Bisoprolol Zentiva Italia

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Bisoprolol Zentiva Italia 2.5 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, because 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bisoprolol Zentiva Italia is and what it is used for

2. What you need to know before taking Bisoprolol Zentiva Italia

3. How to take Bisoprolol Zentiva Italia

4. Possible side effects

5. How to store Bisoprolol Zentiva Italia

6. Contents of the pack and other information

7. What Bisoprolol Zentiva Italia is and what it is used for
   The active substance in Bisoprolol Zentiva Italia 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 the heart rate 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 Zentiva Italia is used to treat stable chronic heart failure. It is used in combination with other medicines available for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking Bisoprololo Zentiva Italia

Do not take Bisoprololo Zentiva Italia if:

• you are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from severe asthma;
• you suffer from severe circulation problems in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or a bluish colour in the fingers of the hands and feet;
• you have untreated phaeochromocytoma, a rare tumour of the adrenal gland;
• you suffer from metabolic acidosis, a condition in which there is too much acid in the blood.

Do not take Bisoprololo Zentiva Italia if you have any of the following heart conditions:

• acute heart failure;
• worsening heart failure requiring intravenous medication to increase the heart's pumping strength;
• if your heartbeat is too slow;
• if you have very low blood pressure;
• certain heart conditions causing a marked reduction in heart rate or irregular heartbeat;
• cardiogenic shock, a serious acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions
If any of the following apply to you, inform your doctor or pharmacist before taking Bisoprololo Zentiva Italia. They may decide to take special measures (for example, prescribe additional treatment or more frequent monitoring):

• Diabetes
• Prolonged fasting
• Certain heart diseases, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• Kidney or liver problems
• Less severe circulation problems in the extremities
• Chronic lung disease or mild asthma
• History of scaly skin eruptions (psoriasis)
• Tumour of the adrenal gland (phaeochromocytoma)
• Thyroid disorders

Also, inform your doctor if you are about to undergo:

• Desensitisation therapy (e.g. for hay fever prevention), because Bisoprololo Zentiva Italia may facilitate the onset of an allergic reaction or make it more severe;
• Anaesthesia (e.g. for surgery), because Bisoprololo Zentiva Italia may affect how your body responds to this situation.

If you have chronic lung disease or mild asthma, inform your doctor immediately if you develop new breathing difficulties, cough, wheezing after physical exertion, etc., while taking Bisoprololo Zentiva Italia.

Children and adolescents
The use of Bisoprololo Zentiva Italia is not recommended in children and adolescents.
For individuals engaged in sports, the use of this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Bisoprololo Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take the following medicines with Bisoprololo Zentiva Italia without first consulting your doctor:

• Certain medicines used to treat irregular or abnormal heartbeats (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.

Before taking Bisoprololo Zentiva Italia together with the following medicines, consult your doctor, who may require more frequent monitoring of your condition:

• Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmics such as amiodarone).
• Locally applied beta-blockers (such as eye drops containing timolol for glaucoma treatment).
• Certain medicines used, for example, in the treatment of 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).
• Antidiabetic medicines, including insulin.
• Anaesthetic agents (e.g. during surgical procedures).
• Digitalis, used in the treatment of 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 a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used in epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental disorders characterised by loss of contact with reality (phenothiazines such as levomepromazine).
• Mefloquine, used in the prevention and treatment of malaria.
• Medicines for depression known as monoamine oxidase inhibitors (MAOIs), except MAO-B inhibitors, such as moclobemide.

Pregnancy and breastfeeding
Pregnancy
There is a risk that using Bisoprololo Zentiva Italia during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor, who will decide whether you can take Bisoprololo Zentiva Italia during pregnancy.

Breastfeeding
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoprololo Zentiva Italia.

Driving and using machines
Your ability to drive or operate machinery may be affected depending on how well you tolerate this medicine. You should be particularly cautious at the beginning of treatment, when the dose is increased or the medicine is changed, as well as when taking it together with alcohol.

Bisoprololo Zentiva Italia contains lactose
Bisoprololo Zentiva Italia contains milk sugar (lactose). If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Bisoprololo Zentiva Italia

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Treatment with Bisoprololo Zentiva Italia requires regular monitoring by your doctor. This is particularly important at the beginning of treatment, during dose increases, and when stopping treatment.
Take the tablet with water in the morning, with or without food. Do not crush or chew the tablet.
Tablets with a score line can be divided into two equal doses.
Treatment with Bisoprololo Zentiva Italia is usually long-term.

Adults, including elderly patients:
Treatment with bisoprolol should start with a low dose and be gradually increased. Your doctor will decide how to increase the dose, usually according to the following schedule:

• 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 for maintenance (ongoing) therapy.

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 intervals between dose increases. If your condition worsens or you can 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.

If treatment needs to be completely discontinued, your doctor will usually advise you to gradually reduce the dose; otherwise, your condition may worsen.

If you take more Bisoprololo Zentiva Italia than you should
If you have taken more tablets of Bisoprololo Zentiva Italia than prescribed, inform your doctor immediately. They will determine the necessary measures to take.
Symptoms of overdose may include slow heartbeat, severe breathing difficulties, dizziness, and tremors (due to low blood sugar).

If you forget to take Bisoprololo Zentiva Italia
Do not take a double dose to make up for the missed dose. Take your usual dose the next morning.

If you stop taking Bisoprololo Zentiva Italia
Never stop taking Bisoprololo Zentiva Italia without first consulting your doctor. Otherwise, your condition may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To prevent serious reactions, contact your doctor immediately if a side effect is severe, occurs suddenly, or worsens rapidly.
The most serious side effects affect heart function:
slowing of the 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 or weak, or have breathing problems, contact your doctor as soon as
possible.
Further side effects are listed below according to how often they may occur:
Common (may affect up to 1 in 10 people):

• Tiredness, feeling weak, dizziness, headache
• Feeling cold or tingling 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.

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

• Hearing problems
• Allergic rhinitis
• Reduced tear flow (important if you wear contact lenses)
• Liver inflammation which may cause yellowing of the skin or whites of the eyes
• Abnormal results in certain blood tests for liver function or fat levels
• Erectile difficulties
• Nightmares, hallucinations
• Fainting.

Very rare (may affect up to 1 in 10,000 people):

• Eye irritation and redness (conjunctivitis)
• Hair loss
• Onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects
If you get 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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Zentiva Italia contains
The active substance is bisoprolol fumarate.
Each 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.
The other components are:
microcrystalline cellulose, monohydrate lactose, magnesium stearate, crospovidone.

Description of the appearance of Bisoprololo Zentiva Italia tablets and pack contents
Bisoprololo Zentiva Italia 2.5 mg tablets: white, oblong, uncoated tablet, with a break line on both the upper and lower sides, with "BI" and "2.5" engraved on either side of the break line only on the upper side.
The tablet can be divided into two equal doses.
Each pack contains: 28, 30 or 90 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer:
Niche Generics Ltd.
Unit 5, 151 Baldoyle Industrial Estate
Dublin 13 - Ireland

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
France: Bisoprololo Zentiva Lab 2.5/5/10 mg, comprime sécable
Italy: Bisoprololo Zentiva Italia 2.5 mg tablets