Bisoprolol Eg Stada

PATIENT INFORMATION LEAFLET

BISOPROLOL EUROGENERICI 1.25 mg tablets

BISOPROLOL EUROGENERICI 2.5 mg tablets
BISOPROLOL EUROGENERICI 3.75 mg tablets
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or
pharmacist. See section 4.
Contents of this leaflet:

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

1. WHAT IS BISOPROLOL EUROGENERICI AND WHAT IS IT USED FOR

The active substance in Bisoprolol Eurogenerici 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, particularly in the heart. As a result, bisoprolol slows the heart rate and
makes it easier for the heart to pump blood around the body.
Heart failure occurs when the heart muscle becomes weakened and is no longer able to pump enough blood to meet the body's needs. Bisoprolol Eurogenerici is indicated for the treatment of stable chronic heart failure.
It is generally used in combination with other medicines used to treat this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. WHAT YOU SHOULD KNOW BEFORE TAKING BISOPROLOL EUROGENERICI

Do not take Bisoprolol Eurogenerici:
Do not take Bisoprolol Eurogenerici if any of the following conditions apply to you:

• hypersensitivity to bisoprolol or to any of the other components of this medicine (listed in section 6)
• severe asthma or severe chronic lung disease
• serious circulatory problems in the extremities (such as Raynaud's syndrome), which may cause tingling in the fingers and toes, possibly accompanied by whitening or bluing of the skin
• untreated phaeochromocytoma, a rare tumour of the adrenal gland
• metabolic acidosis, i.e. a condition in which there is an increased level of acids in the blood.

Do not take Bisoprolol Eurogenerici if any of the following heart conditions apply to you:

• acute heart failure
• worsening heart failure requiring intravenous administration of medicines that increase the heart's pumping force
• slow heart rate (bradycardia)
• low blood pressure (hypotension)
• certain heart conditions causing significant slowing of the heart rate or irregular heartbeat
• cardiogenic shock, i.e. a serious acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions
If you suffer from any of the following conditions, inform your doctor that you are taking this medicine; your doctor may wish to proceed with particular caution (for example, by prescribing additional treatment or performing 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 to moderate peripheral circulatory disorders
• mild asthma or mild chronic lung disease
• history of skin peeling (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorders.

Also inform your doctor if you are about to undergo:

• desensitisation therapy (e.g. to prevent hay fever), as Bisoprolol Eurogenerici may increase the likelihood of an allergic reaction or cause a more severe reaction.
• anaesthesia (e.g. for surgery), as Bisoprolol Eurogenerici may affect your body's responses in this situation.

Children
Bisoprolol Eurogenerici is not recommended for use in children.
For athletes: using the medicine without medical need constitutes doping and may result in a positive anti-doping test.

Other medicines and Bisoprolol Eurogenerici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take the following medicines together with Bisoprolol Eurogenerici 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. Do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines together with Bisoprolol Eurogenerici; 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 felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)
• topical beta-blockers (e.g. timolol eye drops used to treat 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)
• 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 lack of contact with reality (phenothiazines such as levomepromazine)
• mefloquine for prevention or treatment of malaria
• antidepressants known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

Taking Bisoprolol Eurogenerici with food and drink
Bisoprolol Eurogenerici should be taken in the morning, before, during or after breakfast.
The tablets should be swallowed whole with liquid and must not be chewed or crushed.
Avoid drinking excessive amounts of alcohol. This may increase the blood pressure-lowering effect of bisoprolol.
In any case, avoid alcohol if it makes you more prone to dizziness or causes a greater sensation of lightheadedness than usual.

Pregnancy and breastfeeding
Taking Bisoprolol Eurogenerici during pregnancy could harm the unborn child.
Inform your doctor before taking this medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby. Your doctor will decide whether you can take this medicine during pregnancy. It is not known whether bisoprolol passes into breast milk. Breastfeeding is therefore not recommended during treatment with Bisoprolol Eurogenerici.

Driving and using machines
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 increased, when switching medicines, and if alcohol is consumed concurrently.

3. HOW TO TAKE BISOPROLOL EUROGENERICI

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Treatment with Bisoprolol Eurogenerici requires regular monitoring by your
doctor. This is particularly necessary at the beginning of treatment, when increasing the dose,
and when stopping treatment.
Take the tablets with a glass of water in the morning, with or without food. Do not break or chew the
tablet.
Treatment with Bisoprolol Eurogenerici is usually long-term.
Adults, including elderly patients
Treatment with bisoprolol should be started at a low dose and gradually increased.
Your doctor will decide how to increase the dose. Generally, this will proceed 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 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 if 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 of bisoprolol lower than 10 mg may be sufficient.
Your doctor will advise you accordingly.
If you need to stop treatment permanently, your doctor will usually recommend gradually reducing the dose; otherwise, your condition could worsen.
Renal or hepatic impairment
The dose should be increased very gradually and with great caution in patients with severe renal or hepatic problems.
If you take more Bisoprolol Eurogenerici than you should
If you have taken more Bisoprolol Eurogenerici than prescribed, contact your doctor or go immediately to the Emergency Department. Bring this leaflet and any remaining tablets with you.
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 Bisoprolol Eurogenerici
Do not take a double dose to make up for the missed dose. Take the next dose as scheduled the following morning.
If you stop taking Bisoprolol Eurogenerici
Do not stop treatment with Bisoprolol Eurogenerici without first consulting your doctor.
Otherwise, your condition could worsen.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if an adverse reaction occurs in a severe form, starts suddenly, or worsens rapidly, so as to prevent serious reactions. The most serious adverse effects involve cardiac 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)
• slowed or irregular heartbeat (may affect up to 1 in 100 people)
  If you feel unsteady or weak, or have difficulty breathing, contact your doctor as soon as possible.

Other adverse reactions 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
• 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 production
• liver inflammation which may cause yellowing of the skin and whites of the eyes
• abnormalities in certain blood tests for liver function or abnormal levels of fats
• allergy-like reactions such as itching, flushing, skin rash
• impaired erection
• 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 skin scaling (psoriasis); psoriasiform skin rash.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BISOPROLOL EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister. 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. PACK CONTENTS AND OTHER INFORMATION

What Bisoprololo Eurogenerici contains
The active substance is bisoprolol fumarate.
Each 1.25 mg tablet contains 1.25 mg of bisoprolol fumarate.
Each 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.
Each 3.75 mg tablet contains 3.75 mg of bisoprolol fumarate.
The other components are microcrystalline cellulose, colloidal silicon dioxide, croscarmellose
sodium, sodium carboxymethylstarch (type A) and magnesium stearate.

Description of the appearance of Bisoprololo Eurogenerici and pack contents
Bisoprololo Eurogenerici 1.25 mg tablets are available as round, biconvex tablets, white to off-white in colour.
Bisoprololo Eurogenerici 2.5 mg tablets are available as round, biconvex tablets, white to off-white in colour, with a score line on one side.
Bisoprololo Eurogenerici 3.75 mg tablets are available as round, biconvex tablets, white to off-white in colour.
Packs containing 10, 20, 28, 30, 50, 56, 60, 90 and 100 tablets are available (some pack sizes may not be marketed).

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel – Germany
Centrafarm Services B.V., Nieuwe Donk 9, 4879, AC Etten-Leur – The Netherlands
Chanelle Medical, Loughrea, Co. Galway – Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
United Kingdom: Bisoprolol Fumarate Tablets
Belgium: Bisoprolol EG
Germany: Bisoprolol STADA Tabletten
France: BISOPROLOL EG comprimé pelliculé
Italy: BISOPROLOLO EUROGENERICI tablets
Luxembourg: Bisoprolol EG
Sweden: Bisostad filmdragerade tabletter