Bisoprolol Teva

Package leaflet: Information for the user

BISOPROLOL TEVA 1.25 mg tablets, 2.5 mg tablets, 3.75 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine
Please read all of 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 they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What BISOPROLOL TEVA is and what it is used for

BISOPROLOL TEVA contains the active substance bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Bisoprolol prevents irregular heartbeat (arrhythmia) during exertion and reduces the cardiovascular workload. Bisoprolol also dilates blood vessels and thus improves blood flow.

BISOPROLOL TEVA is used to:

• Treat high blood pressure (hypertension).
• Treat coronary heart disease and chest pain (angina pectoris) resulting from insufficient oxygen supply to the heart muscle.
• Treat heart failure in combination with other medicines. Heart failure is the inability of the heart to pump enough blood to meet the body's needs, leading to swelling (oedema) of the extremities and shortness of breath.

2. What you should know before taking BISOPROLOLO TEVA

Do not take BISOPROLOLO TEVA

• If you are allergic to bisoprolol or to any of the other ingredients of this medicine (listed in section 6),
• If you have heart failure that has just developed or has recently worsened, or if you are receiving treatment for circulatory shock due to acute heart failure via intravenous infusion to help your heart function,
• If you have very low blood pressure or a slow heart rate due to a serious heart abnormality (called cardiogenic shock),
• If you have heart conduction disorders, such as sick sinus syndrome, sino-atrial block, or second- or third-degree atrioventricular block,
• If you have a very slow heart rate,
• If you have very low blood pressure,
• If you have an untreated tumour that can increase blood pressure (called phaeochromocytoma),
• If you suffer from symptoms of severe asthma,
• If you suffer from severe circulation problems, such as intermittent claudication (leg pain that occurs easily when walking) or Raynaud's syndrome (characterized by white, bluish, and then red and painful fingers),
• If you have so-called metabolic acidosis, a disturbance in acid-base balance as occurs in diabetic patients when blood sugar levels rise too high.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine, as they may decide to take special precautions (for example, give you additional treatment or perform more frequent checks):

• If you have asymptomatic and well-controlled heart failure,
• If you have liver or kidney problems,
• If you have heart valve problems or a congenital heart disease,
• If you have had a heart attack within the last three months,
• If you suffer from chronic lung disease or less severe asthma (if you are using bronchodilators, their dosage may need adjustment and lung function monitoring may be necessary),
• If you are undergoing surgery or another procedure under sedation or spinal anaesthesia (you must inform the anaesthetist that you are taking BISOPROLOLO TEVA),
• If you have diabetes mellitus and your blood sugar levels vary greatly (BISOPROLOLO TEVA may mask the symptoms of hypoglycaemia and slow down the recovery of blood sugar levels),
• If you are on strict fasting,
• If your thyroid is overactive (BISOPROLOLO TEVA may mask the symptoms of hyperthyroidism),
• If you are undergoing desensitisation therapy (BISOPROLOLO TEVA may worsen allergic reactions and increase the dose of medication required to treat allergic reactions),
• If you have a mild heart conduction disorder (first-degree atrioventricular block),
• If you have chest pain caused by spasms of the coronary arteries of the heart (known as Prinzmetal's angina),
• If you wear contact lenses (BISOPROLOLO TEVA may reduce tear production and cause dry eyes),
• If you suffer from scaly skin eruptions (psoriasis).

If you suffer from chronic lung disease or less severe asthma, inform your doctor immediately if you start experiencing further breathing difficulties, coughing, shortness of breath after physical exertion, etc., during treatment with Bisoprololo Teva.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
The use of Bisoprololo Teva is not recommended in children or adolescents.
Other medicines and BISOPROLOLO TEVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take the following medicines with BISOPROLOLO TEVA without first obtaining specific advice from your doctor:

• quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone (used to treat irregularities or abnormalities in heart rhythm),
• verapamil and diltiazem (used to treat irregular heart rhythms and high blood pressure),
• clonidine, methyldopa, guanfacine, moxonidine, and rilmenidine (to treat high blood pressure and certain neurological conditions). However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines with BISOPROLOLO TEVA: your doctor may need to monitor you more frequently:

• nifedipine, felodipine, and amlodipine (used to treat high blood pressure, angina, or heart rhythm abnormalities),
• amiodarone (used to treat irregular or abnormal heart rhythm),
• beta-blockers, including eye drops containing beta-blockers, such as timolol for glaucoma treatment,
• digitalis preparations, such as digoxin, used to treat heart failure,
• donepezil or tacrine (for the treatment of dementia),
• neostigmine or pyridostigmine (for the treatment of myasthenia gravis, a disease causing muscle weakness),
• physostigmine for treating high eye pressure (glaucoma),
• medicines known as ergot alkaloids (to treat migraine or low blood pressure),
• other antihypertensive medicines,
• other medicines that may have antihypertensive effects, such as tricyclic antidepressants (e.g., imipramine or amitriptyline), phenothiazines (e.g., levomepromazine) for the treatment of psychosis, or barbiturates (e.g., phenobarbital) for the treatment of epilepsy,
• adrenaline for treating allergic reactions,
• baclofen and tizanidine (muscle relaxants),
• amifostine (a protective agent used in some anticancer therapies),
• mefloquine (an antimalarial),
• rifampicin (an antibiotic),
• insulin and other medicines for the treatment of diabetes mellitus,
• anaesthetic agents (used during surgical procedures),
• oral or intravenous corticosteroids,
• so-called monoamine oxidase inhibitors (MAO inhibitors) (excluding MAO-B inhibitors), such as moclobemide or phenelzine (for depression).

Non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, diclofenac, ibuprofen, ketoprofen, naproxen, celecoxib, or etoricoxib (especially if used long-term and regularly) may reduce the effectiveness of BISOPROLOLO TEVA in treating hypertension. However, low daily doses of acetylsalicylic acid, e.g., 100 mg, can be safely used during BISOPROLOLO TEVA treatment to prevent blood clotting.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
BISOPROLOLO TEVA should not be used during pregnancy unless clearly necessary. If you are planning a pregnancy or become pregnant while being treated with BISOPROLOLO TEVA, consult your doctor about continuing the treatment.
It is not known whether bisoprolol from BISOPROLOLO TEVA is excreted in breast milk. Therefore, breastfeeding during treatment with BISOPROLO TEVA is not recommended.
Driving and using machines
BISOPROLOLO TEVA has little or no effect on the ability to drive. Side effects resulting from blood pressure reduction may include dizziness, headache, fatigue, or other adverse effects (see section 4) that could impair your ability to drive and use machinery. If such effects occur, you should avoid driving and performing other activities requiring alertness. This is particularly important at the beginning of treatment and when the dose is increased. BISOPROLOLO TEVA usually does not affect driving ability if the therapy is well balanced.
BISOPROLOLO TEVA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take BISOPROLOL TEVA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose
Adults:
Treatment of hypertension and angina pectoris

• The starting dose is 5 mg once daily.
• Your doctor may gradually increase the dose (usually over several weeks) to a maximum of 10 mg if necessary.

Treatment of stable chronic heart failure
Treatment with bisoprolol should start at the lowest dose and be increased gradually. Your doctor will decide how to increase the dose, which is usually done as follows:

• 1.25 mg once daily for one week
• 2.5 mg once daily for one week
• 3.75 mg once daily for one week
• 5 mg once daily for four weeks
• 7.5 mg once daily for four weeks
• 10 mg once daily as maintenance dose

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 no longer tolerate the medicine, a reduction in dose or discontinuation of treatment may be necessary. In some patients, a maintenance dose lower than 10 mg may be sufficient. Your doctor will advise you accordingly. If you need to stop treatment completely, your doctor will usually recommend gradually reducing the dose, as stopping abruptly may worsen your condition.
Elderly
Dosage adjustment is not usually required in elderly patients, unless they have renal or hepatic impairment; see below.
Patients with renal or hepatic impairment
The dose should be increased very gradually and with caution in patients with severe kidney or liver problems. The dose must not exceed 10 mg once daily in patients with severe renal or hepatic impairment.
Method of administration
Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water), usually once daily in the morning. The tablets should not be chewed. Food does not affect the absorption of the medicine.
BISOPROLOL TEVA tablets 2.5 mg, 5 mg and 10 mg only
The tablet may be divided into equal doses. Divide the tablets as follows: Place the tablets on a flat, hard surface (e.g. a table) and break them by pressing with the index fingers of both hands on either side of the break line at the ends of the tablet towards the surface.
If you take more BISOPROLOL TEVA than you should
If you or anyone else has taken an excessive dose of BISOPROLOL TEVA, contact a doctor immediately or go to the nearest emergency department.
In case of nausea or dizziness, lie the patient down and seek medical assistance. If the patient is unconscious, place them in the recovery position (on their side), with legs elevated.
If you forget to take BISOPROLOL TEVA
Take the next tablet at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking BISOPROLOL TEVA
Treatment with BISOPROLOL TEVA must not be stopped abruptly, especially if the patient has coronary heart disease. The dose should be gradually reduced according to your doctor's instructions, for example over 1 or 2 weeks. Otherwise, symptoms of heart disease may worsen.
If you have any questions about the use of 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 adverse reactions, inform your doctor immediately if a side effect is severe, has occurred suddenly, or worsens rapidly. The most serious side effects are related to heart function, and the most common among these are slowing of the heartbeat, excessive reduction in blood pressure, dizziness, and fatigue.
Other side effects are listed below according to how frequently they may occur.

Very common (may affect more than 1 in 10 people)

• too slow heartbeat (in patients with heart failure)

Common (may affect up to 1 in 10 people)

• dizziness and headache
• worsening of heart failure symptoms (in patients with pre-existing heart failure)
• cold sensation and numbness in the extremities
• blood pressure too low (in patients with heart failure)
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea, or constipation
• asthenia (in patients with heart failure), fatigue

Uncommon (may affect up to 1 in 100 people)

• depression, sleep disorders
• heart block (disturbances in the heart's conduction)
• too slow heartbeat (in patients with hypertension or coronary heart disease)
• bronchospasm (in patients with asthma or chronic obstructive pulmonary disease)
• muscle weakness, muscle cramps
• asthenia (in patients with hypertension or angina pectoris)
• low blood pressure when standing up (orthostatic hypotension)

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

• nightmares and hallucinations
• fainting (syncope)
• reduced tear production (contact lens wearers should take note)
• hearing disturbances
• hepatitis (causes pain in the upper abdomen)
• hypersensitivity reactions, such as itching, redness or skin rashes. You should consult your doctor immediately if you experience more severe allergic reactions, which may involve swelling of the face, neck, tongue, mouth or throat, or breathing difficulties.
• sexual dysfunction
• increased levels of liver enzymes (ALT or AST)
• allergic rhinitis (stuffy, runny, itchy nose)

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

• conjunctivitis (inflammation of the eye)
• hair loss (alopecia), worsening of psoriasis or 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store BISOPROLOL TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton 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 medicines 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 TEVA contains

• The active substance is bisoprolol fumarate. One 1.25 mg tablet contains 1.25 mg of bisoprolol fumarate. One 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate. One 3.75 mg tablet contains 3.75 mg of bisoprolol fumarate. One 5 mg tablet contains 5 mg of bisoprolol fumarate. One 10 mg tablet contains 10 mg of bisoprolol fumarate.
• The other components are: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, sodium starch glycolate (Type A) and magnesium stearate.

Description of the appearance of BISOPROLOLO TEVA and contents of the pack
BISOPROLOLO TEVA 1.25 mg tablets are white or almost white, round, biconvex tablets.
BISOPROLOLO TEVA 2.5 mg tablets are white or almost white, round, biconvex tablets with a break line on one side.
BISOPROLOLO TEVA 3.75 mg tablets are white or almost white, round, biconvex tablets.
BISOPROLOLO TEVA 5 mg tablets are white or almost white, round, biconvex tablets with a break line on one side.
BISOPROLOLO TEVA 10 mg tablets are white or almost white, round, biconvex tablets with a break line on one side.
Boxes containing 20, 21, 28, 30, 50, 56, 60, 90 or 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
TEVA ITALIA S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.
[Only for the 5 mg and 10 mg tablets]
Chanelle Medical Unlimited Company, Dublin Road, Loughrea, H62 FH90, Ireland.

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium: Bisoprolol Teva
Germany: Bisoprolol-Abz
Italy: BISOPROLOLO TEVA
Spain: Bisoprolol Teva
Sweden: Bisoprolol Teva
Netherlands: Bisoprololfumaraat TEVA
United Kingdom (Northern Ireland): Bisoprolol