BISOPROLOL TEVA-RATIOPHARM 2.5 mg TABLETS

2. What you need to know before you take 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 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 of the adrenal gland that can increase blood pressure (also called pheochromocytoma),
• if you have severe asthma symptoms,
• if you have severe blood circulation problems in the limbs, such as intermittent claudication (pain easily triggered 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 kidney or liver problems,
• if you have heart valve problems or have a congenital heart condition,
• if you have had a heart attack in the last three months,
• if you have asthma or chronic obstructive pulmonary disease (if you use bronchodilators, your dose may need to be adjusted and your lung function monitored),
• if you are going to have surgery or another procedure under sedation or spinal anesthesia (you should inform the anesthesiologist that you are taking Bisoprolol Teva-ratiopharm),
• if you have diabetes mellitus and your blood glucose levels vary greatly (bisoprolol can mask the symptoms of hypoglycemia and slow the recovery of blood glucose levels),
• if you are on a strict fast,
• if you have hyperthyroidism (bisoprolol can mask the symptoms of hyperthyroidism),
• if you are receiving desensitization treatment (bisoprolol can 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 have a history of a scaly skin eruption (psoriasis).

If you have a chronic lung disease or mild asthma, please inform your doctor immediately if you start to experience new breathing difficulties, cough, wheezing after exercise, etc., when using 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 take any other medicines.

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 heartbeat or abnormal rhythm)
• Verapamil and diltiazem (used to treat irregular heartbeat and high blood pressure)
• Clonidine, methyldopa, 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-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 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 such as digoxin used to treat heart failure,
• physostigmine (to treat high eye pressure, glaucoma),
• other antihypertensive medicines,
• other medications that can 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 for allergic reactions,
• mefloquine (for malaria),
• insulins and other preparations for diabetes mellitus,
• monoamine oxidase inhibitors, i.e., MAOIs (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 carbacol) or medications used to treat acute heart 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 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 planning to become pregnant during treatment with Bisoprolol Teva-ratiopharm, inform your doctor so they can advise you on suitable treatment.

It is not known if bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during the 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 low blood pressure may include dizziness, headache, fatigue, or other adverse effects (see section 4) that can 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 usually does not affect the ability to drive if the treatment is well balanced.

Bisoprolol Teva-ratiopharm contains sodium

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

3. How to take Bisoprolol Teva-ratiopharm

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

Treatment with bisoprolol is usually long-term.

The recommended dose is

Adults:

For treating high blood pressure 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 20 mg as needed.

For treating chronic stable 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 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, the use of bisoprolol is not recommended in children or adolescents under 18 years.

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 kidney or liver problems.

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

Method of administration

Swallow the tablets with a sufficient amount of 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.

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, dizziness, or tremors (due to low blood sugar).

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

If you forget to take Bisoprolol Teva-ratiopharm

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

If you stop taking Bisoprolol Teva-ratiopharm

Treatment with bisoprolol should not be stopped abruptly, especially 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 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 a side effect is severe, occurs suddenly, or worsens rapidly.

The most serious side effects are related to heart function:

• slow heart rate (can affect more than 1 in 10 people)
• worsening of heart failure (can affect up to 1 in 10 people)
• slow or irregular heartbeats (can 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 side effects are mentioned below according to their frequency of possible occurrence:

Common (can affect up to 1 in 10 people)

• Dizziness, headache.
• Feeling of cold or numbness in the limbs
• 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 (can 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 high blood pressure or angina pectoris)
• Low blood pressure when standing up (orthostatic hypotension)

• Dizziness when standing up

Rare (can 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 can include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• Erectile dysfunction
• High levels of liver enzymes (laboratory tests ALAT or ASAT)
• Allergic rhinitis (nasal secretion, blocked and itchy)

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

• Conjunctivitis (eye inflammation)
• Hair loss (alopecia), worsening of psoriasis or psoriatic eruption

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: 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-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 and carton after EXP. The expiry date refers to the last day of the month stated.

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 a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Teva-ratiopharm

The active substance is bisoprolol fumarate.

Each tablet contains 2.5 mg of bisoprolol fumarate.

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

Appearance and packaging

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

The pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Manufacturing Responsible:

Chanelle Medical

Dublin Road, Loughrea, Co. Galway

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 under the following names:

Spain: Bisoprolol Teva-ratiopharm 2.5 mg EFG tablets

Date of last revision of this leaflet: August 2022

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/

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