Bisoprolol Aurobindo Pharma Italia

Package leaflet: Information for the user

Bisoprolol Aurobindo Pharma Italia 1.25 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. Never give it to other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bisoprololo Aurobindo Pharma Italia is and what it is used for

Bisoprololo Aurobindo Pharma Italia contains bisoprolol fumarate, which belongs to a class of
medicines called beta-blockers.
Bisoprololo Aurobindo Pharma Italia is used to treat:

• stable heart failure. Bisoprolol is given as an additional treatment to other medicines for heart failure.

Heart failure occurs when the heart muscle is too weak to pump blood adequately throughout the body. This results in breathlessness and swelling. Bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood throughout the body.

2. What you should know before taking Bisoprolol Aurobindo Pharma Italia

DO NOT take Bisoprolol Aurobindo Pharma Italia if:

• you are allergic to the active substance or to any of the excipients of this medicine (listed in section 6).
• you have severe asthma or a severe chronic lung disease.
• you have a slow or irregular heartbeat. Ask your doctor if you are unsure.
• you have very low blood pressure.
• you have serious circulation problems (which may cause tingling in the fingers and toes or make them pale or bluish).
• you suffer from heart failure that suddenly worsens and/or may require hospital treatment.
• you have a condition of excessive acid buildup in the body known as metabolic acidosis.
• you have untreated phaeochromocytoma, a rare tumour of the adrenal gland.

Inform your doctor if you are uncertain about any of the above conditions: your doctor will be able to advise you.

Warnings and precautions

Inform your doctor or pharmacist before taking Bisoprolol Aurobindo Pharma Italia if:

• you have asthma or a chronic lung disease.
• you have diabetes. Bisoprolol may mask the symptoms of hypoglycaemia.
• you are not eating solid food.
• you are being treated for hypersensitivity reactions (allergies). Bisoprolol may worsen your allergy or make it more difficult to treat.
• you have heart problems.
• you have liver or kidney problems.
• you have circulation problems in the limbs.
• you are about to undergo general anaesthesia during surgery – inform your doctor that you are taking bisoprolol.
• you are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended; see also section “Other medicines and Bisoprolol Aurobindo Pharma Italia”.
• you suffer from (or have suffered from) psoriasis (a recurring skin rash).
• you have phaeochromocytoma (a tumour of the adrenal gland). Your doctor must treat this condition before prescribing bisoprolol to you.
• you have thyroid problems. The tablets may mask symptoms of an overactive thyroid.

If any of the above warnings apply to you or have applied to you in the past, consult your doctor.

Other medicines and Bisoprolol Aurobindo Pharma Italia

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Some medicines cannot be used at the same time, while others may require specific adjustments (e.g. dose changes).

Do NOT take the following medicines with Bisoprolol Aurobindo Pharma Italia without specific medical advice:

• medicines used to control blood pressure or for heart conditions (such as amiodarone, amlodipine, clonidine, cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• medicines for depression, e.g. imipramine, amitriptyline, moclobemide.
• medicines to treat mental disorders, e.g. phenothiazines such as levomepromazine.
• medicines used as anaesthetics during surgery (see also “Warnings and precautions”).
• medicines used to treat epilepsy, e.g. barbiturates such as phenobarbital.
• certain anti-inflammatory medicines (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• medicines for asthma or medicines used for nasal congestion.
• medicines used for certain eye disorders such as glaucoma (increased pressure inside the eye) or used to dilate (enlarge) the pupil of the eye.
• certain medicines used to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.

All of these medicines, as well as bisoprolol, can affect blood pressure and/or heart function.

• Rifampicin, used to treat infections.
• Medicines used to treat migraine or severe headache (ergotamine derivatives).

It is particularly important to talk to your doctor if you are taking:

• Insulin or other medicines for diabetes. The blood glucose-lowering effect may be increased. Symptoms of hypoglycaemia may be masked.

Bisoprolol Aurobindo Pharma Italia with food, drinks and alcohol

Bisoprolol Aurobindo Pharma Italia may be taken with or without food. The tablets should be swallowed whole with a glass of water.

Pregnancy, breast-feeding and fertility

Do not take bisoprolol if you are pregnant or think you might be pregnant. Bisoprolol Aurobindo Pharma Italia may be harmful to pregnancy and/or the foetus. There is an increased risk of premature birth, miscarriage, low blood sugar levels, and reduced heart rate in the baby. The baby's growth may also be delayed. It is not known whether bisoprolol is excreted in human milk and therefore it is not recommended during breast-feeding.

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

These tablets may cause fatigue, drowsiness or dizziness. If you experience any of these side effects, do not drive or operate machinery. You should be aware that such side effects may occur, especially at the beginning of treatment, when switching to another medicine, or when taking alcohol.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Bisoprolol Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting Bisoprolol Aurobindo Pharma Italia, you will already be taking other medicines for
heart failure, including an ACE inhibitor, a diuretic, and (as an additional option) a cardiac glycoside.

• Your doctor will tell you how many tablets to take.
• You should take Bisoprolol Aurobindo Pharma Italia in the morning, before, with or after breakfast.
• Swallow the tablets with a little water. Do not chew or crush them.

The dose of Bisoprolol Aurobindo Pharma Italia will be gradually increased until the most suitable dose for you is found.
Adults and elderly: The recommended dose is:
1.25 mg once daily for 1 week. If this dose is well tolerated, it may be increased to:
2.5 mg once daily during the following week. If this dose is well tolerated, it may be increased to:
3.75 mg once daily during the following week. If this dose is well tolerated, it may be increased to:
5 mg once daily during the next 4 weeks. If this dose is well tolerated, it may be increased to:
7.5 mg once daily during the next 4 weeks. If this dose is well tolerated, it may be increased to:
10 mg once daily as the maintenance dose.
Maximum dose: 10 mg once daily.
Your doctor will determine the most appropriate dose for you based on your tolerance to bisoprolol and any side effects.
Your heart rate and blood pressure will be closely monitored with each dose increase.
Patients with liver or kidney problems:
Your doctor will pay particular attention when increasing the dose of Bisoprolol Aurobindo Pharma Italia.
Children:
The use of Bisoprolol Aurobindo Pharma Italia is not recommended in children.
If you notice that the effect of Bisoprolol Aurobindo Pharma Italia is too strong or not strong enough, consult
your doctor or pharmacist.
Duration of treatment
Bisoprolol Aurobindo Pharma Italia is usually used long-term.
Take the tablet as follows:

1. Do not press on the tablet

Do not press against the tablet cavity

2. Tear the tablet blister

Fold and tear the tablet blister along the dotted lines

3. Remove the cover

Lift, hold, and pull the cover sheet from the side indicated by the arrow

4. Remove the tablet with dry hands and take it as indicated above.

If you take more Bisoprololo Aurobindo Pharma Italia than you should
If you have accidentally taken a higher dose than prescribed, inform your doctor or pharmacist immediately.
Take the remaining tablets or this leaflet with you so that medical personnel know exactly what you have taken.
Symptoms of an overdose may include dizziness, lightheadedness, fatigue, shortness of breath and/or difficulty breathing.
Additionally, a reduced heart rate, low blood pressure, inadequate heart function, and low blood sugar levels may be expected (which can cause hunger, sweating, palpitations).

If you forget to take Bisoprololo Aurobindo Pharma Italia
Do not take a double dose to make up for the 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 Bisoprololo Aurobindo Pharma Italia
Treatment with Bisoprololo Aurobindo Pharma Italia must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. The dose of bisoprolol should be gradually reduced over several weeks, as advised by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are important and require immediate action.
You must stop taking Bisoprolol Aurobindo Pharma Italia and contact your doctor immediately if you experience any of these symptoms:

Common:

• Worsening of heart failure causing breathlessness and/or fluid retention

Frequency not established:

• Worsening of symptoms of blockage of the main blood vessels to the legs, particularly at the beginning of treatment

The following side effects have also been reported:

Very common: may affect more than 1 in 10 people

• Slow heartbeat

Common: may affect up to 1 in 10 people

• Tiredness, weakness
• Dizziness
• Headache
• Feeling cold or numbness in hands or feet
• Low blood pressure
• Nausea and vomiting
• Diarrhoea
• Constipation

Uncommon: may affect up to 1 in 100 people

• Drowsiness
• Sleep disorders
• Depression
• Irregular heartbeat
• Breathing problems in patients with asthma or chronic lung disease
• Muscle weakness, cramps

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

• Nightmares
• Hallucinations (seeing or imagining things)
• Hearing disturbances
• Inflammation of the nasal lining causing runny nose with irritation
• Allergic reactions (itching, redness, skin rash)
• Dry eyes due to reduced tear flow (may be particularly bothersome if you wear 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)
• Changes in blood test results
• Fainting

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

• Worsening of psoriasis or appearance of a similar scaly skin rash
• Hair loss
• Itching or inflammation of the eye (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 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 Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
[HDPE bottle of 500 tablets]
Use within 6 months after first opening the HDPE bottle.
Do not use this medicine after the expiry date which is stated on the carton/bottle after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Aurobindo Pharma Italia contains

• The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg of bisoprolol fumarate.
• The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, anhydrous colloidal silica, crospovidone (Type A), magnesium stearate. Tablet coating: hypromellose 6cP (E464), titanium dioxide (E171), macrogol 400.

Description of the appearance of Bisoprololo Aurobindo Pharma Italia and pack contents
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Bisoprololo Aurobindo 1.25 mg Filmtabletten
Italy: Bisoprololo Aurobindo Pharma Italia
Poland: Ripit
United Kingdom: Bisoprolol Fumarate 1.25 mg film-coated tablets

Patient Information Leaflet: Information for the user

Bisoprolol Aurobindo Pharma Italia 2.5 mg film-coated tablets, 3.75 mg film-coated tablets, 5 mg film-coated tablets, 7.5 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. Never give it to other people, even if their symptoms are the same as yours.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bisoprololo Aurobindo Pharma Italia is and what it is used for

Bisoprololo Aurobindo Pharma Italia contains bisoprolol fumarate, which belongs to a class of
medicines called beta-blockers.
Bisoprololo Aurobindo Pharma Italia is used to treat:

• stable heart failure. Bisoprolol is given as additional treatment to other medicines for heart failure. Heart failure occurs when the heart muscle is too weak to pump blood adequately throughout the body. This results in breathlessness and swelling. Bisoprolol slows the heart rate and makes the heart more efficient at pumping blood throughout the body.

2. What you need to know before taking Bisoprolol Aurobindo Pharma Italia

Do NOT take Bisoprolol Aurobindo Pharma Italia if:

• you are allergic to the active substance bisoprolol fumarate or to any of the excipients of this medicine (listed in section 6).
• you have severe asthma or severe chronic lung disease.
• you have a slow or irregular heartbeat. Ask your doctor if you are unsure.
• you have very low blood pressure.
• you have serious circulation problems (which may cause tingling in the fingers and toes or make them pale or bluish).
• you suffer from heart failure that suddenly worsens and/or may require hospital treatment.
• you have a condition of excessive acid accumulation in the body known as metabolic acidosis.
• you have untreated phaeochromocytoma, a rare tumour of the adrenal gland.

Inform your doctor if you are unsure about any of the above conditions: your doctor will be able
to advise you.
Warnings and precautions
Inform your doctor or pharmacist before taking Bisoprolol Aurobindo Pharma Italia if:

• you have asthma or chronic lung disease.
• you have diabetes. Bisoprolol may mask the symptoms of hypoglycaemia.
• you are not eating solid food.
• you are being treated for hypersensitivity reactions (allergies). Bisoprolol may worsen your allergy or make it more difficult to treat.
• you have heart problems.
• you have liver or kidney problems.
• you have circulation problems in the limbs.
• you are about to undergo general anaesthesia during surgery – inform the doctor that you are taking bisoprolol.
• you are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended; see also section “Other medicines and Bisoprolol Aurobindo Pharma Italia”.
• you suffer (or have suffered) from psoriasis (a recurring skin rash).
• you have phaeochromocytoma (a tumour of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol to you.
• you have thyroid problems. The tablets may mask symptoms of an overactive thyroid.
• If any of the above warnings apply to you or have applied to you in the past, consult your doctor.

Other medicines and Bisoprolol Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. Some medicines cannot be used together, while others may require specific adjustments (such as dosage changes).
Do NOT take the following medicines with Bisoprolol Aurobindo Pharma Italia without specific medical advice:

• medicines used to control blood pressure or for heart conditions (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• medicines for depression, for example imipramine, amitriptyline, moclobemide.
• medicines used to treat mental disorders, for example phenothiazines such as levomepromazine.
• medicines used as anaesthetics during surgery (see also “Warnings and precautions”).
• medicines used to treat epilepsy, for example barbiturates such as phenobarbital.
• certain anti-inflammatory medicines (e.g. acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen).
• medicines for asthma or medicines used for nasal congestion.
• medicines used for certain eye disorders such as glaucoma (increased pressure inside the eye) or used to dilate (enlarge) the pupil of the eye.
• certain medicines used to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.

All of these medicines, as well as bisoprolol, can affect blood pressure and/or heart function.

• rifampicin for the treatment of infections.
• medicines used to treat migraine or severe headache (ergotamine derivatives).

It is also particularly important to talk to your doctor if you are taking:

• Insulin or other medicines for diabetes. The blood glucose-lowering effect may be increased. Symptoms of hypoglycaemia may be masked.

Bisoprolol Aurobindo Pharma Italia with food, drinks and alcohol
Bisoprolol Aurobindo Pharma Italia may be taken with or without food. The tablets should be swallowed whole with a glass of water.
Pregnancy, breastfeeding and fertility
Do not take bisoprolol if you are pregnant or if you might be pregnant. Bisoprolol Aurobindo Pharma Italia may
be harmful to pregnancy and/or the foetus. There is an increased risk of premature birth, spontaneous
abortion, low blood sugar levels and reduced heart rate in the baby. The baby's growth may also be delayed.
It is not known whether bisoprolol is excreted in human milk and therefore it is not recommended during
breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
These tablets may cause fatigue, drowsiness or dizziness. If you experience any of these side effects, do not drive or operate machinery. You should be aware that such side effects may occur, particularly at the beginning of treatment, when switching to another medicine, or when combined with alcohol.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Bisoprolol Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting Bisoprolol Aurobindo Pharma Italia, you will already be taking other medicines for
heart failure, including an ACE inhibitor, a diuretic, and (as an additional option) a cardiac glycoside.

• Your doctor will tell you how many tablets to take.
• You should take Bisoprolol Aurobindo Pharma Italia in the morning, before, with or after breakfast.
• Swallow the tablets with some water. Do not chew or crush them.

The dose of Bisoprolol Aurobindo Pharma Italia will be gradually increased until the most suitable dose for you is found.
Adults and elderly: The recommended dose is:
1.25 mg once daily for 1 week. If this dose is well tolerated, it may be increased to:
2.5 mg once daily during the following week. If this dose is well tolerated, it may be increased to:
3.75 mg once daily during the following week. If this dose is well tolerated, it may be increased to:
5 mg once daily over the next 4 weeks. If this dose is well tolerated, it may be increased to:
7.5 mg once daily over the next 4 weeks. If this dose is well tolerated, it may be increased to:
10 mg once daily as the maintenance dose.
Maximum dose: 10 mg once daily.
Your doctor will determine the most appropriate dose for you based on your tolerance to bisoprolol and any side effects.
Your heart rate and blood pressure will be carefully monitored with each dose increase.
Patients with liver or kidney problems:
Your doctor will pay particular attention when increasing the dose of Bisoprolol Aurobindo Pharma Italia.
Children:
The use of Bisoprolol Aurobindo Pharma Italia is not recommended in children.
If you notice that the effect of Bisoprolol Aurobindo Pharma Italia is too strong or not strong enough, consult
your doctor or pharmacist.
Duration of treatment
Bisoprolol Aurobindo Pharma Italia is usually used long-term.
The tablet may be divided into two equal halves.
If you take more Bisoprolol Aurobindo Pharma Italia than you should
If you have accidentally taken more than the prescribed dose, inform your doctor or pharmacist immediately.
Take the remaining tablets or this leaflet with you so that medical staff know exactly what you have taken.
Symptoms of overdose may include dizziness, lightheadedness, fatigue, shortness of breath and/or difficulty breathing.
In addition, a reduced heart rate, low blood pressure, inadequate heart function, and low blood glucose levels
(which may cause hunger, sweating, palpitations) may also occur.
If you forget to take Bisoprolol Aurobindo Pharma Italia
Do not take a double dose to make up for the missed dose. Take the usual dose as soon as you remember, and then continue with your regular dosing schedule the next day.
If you stop taking Bisoprolol Aurobindo Pharma Italia
Treatment with Bisoprolol Aurobindo Pharma Italia must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. The dose of bisoprolol should be gradually reduced over several weeks, as advised by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are important and require immediate medical attention.
You must stop taking Bisoprololo Aurobindo Pharma Italia and contact your doctor immediately if you experience any of the following symptoms:

Common:

• Worsening of heart failure causing shortness of breath and/or fluid retention

Frequency not established:

• Worsening of symptoms of blockage of major blood vessels in the legs, particularly at the beginning of treatment

The following additional side effects have also been reported:

Very common: may affect more than 1 in 10 people

• Slow heartbeat

Common: may affect up to 1 in 10 people

• Tiredness, weakness
• Dizziness
• Headache
• Cold sensation or numbness in hands or feet
• Low blood pressure
• Nausea and vomiting
• Diarrhoea
• Constipation

Uncommon: may affect up to 1 in 100 people

• Drowsiness
• Sleep disorders
• Depression
• Irregular heartbeat
• Breathing problems in patients with asthma or chronic lung disease
• Muscle weakness, cramps

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

• Nightmares
• Hallucinations (seeing or hearing things that are not there)
• Hearing disturbances
• Inflammation of the nasal lining causing runny nose with irritation
• Allergic reactions (itching, redness, rash)
• Dry eyes due to reduced tear flow (may be particularly uncomfortable if you wear 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)
• Changes in blood test results
• Fainting

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

• Worsening of psoriasis or appearance of a similar scaly skin rash
• Hair loss
• Itching or inflammation of the eye (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 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 Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
[HDPE bottle of 500 tablets]
Use within 6 months after first opening of the HDPE bottle.
Do not use this medicine after the expiry date which is stated on the carton/bottle after EXP. The expiry
date refers to the last day of that month.
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. Package contents and other information

What Bisoprololo Aurobindo Pharma Italia contains

• The active substance is bisoprolol fumarate. Each tablet contains 2.5 mg, 3.75 mg, 5 mg, 7.5 mg or 10 mg of bisoprolol fumarate.
• The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, anhydrous colloidal silica, crospovidone (Type A), magnesium stearate. Tablet coating: hypromellose 6cP (E464), titanium dioxide (E171), macrogol 400.

Description of the appearance of Bisoprololo Aurobindo Pharma Italia and contents of the pack
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:
Germany: Bisoprololo PUREN 2.5 mg, 3.75 mg, 5 mg, 7.5 mg & 10 mg Filmtabletten
Italy: Bisoprololo Aurobindo Pharma Italia
Poland: Ripit
United Kingdom: Bisoprolol Fumarate 2.5 mg, 3.75 mg, 5 mg, 7.5 mg & 10 mg film-coated tablets