Bisoprolol Teva-Ratiopharm 2.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bisoprolol Teva-ratiopharm 2.5 mg tablets EFG

bisoprolol fumarate

Package leaflet contents

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

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

Bisoprolol Teva-ratiopharm contains the active substance bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Bisoprolol prevents irregular heartbeats (arrhythmia) during stress and reduces the workload on the heart. Bisoprolol also dilates blood vessels and thereby improves blood flow.

Bisoprolol is used to:

• Treat high blood pressure (hypertension).
• Treat coronary heart disease and chest pain (angina pectoris) caused by insufficient oxygen supply to 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, leading to swelling (edema) of the limbs and difficulty breathing.

2. What you need to know before taking Bisoprolol Teva-ratiopharm

Do not take Bisoprolol Teva-ratiopharm

• 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 just occurred or has recently worsened, or if you are receiving treatment for circulatory shock due to acute heart failure via intravenous infusion to help your heart function,
• 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 tumour of the adrenal gland that can increase blood pressure (also called phaeochromocytoma),
• if you have severe asthma symptoms,
• if you have severe circulation problems in the limbs, such as intermittent claudication (easily triggered leg pain when walking) or Raynaud's syndrome (whitish, bluish, and finally reddish discoloration in fingers or toes associated with pain),
• if you have metabolic acidosis, which is an acid-base imbalance such as in diabetic patients when blood glucose levels rise too high.

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine; special precautions may be needed (for example, additional treatment or more frequent monitoring):

• 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 last three months,
• if you have asthma or chronic obstructive pulmonary disease (if you use bronchodilators, dosage adjustments may be needed and your lung function may need to be monitored),
• if you are undergoing surgery or another procedure under sedation or spinal anaesthesia (you must inform the anaesthetist that you are taking Bisoprolol Teva-ratiopharm),
• if you have diabetes mellitus and your blood glucose levels fluctuate significantly (bisoprolol may mask symptoms of hypoglycaemia and slow recovery of blood glucose levels),
• if you are on strict fasting,
• if you have overactive thyroid gland (bisoprolol may mask symptoms of hyperthyroidism),
• if you are receiving desensitisation treatment (bisoprolol may intensify allergic reactions, and more medication may be needed to treat the allergic reaction),
• if you have a mild heart conduction disorder (first-degree atrioventricular block),
• if you have chest pain caused by spasms of the coronary arteries (also called Prinzmetal's angina),
• if you have a history of scaly skin rash (psoriasis).

If you have a chronic lung disease or less severe asthma, please inform your doctor immediately if you start experiencing new breathing difficulties, cough, wheezing after exercise, etc., while taking bisoprolol.

Children and adolescents

Bisoprolol is not recommended for use in children or adolescents.

Other medicines and Bisoprolol Teva-ratiopharm

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

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

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

However, do not stop taking these medicines without first consulting your doctor.

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

• nifedipine, felodipine and amlodipine (used to treat high blood pressure, angina, or abnormal heartbeat),

• amiodarone (used to treat irregular or abnormal heartbeat),

• beta-blockers, including beta-blockers contained in eye drops, such as timolol for glaucoma treatment,

• digitalis agents such as digoxin used to treat heart failure,

• physostigmine (to treat elevated intraocular pressure, glaucoma),

• other antihypertensive medicines,

• other drugs that may lower blood pressure such as tricyclic antidepressants (e.g. imipramine or amitriptyline), phenothiazines such as levomepromazine (for psychosis) or barbiturates such as phenobarbital (for epilepsy),

• adrenaline (epinephrine) for treating allergic reactions,

• mefloquine (for treating malaria),

• insulin and other preparations for treating diabetes mellitus,

• so-called monoamine oxidase inhibitors (MAOIs), i.e. MAO inhibitors (except MAO-B inhibitors) such as moclobemide or phenelzine (for depression).

• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart conditions (sympathomimetics such as isoprenaline and dobutamine),

• anaesthetic 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 plan to become pregnant while being treated with Bisoprolol Teva-ratiopharm, inform your doctor so they can advise you on appropriate treatment.

It is unknown whether bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and operating machinery

Bisoprolol has minimal or no 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 could impair the ability to drive or operate machinery. If you experience these adverse effects, do not drive or operate machinery requiring full attention. Particular caution is required at the beginning of treatment and after increasing the dose. Bisoprolol usually does not affect driving ability if the treatment is well balanced.

Bisoprolol Teva-ratiopharm contains sodium

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

3. How to take Bisoprolol Teva-ratiopharm

Follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist.

Treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increases, and when stopping treatment.

Treatment with bisoprolol is usually long-term.

Recommended dose

Adults:

For treating hypertension and angina pectoris

• The initial dose is 5 mg once daily.
• Your doctor may increase the dose in small increments (usually every few weeks) to 10 mg or up to a maximum of 20 mg if necessary.

For treating chronic stable heart failure

Treatment with bisoprolol should be initiated at a low dose and gradually increased. Your doctor will decide how to increase the dose, which is usually 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 (ongoing) therapy.

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will advise 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.

Use in children and adolescents (under 18 years of age)

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

Elderly patients

Dose adjustment is not 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 cautiously 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.

Dose adjustment is usually not required in patients with mild to moderate 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 must not be chewed. Food does not affect the absorption of the medicine.

If you take more Bisoprolol Teva-ratiopharm than you should

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

Symptoms of overdose may include a reduced heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

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

If you forget to take Bisoprolol Teva-ratiopharm

Take the next tablet at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Bisoprolol Teva-ratiopharm

Treatment with bisoprolol must not be stopped abruptly, especially if you have heart disease. The dose should be gradually reduced, for example over 1–2 weeks. Otherwise, symptoms of heart disease may worsen.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

To prevent serious reactions, speak 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:

• Slowing of 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 adverse effects are listed below according to their possible frequency of occurrence:

Frequent (may affect up to 1 in 10 people)

• Dizziness, headache
• Feeling of coldness or numbness in the limbs
• Blood pressure too low (in patients with heart failure)
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea 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 in the heart)
• 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 (orthostatic hypotension)
• Dizziness upon standing

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

• Nightmares, hallucinations
• Fainting (syncope)
• Reduced tear production (take into account if you wear contact lenses)
• Hearing disorders
• Hepatitis (causing upper abdominal pain)
• Hypersensitivity 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.
• Erectile dysfunction
• Elevated liver enzyme levels (laboratory tests ALT or AST)
• Allergic rhinitis (runny, blocked and itchy nose)

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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Teva-ratiopharm

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 blister pack and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Storage of the container and additional information

Composition of Bisoprolol Teva-ratiopharm

The active substance is bisoprolol fumarate.

Each tablet contains 2.5 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the package

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

The package contains 28 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid, Spain

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

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

Spain: Bisoprolol Teva-ratiopharm 2.5 mg tablets EFG

Date of the most recent review of this package leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83408/P_83408.html