Bisoprolol Sandoz

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Bisoprolol Sandoz 1.25 mg film-coated tablets, 2.5 mg film-coated tablets, 3.75 mg film-coated tablets, 7.5 mg film-coated 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 others, even if their symptoms are the same as yours, as it could 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 Sandoz is and what it is used for
2. What you need to know before taking Bisoprolol Sandoz
3. How to take Bisoprolol Sandoz
4. Possible side effects
5. How to store Bisoprolol Sandoz
6. Package contents and other information

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

Bisoprolol Sandoz belongs to a group of medicines called beta-blockers, which protect the heart from excessive activity.
Bisoprolol Sandoz is used to treat:

• heart failure causing breathlessness on exertion or fluid retention. In this case, Bisoprolol Sandoz may be given as additional treatment alongside other medicines used for heart failure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING BISOPROLOL SANDOZ

Do not take Bisoprolol Sandoz

• if you are allergic to bisoprolol fumarate or any of the other ingredients of Bisoprolol Sandoz (listed in section 6)
• if you have cardiogenic shock, a severe heart condition causing rapid, weak heartbeat, low blood pressure, cold and clammy skin, weakness, and fainting
• if you have previously suffered from severe breathlessness or asthma, conditions that may impair breathing
• if your heart rate is slow (less than 60 beats per minute). If in doubt, consult your doctor
• if your blood pressure is very low
• if you suffer from severe circulatory disorders (which may cause tingling in the fingers and toes, which may also turn pale or bluish)
• if you suffer from certain severe heart rhythm disorders
• if you have recently developed or unstable heart failure requiring hospital treatment
• if you suffer from a condition causing excessive acid buildup in the body known as metabolic acidosis. Your doctor will provide appropriate advice
• if you have an untreated tumour of the adrenal glands known as phaeochromocytoma.

If you have any doubts about any of the conditions listed above, consult your doctor.
Warnings and precautions
Talk to your doctor before taking Bisoprolol Sandoz:

• if you suffer from breathlessness or breathing difficulties (asthma). Bronchodilator therapy should be administered concomitantly. A higher dose of beta-agonists may be required.
• if you have diabetes. The tablets may mask symptoms of low blood sugar (such as rapid heartbeat, palpitations, or sweating)
• if you are on a diet without solid food
• if you are being treated for hypersensitivity reactions (allergy). Bisoprolol Sandoz may intensify hypersensitivity to substances you are allergic to and increase the severity of hypersensitivity reactions. Treatment with adrenaline may therefore be less effective. A higher dose of adrenaline (epinephrine) may thus be required
• in case of first-degree heart block (a heart conduction disorder)
• if you suffer from Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries supplying the heart muscle
• if you have circulation problems in the extremities such as hands and feet
• if you are due to undergo surgery requiring anaesthesia, inform your doctor, dentist, or hospital staff about the medicines you are taking
• if you suffer from (or have previously suffered from) psoriasis (a recurring skin disease causing scaling and skin rash due to dry skin)
• if you suffer from phaeochromocytoma (a tumour of the adrenal medulla). Your doctor must treat this condition before prescribing Bisoprolol Sandoz
• if you suffer from a thyroid disorder. The tablets may mask symptoms of an overactive thyroid.

There is currently no therapeutic experience with the treatment of heart failure using Bisoprolol Sandoz in patients affected by the following diseases and conditions:

• insulin-treated diabetes mellitus (type I)
• severe kidney disease
• severe liver disease
• certain heart diseases
• heart attack within the last 3 months.

Treatment of heart failure with Bisoprolol Sandoz requires regular medical monitoring. This is absolutely necessary, particularly at the beginning of therapy.
Treatment with Bisoprolol Sandoz must not be stopped suddenly unless for compelling reasons.
If any of the conditions listed above apply to you, or have applied to you in the past, consult your doctor.
For athletes: using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Bisoprolol Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines must not be used together, while others require specific adjustments (e.g. in dosage).
Always inform your doctor if you are using or receiving any of the following medicines in addition to Bisoprolol Sandoz:

• medicines used to control blood pressure or medicines used for heart disorders (e.g. amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)
• sedatives and treatments for psychosis (a mental illness), e.g. barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting)
• medicines used for depression, e.g. tricyclic antidepressants, MAO-A inhibitors
• medicines used for anaesthesia during surgery (see also section “Warnings and precautions”)
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen)
• medicines for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure) or pupil dilation (enlargement)
• certain medicines used to treat shock (e.g. adrenaline, dobutamine, noradrenaline)
• mefloquine, an antimalarial medicine
• the antibiotic rifampicin
• ergotamine derivatives for migraine

All of these medicines, as well as Bisoprolol Sandoz, may affect blood pressure and/or heart function.

• insulin or other medicines for diabetes. The blood glucose-lowering effect may be enhanced, and symptoms of low blood glucose may also be masked.

Bisoprolol Sandoz and alcohol
Dizziness and drowsiness caused by Bisoprolol Sandoz may be worsened by alcohol consumption: if you experience these symptoms, avoid alcoholic drinks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Bisoprolol Sandoz may harm pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar levels, and reduced heart rate in the baby. The newborn's growth may also be impaired. Therefore, Bisoprolol Sandoz must not be used during pregnancy.
It is not known whether Bisoprolol Sandoz is excreted in breast milk and therefore it is not recommended during breastfeeding.
Driving and using machines
This medicine may cause fatigue, drowsiness, or dizziness. If you experience these side effects, do not drive or operate machinery. Exercise particular caution at the beginning of treatment, when treatment is changed, or when taking alcohol-containing beverages.
Bisoprolol Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially sodium-free.

3. HOW TO TAKE BISOPROLOL SANDOZ

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many tablets to take. You should take the medicine in the morning, before, during, or
after breakfast. Swallow the tablet(s) with a glass of water, without chewing or crushing them.
Usual dose:
Heart failure (reduced heart function)
Before starting Bisoprolol Sandoz, you should already be taking an ACE inhibitor, a diuretic, or a cardiac glycoside
(a medicine for heart/blood pressure).
The dose will be gradually increased to determine the most appropriate dose for your condition:
1.25 mg once daily for 1 week; if well tolerated, the dose may be increased to
2.5 mg once daily for an additional week; if well tolerated, the dose may be increased to
3.75 mg once daily for an additional week; if well tolerated, the dose may be increased to
5 mg once daily for the next 4 weeks; if well tolerated, the dose may be increased to
7.5 mg once daily for the next 4 weeks; if well tolerated, the dose may be increased to
10 mg once daily as maintenance dose.
The maximum dose is 10 mg once daily.
Your doctor will determine the optimal dose for your condition, taking into account, among other factors, any
adverse effects.
After the very first 1.25 mg dose, your doctor will monitor your blood pressure, heart rate, and any signs of
cardiac dysfunction.
Impaired liver or kidney function:
Your doctor will exercise extreme caution when increasing the dose.
Elderly patients
Dosage adjustment is generally not required.
If you notice that the effect of Bisoprolol Sandoz is too strong or too weak, consult your doctor or
pharmacist.
2.5 mg tablet :

Place the tablet on a flat, solid surface with the break line facing
upwards.
Press with your thumb in the center of the tablet, and it will split into two equal parts.
3.75 mg and 7.5 mg tablets:
Place the tablet on a flat, solid surface with the break line facing
upwards. Press with your thumb in the center of the tablet, and it will
split into three parts.
Duration of treatment
Treatment with Bisoprolol Sandoz is generally long-term.
Use in children and adolescents
There is no experience with the use of Bisoprolol Sandoz in children and adolescents; therefore, its use in
children is not recommended.
If you take more Bisoprolol Sandoz than you should
If you have accidentally taken more than the prescribed dose, inform your doctor/pharmacist immediately.
Bring all remaining tablets or this leaflet with you, so that medical personnel know exactly which medicine you have taken.
Symptoms of overdose may include dizziness, lightheadedness, fatigue, shortness of breath and/or wheezing.
Other possible effects include slow heart rate, low blood pressure, inadequate heart function, and a decrease in blood glucose levels (which may be associated with hunger, sweating, and palpitations).
If you forget to take Bisoprolol Sandoz
Do not take a double dose to make up for a forgotten dose. Take the missed dose as soon as you remember, then take your next dose at the usual time the following day.
If you stop taking Bisoprolol Sandoz
Treatment with Bisoprolol Sandoz must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. The dose should be gradually reduced over several weeks, as directed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To prevent serious reactions, consult a 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 heartbeat (may affect up to 1 in 100 people)
  If you experience dizziness, weakness, or difficulty breathing, contact your doctor as soon as possible.

You must consult a doctor immediately if you experience more severe allergic reactions, which may cause swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
Further adverse effects are listed below according to how frequently they may occur:

Common (may affect up to 1 in 10 people):

• tiredness, exhaustion
• dizziness
• headache
• sensation of coldness or numbness in the extremities (fingers of hands or feet, ears and nose); increased frequency of leg pain (cramp-like) when walking
• marked lowering of blood pressure (hypotension), especially in patients with heart failure
• nausea, vomiting
• diarrhoea, constipation

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

• drop in blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting
• sleep disorders
• depression
• irregular heartbeat
• patients with asthma or a history of respiratory disorders may experience breathing difficulties
• muscle weakness and cramps

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

• nightmares
• hallucinations (believing to see things that do not exist)
• fainting (syncope)
• hearing impairment
• inflammation of the nasal mucosa causing runny nose and irritation
• skin allergic reactions (such as itching, redness, rash)
• dry eyes due to reduced tear flow (which may be particularly bothersome if wearing contact lenses)
• inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the whites of the eyes and skin, and dark urine
• reduced sexual performance (impotence)
• increased levels of lipids in the blood (triglycerides) and liver enzymes

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

• chest pain
• worsening of psoriasis (a skin disorder) or development of a dry, scaly skin rash resembling psoriasis, and hair loss
• eye itching or redness (conjunctivitis)

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

5. HOW TO STORE BISOPROLOL SANDOZ

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 on the blisters 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 no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bisoprololo Sandoz contains
The active substance is bisoprolol fumarate.
Each tablet contains 1.25 mg of bisoprolol fumarate.
Each tablet contains 2.5 mg of bisoprolol fumarate.
The other ingredients are dibasic calcium phosphate, anhydrous, microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).
Each tablet contains 3.75 mg of bisoprolol fumarate.
Each tablet contains 7.5 mg of bisoprolol fumarate.
The other ingredients are:
dibasic calcium phosphate, anhydrous
microcrystalline cellulose
pregelatinized maize starch
sodium croscarmellose
anhydrous colloidal silica
magnesium stearate
lactose monohydrate
hypromellose
macrogol 4000
titanium dioxide (E171)
yellow titanium dioxide (E172).

Description of the appearance of Bisoprololo Sandoz and contents of the pack
Bisoprololo Sandoz 1.25 mg film-coated tablets

• Round, white film-coated tablets marked with "BIS 1.25".

Bisoprololo Sandoz 2.5 mg film-coated tablets
Round, white film-coated tablets marked with "BIS 2.5" on one side.
The tablet can be divided into two equal doses.
Bisoprololo Sandoz 3.75 mg film-coated tablets
Round, white-yellow film-coated tablets marked with "BIS 3.75" on one side. The tablet can be divided into three equal doses.
Bisoprololo Sandoz 7.5 mg film-coated tablets

• Round, yellow film-coated tablets marked with "BIS 7.5" on one side. The tablet can be divided into three equal doses.

The film-coated tablets are packed in OPA/Alu/PVC/Alu blisters and placed in cardboard boxes.
Pack sizes:
Film-coated tablets 1.25 mg:
10, 20, 28, 30, 50, 60, 100, 10x20, 10x30 film-coated tablets
Film-coated tablets 2.5 mg, 3.75 mg, 7.5 mg:
7, 10, 20, 28, 30, 50, 60, 100, 10x30 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA)

Responsible manufacturers for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
ROWA Pharmaceuticals Limited
Newtown, Bantry, Co. Cork
Ireland
Lek Pharmaceuticals d.d
Verovskova 57, 1526 Ljubljana
Slovenia
Lek S.A
Ul. Domaniewska 50 C, 02-672 Warszawa
Poland
Lek S.A
Ul. Podlipie 16, 95 010 Strykow
Poland

This medicinal product has been authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria Bisoprolol Sandoz 1.25 mg - Filmtabletten
Bisoprolol Sandoz 2.5 mg – Filmtabletten
Bisoprolol Sandoz 3.75 mg – Filmtabletten
Bisoprolol Sandoz 7.5 mg – Filmtabletten
Belgium Bisoprolol Sandoz 2.5 mg filmomhulde tabletten
Germany Bisoprolol Sandoz 2.5 mg Filmtabletten
Spain Bisoprolol Cor 1.25 mg comprimidos recubiertos con película EFG
Bisoprolol Cor 2.5 mg comprimidos recubiertos con película EFG
Finland Bisoprolol Sandoz 2.5 mg tabletti, kalvopäällysteinen
France BISOPROLOL Sandoz 1.25 mg, comprimé pelliculé
BISOPROLOL Sandoz 2.5 mg, comprimé pelliculé
BISOPROLOL Sandoz 3.75 mg, comprimé pelliculé
BISOPROLOL Sandoz 7.5 mg, comprimé pelliculé
United Kingdom Bisoprolol Fumarate 1.25 mg film-coated Tablets
Bisoprolol Fumarate 2.5 mg film-coated Tablets
Bisoprolol Fumarate 3.75 mg film-coated Tablets
Bisoprolol Fumarate 7.5 mg film-coated Tablets
Hungary Bisoprolol Sandoz 2.5 mg filmtabletta
Italy BISOPROLOLO SANDOZ
Netherlands Bisoprololfumaraat Sandoz Tablet 1.25 mg, filmomhulde tabletten 1.25 mg
Bisoprololfumaraat Sandoz Tablet 2.5 mg, filmomhulde tabletten 2.5 mg
Bisoprololfumaraat Sandoz Tablet 3.75 mg, filmomhulde tabletten 3.75 mg
Bisoprololfumaraat Sandoz Tablet 7.5 mg, filmomhulde tabletten 7.5 mg
Norway Bisoprolol Sandoz 1.25 mg filmdrasjerte tabletter
Bisoprolol Sandoz 2.5 mg filmdrasjerte tabletter
Poland Bibloc
Sweden Bisoprolol Sandoz 1.25 mg filmdragerade tabletter
Bisoprolol Sandoz 2.5 mg filmdragerade tabletter
Slovenia Byol 1.25 mg filmsko obložene tablete
Byol 2.5 mg filmsko obložene tablete

This Patient Information Leaflet was last approved on

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Bisoprolol Sandoz 5 mg film-coated tablets, 10 mg film-coated 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Bisoprolol Sandoz is and what it is used for
8. What you need to know before taking Bisoprolol Sandoz
9. How to take Bisoprolol Sandoz
10. Possible side effects
11. How to store Bisoprolol Sandoz
12. Contents of the pack and other information

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

Bisoprolol Sandoz belongs to a group of medicines called beta-blockers, which protect the heart from excessive activity.
Bisoprolol Sandoz is used to treat:

• high blood pressure
• angina pectoris (chest pain)
• heart failure causing breathlessness on exertion or fluid retention. In this case, Bisoprolol Sandoz may be given as additional treatment alongside other medicines used for heart failure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BISOPROLOL SANDOZ

Do not take Bisoprolol Sandoz

• if you are allergic to bisoprolol fumarate or any of the other ingredients of Bisoprolol Sandoz (listed in section 6)
• if you have cardiogenic shock, a serious heart condition causing rapid and weak heartbeat, low blood pressure, cold and clammy skin, weakness, and fainting
• if you have previously suffered from severe breathlessness or asthma, conditions that could impair breathing
• if you have a slow heart rate (less than 60 beats per minute). If in doubt, consult your doctor
• if your blood pressure is very low
• if you suffer from severe circulatory disorders (which may cause tingling in fingers and toes, which may also become pale or turn bluish)
• if you suffer from certain severe heart rhythm disorders
• if you have recently developed or unstable heart failure requiring hospital treatment
• if you suffer from a condition causing excessive acid buildup in the body known as metabolic acidosis. Your doctor will provide appropriate advice
• if you have an untreated tumour of the adrenal glands known as phaeochromocytoma.

If you have any doubts about the conditions listed above, consult your doctor.
Warnings and precautions
Talk to your doctor before taking Bisoprolol Sandoz:

• if you suffer from breathlessness or breathing difficulties (asthma). Bronchodilator therapy should be administered concomitantly. A higher dose of beta-stimulants may be required.
• if you have diabetes. The tablets may mask symptoms of low blood sugar (such as rapid heartbeat, palpitations, or sweating)
• if you are on a diet without solid food
• if you are being treated for hypersensitivity reactions (allergy). Bisoprolol Sandoz may intensify hypersensitivity to substances you are allergic to and increase the severity of hypersensitivity reactions. Treatment with adrenaline may therefore not produce the desired effects, and a higher dose of adrenaline (epinephrine) may need to be administered
• in case of first-degree heart block (a heart conduction disorder)
• if you suffer from Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries supplying the heart muscle
• if you have circulation problems in the extremities such as hands and feet
• if you are scheduled for surgery requiring anaesthesia, inform your doctor, dentist, or hospital staff about the medicines you are taking
• if you are taking calcium antagonists such as diltiazem and verapamil at the same time. Concomitant use is not recommended; see also section “Other medicines and Bisoprolol Sandoz”
• if you suffer from (or have suffered from) psoriasis (a recurring skin disease causing scaling and rash due to dry skin)
• if you suffer from phaeochromocytoma (a tumour of the adrenal medulla). Your doctor must treat this condition before prescribing Bisoprolol Sandoz to you
• if you suffer from a thyroid disorder. The tablets may mask symptoms of an overactive thyroid. There is currently no therapeutic experience with Bisoprolol Sandoz in treating heart failure in patients with the following diseases and conditions:
• insulin-treated diabetes mellitus (type I)
• severe kidney disease
• severe liver disease
• certain heart diseases
• heart attack within the last 3 months.

Treatment of heart failure with Bisoprolol Sandoz requires regular medical monitoring. This is absolutely necessary, especially at the beginning of therapy.
Treatment with bisoprolol must not be stopped suddenly unless for compelling reasons.
For patients with concomitant hypertension and angina pectoris along with heart failure, treatment must not be stopped abruptly. The dosage should be gradually reduced by halving the dose weekly.
If any of the conditions listed above apply to you, or have applied to you in the past, consult your doctor.
For athletes: using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Bisoprolol Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines cannot be used together, while others require specific adjustments (for example, in dosage).
Always inform your doctor if you are using or receiving any of the following medicines in addition to Bisoprolol Sandoz:

• medicines used to control blood pressure or medicines used for heart disorders (for example amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)
• sedatives and treatments for psychosis (a mental illness), for example barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting)
• medicines used for depression, for example tricyclic antidepressants, MAO-A inhibitors
• medicines used for anaesthesia during surgery (see also section “Warnings and precautions”)
• certain painkillers (for example acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen)
• medicines for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure) or dilation (enlargement) of the pupil
• certain medicines used to treat shock (for example adrenaline, dobutamine, noradrenaline)
• mefloquine, an antimalarial medicine
• ergotamine derivatives for migraine. All these medicines, as well as Bisoprolol Sandoz, may affect blood pressure and/or heart function.
• insulin or other medicines for diabetes. The blood glucose-lowering effect may be enhanced, and symptoms of low blood glucose may also be masked.

Bisoprolol Sandoz and alcohol
Dizziness and drowsiness caused by Bisoprolol Sandoz may be worsened by alcohol consumption: if you experience these symptoms, you should avoid alcoholic drinks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. Bisoprolol Sandoz may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the baby. The newborn's growth may also be impaired. Therefore, Bisoprolol Sandoz must not be used during pregnancy.
It is not known whether Bisoprolol Sandoz is excreted in breast milk and therefore it is not recommended during breastfeeding.
Driving and using machines
This medicine may cause fatigue, drowsiness, or dizziness. If you experience these side effects, do not drive or operate machinery. Be especially careful at the beginning of treatment, when therapy is changed, or if you consume alcohol concurrently.
Bisoprolol Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially sodium-free.

3. HOW TO TAKE BISOPROLOL SANDOZ

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many tablets to take. You should take the medicine in the morning, before, during, or
after breakfast. Swallow the tablet(s) with a glass of water, without chewing or crushing them.
The usual dose is
Adults
High blood pressure/angina pectoris
The dose should be individually adjusted.
The recommended starting dose is 5 mg once daily.
The usual dose for adults is 10 mg once daily. Your doctor may decide to increase or decrease the dose.
The maximum dose is 20 mg once daily.
Severe renal or hepatic impairment
If you suffer from severe renal impairment or severe hepatic impairment, the maximum dose is 10 mg daily.
Elderly
Dosage adjustment is generally not required. Your doctor will start treatment with the lowest possible dose.
Heart failure (reduced heart function)
Before starting treatment with Bisoprolol Sandoz, you should already be receiving an ACE inhibitor, a diuretic, or a cardiac glycoside (a medicine for heart/ blood pressure).
The dose will be gradually increased to determine the most appropriate dose for your condition:
1.25 mg once daily for 1 week; if well tolerated, the dose may be increased to
2.5 mg once daily for another week; if well tolerated, the dose may be increased to
3.75 mg once daily for another week; if well tolerated, the dose may be increased to
5 mg once daily for the following 4 weeks; if well tolerated, the dose may be increased to
7.5 mg once daily for the following 4 weeks; if well tolerated, the dose may be increased to
10 mg once daily, as the maintenance dose.
The maximum dose is 10 mg once daily.
Your doctor will determine the optimal dose for your condition, taking into account, among other factors, any adverse effects.
After the first dose of 1.25 mg, your doctor will monitor your blood pressure, heart rate, and any signs of cardiac dysfunction.
Hepatic or renal impairment:
Your doctor will exercise extreme caution when increasing the dose.
Elderly
Dosage adjustment is generally not required.
If you notice that the effect of Bisoprolol Sandoz is too strong or too weak, consult your doctor or pharmacist.

Place the tablet on a flat, solid surface with the break line facing upwards.
Press with your thumb in the center of the tablet, and it will split into two equal parts.
Press with your thumb in the center of each half to obtain four equal parts.
Duration of treatment
Treatment with Bisoprolol Sandoz is usually long-term.
Use in children and adolescents
There is no experience with the use of Bisoprolol Sandoz in children and adolescents; therefore, its use in children is not recommended.
If you take more Bisoprolol Sandoz than you should
If you have accidentally taken more than the prescribed dose, inform your doctor or pharmacist immediately. Bring any remaining tablets or this leaflet with you so that medical personnel know exactly which medicine you have taken. Symptoms of overdose may include dizziness, lightheadedness, fatigue, shortness of breath and/or wheezing. There may also be a slow heart rate, low blood pressure, inadequate heart function, and a drop in blood sugar levels (which may be associated with hunger, sweating, and palpitations).
If you forget to take Bisoprolol Sandoz
Do not take a double dose to make up for a forgotten dose. Take the usual dose as soon as you remember, then continue with your regular dosing schedule the next day.
If you stop taking Bisoprolol Sandoz
Treatment with Bisoprolol Sandoz must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. The dose should be gradually reduced over several weeks, as directed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To prevent serious reactions, consult a doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly.
The most serious adverse effects are related to cardiac 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 experience dizziness, weakness, or breathing difficulties, contact your doctor as soon as possible.

Seek immediate medical attention if you experience more severe allergic reactions, which may cause swelling of the face, neck, tongue, mouth, or throat, or breathing difficulties.
Additional adverse effects are listed below according to how frequently they may occur:

Common (may affect up to 1 in 10 of 100 patients):

• Fatigue. In the treatment of hypertension or angina pectoris, this adverse effect is uncommon.
• Dizziness, tiredness, and headache (especially at the beginning of therapy in patients with angina pectoris and hypertension; symptoms are usually mild and disappear within 1–2 weeks)
• Cold sensation or numbness in the extremities (fingers or toes, ears, and nose); increased frequency of leg pain (cramp-like) when walking
• Marked lowering of blood pressure (hypotension), especially in patients with heart failure
• Nausea, vomiting
• Diarrhea, constipation

Uncommon (may affect up to 1 in 100):

• Fatigue. In the treatment of heart failure, this adverse effect is common.
• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting
• Sleep disturbances
• Depression
• Irregular heartbeat
• Patients with asthma or a history of respiratory disorders may experience breathing difficulties
• Muscle weakness and cramps

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

• Nightmares
• Hallucinations (believing to see things that do not exist)
• Syncope
• Hearing impairment
• Inflammation of the nasal mucosa causing runny nose and irritation
• Skin allergic reactions (such as itching, redness, rash)
• Dry eyes due to reduced tear flow (which may be particularly bothersome if wearing contact lenses)
• Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite, and sometimes jaundice, with yellowing of the whites of the eyes and skin, and dark urine
• Reduced sexual performance (impotence)
• Increased levels of lipids in the blood (triglycerides) and liver enzymes

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

• Worsening of psoriasis (a skin disorder) or development of a dry, scaly skin rash resembling psoriasis, and hair loss
• Itching or redness of the eyes (conjunctivitis)

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

5. HOW TO STORE BISOPROLOL SANDOZ

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 blisters 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 in the 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 Sandoz contains
The active substance is bisoprolol fumarate.
Each film-coated tablet contains 5 mg of bisoprolol fumarate.
5 mg film-coated tablets:
The other ingredients are:
dibasic calcium phosphate, anhydrous
microcrystalline cellulose
pregelatinized maize starch
sodium croscarmellose
anhydrous colloidal silica
magnesium stearate
lactose monohydrate
hypromellose
macrogol 4000
titanium dioxide (E171)
yellow iron oxide (E172)
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
5 mg film-coated tablets:
The other ingredients are:
dibasic calcium phosphate, anhydrous
microcrystalline cellulose
pregelatinized maize starch
sodium croscarmellose
anhydrous colloidal silica
magnesium stearate
lactose monohydrate
hypromellose
macrogol 4000
titanium dioxide (E171)
yellow iron oxide (E172)
red iron oxide (E172)

Description of the appearance of Bisoprololo Sandoz and pack contents
Bisoprololo Sandoz 5 mg film-coated tablets
Round, yellow film-coated tablets marked with "BIS 5" on one side. The tablet can be divided into four equal doses.
Bisoprololo Sandoz 10 mg film-coated tablets
Round, apricot-coloured, convex film-coated tablets marked with "BIS 10" on one side. The tablet can be divided into four equal doses.
The film-coated tablets are packaged in OPA/Alu/PVC/Alu blisters and placed in cardboard boxes.
Pack sizes:

• 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x30 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)
Italy

Responsible manufacturers for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
ROWA Pharmaceuticals Limited
Newtown, Bantry, Co. Cork
Ireland
Lek Pharmaceuticals d.d
Verovskova 57, 1526 Ljubljana
Slovenia
Lek S.A
Ul. Domaniewska 50 C, 02-672 Warszawa
Poland
Lek S.A
Ul. Podlipie 16, 95-010 Strykow
Poland

This medicinal product has been authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria Bisoprolol Sandoz 5 mg Filmtabletten
Bisoprolol Sandoz 10 mg Filmtabletten
Belgium Bisoprolol Sandoz 5 mg filmomhulde tabletten
Bisoprolol Sandoz 10 mg filmomhulde tabletten
Denmark Bisoprolol Sandoz
Finland Bisoprolol Sandoz
Bisoprolol Sandoz
France BISOPROLOL Sandoz 5 mg, comprimé pelliculé
BISOPROLOL Sandoz 10 mg, comprimé pelliculé
Hungary Bisoprolol Sandoz 5 mg filmtabletta
Bisoprolol Sandoz 10 mg filmtabletta
Italy BISOPROLOLO SANDOZ
Netherlands Bisoprololfumaraat Sandoz Tablet 5 mg, filmomhulde tabletten 5 mg
Bisoprololfumaraat Sandoz Tablet 10 mg, filmomhulde tabletten 10 mg
Norway Bisoprolol Sandoz 5 mg filmdrasjerte tabletter
Bisoprolol Sandoz 10 mg filmdrasjerte tabletter
Poland Bibloc
Slovenia Byol 5 mg filmsko obložene tablete
Byol 10 mg filmsko obložene tablete
Spain Bisoprolol Cor Sandoz 5 mg comprimidos recubiertos con película EFG
Bisoprolol Cor Sandoz 10 mg comprimidos recubiertos con película EFG
Sweden Bisoprolol Sandoz 5 mg filmdragede tabletter
Bisoprolol Sandoz 10 mg filmdragede tabletter
United Kingdom Bisoprolol Fumarate 5 mg film-coated Tablets
Bisoprolol Fumarate 10 mg film-coated Tablets

This summary of product characteristics was last approved on