Bisoprolol Bluefish 1.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol Bluefish 1.25 mg tablets EFG

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

1. What Bisoprolol Bluefish is and what it is 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 heartbeat 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 appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).
• Treat coronary heart disease and chest pain (angina pectoris) caused by oxygen deficiency in the heart muscle.
• Treat high blood pressure (hypertension).

2. What you need to know before taking Bisoprolol Bluefish

Do not take Bisoprol combustible Bluefish

if you have any of the following conditions:

• If you are allergic to the active substance or to any of the other components 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 Bluefish if you have any of the following heart problems:

• Acute heart failure.
• Worsening heart failure requiring intravenous injection of medicines that increase the strength of heart contractions.
• Slow heart rate.
• 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 before starting bisoprolol if you have any of the following conditions; your doctor may want 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) or are currently undergoing treatment for an adrenal gland tumor.
• Thyroid disorder.

During treatment

Additionally, inform your doctor if you are undergoing:

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

Children and adolescents

Administration 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 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, or propafenone).
• Certain medicines used to treat high blood pressure, angina, 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 first consulting your doctor.

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 (calcium antagonists of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medicines such as amiodarone).
• Topically applied beta-blockers (such as timolol eye drops for the treatment of glaucoma).
• Certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• Insulin or other medicines for treating diabetes.
• Anaesthetic agents (for example, during surgery).
• Digitalis, used to treat heart failure.
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac).
• Medicines for asthma or medicines used for nasal congestion.
• Mefloquine, used for prevention or treatment of malaria.
• Any medicine that may lower blood pressure as either 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 used to treat 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 using 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 unknown 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 machinery 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 when combined with alcohol.

Bisoprolol Bluefish contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 1.25 mg tablet; this is essentially “sodium-free”.

3. How to take Bisoprolol Bluefish

Follow exactly the instructions for use of this medicine provided by your doctor. 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 some 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.

Chronic stable heart failure

Treatment must be managed by a doctor experienced in the treatment of chronic heart failure.

Treatment with bisoprolol should be initiated at a low dose and gradually increased. Your doctor will decide how to increase the dose, which is normally 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).

The maximum recommended daily dose of bisoprolol is 10 mg.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 advise you on 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 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 or adolescents.

If you take more Bisoprolol Bluefish 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Bluefish

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

If you stop taking Bisoprolol Bluefish

Treatment must not be stopped suddenly or the recommended dose changed unless instructed by your doctor. Otherwise, your condition could worsen significantly. If you are considering stopping treatment, your doctor will advise you on 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 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 you experience an adverse effect that is severe, sudden in onset, or rapidly worsening. The most serious adverse effects are related to heart function:

• Slowing of 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.

Other adverse effects, listed below, are categorized according to their possible frequency of occurrence:

Frequent (may affect up to 1 in 10 people)

• Fatigue*, weakness, dizziness, headache
• Headache*
• Cold sensation or numbness in hands and/or feet
• Low blood pressure
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea, or constipation

*These symptoms occur at the beginning 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
• Changes in normal heart rhythm
• Breathing problems in patients with asthma or chronic respiratory disease
• Depression
• Dizziness upon standing

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

• Hearing problems
• Allergic nasal discharge
• Reduced tear production
• Liver inflammation, which may cause yellowing of the skin or whites of the eyes
• Abnormal blood test results for liver function or fat levels
• Allergy-like reactions such as itching, redness, and skin rashes. 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 dysfunction
• 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 kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Bluefish

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Bluefish

The active substance is bisoprolol fumarate.

Bisoprolol Bluefish 1.25 mg: each tablet contains 1.25 mg of bisoprolol fumarate.

The other components are:

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

Appearance of the product and contents of the pack

White to off-white, round, biconvex tablet, engraved with "1.25" on one side and smooth on the other.

Packaged in blisters made of PVC/PVDC-Al or PVC/PCTFE-Al.

Pack size:

20 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U
P.O. Box 36007
28320 Las Rozas, Branch 36
Madrid, Spain

This medicinal product is authorized in the EEA Member States under the following names:

Portugal: Bisoprolol Bluefish 1,25 mg tablets

Spain: Bisoprolol Bluefish 1,25 mg tablets EFG

Date of the most recent review of this leaflet: October 2024

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