mg of bisoprolol once daily for four weeks.
• 10 mg of bisoprolol once daily 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.

Elderly patients

No dose adjustment is necessary in elderly patients unless they have renal or hepatic impairment, see below.

Patients with renal or hepatic impairment

The dose should be increased gradually and with caution in patients with severe liver or kidney problems. The dose should not exceed 10 mg once daily in patients with severe renal or hepatic impairment.

Method of administration

Swallow the tablets with sufficient liquid (e.g., a glass of water) usually once daily in the morning. The tablets should not be chewed. Food does not affect the absorption of the medicine.

The tablet can be divided into equal doses. Divide the tablets as follows: place the tablets with the break line facing up on a flat, hard surface (e.g., a table) and divide the tablets by pressing with the index fingers of both hands to the right and left of the break line on the outer part of the tablet towards the surface.

If you take more Bisoprolol Teva than you should

If you have taken an overdose of Bisoprolol Teva, consult your doctor or a hospital immediately.

In case of nausea or dizziness, place the patient in a lying position and seek medical assistance. An unconscious patient should be placed in a recovery position; however, the legs may be elevated.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Bisoprolol Teva

Take the next tablet at the usual time. Do not take a double dose or a larger dose to make up for forgotten doses.

If you stop taking Bisoprolol Teva

Treatment should not be stopped abruptly, especially when the patient has ischemic heart disease. The dose should be reduced slowly, e.g., over 1-2 weeks. Otherwise, the symptoms of heart disease may worsen.

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 adverse reactions, talk 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, among them, the most common adverse effects have been slowing of the heart rate, excessive decrease in blood pressure, dizziness, and fatigue.

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

Very common (may affect more than 1 in 10 people)

• Slowing of the heart rate (in patients with heart failure)

Common (may affect up to 1 in 10 people)

• Dizziness, headache.
• Worsening of heart failure symptoms (in patients with pre-existing heart failure)
• Feeling of cold or numbness in the limbs
• Too low blood pressure (in patients with heart failure)
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation
• Asthenia (in patients with heart failure), fatigue

Uncommon (may affect up to 1 in 100 people)

• Depression, sleep disturbances
• Heart block (conduction disorders of the heart)
• Excessive slowing of the heart rate (in patients with hypertension or coronary heart disease)
• Bronchospasm (wheezing in patients with asthma or chronic obstructive pulmonary disease)
• Muscle weakness, muscle cramps
• Asthenia (in patients with hypertension or angina pectoris)
• Low blood pressure when standing up (orthostatic hypotension)

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

• Nightmares, hallucinations
• Fainting (syncope)
• Reduced tear production (consider if you wear contact lenses)
• Hearing disorders
• Hepatitis (causing upper abdominal pain)
• Allergic reactions, such as itching, flushing, or rash. You should see 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.
• Sexual dysfunction
• High levels of liver enzymes (laboratory tests (ALAT or ASAT)
• Allergic rhinitis (nasal secretion, blocked and itchy)

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

• Conjunctivitis (inflammation of the eyes)
• Hair loss (alopecia), worsening of psoriasis or psoriasis with rash

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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. Storage of Bisoprolol Teva

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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. Storage of the container and additional information

Composition of Bisoprolol Teva 2.5 mg tablets

The active ingredient is bisoprolol fumarate

Each Bisoprolol Teva 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.

The other components are: microcrystalline cellulose (E 460), anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethyl starch type A (derived from potato) and magnesium stearate (E 572).

Appearance of the product and container content

Bisoprolol Teva 2.5 mg tablets are white to off-white, round, biconvex tablets with a score line on one side.

The containers include 20, 21, 28, 30, 50, 56, 60, 90 or 100 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, H62 FH90,

Ireland

Or

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names

Germany: Bisoprolol AbZ 2.5 mg Tabletten

Belgium: Bisoprolol Teva 2.5 mg tablets

Spain: Bisoprolol Teva 2.5 mg tablets EFG

Netherlands: Bisoprololfumaraat 2.5 mg Teva, tablets

Italy: Bisoprololo Doc 2.5 mg compressa

Sweden: Bisoprolol Teva 2.5 mg tablets

United Kingdom (Northern Ireland): Bisoprolol Fumarate 2.5 mg tablets

Date of the last revision of this leaflet: May 2024

Detailed and updated 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/