Leaflet: information for the user

Bisoprolol Teva-ratiopharm 2.5mg tablets EFG

bisoprolol fumarate

Bisoprolol Teva-ratiopharm contains the active ingredient bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-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 medicines. 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-ratiopharm

• if you are allergic to bisoprolol or any of the other ingredients of this medication (listed in section 6),
• if you have heart failure, which has recently occurred or 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 arrhythmias, such as sinus node dysfunction, 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 adrenal gland tumor that can increase blood pressure (also known as pheochromocytoma),
• if you have severe asthma symptoms,
• if you have severe peripheral circulation problems, such as intermittent claudication (pain easily triggered 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, a disturbance of the acid-base balance, such as in diabetic patients when blood glucose levels become too high.

Warnings and precautions

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

• if you have kidney or liver problems,
• if you have heart valve problems or a congenital heart condition,
• if you have had a heart attack within the past three months,
• if you have asthma or chronic obstructive pulmonary disease (if you use bronchodilators, you may need to adjust doses and monitor/monitor your lung function),
• if you are about to undergo surgery or other procedure under sedation or spinal anesthesia (you must inform the anesthesiologist that you are taking Bisoprolol Teva-ratiopharm),
• if you have diabetes mellitus and your blood glucose levels vary greatly (bisoprolol may mask hypoglycemia symptoms and slow the recovery of blood glucose levels),
• if you are on a strict fast,
• if you have hyperthyroidism (bisoprolol may mask 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 (first-degree atrioventricular block),
• if you have chest pain caused by coronary artery spasms (also known as Prinzmetal's angina),
• if you have a history of psoriasis.

If you have a chronic lung disease or mild asthma, please inform your doctor immediately if you begin to experience new breathing difficulties, cough, whistling after exercise, etc., while using bisoprolol.

Children and adolescents

Bisoprolol is not recommended for use in children or adolescents.

Other medications and Bisoprolol Teva-ratiopharm

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

Do not take the following medications with Bisoprolol Teva-ratiopharm without special advice from your doctor:

• Quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone (used to treat irregular or abnormal heartbeats)
• Verapamil and diltiazem (used to treat irregular heartbeats and high blood pressure)
• Clonidine, methyldopa, moxonidine, and rilmenidine (to treat high blood pressure and certain neurological diseases).

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

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

• nifedipine, felodipine, and amlodipine (used to treat high blood pressure or angina or abnormal heartbeats),
• amiodarone (used to treat irregular or abnormal heartbeats),
• beta-blockers, including those contained in eye drops, such as timolol for glaucoma treatment,
• digitalis such as digoxin used to treat heart failure,
• fisostigmine (to treat high eye pressure, glaucoma),
• other antihypertensive medications,
• other medications that can 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 to treat allergic reactions,
• mefloquine (to treat malaria),
• insulins and other preparations to treat diabetes mellitus,
• the so-called monoamine oxidase inhibitors, i.e. MAOIs (except MAO-B inhibitors) such as moclobemide or phenelzine (for depression).

• certainmedications used to treat Alzheimer's disease or for glaucoma treatment (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine),
• anesthetic agents (e.g. during surgery),
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g. ibuprofen or diclofenac).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Bisoprolol should not be used during pregnancy unless clearly necessary. If you are pregnant or plan to become pregnant during treatment with Bisoprolol Teva-ratiopharm, inform your doctor for advice on an appropriate treatment.

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

Driving and operating machinery

Bisoprolol has a minimal or no 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 operate machinery 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-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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.

The treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of treatment.

The treatment with bisoprolol is usually long-term.

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

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.

Use in children and adolescents (under 18 years)

There is not enough experience with the use of bisoprolol in children, and therefore bisoprolol is not recommended for use in children or adolescents under 18 years.

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 problems. The dose should not exceed 10 mg once a day in patients with severe renal or hepatic problems.

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic insufficiency.

Administration form

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.

If you take more Bisoprolol Teva-ratiopharm than you should

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

The symptoms of an overdose may include a reduced heart rate, severe difficulty breathing, feeling of dizziness, or tremors (due to decreased blood sugar).

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 forgot to take Bisoprolol Teva-ratiopharm

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

If you discontinue treatment with Bisoprolol Teva-ratiopharm

Treatment with bisoprolol should not be discontinued abruptly, particularly when the patient has 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

The most serious side effects are related to heart function:

• Slowed 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.

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

Frequent(may affect up to 1 in 10 people)

• Dizziness, headache.
• 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 (conduction disorders in the heart)
• Asthma or chronic obstructive pulmonary disease (COPD) bronchospasm (wheezing)
• Muscle weakness, muscle cramps
• Weakness (in patients with hypertension or angina pectoris)
• Low blood pressure in an upright position (orthostatic hypotension)

• Dizziness when standing up

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, redness, or rash.Seek medical attention immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• Erectile dysfunction
• 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 the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date refers to the last day of the month indicated.

This medication does not require special conditions for conservation.

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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bisoprolol Teva-ratiopharm

The active ingredient is bisoprolol fumarate.

Each tablet contains 2.5 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the packaging

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

The packaging includes 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U

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

28108 Alcobendas. Madrid

Responsible for manufacturing:

Chanelle Medical

Dublin Road, Loughrea, Co. Galway

Irlanda

or

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

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

Spain: Bisoprolol Teva-ratiopharm 2.5 mg tablets EFG

Last review date of this leaflet: August 2022

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83408/P_83408.html