Leaflet: information for the user

Bisoprolol Teva 2.5mg tablets EFG

bisoprolol fumarate

Bisoprolol Teva contains the active ingredient bisoprolol fumarate.Bisoprolol belongstoagroup of medicines calledbeta-blockers.Bisoprolol prevents irregular heartbeats (arrhythmia) during stress and reduces the cardiovascular workload. Bisoprolol also dilates blood vessels and therefore facilitates blood flow.

Bisoprolol is used for:

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

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, which has recently occurred or has recently worsened, or are receiving treatment for acute heart failure due to circulatory shock by intravenous infusion to help your heart work,
• if you have very low blood pressure or a slow heart rate due to severe heart failure (also known as cardiogenic shock),
• if you have heart rhythm disorders, such as sinus dysfunction 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 known as pheochromocytoma),
• if you have severe asthma,
• if you have severe circulatory disorders in the limbs, such as intermittent claudication (easily provoked pain in the legs when walking) or Raynaud's syndrome (white, blue, and finally red discoloration of the fingers of the hands or feet associated with pain),
• if you have metabolic acidosis, which is an imbalance of the acid-base equilibrium, such as in diabetic patients when the blood glucose level is too high.

Warnings and precautions

Inform your doctor or pharmacist before taking this medicine, they may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• if you have asymptomatic and well-treated heart failure,
• kidney or liver problems,
• if you have heart valve problems or a congenital heart condition.
• if you have had a heart attack in the past three months,
• if you have chronic obstructive pulmonary disease or mild asthma (if you use bronchodilators, you may need to adjust the doses and monitor your lung function),
• if you are about to undergo surgery or other procedure under sedation or spinal anesthesia (you must inform the anesthetist 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 down the recovery of blood glucose levels,
• if you are following 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 known as Prinzmetal's angina),
• if you wear contact lenses, (bisoprolol may reduce tear excretion and cause dry eyes),
• history of a scaly skin rash (psoriasis).

If you have chronic obstructive pulmonary disease or mild asthma, inform your doctor immediately if you start to notice difficulty breathing, coughing, wheezing after exercise, etc., while taking bisoprolol.

Children and adolescents

This medicine is not recommended for children or adolescents.

Other medicines and Bisoprolol Teva

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

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 or abnormal heartbeats)
• Verapamil, diltiazem (used to treat irregular heartbeats and high blood pressure)
• Clonidine, methyldopa, guanfacine, moxonidine, and rilmenidine (to treat 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 irregular heartbeats),
• amiodarone (used to treat irregular heartbeats or abnormal heartbeats),
• beta-blockers, including those contained in eye drops such as timolol for glaucoma treatment,
• digitalis, used to treat heart failure,
• donepezil or tacrine (to treat dementia),
• neostrigmina or pridostigmina (to treat myasthenia gravis, a disease that causes muscle weakness,
• physostigmine for treating high eye pressure, glaucoma,
• the so-called ergot alkaloids (to treat migraine or high blood pressure),
• other antihypertensive drugs,
• other drugs that may lower blood pressure such as tricyclic antidepressants (such as imipramine or amitriptyline), phenothiazines (such as levomepromazine (to treat psychosis) or barbiturates such as phenobarbital (to treat epilepsy),
• adrenaline for treating allergic reactions,
• baclofen and tizanidine (muscle relaxants),
• amifostine (a protective substance during certain cancer treatments),
• mefloquine (to treat malaria),
• rifampicin (an antibiotic),
• insulins and other preparations for treating diabetes mellitus,
• anesthetic agents (used during surgery),
• oral or intravenous cortisone,
• the so-called monoamine oxidase inhibitors, that is, MAOIs (except MAO-B inhibitors) such as moclobemide or phenelzine (to treat depression).

Nonsteroidal anti-inflammatory drugs such as aspirin, diclofenac, ibuprofen, ketoprofen, naproxen, celecoxib, or etoricoxib (especially if used long-term or regularly) may weaken the effectiveness of bisoprolol in treating hypertension. However, small daily doses of aspirin, for example 100 mg, can be used safely concomitantly with bisoprolol to prevent blood clots.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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 to advise you on an appropriate treatment.

The excretion of bisoprolol in breast milk is unknown. Therefore, breastfeeding is not recommended during the use of this medicine.

Driving and operating machinery

Bisoprolol has a minimal or non-existent impact on the ability to drive. Adverse effects related to low blood pressure may include dizziness, headache, fatigue, or other adverse effects (see section 4) that may impair the ability to drive or operate machinery. If you experience these adverse effects, do not drive vehicles and/or machinery that require your full attention. In particular, attention is required at the start of treatment and after increasing the dose. Bisoprolol usually 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; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated 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 a day.
• Your doctor may increase in small increments (usually every few weeks) to 10mg or up to 20 mg as needed

For treating chronic stable heart failure

The treatment with bisoprolol should be initiated at a low dose and increased gradually. Your doctor will decide how to increase the dose, and this will be done normally 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 (continuous)

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may decide to also 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 discontinue treatment. In some patients, a maintenance dose less than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do. Normally, if you have to discontinue treatment completely, your doctor will advise you to reduce the dose gradually, as otherwise your condition may worsen.

Older patients

No dose adjustment is necessary in the elderly unless you have renal or hepatic insufficiency, see below.

Patients with renal or hepatic insufficiency

The dose must be increased gradually and with caution in patients with severe hepatic or renal disease. The dose should not exceed 10 mg once a day in patients with severe renal or hepatic disease.

Method of administration

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

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

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 on their back and request 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 Toxicology Information Service. Telephone 91562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Bisoprolol Teva

Take the next tablet normally when it is time to take it. Do not take a double or higher dose to compensate for the missed doses.

If you discontinue treatment with Bisoprolol Teva

Treatment should not be discontinued abruptly, particularly when the patient has coronary heart disease. The dose should be reduced gradually, for example over 1-2 weeks. Otherwise, the symptoms of heart disease may worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

The most severe side effects are related to heart function, including the most common side effects, which have been slowed heart rate, excessive decrease in blood pressure, dizziness, and fatigue.

Below, other side effects are listed according to their frequency of possible occurrence:

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

• Slowed heart rate (in patients with heart failure)

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• Depression, sleep disturbances
• Heart block (heart conduction disorders)
• Excessive slowing of 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
• Weakness (in patients with hypertension or angina pectoris)
• Low blood pressure in the upright position (orthostatic hypotension)

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

• Nightmares, hallucinations
• Fainting (syncope)
• Reduced tear production (take note if you wear contact lenses)
• Auditory disorders
• Hepatitis (causing upper abdominal pain)
• Hypersensitivity reactions, such as itching, flushing, or rash. Go to 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 potency disorders
• Elevated liver enzyme levels (laboratory tests (ALAT or ASAT)
• Allergic rhinitis (nasal discharge, blocked, and itching)

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 type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and on the blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Bisoprolol Teva 2.5 mg Tablets Composition

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, carboxymethylstarch sodium type A (from potato) and magnesium stearate (E 572).

Appearance of the product and contents of the package

Bisoprolol Teva 2.5 mg tablets are white to off-white, round, biconvex, and have a notch on one face.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas. Madrid

Manufacturer responsible:

Chanelle Medical Unlimited Company

Dublín Road, Loughrea, H62 FH90,

Ireland

Or

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

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

Germany:Bisoprolol AbZ 2.5 mg Tablets

Belgium::Bisoprolol Teva2.5 mg tablets

Spain:Bisoprolol Teva 2.5 mg tablets EFG

Netherlands:Bisoprololfumaraat2.5 mg Teva, tablets

Italy:Bisoprololo Doc2.5 mg tablets

Sweden:Bisoprolol Teva2.5 mg tablets

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

Last review date of this leaflet: May 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/