Bisoprolol Pensa 1.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol Pensa 1.25 mg tablets EFG

Bisoprolol 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, ask your doctor or pharmacist.

- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Bisoprolol Pensa is and what it is 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 down the heartbeat and makes the heart more effective at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and its blood supply.

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 to:

• treat high blood pressure (hypertension).

• treat chronic stable angina pectoris.

• treat chronic stable heart failure. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking Bisoprolol Pensa

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 substance or to 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 may cause tingling in the fingers and toes or make them pale or blue
• untreated phaeochromocytoma, which is a rare tumour 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 any of the following heart problems:

• acute heart failure
  • worsening heart failure requiring intravenous injection of medicines that increase the heart's contraction force
  • low blood pressure
  • certain heart conditions causing very slow heart rate or irregular pulse, and you do not have a pacemaker
  • cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure
  • slow heart rate

Warnings and precautions

Talk to 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 wish 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)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder
• first-degree heart block (a condition in which nerve signals to the heart are altered, potentially causing occasional missed beats or irregular heartbeat)

In addition, inform your doctor if you are undergoing:

• desensitisation treatment (e.g. for prevention of hay fever), as Bisoprolol Pensa may make it more likely that you experience an allergic reaction, or that such a reaction could be more severe.
• anaesthesia (e.g. for surgery), as Bisoprolol Pensa 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 begin to experience new breathing difficulties, cough, wheezing after exercise, etc., while taking bisoprolol.

Taking Bisoprolol Pensa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Do not take the following medicines with Bisoprolol Pensa without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeats (Class I antiarrhythmics 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 Pensa; 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 heartbeat (Class III antiarrhythmics 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 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 (e.g. during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain or inflammation (e.g. ibuprofen or diclofenac)
• 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 anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterised by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• medicines for treating depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide

Pregnancy and breastfeeding

There is a risk that using Bisoprolol Pensa 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.

It is unknown whether bisoprolol passes 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 using machines

Your ability to drive or operate 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, when medication is changed, and also when combined with alcohol.

3. How to take Bisoprolol Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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.

Treatment with Bisoprolol Pensa requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, when increasing the dose, and when stopping 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 daily. If necessary, the dose may be increased to 10 mg daily.

The maximum recommended dose is 20 mg once daily.

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, which will normally 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 (ongoing).

The maximum recommended daily dose is 10 mg of bisoprolol.

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 accordingly.

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 renal and/or hepatic impairment

Dosage adjustment is usually not 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, the dose should not exceed 10 mg of bisoprolol once daily.

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.

Symptoms of overdose may include a reduced 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 telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Pensa:

Do not take a double dose to make up for a missed dose. Take your usual dose the following morning.

If you stop taking Bisoprolol Pensa

Do not stop taking Bisoprolol Pensa unless your doctor tells you to. Otherwise, your condition could worsen significantly. Treatment must not be stopped suddenly, especially in patients with systemic heart failure. If you are considering stopping treatment, your doctor will advise you on how to reduce the dose gradually.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Bisoprolol Pensa may produce adverse effects, although not everyone experiences them.

To prevent serious adverse reactions, speak to your doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly.

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 patients):

• fatigue, weakness, dizziness, headache
• sensation of coldness or numbness in hands and/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 upon standing
• breathing 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
• reduced tear production (dry eyes)
• liver inflammation that may cause yellowing of the skin or whites of the eyes (jaundice)
• certain abnormal blood test results for liver function or fat levels
• allergic-type reactions such as itching, redness, and skin rashes. 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 problems
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Pensa

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at the pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Pensa

The active substance is bisoprolol fumarate.

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) (derived from potato starch), and magnesium stearate.

Appearance of the product and contents of the pack

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

Bisoprolol Pensa 1.25 mg is available in packs containing 20 or 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

Co. Galway

Ireland

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

Spain: Bisoprolol Pensa 1,25 mg tablets EFG

Italy: Bisoprololo Pensa Pharma 1,25 mg Compresse

This leaflet was approved in: November 2023

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