BISOPROLOL COR VIATRIS 5 mg FILM-COATED TABLETS

2. What you need to know before taking Bisoprolol COR Viatris

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 heartbeat. Consult your doctor if you are unsure.
• You have very low blood pressure.
• You have severe circulatory problems in the limbs (which can cause tingling in the fingers and toes or turn them pale or blue).
• You have heart failure that suddenly worsens and/or requires hospital treatment.
• You have an excess of acid in the blood, a condition known as metabolic acidosis.
• You have an untreated pheochromocytoma, 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 circulation problems in the limbs.
• 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 rash).
• You have a thyroid problem. The tablets may mask the symptoms of hyperthyroidism.

During treatment

Consult your doctor or pharmacist if:

• You are going 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 more difficult to treat.
• You have chronic lung disease or less severe asthma, inform your doctor immediately if, when using bisoprolol, you start to experience difficulty breathing, coughing, wheezing after exercise, etc.
• There is a worsening of the symptoms of blockage of the main blood vessels to the legs, especially at the start of treatment.

Children and adolescents

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

Bisoprolol COR Viatris and other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other 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 for 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.
• Certain pain relievers (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medications for asthma or medications used to decongest the nose.
• Medications used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to dilate the pupil of the eye.
• Certain medications for treating clinical shock (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication for malaria.
• All medications, like bisoprolol, that may affect blood pressure and/or heart function.

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

Fertility, pregnancy, and breastfeeding

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

Therefore, do notuse this medication during pregnancy.

It is unknown if bisoprolol is excreted in breast milk. Breastfeeding during the use of this medication is notrecommended.

There is no information available on the effects of bisoprolol on fertility.

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

Driving and using machines

The use of bisoprolol may occasionally 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 when changing the dose of bisoprolol.

Bisoprolol COR Viatris containsorange yellow S

This medication may cause adverse reactions because it contains orange yellow 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".

3. How to take Bisoprolol COR Viatris

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

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

Adults

Treatment with bisoprolol should be started at a low dose and 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 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 lower 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 be particularly careful when adjusting the dose of bisoprolol.

Use in children and adolescents

Do notrecommend the use of bisoprolol, as there is not enough experience with the use of this medication in children and adolescents.

Elderly patients

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

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

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 pharmacist immediatelyor call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the packaging and remaining tablets with you.

If you forget to take Bisoprolol COR Viatris

Do nottake a double dose to make up for forgotten doses. Take the next dose on time. If you forget several doses, consult your doctor.

If you stop taking Bisoprolol COR Viatris

If you stop taking Bisoprolol COR Viatris, you are likely to experience side effects. Your doctor will gradually reduce your dose over 2 weeks.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects are important 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 heartbeat.

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.
• Breathing 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, yellowing of the whites of the eyes and skin, and darkening of the urine.
• Allergic reactions such as itching, redness, and skin rashes. Among the severe allergic reactions, facial swelling, neck, tongue, or throat inflammation, or breathing difficulties may occur.

If you feel dizzy or weak, or 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):

• Cooling 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).
• Hearing disorders.
• Nasal congestion.
• Decreased sexual appetite.
• Difficulty achieving and maintaining an erection (erectile dysfunction).
• Nightmares.
• Hallucinations (imagining things).
• Fainting.

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

• Eye inflammation (conjunctivitis).
• Worsening of psoriasis or the appearance of a similar, dry, and scaly rash.
• Hair loss.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bisoprolol COR Viatris

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. 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 wastewater or household waste. Deposit the packaging and unused medications in 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. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bisoprolol COR Viatris

The active substance 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 section 2, 'Bisoprolol fumarate contains sodium'), yellow iron oxide (E-172). Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), quinoline yellow (E104), macrogol, carmine indigo (E-132), orange yellow S (E-110) (see section 2 "Bisoprolol COR Viatris contains orange yellow S").

Appearance of the product and packaging contents

Light yellow, oval, biconvex film-coated tablets with lateral notches, engraved with "BL" and "4" on either side of the score line on one face 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 of 10, 28, 30, 50, 56, 84, 98, 100, 500, and 1,000 film-coated tablets. Not all pack sizes may 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

You can request more information about this medication by contacting 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 under the following names:

Spain Bisoprolol COR Viatris 5 mg film-coated tablets EFG

Ireland Bisoprolol Mylan 5 mg film-coated tablets

United Kingdom Bisoprolol fumarate 5 mg film-coated tablets

(Northern Ireland)

Sweden Bisomyl 5 mg film-coated tablets

Date of the last revision of this leaflet:July 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/