Bisoprolol Pensapharma

Patient Information Leaflet: Information for the Patient

Bisoprololo Pensa Pharma 1.25 mg tablets, 3.75 mg tablets, 7.5 mg tablets

Bisoprolol fumarate
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bisoprololo Pensa Pharma is and what it is used for

The active substance is bisoprolol. Bisoprolol belongs to a group of medicines known as
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 heart rate and allows the heart to pump blood more easily 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 becomes weakened and is no longer able to pump enough blood to meet the body's needs.
Bisoprololo Pensa Pharma is indicated for:

• treatment of high blood pressure (hypertension)
• treatment of chronic stable angina pectoris
• treatment of chronic stable heart failure in combination with other medicines indicated for this condition (such as ACE inhibitors, diuretics and cardiac glycosides).

2. What you need to know before taking Bisoprololo Pensa Pharma

Do not take Bisoprololo Pensa Pharma if any of the following apply to you:

• allergy to bisoprolol or to any of the components of this medicine (listed in section 6);
• severe asthma;

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• severe circulatory problems in the extremities (such as Raynaud's syndrome), which may cause tingling sensations or pale or bluish skin on the fingers of the hands and feet;
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland;
• metabolic acidosis, i.e. a condition in which there is an increase in acid levels in the blood.

Do not take Bisoprololo Pensa Pharma if you suffer from any of the following heart conditions:

• acute heart failure;
• worsening heart failure requiring intravenous administration of medicines that increase the heart's contraction force;
• low blood pressure;
• certain heart conditions causing a slowed heart rate or irregular heartbeat, and you are not using a pacemaker;
• cardiogenic shock, i.e. a serious acute heart condition causing low blood pressure and circulatory failure;
• slow heartbeat.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprololo Pensa Pharma. If you have or have previously had any of the following conditions, inform your doctor before taking Bisoprololo Pensa Pharma; your doctor may wish to proceed with caution (for example, prescribe additional treatment or perform more frequent checks):

• diabetes;
• prolonged fasting;
• certain heart diseases such as heart rhythm disorders 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 skin peeling (psoriasis);
• tumour of the adrenal gland (phaeochromocytoma);
• thyroid disorders;
• first-degree heart block (a condition in which nerve signals to the heart are altered, usually causing occasional missed beats or irregular heartbeat).

Also inform your doctor if you are about to undergo:

• desensitisation therapy (e.g. to prevent hay fever), as Bisoprololo Pensa Pharma may make allergic reactions more likely or may cause them to be more severe;
• anaesthesia (e.g. for surgery), as Bisoprololo Pensa Pharma may affect your body's responses in this situation.

If you have chronic lung disease or mild asthma, inform your doctor immediately if, while taking bisoprolol, you begin to experience new breathing difficulties, coughing, wheezing after physical exertion, etc.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Bisoprololo Pensa Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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Do not take the following medicines together with Bisoprololo Pensa Pharma unless specifically instructed by your doctor:

• certain medicines used to treat abnormal or irregular heartbeat (Class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines together with Bisoprololo Pensa Pharma; your doctor may consider it necessary to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists such as nifedipine, felodipine, and amlodipine);
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic drugs such as amiodarone);
• topical beta-blockers (e.g. timolol eye drops used to treat glaucoma);
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbacol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline or dobutamine);
• antidiabetic medicines, including insulin;
• anaesthetics (e.g. during surgical procedures);
• 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 capable of lowering blood pressure, whether intended or not, such as antihypertensives, certain medicines used to treat depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or used during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat psychotic disorders characterised by loss of contact with reality (phenothiazines such as levomepromazine);
• mefloquine, used to prevent or treat malaria;
• antidepressants known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding
Taking Bisoprololo Pensa Pharma during pregnancy could harm the unborn child.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you may take bisoprolol during pregnancy.
It is not known whether bisoprolol passes into breast milk. Breastfeeding is therefore not recommended during treatment with Bisoprololo Pensa Pharma.

Children and adolescents
The use of Bisoprololo Pensa Pharma is not recommended in children and adolescents.

Driving and using machines
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Your ability to drive or operate machinery may be impaired depending on your individual response to the medicine. Exercise particular caution at the beginning of treatment, when the dose is being increased, when switching to another medicine, and also if you consume alcohol at the same time.

3. How to take Bisoprololo Pensa Pharma

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take the tablet with a glass of water in the morning, with or without food. Do not crush or chew the
tablet.
Treatment with Bisoprololo Pensa Pharma must be carried out under regular medical supervision,
particularly at the beginning of treatment, during dose escalation, and at the end of treatment.
Treatment with Bisoprololo Pensa Pharma 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 up
to 10 mg once daily.
The maximum recommended daily dose is 20 mg of bisoprolol.

Chronic stable heart failure
Adults, including elderly patients
Treatment with bisoprolol should be initiated at a low dose, gradually increased over time.
Your doctor will decide how to increase the dose. Typically, this will 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 the maintenance (long-term) dose.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on your tolerance to the medicine, your doctor may decide to extend the intervals
between dose increases. If your condition worsens or you can no longer tolerate the medicine, it
may be necessary to reduce the dose or discontinue treatment. In some patients, a maintenance
dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will advise you accordingly.
If you need to stop treatment permanently, your doctor will usually advise you to gradually reduce
the dose. Otherwise, your condition could worsen.

Renal or hepatic impairment
Generally, no dose adjustment is required in patients with mild to moderate renal or hepatic
impairment. In patients with severe renal impairment (creatinine clearance < 20 ml/min) or
severe hepatic impairment, the daily dose should not exceed 10 mg of bisoprolol.

Use in children and adolescents
The use of Bisoprololo Pensa Pharma is not recommended in children.

If you take more Bisoprololo Pensa Pharma than you should
If you have taken more tablets of Bisoprololo Pensa Pharma than prescribed, inform your doctor
immediately. Your doctor will decide which measures to take.
Symptoms of overdose may include: slowed heart rate, severe breathing difficulties, dizziness, or
tremor (due to low blood sugar).

If you forget to take Bisoprololo Pensa Pharma
Do not take a double dose to make up for the missed dose. Take your usual dose the following
morning.

If you stop taking Bisoprololo Pensa Pharma
Do not stop taking Bisoprololo Pensa Pharma unless instructed by your doctor. Otherwise, your
condition may worsen seriously. Treatment should not be stopped abruptly, especially in
patients with systemic heart failure. If you need to discontinue treatment, your doctor will advise
you on how to do so gradually.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
To prevent serious reactions, contact your doctor immediately if the side effect is severe, occurs suddenly, or worsens rapidly.
The most serious side effects involve 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 heartbeat (may affect up to 1 in 100 people)
  If you feel dizzy, weak, or have difficulty breathing, consult your doctor as soon as possible.

Other side effects listed below are categorized according to their frequency of occurrence:
Common (may affect up to 1 in 10 people):

• tiredness, weakness, dizziness, headache;
• cold sensation or numbness in hands or feet;
• low blood pressure;
• stomach or intestinal problems such as nausea, vomiting, diarrhoea or constipation.

Uncommon (may affect up to 1 in 100 people):

• sleep disorders;
• depression;
• dizziness upon standing up;
• breathing problems in patients with asthma or chronic lung disease;
• muscle weakness, muscle cramps.

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

• hearing problems;
• allergic rhinitis;
• reduced tear production;
• inflammatory liver disorder that may cause yellowing of the skin or whites of the eyes (jaundice);
• abnormal results in certain blood tests for liver function or abnormal levels of fats in the blood;
• allergic-like reactions such as itching, flushing, skin rash. Contact your doctor immediately if you experience more severe allergic reactions, such as swelling of the face, neck, tongue, mouth or throat, or difficulty breathing;
• impaired erection;
• nightmares, hallucinations;
• fainting.

Very rare (reported in fewer than 1 in 10,000 people):

• eye irritation and redness (conjunctivitis);
• hair loss;
• onset or worsening of skin peeling (psoriasis); psoriasis in the form of a skin rash.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol Pensa Pharma

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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Pensa Pharma contains:
The active substance is bisoprolol fumarate.
Each tablet contains 1.25 mg of bisoprolol fumarate.
Each tablet contains 3.75 mg of bisoprolol fumarate.
Each tablet contains 7.5 mg of bisoprolol fumarate.
The other components are: microcrystalline cellulose, anhydrous colloidal silica, croscarmellose
sodium, sodium starch glycolate (type A) (potato starch) and magnesium stearate.
Description of the appearance of Bisoprololo Pensa Pharma and package contents
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1.25 mg
White to off-white, round, biconvex tablet, imprinted with "1.25" on one side and smooth on the other side.
3.75 mg
White to off-white, round, biconvex tablet, imprinted with "3.75" on one side and smooth on the other side.
7.5 mg
White to off-white, round, biconvex tablet with a break line on one side.
The tablet can be divided into equal doses.
Bisoprololo Pensa Pharma is available in packs of 28 tablets.
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano – Italy
Manufacturer
Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Spain - Bisoprolol Pensa 1.25 mg, 3.75 mg, 7.5 mg tablets EFG
Italy - Bisoprololo Pensa Pharma 1.25 mg, 3.75 mg, 7.5 mg tablets
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