Bisoprolol Almus

PATIENT INFORMATION LEAFLET

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

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

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

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING BISOPROLOL ALMUS

Do not take Bisoprolol Almus

• if you are allergic to bisoprolol fumarate or any of the other ingredients of Bisoprolol Almus (listed in section 6)
• if you have cardiogenic shock, a serious 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 which may 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 bluish)
• if you suffer from certain severe heart rhythm disorders
• if you have recently developed or unstable heart failure requiring hospital treatment
• if you have a condition causing excessive accumulation of acid in the body, known as metabolic acidosis. Your doctor will advise you accordingly
• if you have an untreated tumour of the adrenal glands, known as phaeochromocytoma.

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

• 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 Almus may worsen hypersensitivity to substances you are allergic to and increase the severity of hypersensitivity reactions. Treatment with adrenaline may therefore be ineffective. A higher dose of adrenaline (epinephrine) may thus be required
• if you have 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 all medicines you are taking
• if you suffer from (or have previously suffered from) psoriasis (a recurring skin disease causing scaling and dry skin eruptions)
• if you suffer from phaeochromocytoma (a tumour of the adrenal medulla). Your doctor must treat this condition before prescribing Bisoprolol Almus
• if you have a thyroid disorder. The tablets may mask symptoms of an overactive thyroid.

There is currently no therapeutic experience with the use of Bisoprolol Almus for the treatment of 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 Almus requires regular medical monitoring. This is absolutely necessary, particularly at the beginning of therapy.
Treatment with Bisoprolol Almus must not be stopped suddenly unless for compelling reasons.
If any of the above conditions affect you, or have affected you in the past, consult your doctor.
For athletes: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Bisoprolol Almus
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 cannot 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 Almus:

• medicines used to control blood pressure or 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 dilation (enlargement) of the pupil
• certain medicines used to treat shock (e.g. adrenaline, dobutamine, noradrenaline)
• mefloquine, an antimalarial medicine
• rifampicin, an antibiotic
• ergotamine derivatives for migraine. All these medicines, as well as Bisoprolol Almus, 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 be masked.

Bisoprolol Almus and alcohol
Dizziness and lightheadedness caused by Bisoprolol Almus may be worsened by alcohol consumption: if you experience these symptoms, you should avoid alcoholic drinks.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Bisoprolol Almus 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. Bisoprolol Almus should therefore not be used during pregnancy.
It is not known whether Bisoprolol Almus is excreted in breast milk and is therefore 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 cautious at the beginning of treatment, when treatment is changed, or when taking alcohol-containing beverages.
Bisoprolol Almus 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 ALMUS

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 little water, without chewing or crushing them.
The usual dose is:
Heart failure (reduced heart function)
Before starting Bisoprolol Almus, 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 a further week; if well tolerated, the dose may be increased to
3.75 mg once daily for a further 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 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.
Liver or kidney impairment:
Your doctor will exercise extreme caution when increasing the dose.
Elderly patients:
Dose adjustment is generally not required.
If you notice that the effect of Bisoprolol Almus 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 score line facing
upwards.
Press with your thumb in the center of the tablet, and it will break into two equal parts.
3.75 mg and 7.5 mg tablets:
Place the tablet on a flat, solid surface with the score line facing
upwards. Press with your thumb in the center of the tablet, and it will break into three parts.
Duration of treatment:
Treatment with Bisoprolol Almus is generally long-term.
Use in children and adolescents:
There is no experience with the use of Bisoprolol Almus in children and adolescents; therefore, its use in
children is not recommended.
If you take more Bisoprolol Almus 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.
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 feelings of hunger, sweating, and palpitations).
If you forget to take Bisoprolol Almus:
Do not take a double dose to make up for a forgotten dose. Take the missed dose as soon as you remember, then continue with your regular dosing schedule the next day.
If you stop taking Bisoprolol Almus:
Treatment with Bisoprolol Almus must not be stopped abruptly. If you suddenly stop treatment with 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 how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To prevent serious reactions, consult a doctor immediately if you experience a serious adverse effect suddenly or if it worsens rapidly.
The most serious side 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 breathing difficulties, contact your doctor as soon as possible.
You must consult a doctor immediately if you develop more severe allergic reactions, which may cause swelling of the face, neck, tongue, mouth or throat, or breathing difficulties.

Additional side effects are listed below according to how frequently they may occur:

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

• fatigue, exhaustion
• dizziness
• headache
• sensation of coldness or numbness in the extremities (fingers or toes, ears and nose); increased occurrence of pain (cramp-like) in the legs 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 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 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)
• liver inflammation (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):

• worsening of psoriasis (a skin disorder) or development of a dry, scaly skin rash similar to 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, talk to your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at the following website: 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 ALMUS

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.
Blister:
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 no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Bisoprololo Almus 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 components 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 components 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)

Description of the appearance of Bisoprololo Almus and pack contents
1.25 mg film-coated tablets:
White, round, film-coated tablets, with "BIS 1.25" printed on one side.
2.5 mg film-coated tablets:
White, round, film-coated tablets, with "BIS 2.5" printed on one side.
The tablet can be divided into two equal doses.
3.75 mg film-coated tablets:
White-yellow, round, film-coated tablets, with "BIS 3.75" printed on one side.
The tablet can be divided into three equal doses.
7.5 mg film-coated tablets:
Yellow, round, film-coated tablets, with "BIS 7.5" printed on one side.
The tablet can be divided into three equal doses.

The tablets are packaged in OPA/Alu/PVC/Alu blisters and placed in cardboard boxes, or packaged in HDPE bottles with PP caps and desiccant.

Pack sizes:
Blister:
1.25 mg film-coated tablets:
7, 10, 20, 28, 30, 50, 60, 100, 10x20, 10x30 film-coated tablets
2.5 mg, 3.75 mg, 7.5 mg film-coated tablets:
7, 10, 20, 28, 30, 50, 60, 100, 10x30 film-coated tablets

Bottle:
2.5 mg film-coated tablets:
100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
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 Warsaw
Poland
Lek S.A.
Ul. Podlipie 16, 95010 Strykow
Poland
Lek Pharmaceuticals d.d.
Trimlini 2d, 9220 Lendava
Slovenia

This medicinal product has been authorized in the Member States of the European Economic Area
under the following names:
Germany: BISOHEXAL 1.25 MG FILMTABLETS
BISOHEXAL 2.5 MG FILMTABLETS
BISOHEXAL 3.75 MG FILMTABLETS
BISOHEXAL 7.5 MG FILMTABLETS
Ireland: BISOP 1.25 MG FILM-COATED TABLETS
BISOP 2.5 MG FILM-COATED TABLETS
BISOP 3.75 MG FILM-COATED TABLETS
BISOP 7.5 MG FILM-COATED TABLETS
Italy: BISOPROLOLO ALMUS
Netherlands: BISOPROLOLFUMARAAT 1.25 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 2.5 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 3.75 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 7.5 MG, FILMOMHULDE TABLETTEN

PATIENT INFORMATION LEAFLET

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

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

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

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING BISOPROLOL ALMUS

Do not take Bisoprolol Almus

• if you are allergic to bisoprolol fumarate or any of the other ingredients of Bisoprolol Almus (listed in section 6)
• if you have cardiogenic shock, a serious heart condition causing rapid or 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 circulation disorders (which may cause tingling in the fingers and toes, which may also become 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 accumulation of acid 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 above conditions, consult your doctor.
Warnings and precautions
Talk to your doctor before taking Bisoprolol Almus:

• if you suffer from breathlessness or breathing difficulties (asthma). Bronchodilator therapy must be administered concomitantly. A higher dose of beta-2 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 free of solid foods
• if you are being treated for hypersensitivity reactions (allergy). Bisoprolol Almus may worsen hypersensitivity to substances you are allergic to and increase the severity of hypersensitivity reactions. Treatment with adrenaline may therefore be ineffective. 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 of the body such as hands and feet
• if you are scheduled for surgery involving 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 Almus”
• if you suffer (or have suffered) from psoriasis (a recurring skin disease causing scaling and dry skin rash)
• if you suffer from phaeochromocytoma (a tumour of the adrenal medulla). Your doctor must treat this condition before prescribing Bisoprolol Almus
• 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 Almus 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 Almus requires regular medical monitoring. This is absolutely necessary, especially at the beginning of therapy.
Bisoprolol Almus treatment must not be stopped suddenly unless for compelling reasons.
For patients with concomitant hypertension and angina pectoris associated with heart failure, treatment must not be stopped suddenly. The dosage should be gradually reduced by halving the dose weekly.
If any of the above conditions affect you, or have affected you in the past, consult your doctor.
For athletes: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Bisoprolol Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription. Some medicines cannot 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 Almus:

• 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), 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 (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
• ergotamine derivatives for migraine. All these medicines, as well as Bisoprolol Almus, 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 Almus and alcohol
Dizziness and drowsiness caused by Bisoprolol Almus may be worsened by alcohol consumption: if you experience these symptoms, avoid drinking alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine. Bisoprolol Almus may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar and reduced heart rate in the baby. The newborn's growth may also be impaired. Bisoprolol Almus should therefore not be used during pregnancy.
It is not known whether Bisoprolol Almus is excreted in breast milk and is therefore 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 when taking alcohol-containing beverages.
Bisoprolol Almus 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 ALMUS

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 little water, without chewing or crushing them.
High blood pressure/angina pectoris
Adults
The dose is individually determined.
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 per day.
Elderly
Dosage adjustment is generally not required. Your doctor will start treatment with the lowest possible dose.
Heart failure (reduced heart function)
Before starting Bisoprolol Almus, you are already being treated with an ACE inhibitor, a diuretic, or a cardiac glycoside (a medicine for heart conditions/high blood pressure).
The dosage will be gradually increased until the most suitable dose for your condition is reached:
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 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 first 1.25 mg dose, your doctor will monitor your blood pressure, heart rate, and any possible 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 Almus is too strong or too weak, consult your doctor or
pharmacist.

Place the tablet on a flat, hard surface with the score line facing
upwards.
Press with your thumb in the center of the tablet to split it into two equal parts.
Then press with your thumb on the center of each half to obtain four equal parts.
Duration of treatment
Treatment with Bisoprolol Almus is usually long-term.
Use in children and adolescents
There is no experience with the use of Bisoprolol Almus in children and adolescents; therefore, its use in children is not recommended.
If you take more Bisoprolol Almus than you should
If you have accidentally taken more than the prescribed dose, inform your doctor or 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.
Additionally, a 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) may occur.
If you forget to take Bisoprolol Almus
Do not take a double dose to make up for the missed dose. Take the missed dose as soon as you remember, then continue with your regular dose the next day.
If you stop taking Bisoprolol Almus
Treatment with Bisoprolol Almus must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. The dose must be gradually reduced over several weeks, as directed by your doctor.
If you have any doubts about how to use 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, consult a doctor immediately if a serious side effect occurs suddenly or worsens rapidly.
The most serious side effects are related to 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 experience dizziness, weakness, or breathing difficulties, contact your doctor as soon as possible.
You must consult a doctor immediately if you develop more severe allergic reactions, which may cause swelling of the face, neck, tongue, mouth, or throat, or breathing difficulties.

Further side effects are listed below according to how frequently they may occur:

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

• fatigue. In the treatment of hypertension or angina pectoris, this side 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)

• sensation of coldness 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

• diarrhoea

• constipation

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

• fatigue. In the treatment of heart failure, this side 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 people):

• 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)
• liver inflammation (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):

• 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 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 HEXAL

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.
Blister:
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. PACKAGING CONTENTS AND OTHER INFORMATION

What Bisoprololo Almus contains

• The active substance is bisoprolol fumarate. Each tablet contains 5 mg of bisoprolol fumarate. Each tablet contains 10 mg of bisoprolol fumarate.

5 mg film-coated tablets:
The other ingredients are anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172).
10 mg film-coated tablets:
The other ingredients are anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Bisoprololo Almus and packaging contents

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.

10 mg film-coated tablets
Round, apricot-colored, 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-Al-PVC/Al blisters and placed in cardboard boxes.

Pack sizes:
7, 10, 14, 20, 28, 30, 50, 56, 60, 100, 10x30 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
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 Warsaw
Poland
Lek S.A.
Ul. Podlipie 16, 95010 Strykow
Poland

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Ireland: BISOP 5 MG FILM-COATED TABLETS
BISOP 10 MG FILM-COATED TABLETS
Italy: BISOPROLOLO ALMUS
Netherlands: BISOPROLOLFUMARAAT 5 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 10 MG, FILMOMHULDE TABLETTEN