Leaflet: information for the user

Bisoprolol pensa 1,25 mg tablets EFG

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, ask your doctor or pharmacist.

­- This medicine has been prescribed for you only. Do 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.

1. What isBisoprolol Pensaand what it is used for

2. What you need to know before you start takingBisoprolol Pensa

3. How to takeBisoprolol Pensa

4. Possible side effects

5. Storage ofBisoprolol Pensa

6. Contents of the pack and additional information

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 Pensa is used for:

• treating high blood pressure (hypertension).
• treating chronic stable angina.

- 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).

Do not take Bisoprolol Pensa

Do not take Bisoprolol Pensa 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
• serious circulatory problems in your extremities (such as Raynaud's syndrome), which can cause numbness in your 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 Pensa 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
  • certain heart conditions that cause a very slow or irregular heart rate and you do not have a pacemaker.
  • cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.
  • slow heart rate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol Pensa. If you have any of the following conditions, consult your doctor before taking Bisoprolol Pensa; your doctor may want to take special precautions (for example, 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

– less serious circulatory problems in your extremities

– chronic lung disease or less severe 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, capable of causing occasional omission of the beat or irregular heartbeat)

Inform your doctor if you are going to undergo: •

• treatment for desensitization (for example, for hay fever prevention), because Bisoprolol Pensa may make it more likely that you will experience an allergic reaction, or that such a reaction may be more severe.
• anesthesia (for example, for surgery), because Bisoprolol Pensa 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, cough, wheezing after exercise, etc. while taking bisoprolol.

Taking Bisoprolol Pensa with other medications

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 Pensa 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 Pensa, 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)

– beta-blockers applied locally (such as eye drops of timolol 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

– anesthetics (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 may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medications for depression (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)

– mefloquine, used to prevent or treat malaria

– medications for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide

Pregnancy and breastfeeding

There is a risk that the use of Bisoprolol Pensa during pregnancy may harm the baby. 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. Your doctor will decide if you can take bisoprolol during pregnancy.

Bisoprolol is unknown to pass into breast milk and therefore breastfeeding is not recommended during treatment with bisoprolol.

Children and adolescents

Bisoprolol Pensa is not recommended for use in children and adolescents.

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.

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

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet.

Regular monitoring by your doctor is required for treatment with Bisoprolol Pensa. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of treatment.

Treatment with Bisoprolol Pensa is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

The recommended starting dose is 5 mg once a day. If necessary, the dose can be increased to 10 mg per day.

The maximum recommended dose is 20 mg once a 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 Pensa is not recommended in children.

If you take more Bisoprolol Pensa than you should

If you have taken more Bisoprolol Pensa 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, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Bisoprolol Pensa:

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

If you interrupt treatment with Bisoprolol Pensa

Do not stop taking Bisoprolol Pensa unless your doctor tells you to. Otherwise, your condition may worsen significantly. Treatment should not be interrupted abruptly, especially in patients with systemic heart failure. If you are considering interrupting treatment, your doctor will advise you on how to gradually reduce the dose.

If you have doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, Bisoprolol Pensa 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 possible frequency of occurrence:

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

- Fatigue, weakness, dizziness, headaches

- Feeling cold or numbness in hands and/or feet

- Low blood pressure.

- Gastrointestinal 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):

- Hearing problems

- Nasal discharge

- Decreased tear production (dry eyes)

- Inflammation of the liver that may cause yellowing of the skin or the white part of the eyes

- Abnormal results of liver function tests or abnormal levels of fat in the blood

- Allergic-like reactions such as itching, redness, and rashes on the skin. You should 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 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 for Pharmacovigilance of Medicinal Products 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 out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bisoprolol Pensa

The active ingredient is bisoprolol fumarate.

Each tablet contains 1.25 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the packaging

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

Bisoprolol Pensa 1.25 mg is presented in packaging containing 20 or 28 tablets.

Only some packaging formats may be commercially marketed

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

Co. Galway

Ireland.

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

Spain: Bisoprolol Pensa 1.25 mg tablets EFG

Italy: Bisoprololo Pensa Pharma 1.25 mg Compresse

This leaflet has been approved in:November 2023

The 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/.