Bisoprolol CINFA 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

bisoprolol cinfa 5 mg tablets EFG

bisoprolol fumarate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is bisoprolol cinfa and what is it used for

The active substance is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows the heartbeat and makes the heart more effective at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and its blood supply.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol is used for:

• treating high blood pressure (hypertension).
• treating angina pectoris.
• treating stable chronic heart failure. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking bisoprolol cinfa

Do not take bisoprolol cinfa

Do not take bisoprolol if you have any of the following conditions:

• if you are allergic to bisoprolol or to any of the other ingredients of this medicine (listed in section 6).
• severe asthma.
• severe circulatory problems in the limbs (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make them pale or blue.
• untreated phaeochromocytoma, which is a rare tumor of the adrenal gland.
• metabolic acidosis, a condition that occurs when there is too much acid in the blood.

Do not take bisoprolol if you have any of the following heart problems:

• acute heart failure.
• worsening heart failure requiring intravenous injection of medicines that increase the force of the heart's contraction.
• low blood pressure.
• certain heart conditions causing a very slow heart rate or irregular pulse.
• cardiogenic shock, a serious and acute heart disease causing low blood pressure and circulatory failure.

Warnings and precautions

Talk to your doctor or pharmacist before taking bisoprolol cinfa.

If you have any of the following conditions, consult your doctor before starting bisoprolol; your doctor may wish to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• diabetes
• strict fasting
• certain heart diseases such as heart rhythm disorders, or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• less severe circulatory problems in your limbs
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• tumor of the adrenal gland (phaeochromocytoma)
• thyroid disorder
• first-degree heart block (a condition in which nerve signals to the heart are altered, possibly causing occasional missed beats or irregular heartbeat)

In addition, inform your doctor if you are undergoing:

• desensitization treatment (e.g., for hay fever prevention), because bisoprolol may make allergic reactions more likely or more severe.
• anesthesia (e.g., for surgery), because bisoprolol may affect how your body responds to this situation.

Children and adolescents

The administration of bisoprolol is not recommended in children and adolescents.

Other medicines and bisoprolol cinfa

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

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

• certain medicines used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone).
• certain medicines used to treat high blood pressure, angina, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem).
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines with bisoprolol, as your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina (calcium antagonists of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone).
• locally applied beta-blockers (such as timolol eye drops for the treatment of glaucoma).
• certain medicines used, for example, for Alzheimer's disease or for the treatment of glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• antidiabetic medicines including insulin and sulfonylureas (e.g., glibenclamide, gliquidone, gliclazide, glipizide, glimepiride, or tolbutamide). Bisoprolol may increase the risk of severe hypoglycemia when used with these medicines.
• anaesthetic agents (e.g., during surgery).
• digitalis, used to treat heart failure.
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac).
• any medicine that may lower blood pressure as either a desired or an undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• mefloquine, used for the prevention or treatment of malaria.
• medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.
• moxisylylate, used to treat circulatory problems such as Raynaud's syndrome.

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.

Pregnancy

There is a risk that the use of bisoprolol during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide whether you can take bisoprolol during pregnancy.

Breastfeeding

It is unknown whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and using machines

Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Be especially cautious at the beginning of treatment, when the dose is increased, when medication is changed, and also when combined with alcohol.

bisoprolol cinfa 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 cinfa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. 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.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The tablet may be divided into equal doses.

Treatment with bisoprolol cinfa is usually long-term.

High blood pressure and angina pectoris

Adults, including elderly patients

The dose should be individually adjusted. The usual daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to reduce the dose to 5 mg or increase it to 20 mg. The dose must not exceed 20 mg per day.

Chronic stable heart failure

Adults, including elderly patients

Treatment with bisoprolol should be initiated at a low dose and gradually increased.

Your doctor will decide how to increase the dose, and this will normally 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 (ongoing treatment).

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 discontinue 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.

Use in patients with renal and/or hepatic impairment

Dose adjustment is usually not required in patients with mild to moderate renal or hepatic impairment.

In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment, it is recommended not to exceed 10 mg of bisoprolol once daily.

Use in children and adolescents

The use of bisoprolol is not recommended in this age group.

If you take more bisoprolol cinfa than you should

If you have taken more bisoprolol tablets than you should, inform your doctor immediately. Your doctor will decide which measures are necessary.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take bisoprolol cinfa

Do not take a double dose to make up for missed doses. Take the recommended dose the following morning.

If you stop taking bisoprolol cinfa

Never stop taking bisoprolol unless your doctor tells you to do so. Otherwise, your condition could worsen significantly. Treatment must not be stopped suddenly, especially in patients with systemic heart failure. If you are considering stopping treatment, your doctor will usually advise you to gradually reduce the dose.

If you have any further questions about the use of 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 your 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 up to 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 listed below are categorized according to their possible frequency of occurrence:

Common (may affect up to 1 in 10 patients):

• Tiredness, weakness, dizziness, headache.
• Cold sensation or numbness in hands or feet.
• Low blood pressure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

Uncommon (may affect up to 1 in 100 patients):

• Sleep disturbances.
• Depression.
• Dizziness upon standing.
• Breathing problems in patients with asthma or chronic respiratory disease.
• Muscle weakness, muscle cramps.

Rare (may affect up to 1 in 1,000 patients):

• Hearing problems.
• Runny nose.
• Reduced tear production (dry eyes).
• Liver inflammation that may cause yellowing of the skin or whites of the eyes.
• Certain abnormal blood test results regarding liver function or fat levels.
• Allergy-like reactions such as itching, redness, and skin rash. You must consult 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 problems.
• Nightmares, hallucinations.
• Fainting.

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

• Eye irritation and redness (conjunctivitis).
• Hair loss.
• Onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of adverse effects

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

5. Storage of bisoprolol cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of bisoprolol cinfa

• The active substance is bisoprolol fumarate.

Each tablet contains 5 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the container

bisoprolol cinfa 5 mg are white or almost white, round, biconvex tablets, with a score line on one side and a diameter of approximately 8.5 mm.

Pack sizes:

PVC/PVDC/aluminium or PVC/PCTFE/aluminium blisters.

Pack presentations of 28, 30 or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer:

Chanelle Medical Unlimited Company

Loughrea

Co. Galway

Ireland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of latest revision of this leaflet: October 2025

Detailed and up-to-date 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78903/P_78903.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78903/P_78903.html