Bisoprolol Mylan

Package leaflet: Information for the patient

BISOPROLOL MYLAN 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg or 10 mg film-coated tablets

film
bisoprolol fumarate
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bisoprolol Mylan is and what it is used for

Bisoprolol belongs to a class of medicines called beta-blockers. Beta-blockers protect the
heart from excessive activity.
Bisoprolol Mylan 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg tablets is used in
combination with other medicines to treat stable heart failure. Heart failure
occurs when the heart muscle is too weak to pump blood effectively around the body.
This causes breathlessness and swelling. Bisoprolol reduces heart rate and makes the heart
more efficient at pumping blood around the body.
Bisoprolol Mylan 5 mg and 10 mg tablets is also used to treat hypertension and angina
pectoris (chest pain caused by blockages in the arteries supplying the heart muscle).

2. What you need to know before taking BISOPROLOL MYLAN

Do not take Bisoprolol Mylan if you:

• are allergic to bisoprolol or to any of the excipients of this medicine (listed in section 6).
• suffer from severe asthma or severe chronic lung diseases
• have a slow or irregular heartbeat (less than 60 beats per minute). Ask your doctor if you are unsure
• have very low blood pressure
• suffer from severe circulatory problems (which may cause tingling sensations or pale or bluish skin on fingers and toes)
• suffer from heart failure that suddenly worsens and/or requires hospital treatment
• have excess acid in the blood, a condition known as metabolic acidosis
• have untreated phaeochromocytoma, a rare tumour of the adrenal glands.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

• you suffer from asthma or chronic lung diseases
• you have diabetes. Bisoprolol may mask symptoms of low blood sugar levels
• you are not eating solid food
• you are being treated for hypersensitivity reactions (allergies). Bisoprolol may worsen your allergy or make it harder to treat
• you have certain heart conditions, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• you have liver or kidney problems
• you have circulation problems in the limbs
• you need to undergo general anaesthesia for surgery; in this case, 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 Mylan”
• you have (or have had) psoriasis (a recurring skin rash)
• you have phaeochromocytoma (a rare tumour of the adrenal glands). Your doctor must treat this condition before prescribing Bisoprolol Mylan
• you have thyroid problems. These tablets may mask symptoms of overactive thyroid.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
There is no available information on the use of this medicine in children.
Other medicines and Bisoprolol Mylan Inform your doctor or pharmacist if you are taking any of the following medicines, as they may interact with Bisoprolol Mylan:

• medicines for controlling high blood pressure or heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• medicines for depression, such as imipramine, amitriptyline, moclobemide
• medicines for treating mental disorders, e.g. phenothiazines such as levomepromazine
• medicines used for anaesthesia during surgery (see also “Warnings and precautions”)
• medicines used to treat epilepsy, e.g. barbiturates such as phenobarbital
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen)
• medicines for asthma or nasal congestion
• medicines used for certain eye disorders, such as glaucoma (increased eye pressure) or to dilate the pupil
• certain medicines used to treat shock (e.g. adrenaline, dobutamine, noradrenaline)
• mefloquine, a medicine used for malaria.
• all these medicines, as well as bisoprolol, may affect blood pressure and/or heart function
• rifampicin, for treating infections
• medicines used to treat severe headaches or migraines (ergotamine and derivatives).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bisoprolol Mylan with food and drinks
Bisoprolol Mylan should be taken in the morning, with or without food. The tablets should be swallowed with liquid and must not be chewed.
Pregnancy, breastfeeding and fertility
Bisoprolol Mylan may be harmful during pregnancy and/or to the baby (increased risk of premature birth, miscarriage, developmental delay, low blood glucose levels and reduced heart rate in the baby).
Therefore, you must not use this medicine during pregnancy.
It is unknown whether bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during treatment with this medicine.
There is no information available on the effect of Bisoprolol Mylan on fertility.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Taking Bisoprolol Mylan may sometimes cause dizziness or fatigue (see “Possible side effects”). If you experience these side effects, you must not drive or operate machinery. These side effects are more likely to occur at the beginning of treatment or when the dose is changed.
Bisoprolol Mylan contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.
For 5 mg, 7.5 mg and 10 mg tablets only:
Bisoprolol Mylan contains sunset yellow dye
Sunset yellow dye (E110) may cause allergic reactions.

3. How to take BISOPROLOL MYLAN

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults
Chest pain and high blood pressure (angina and hypertension)
Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will closely monitor you at the beginning of treatment. Your doctor will increase the dose to achieve the best possible dosage.
The maximum recommended dose is 20 mg once daily.
Patients with kidney disease
Patients with severe kidney disease must not exceed a dose of 10 mg of bisoprolol once daily. Consult your doctor before starting to take this medicine.
Patients with liver disease
Patients with severe liver disease must not exceed a dose of 10 mg of bisoprolol once daily. Consult your doctor before starting to use this medicine.
Heart failure
Before starting treatment with Bisoprolol Mylan, you must already be receiving treatment for heart failure with other medicines, including an ACE inhibitor, a diuretic, and (as an optional addition) a cardiac glycoside.
Treatment with Bisoprolol Mylan must start at a low dose and be gradually increased. Your doctor will decide how to increase the dose, and this will normally be done as follows:

• 1.25 mg of bisoprolol once daily for 1 week,
• 2.5 mg of bisoprolol once daily for 1 week,
• 3.75 mg of bisoprolol once daily for 1 week,
• 5 mg of bisoprolol once daily for 4 weeks,
• 7.5 mg of bisoprolol once daily for 4 weeks,
• 10 mg of bisoprolol once daily for maintenance therapy.

The maximum recommended dose is 10 mg of bisoprolol per day.
Depending on how well you tolerate the medicine, your doctor may decide to extend the time between dose increases. If your condition worsens or you no longer tolerate the medicine, it may be necessary to reduce the dose or discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
Your doctor will advise you on what to do.
Use in children and adolescents
The use of Bisoprolol Mylan is not recommended, as experience with this medicine in children and adolescents is insufficient.
Elderly patients
Dose adjustment is generally not required. It is recommended to start with the lowest possible dose.
If you notice that the dose of Bisoprolol Mylan is too strong or not effective enough, consult your doctor or pharmacist.
Route and/or method of administration:

• Swallow the tablets with a glass of water.
• The tablets must not be chewed.
• The 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg tablets may be divided into two equal doses. The 1.25 mg tablet must not be broken.

If you take more Bisoprolol Mylan than you should
If you take more Bisoprolol Mylan than prescribed, contact your doctor or the Emergency Department immediately. Take the container and any remaining tablets with you.
If you forget to take Bisoprolol Mylan
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time. If you have missed several doses, contact your doctor.
If you stop taking Bisoprolol Mylan
If you suddenly stop taking Bisoprolol Mylan, you may experience adverse effects. Your doctor will gradually reduce your dose over a period of 2 weeks.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects are important and require immediate medical attention. You must stop taking Bisoprololo Mylan tablets and contact a doctor immediately if you experience any of the following symptoms:
Common (occur in less than 1 in 10 patients):

• worsening of heart failure causing shortness of breath and/or fluid retention if you suffer from chronic heart failure.

Rare (affect less than 1 in 1,000 people):
Allergic reactions such as itching, redness and skin rash. Severe allergic reactions may cause swelling of the face, neck, tongue, mouth or throat, or breathing difficulties.
Not known (frequency cannot be estimated from the available data):

• worsening of symptoms of obstruction in the main blood vessels of the legs, particularly at the beginning of treatment.

The following side effects have also been reported:
Very common (occur in more than 1 in 10 patients):

• slowing of the heartbeat.

Common (occur in less than 1 in 10 patients):

• cold hands and/or feet
• numbness of hands and/or feet
• low blood pressure
• nausea, vomiting, diarrhoea, constipation
• fatigue*
• feeling weak
• dizziness*
• headache*

Uncommon (occur in less than 1 in 100 patients):

• worsening of heart failure if you have high blood pressure or suffer from angina pectoris
• worsening of irregular heartbeat
• sleep disturbance
• depression
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.

Rare (occur in less than 1 in 1,000 patients):

• changes in blood test results
• reduced tear production (may be a problem if you wear contact lenses)
• hearing disturbances
• stuffy or runny nose
• 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
• inability to achieve or maintain an erection (erectile dysfunction)
• nightmares
• hallucinations (seeing imaginary things)
• fainting.

Very rare (occur in less than 1 in 10,000 patients):

• inflammation of the eyes (conjunctivitis)
• worsening of psoriasis or appearance of a similar skin rash with dry, scaly skin
• hair loss

* during treatment for hypertension or angina, these symptoms occur especially at the beginning of treatment or when the dose is changed. They are usually mild and often disappear within 1–2 weeks.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 MYLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word “Exp”. The expiry date refers to the last day of that month.
Blister packs: do not store above 30°C.
Bottles: This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Mylan contains
Each film-coated tablet contains 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, or 10 mg of the active substance
bisoprolol fumarate.
The other excipients are:
Tablet core: microcrystalline cellulose, butylhydroxyanisole, anhydrous colloidal silica, magnesium stearate,
sodium lauryl sulfate, sodium croscarmellose (see section 2 “Bisoprololo Mylan contains sodium”),
yellow iron oxide (E172) (only in tablets of 2.5 mg, 3.75 mg, 5 mg, and 7.5 mg), red iron oxide (E172)
(only in tablets of 2.5 mg and 10 mg).
Film coating: titanium dioxide (E171), polydextrose (E1200), hypromellose (E464), quinoline yellow
(only for 5 mg and 7.5 mg tablets), macrogol, yellow iron oxide (E172) (only in 3.75 mg and 10 mg tablets),
indigo carmine (E132) (only in 5 mg tablets), sunset yellow FCF (only in 5 mg, 7.5 mg, and 10 mg tablets).

What Bisoprololo Mylan looks like and contents of the pack
Film-coated tablets
1.25 mg tablet: White, oval, biconvex, film-coated tablets, with “BL&1” engraved on one side and “M”
engraved on the other side.
2.5 mg tablet: White, oval, biconvex, film-coated tablets with a scored edge; “BL&2” engraved on one side adjacent to the break line and “M” engraved on the other side.
3.75 mg tablet: Cream-coloured, oval, biconvex, film-coated tablets with a scored edge; “BL&3” engraved on one side adjacent to the break line and “M” engraved on the other side.
5 mg tablet: Pale yellow, oval, biconvex, film-coated tablets with a scored edge; “BL&4” engraved on one side adjacent to the break line and “M” engraved on the other side.
7.5 mg tablet: Yellow, oval, biconvex, film-coated tablets with a scored edge; “BL&5” engraved on one side adjacent to the break line and “M” engraved on the other side.
10 mg tablet: Light orange to pale orange, oval, biconvex, film-coated tablets with a scored edge; “BL&6” engraved on one side adjacent to the break line and “M” engraved on the other side.

Bisoprololo Mylan tablets are packaged in blisters containing 28, 30, 84, or 90 film-coated tablets.
Bisoprololo Mylan tablets are also packaged in bottles containing 100 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturer responsible for batch release:
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories (trading as Gerard Laboratories), 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900, Komárom, Mylan útca.1, Hungary
Mylan S.A.S (Meyzieu), Zac des Gaulnes, 360 Avenue Henri Schneider, 69330 Meyzieu, France

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Bisoprololo Mylan
United Kingdom: Bisoprolol fumarate 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg film-coated tablets