Leaflet: information for the user

bisoprolol cinfa 5 mg EFG tablets

bisoprolol fumarate

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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:

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

Do not take bisoprolol cinfa

Do not takebisoprololif you have any of the following conditions:

• if you are allergic to bisoprolol or to any of the other ingredients of this medication (listed in section 6).
• severe asthma.
• severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or make them pale or blue.
• untreated phaeochromocytoma, 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 one of the following heart problems:

• acute heart failure.
• exacerbation of heart failure that requires intravenous medication to increase the heart's contraction force.
• low blood pressure.
• specific heart conditions that cause a very slow or irregular heart rate.
• cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bisoprolol cinfa.

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

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

Also, inform your doctor if you are going to:

• undergo desensitization treatment (for example, for hay fever prevention), because bisoprolol may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe.
• have anesthesia (for example, for surgery), because bisoprolol may affect how your body reacts to this situation.

Children and adolescents

Bisoprolol cinfa is not recommended for children or adolescents.

Other medications and bisoprolol cinfa

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 without special advice from your doctor:

• specific medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone).
• specific medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem).
• specific medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However,do not stop taking these medicationswithout consulting your doctor first.

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

• specific medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• specific medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmics such as amiodarone).
• beta-blockers applied locally (such as eye drops of timolol for glaucoma treatment).
• specific medications used to treat, for example, Alzheimer's disease or for glaucoma treatment (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute heart conditions (sympathomimetics such as isoprenaline and dobutamine).
• antidiabetic medications, including insulin.
• anesthetic agents (for example, during surgery).
• digitalis, used to treat heart failure.
• nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac).
• any medication that can lower blood pressure as a desired or undesired effect, such as antihypertensives, specific medications used to treat depression (tricyclic antidepressants such as imipramine or amitriptyline), specific medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or specific medications used to treat mental disorders characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• mefloquine, used to prevent or treat malaria.
• medications used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• moxisilat, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding

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

Pregnancy

There is a risk that using bisoprolol during pregnancy may harm the baby.Inform your doctor if you are pregnant or plan to become pregnant.Your doctor will decide if you can take bisoprolol during pregnancy.

Breastfeeding

The passage of bisoprolol into human breast milk is unknown.Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and operating machinery

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

bisoprolol cinfa contains sodium

This medication 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. 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.

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

Treatment with bisoprolol cinfa is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

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

Depending on how well you tolerate the medication, your doctor may decide to reduce the dose to 5 mg or increase it to 20 mg. The dose should 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 usually be done 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 (continue).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may also decide to 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 patients with renal and/or hepatic insufficiency

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

In patients with severe renal insufficiency (creatinine clearance <20

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 tablets of bisoprolol than you should, inform your doctor immediately. Your doctor will decide what measures are necessary.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take bisoprolol cinfa

Do not take a double dose to compensate for the missed doses. Take the recommended dose the next morning.

If you interrupt treatment with bisoprolol cinfa

Never stop taking bisoprolol unless your doctor tells you to. Otherwise, your condition may worsen significantly. Treatment should not be interrupted suddenly, especially in patients with systemic heart failure. If you are considering interrupting treatment, your doctor will usually advise you to gradually reduce the dose.

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 your doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

The most severe side effects are related to heart function:

• Slowed heart rate (may affect up to 1 in 10 people)
• Worsening 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 side effects are listed below according to their frequency of possible occurrence:

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

• Fatigue, weakness, dizziness, headache.
• Sensation of coldness or numbness in hands or feet.
• Low blood pressure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

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

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

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

• Ear problems.
• Nasal discharge.
• Decreased tear production(dry eyes).
• Liver inflammation that may cause yellowing of the skin or white of the eyes
• Abnormal results of blood tests for liver function or abnormal levels of fat.
• Allergic-like reactions such as itching, redness, and skin rash.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 dysfunction.
• Nightmares, hallucinations.
• Fainting.

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

• Irritation and redness of the eyes (conjunctivitis).
• Hair loss.
• Appearance or worsening of scaly skin rash (psoriasis); rash similar
  to psoriasis.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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 medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of bisoprolol cinfa

• Theactive ingredient is bisoprolol fumarate.

Each tablet contains 5 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the packaging

bisoprolol cinfa 5 mg are white or off-white, round, biconvex tablets with a notch on one face and a diameter of approximately 8.5 mm.

Packaging sizes:

PVC/PVDC/aluminum or PVC/PCTFE/aluminum blisters.

Presentations of 28, 30 or 60 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Manufacturer responsible:

Chanelle Medical Unlimited Company

Loughrea

Co. Galway

Ireland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 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 leaflet and packaging with your smartphone. 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