BISOPROLOL BLUEFISH 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Bluefish 2.5 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience 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 Package Leaflet

1. What is Bisoprolol Bluefish and what is it used for
2. What you need to know before you take Bisoprolol Bluefish
3. How to take Bisoprolol Bluefish
4. Possible side effects
5. Storage of Bisoprolol Bluefish
6. Contents of the pack and further information

1. What is Bisoprolol Bluefish and what is it used for

Bisoprolol Bluefish contains the active substance bisoprolol fumarate. Bisoprolol fumarate 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.

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 stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).
• Treat coronary heart disease and angina pectoris (chest pain) caused by a lack of oxygen in the heart muscle.
• Treat high blood pressure (hypertension).

2. What you need to know before you take Bisoprolol Bluefish

Do not take Bisoprolol Bluefish

If you have any of the following conditions:

• If you are allergic to the active substance 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, numbness, or pale or blue discoloration of the fingers or toes.
• Untreated pheochromocytoma, 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 Bluefish 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 strength.
• Slow heart rate.
• Low blood pressure.
• Certain heart conditions that cause a very slow or irregular heartbeat.
• Cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.

Warnings and precautions

Talk to your doctor before starting to take bisoprolol if you have any of the following conditions, 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) or are currently undergoing treatment for adrenal gland tumor.
• Thyroid disorder.

During treatment

Also, inform your doctor if you are going to undergo:

• Desensitization treatment (e.g., for hay fever prevention), as bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe.
• Anesthesia (e.g., for surgery), as bisoprolol may affect how your body reacts to this situation.
• If you have chronic lung disease or less severe asthma, inform your doctor immediately if you start experiencing new breathing difficulties, coughing, wheezing after exercise, etc. while taking bisoprolol.

Children and adolescents

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

Other medicines and Bisoprolol Bluefish

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 heartbeats (Class I anti-arrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone).
• Certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeats (calcium antagonists such as verapamil and diltiazem).
• Certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, or rilmenidine.

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

Talk to 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-type calcium antagonists such as nifedipine, felodipine, and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeats (Class III anti-arrhythmic medicines such as amiodarone).
• Beta-blockers applied locally (such as eye drops containing timolol for glaucoma treatment).
• Certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• Insulin or other diabetes medicines.
• 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).
• Medicines for asthma or medicines used for nasal congestion.
• Mefloquine, used for the prevention or treatment of malaria.
• Any medicine that may lower blood pressure as a desired or 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 for mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• Medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

Pregnancy

Bisoprolol is not recommended during pregnancy. There is a risk that the use of bisoprolol during pregnancy may harm the baby. 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. Your doctor will decide whether you can take bisoprolol during pregnancy.

Breastfeeding

It is not known whether bisoprolol passes into breast milk, and 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 Bluefish contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 2.5 mg tablet; this is essentially "sodium-free".

3. How to take Bisoprolol Bluefish

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

Treatment with bisoprolol requires regular monitoring by your doctor. This is especially 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 is usually long-term.

Adults and elderly patients

Hypertension or angina pectoris

The maximum recommended dose is 20 mg once daily.

Stable chronic heart failure

Treatment should be initiated by a doctor with experience in the treatment of chronic 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 of bisoprolol is 10 mg.

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 kidney and/or liver impairment

In patients with kidney impairment and in patients with severe liver impairment, the dose of bisoprolol should not exceed 10 mg once daily.

Use in children and adolescents

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

If you take more Bisoprolol Bluefish 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 Bluefish

If you forget to take a dose, take it as soon as you remember, unless it is time to take the next dose. Do not take a double dose to make up for the forgotten dose. Take your usual dose the next morning.

If you stop taking Bisoprolol Bluefish

Do not stop treatment suddenly or change the recommended dose unless your doctor tells you to. Otherwise, your condition may worsen significantly. If you are considering stopping treatment, your doctor will tell you how to gradually reduce the dose to avoid any adverse effects.

If you have any further questions about 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 your doctor immediately if a side effect is severe, occurs suddenly, or worsens rapidly. The most serious side effectsare related to heart function:

• Slow 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.

Below are mentioned other side effects according to their frequency of possible occurrence:

Common (may affect up to 1 in 10 people)

• Fatigue, weakness, dizziness, headache
• Headache
• Cold or numb hands and/or feet
• Low blood pressure
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

*These symptoms occur at the start of treatment in patients with hypertension or angina pectoris. They are usually mild and disappear within 1-2 weeks.

Uncommon (may affect up to 1 in 100 people)

• Sleep disturbances
• Muscle weakness, muscle cramps
• Breathing problems in patients with asthma or chronic respiratory disease.
• Depression.
• Changes in normal heart rhythm
• Dizziness when standing up.

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

• Hearing problems
• Runny nose due to allergy
• Decreased tear production
• 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 rashes. 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.
• Erection problems
• 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); psoriasis-like rash

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 via the Spanish Medicines Surveillance 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 Bluefish

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.

Store below 25°C.

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 further information

Composition of Bisoprolol Bluefish

The active substance is bisoprolol fumarate.

Bisoprolol Bluefish 2.5 mg: each tablet contains 2.5 mg of bisoprolol fumarate.

The other ingredients are:

microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethyl starch (Type A), and magnesium stearate.

Appearance and packaging of the product

White to almost white, round, biconvex tablet, engraved with "2" and a score line "5" and smooth on the other side

It is packaged in blisters made of PVC/PVDC-Al or PVC/PCTFE-Al.

Pack size:

28 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Chanelle Medical Unlimited Company

Loughrea,

County Galway

Ireland

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Sucursal 36

This medicine is authorized in the Member States of the EEA under the following names:

Portugal: Bisoprolol Bluefish 2.5 mg tablets

Spain: Bisoprolol Bluefish 2.5 mg tablets EFG

Date of last revision of this leaflet:October 2024

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