Package Insert: Information for the User

Bisoprolol Bluefish 1.25 mg Tablets EFG

bisoprolol fumarate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Bisoprolol Bluefish and how is it used

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

3. How to take Bisoprolol Bluefish

4. Possible adverse effects

5. Storage of Bisoprolol Bluefish

6. Contents of the package and additional information

Bisoprolol Bluefish contains the active ingredient 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 down the heartbeat and makes the heart more efficient, 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 for:

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

Do not take Bisoprolol Bluefish

if you have any of the following conditions:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• Severe asthma.
• Severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause numbness in the fingers of the hands and feet 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 Bluefish if you have any of the following heart problems:

• Acute heart failure.
• Worsening heart failure that requires intravenous medication to increase heart contractions.
• Slow heart rate.
• Low blood pressure.
• Certain heart conditions that cause a very slow or irregular heart rate.
• Cardiogenic shock, a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor before starting bisoprolol if you have any of the following conditions; your doctor may want to take special precautions (e.g., provide additional treatment or perform more frequent examinations):

• Diabetes.
• Strict fasting.
• Certain heart conditions, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina).
• Kidney or liver problems.
• Mild circulatory problems in the extremities.
• Chronic lung disease or mild asthma.
• History of scaly skin rash (psoriasis).
• Adrenal gland tumor (pheochromocytoma) or currently undergoing treatment for the 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 it more likely that you will experience an allergic reaction, or that such a reaction may be more severe.
• Undergo anesthesia (e.g., for surgery), as bisoprolol may affect how your body reacts to this situation.
• Have chronic lung disease or mild asthma, inform your doctor immediately if you start experiencing new breathing difficulties, cough, wheezing after exercise, etc. while taking bisoprolol.

Children and adolescents

Bisoprolol is not recommended for children or adolescents.

Other medications and Bisoprolol Bluefish

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:

• Certain medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone).
• Certain medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem).
• Certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, or rilmenidine.

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

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

• Certain medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• Certain medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medications such as amiodarone).
• Topically applied beta-blockers (such as timolol eye drops for glaucoma treatment).
• Certain 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 cardiac problems (sympathomimetics such as isoproterenol and dobutamine).
• Insulin or other medications for diabetes.
• Anesthetic agents (e.g., during surgery).
• Digitals used to treat heart failure.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac).
• Asthma medications or medications used for nasal congestion.
• Mefloquine, used to prevent or treat malaria.
• Any medication that can lower blood pressure as a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital) or certain medications used to treat mental disorders characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• Medications for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and lactation

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, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take bisoprolol during pregnancy.

Lactation

The passage of bisoprolol into breast milk is unknown, and 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 Bluefish contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per 1.25 mg 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..

Monitoring by your doctor is required for treatment with bisoprolol. 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.

Treatment with bisoprolol is usually long-term.

Adults and elderly patients:

Hypertension or angina pectoris

The maximum recommended dose is 20 mg once a day.

Chronic stable heart failure

Treatment should be carried out by a doctor experienced in the treatment of chronic heart failure.

Bisoprolol treatment 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 (continuation).

The maximum recommended daily dose of bisoprolol is 10 mg.

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 kidney and/or liver insufficiency

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

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 what measures are necessary.

The symptoms of an overdose may include a reduced heart rate, severe difficulty breathing, 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 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 compensate for the missed dose.Take your usual dose the next morning.

If you interrupt treatment with Bisoprolol Bluefish

Treatment should not be interrupted suddenly or the recommended dose changed unless your doctor advises you to do so. Otherwise, your condition may worsen significantly.If you are considering interrupting treatment, your doctor will indicate how to reduce the dose gradually to avoid any adverse effects.

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 more than 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..

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

Frequent (may affect up to 1 in 10 people)

• Fatigue*,weakness, dizziness, headache
• Headache*
• Sensation of coldness or numbness in hands and/or feet.
• Low blood pressure
• Gastrointestinal problems such as nausea, vomiting, diarrhea, 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.

Infrequent(may affect up to 1 in 100 people)

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

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

• Auditory problems
• Allergic nasal discharge
• Decreased tear production
• 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 reactions similar to those of type I hypersensitivity, such as itching, redness, and skin eruptions.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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse 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.

Store below 25°C.

Medications should not be disposed of through drains or 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 unused packaging and medications. By doing so, you will help protect the environment.

Compositionof Bisoprolol Bluefish

The active ingredient 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 carboxymethylcellulose (type A), and magnesium stearate.

Appearance of the product and content of the container

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

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

Container size:

20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Bluefish Pharmaceuticals AB
P.O. Box 49013

100 28 Stockholm

Sweden

Responsible for manufacturing:

Chanelle Medical Unlimited Company

Loughrea,

County Galway

Ireland

You can requestmore information about this medication by contacting the local representative of the holder of the marketing authorization:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the EEA member states with the following names:

Portugal: Bisoprolol Bluefish 1,25 mg tablets

Spain: Bisoprolol Bluefish 1,25 mg tablets EFG

Last review date of this leaflet:October 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/