Prospect: Information for the Patient

Bisoprolol COR Viatris 5 mg Film-Coated Tablets

Bisoprolol fumarate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Bisoprolol COR Viatris and for what it is used

2. What you need to know before starting to take Bisoprolol COR Viatris

3. How to take Bisoprolol COR Viatris

4. Possible adverse effects

5. Storage of Bisoprolol COR Viatris

6. Contents of the package and additional information

This medication contains the active substance bisoprolol fumarate, which belongs to a group of medicines called beta-blockers. Bisoprolol is used in combination with other medications to treat stable heart failure.

Heart failure occurs when the heart muscle is too weak to pump blood throughout the body properly. This results in difficulty breathing and swelling.

Bisoprolol slows down the heart rate and makes the heart more effective at pumping blood throughout the body.

Do not take Bisoprolol COR Viatris if:

• You are allergic to bisoprolol or any of the other components of this medication (listed in section 6).
• You have severe asthma.
• You have a slow or irregular heart rate. Consult your doctor if you are unsure.
• You have very low blood pressure.
• You have severe circulatory problems in your extremities (which may cause numbness in your fingers and toes or make them pale or blue).
• You have heart failure that suddenly worsens and/or may require hospital treatment.
• You have metabolic acidosis, a condition characterized by excess acid in the blood.
• You have untreated phaeochromocytoma, a rare tumor of the adrenal gland.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

• You have asthma or chronic lung disease.
• You have diabetes. Bisoprolol may mask the symptoms of low blood sugar levels.
• You are fasting from solid foods.
• You have heart problems.
• You have liver or kidney problems.
• You have circulatory problems in your extremities.
• You are taking verapamil or diltiazem, medications used to treat heart diseases. Concomitant use is not recommended, see also “Bisoprolol COR Viatris and other medications”.
• You have (or have had) psoriasis (a recurring skin eruption).
• You have phaeochromocytoma (a rare tumor of the adrenal gland). Your doctor will need to treat you before prescribing bisoprolol.
• You have a thyroid problem. The tablets may mask the symptoms of hyperthyroidism.

During treatment

Consult your doctor or pharmacist if:

• You are to receive general anesthesia during an operation – tell your doctor that you are taking bisoprolol.
• You receive treatment for hypersensitivity reactions (allergies). Bisoprolol may make your allergy worse or harder to treat.
• You have chronic lung disease or mild asthma, inform your doctor immediately if, when using bisoprolol, you start experiencing difficulty breathing, coughing, wheezing after exercise, etc.
• You experience a worsening of symptoms of main vessel blockage to the legs, especially at the beginning of treatment.

Children and adolescents

No information is available on the use of this medication in children.

Bisoprolol COR Viatris and other medications

Inform your doctor or pharmacist if you are taking or have taken any of the following medications, as they may interact with bisoprolol:

• Medications to control blood pressure or medications for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medications for depression, e.g., imipramine, amitriptyline, moclobemide.
• Medications used to treat mental illnesses, e.g., phenothiazines, such as levomepromazine.
• Medications used for anesthesia during an operation (see also "Warnings and precautions").
• Medications used to treat epilepsy, e.g., barbiturates, such as phenobarbital.
• Some analgesics (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medications for asthma or medications used to decongest the nose.
• Medications used to treat certain eye disorders, such as glaucoma (increased eye pressure) or used to dilate the pupil of the eye.
• Some medications used to treat clinical shock (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication for malaria.
• All medications, like bisoprolol, that can affect blood pressure and/or heart function.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Fertility, pregnancy, and breastfeeding

Bisoprolol may be harmful to the fetus and/or the child (increased risk of premature birth, spontaneous abortion, growth delay, low blood sugar levels, and reduced heart rate in the child).

Therefore,do notuse this medication during pregnancy.

The excretion of bisoprolol in breast milk is unknown. Breastfeeding while using this medicationis notrecommended.

No information is available on the effects of bisoprolol on fertility.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The use of bisoprolol may cause dizziness or fatigue (see "Possible side effects"). If you experience any of these side effects,do notdrive or operate machines. These side effects are likely to occur at the beginning of treatment or due to a change in the amount of bisoprolol you take.

Bisoprolol COR Viatris containsyellow orange S

This medication may cause adverse reactions because it contains yellow orange S (E-110).

Bisoprolol COR Viatris containssodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Before starting to take Bisoprolol COR Viatris, you must already be taking other medications for heart failure, including an ACE inhibitor, a diuretic, and (as an additional option) a cardiac glycoside.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Adults

The treatment with bisoprolol should be initiated at a low dose and increased gradually. Your doctor will decide how to increase the dose and this will be done normally in the following way:

• 1.25 mg of bisoprolol once a day for one week.
• 2.5 mg of bisoprolol once a day for one week.
• 3.75 mg of bisoprolol once a day for one week.
• 5 mg of bisoprolol once a day for four weeks.
• 7.5 mg of bisoprolol once a day for four weeks.
• 10 mg of bisoprolol once a day as maintenance therapy (continuous).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose less than 10 mg of bisoprolol may be sufficient.

Your doctor will tell you what to do.

Patients with liver or kidney problems

Your doctor will have special care when adjusting the bisoprolol dose.

Use in children and adolescents

Nobisoprolol use is recommended, as there is not enough experience with the use of this medication in children and adolescents.

Older patients

Generally, a dose adjustment is not necessary. It is recommended to start with the lowest possible dose.

If you notice that the bisoprolol dose is too strong or does not work well enough, consult your doctor or pharmacist.

Route and/or method of administration

• The tablets should be taken in the morning.
• Swallow the tablets with a glass of water.
• The tablets should not be chewed.
• The tablets can be divided into equal doses.

If you take more Bisoprolol COR Viatris than you should

If you take more Bisoprolol COR Viatris than you should, contact your doctor or pharmacistimmediatelyor call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging and remaining tablets with you.

If you forget to take Bisoprolol COR Viatris

Notake a double dose to compensate for the missed doses. Take the next dose on time. If you forget several doses, consult your doctor.

If you interrupt treatment with Bisoprolol COR Viatris

If you interrupt treatment with Bisoprolol COR Viatris, it is likely that you will experience adverse effects. Your doctor will reduce your dose gradually over 2 weeks.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects are serious and will require immediate action if you experience them. You should stop taking bisoprolol and consult your doctor immediately if you experience the following symptoms:

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

• Slow heart rate.

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

• Worsening of heart failure, causing increased difficulty breathing and/or fluid retention.

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

• Worsening of irregular heartbeats.
• Depression.
• Respiratory problems in patients with asthma or chronic lung disease.

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

• Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite, and, in some cases, jaundice with yellow discoloration of the whites of the eyes and skin and darkening of the urine.
• Allergic reactions such as itching, redness, and skin rashes. Severe allergic reactions may include inflammation of the face, neck, tongue, or throat, or difficulty breathing.

If you feel dizzy or weak, or if you have difficulty breathing, contact your doctor as soon as possible.

The following side effects have also been reported:

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

• Chilly hands and/or feet.
• Numbness of hands and/or feet.
• Low blood pressure.
• Discomfort, vomiting, diarrhea, constipation.
• Fatigue.
• Headache.

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

• Sleep disorders.
• Dizziness when standing up
• Muscle weakness, muscle cramps.

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

• Changes in blood test results.
• Decreased tear flow (may be a problem if you wear contact lenses).
• Auditory disorders.
• Congestion.
• Decreased libido.
• Inability to achieve and maintain an erection (erectile dysfunction).
• Nightmares.
• Hallucinations.
• Syncopal episodes.

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

• Conjunctivitis.
• Worsening of psoriasis or the appearance of a dry, scaly rash.
• Hair loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister: Store below 30°C. Bottle: This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Bisoprolol COR Viatris Composition

The active ingredient is bisoprolol fumarate. Each film-coated tablet contains 5 mg of bisoprolol fumarate.

The other components are: Tablet: microcrystalline cellulose, butylhydroxyanisole, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate, sodium croscarmellose,(see section2, ‘Bisoprolol fumarate contains sodium’),yellow iron oxide (E-172). Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), quinoline yellow (E104), macrogol, indigo carmine (E-132), yellow orange S (E-110) (see section 2 “BisoprololCOR Viatriscontains yellow orange”).

Appearance of the product and contents of the package

Film-coated tabletswith a clear yellow film, oval, biconvex, with lateral notches, engraved with “BL” and “4” on both sides of the groove of one of the faces of the tablet and “M” on the other.

Bisoprolol COR Viatris is packaged in blisters containing 10, 20, 28, 30, 50, 56, 84, 98, and 100 film-coated tablets. Bisoprolol COR Viatris is packaged in bottles containing 10, 28, 30, 50, 56, 84, 98, 100, 500, and 1,000 film-coated tablets. Some package sizes may only be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Generics (UK) Ltd

Station Close, Hertfordshire, EN6 1TL

United Kingdom

or

Mylan Hungary Kft.

H-2900, Komárom

Mylan útca.1

Hungary

Further information about this medicine can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainBisoprolol COR Viatris 5 mg film-coated tablets EFG

IrelandBisoprolol Mylan 5 mg film-coated tablets

United KingdomBisoprolol fumarate 5 mg film-coated tablets

(Northern Ireland)

SwedenBisomyl 5 mg film-coated tablets

Last review date of this leaflet:July 2021

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/