BISOPROLOL CINFA 1.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

bisoprolol cinfa 1.25 mg tablets EFG

bisoprolol fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is bisoprolol cinfa and what is it used for
2. What you need to know before you take bisoprolol cinfa
3. How to take bisoprolol cinfa
4. Possible side effects
5. Storage of 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 heart rate and makes the heart more efficient at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's need for oxygen and 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 to:

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

2. What you need to know before you take 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 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 can cause tingling in the fingers or toes or turn them pale or blue.
• untreated pheochromocytoma, which is a rare tumor of the adrenal gland.
• metabolic acidosis, which is 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 of heart failure that requires intravenous injection of medicines that increase the heart's pumping power.
• low blood pressure.
• certain heart conditions that cause a very slow or irregular heartbeat.
• cardiogenic shock, which is 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.

If you have any of the following problems, consult your doctor before starting to take bisoprolol; your doctor may want to take special precautions (such as providing additional treatment or performing more frequent tests):

• diabetes.
• strict fasting.
• certain heart diseases such as arrhythmias or severe chest pain at rest (Prinzmetal's angina).
• kidney or liver problems.
• less severe circulatory problems in the limbs.
• chronic lung disease or less severe asthma.
• history of scaly skin rash (psoriasis).
• adrenal gland tumor (pheochromocytoma).
• thyroid disorder.
• first-degree heart block (a condition in which the nerve signals to the heart are altered, causing the heart to skip a beat or beat irregularly).

In addition, inform your doctor if you are going to undergo:

• desensitization treatment (e.g., for the prevention of hay fever), because bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe.
• anesthesia (e.g., for surgery), because bisoprolol may affect how your body reacts 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 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 heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone).
• certain medicines used to treat high blood pressure, angina pectoris, 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 medicineswithout consulting your doctor first.

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

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists 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 to treat, for example, 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.
• anesthetic agents (e.g., during surgery).
• digitalis, used to treat heart failure.
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac).
• any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensive medicines, 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 for 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 for MAO-B inhibitors) such as moclobemide.
• moxisylate, 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 not known 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 machines may be affected depending on how well you tolerate the medicine. Be especially careful 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 medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take bisoprolol cinfa

Follow the instructions for administration of this medicine exactly 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 start of treatment, during dose increase, 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.

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 medicine, your doctor may decide to reduce the dose to 5 mg or may decide to increase it to 20 mg. The dose should not exceed 20 mg per day.

Stable chronic heart failure

Adults, including elderly patients

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 gradually reduce the dose, as otherwise, your condition may worsen.

Use in patients with renal and/or hepatic impairment

Normally, no dose adjustment is 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.< p>

Use in children and adolescents

The use of bisoprolol is not recommended in children.

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 decrease in heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

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

If you forget to take bisoprolol cinfa

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

If you stop taking bisoprolol cinfa

Never stop taking bisoprolol unless your doctor tells you to. Otherwise, your condition could worsen significantly. Treatment should not be stopped abruptly, especially in patients with systolic heart failure. If you are considering stopping treatment, your doctor will normally advise you to gradually reduce the dose.

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 side effects, talk to your 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 (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 side effects are mentioned below according to their frequency of possible occurrence:

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

• fatigue, weakness, dizziness, headache.
• feeling of cold 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 when standing up.
• respiratory 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.
• decreased tear production (dry eyes).
• liver inflammation that can cause yellowing of the skin or the whites of the eyes.
• certain abnormal blood test results for liver function or fat levels.
• allergic reactions such as itching, redness, and skin rash. You should consult 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.
• nightmares, hallucinations.
• fainting.

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

• eye irritation and redness (conjunctivitis).
• hair loss.
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of bisoprolol cinfa

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 carton after EXP. The expiry date is 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 your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of bisoprolol cinfa

• The active substance is bisoprolol fumarate.

Each tablet contains 1.25 mg of bisoprolol fumarate.

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

Appearance of the product and pack size

bisoprolol cinfa are white or almost white, round, and flat biconvex tablets with a diameter of approximately 5 mm.

Package sizes:

PVC/PVDC/aluminum or PVC/PCTFE/aluminum blister packs in packs of 20 tablets.

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 last revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information about 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/87952/P_87952.html.

QR code to: https://cima.aemps.es/cima/dochtml/p/87952/P_87952.html