Prospect: Information for the Patient

Bisoprolol COR Viatris 10 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 what it is used for

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 pack and additional information

This medication contains the active substance bisoprolol fumarate, which belongs to a family of medications 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 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 to any of the other ingredients of this medicine (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 limbs (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 medicine 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 limbs.
• You are taking verapamil or diltiazem, medicines used to treat heart diseases. Concomitant use is not recommended, see also “Bisoprolol COR Viatris and other medicines”.
• 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 are receiving 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 to experience difficulty breathing, coughing, wheezing after exercise, etc.
• You experience a worsening of the symptoms of main limb artery blockage, especially at the start of treatment.

Children and adolescents

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

Bisoprolol COR Viatris and other medicines

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

• Medicines to control 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, e.g. imipramine, amitriptyline, moclobemide.
• Medicines to treat mental illnesses, e.g. phenothiazines, such as levomepromazine.
• Medicines used for anesthesia during an operation (see also "Warnings and precautions").
• Medicines used to treat epilepsy, e.g. barbiturates, such as phenobarbital.
• Some analgesics (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines for asthma or medicines used to decongest the nose.
• Medicines used to treat certain eye disorders such as glaucoma (increased eye pressure) or used to dilate the pupil of the eye.
• Some medicines used to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.
• All those medicines, like bisoprolol, that may 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 medicine.

Fertility, pregnancy and breastfeeding

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

Therefore,do notuse this medicine during pregnancy.

The excretion of bisoprolol in breast milk is unknown. Breastfeeding during the use of this medicineis notrecommended.

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

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

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 start of treatment or due to a change in the amount of bisoprolol you take.

Bisoprolol COR Viatris containssodium

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

Bisoprolol COR Viatris containsyellow orange

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

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 for 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 as follows:

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

Older patients

In general, 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 doubts 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 the following symptoms appear:

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):

• Liver inflammation (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):

• Chilliness of 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.
• Nasal congestion.
• Decreased libido.
• Inability to achieve and maintain an erection (erectile dysfunction).
• Nightmares.
• Hallucinations (imagining things).
• Passing out.

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

• Eye inflammation (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.

Medicines should not be disposed of through drains or in the 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 10 mg 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’),red iron oxide (E-172). Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), macrogol, yellow iron oxide (E-172), yellow orange S (E-110) (see section 2 “BisoprololCOR Viatriscontains yellow orange”).

Product Appearance and Packaging Contents

Film-coated tabletswith a clear orange to bright orange color, oval, biconvex, with lateral notches, engraved with “BL” and “6” on both sides of the groove of one of the tablet faces 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 Responsible Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

SpainBisoprolol COR Viatris 10 mg film-coated tablets EFG

IrelandBisoprolol Mylan 10 mg film-coated tablets

United KingdomBisoprolol fumarate 10 mg film-coated tablets

(Northern Ireland)

SwedenBisomyl 10 mg film-coated tablets

Last review date of this leaflet:July 2021

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/