BISOPROLOL COR VIATRIS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol COR Viatris 2.5 mg Film-Coated Tablets EFG

Bisoprolol Fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

This medicine contains the active substance bisoprolol fumarate, which belongs to a group of medicines called beta-blockers. Bisoprolol 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 through the body properly. This leads to difficulty breathing and swelling.

Bisoprolol slows the heart rate and makes the heart more efficient, pumping blood through the body.

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

Do not take Bisoprolol COR Viatris if:

• You are allergic to bisoprolol or 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 not sure.
• You have very low blood pressure.
• You have severe circulatory problems in your limbs (which may cause tingling in your fingers or toes or turn them pale or blue).
• You have heart failure that has suddenly worsened and/or may require hospital treatment.
• You have excess 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 taking this medicine if:

• You have asthma or chronic lung disease.
• You have diabetes. Bisoprolol may hide 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 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 rash).
• You have pheochromocytoma (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 going to receive general anesthesia during an operation – tell your doctor that you are taking bisoprolol.
• You receive treatment for hypersensitivity reactions (allergy). 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 medicine in children.

Bisoprolol COR Viatris and other medicines

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

• Medicines to control blood pressure or medicines for heart problems (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 illnesses, for example, phenothiazines, such as levomepromazine.
• Medicines used for anesthesia during an operation (see also “Warnings and precautions”).
• Medicines used to treat epilepsy, for example, barbiturates, such as phenobarbital.
• Certain pain relievers (for example, acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines for asthma or medicines used to decongest the nose.
• Medicines used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to dilate the pupil of the eye.
• Certain medicines for clinical shock (for example, adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.
• All those medicines, like bisoprolol, that may affect blood pressure and/or heart function.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fertility, pregnancy, and breastfeeding

Bisoprolol may be harmful to pregnancy and/or the unborn 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 medicine during pregnancy.

It is not known whether bisoprolol is excreted in breast milk. Breastfeeding during the use of this medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 use machines. These side effects are likely to occur at the start of treatment or when changing 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”.

3. How to take Bisoprolol COR Viatris

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

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in 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 usually 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 medicine, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medicine, it may be necessary to reduce the dose again or stop 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 notuse bisoprolol, as there is not enough experience with the use of this medicine 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 medicine and the amount taken. Bring the package and the 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 further questions on 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 if you experience them. You must 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.
• 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 occasionally jaundice with yellowing of the whites of the eyes and skin and darkening of the urine.
• Allergic reactions such as itching, redness, and skin rash. Among the severe allergic reactions, swelling of the face, neck, tongue, or throat, or difficulty breathing 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.
• Impotence (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, scaly rash.
• Hair loss.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol COR Viatris

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

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month stated.

Blister: Store below 30°C.

Bottle: This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol COR Viatris

The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.

The other ingredients are: Tablet: microcrystalline cellulose, butylhydroxyanisole, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate, sodium croscarmellose, (see section 2, 'Bisoprolol COR contains sodium'), yellow iron oxide (E-172). Coating: titanium dioxide (E-171), talc, hypromellose (E-464), macrogol.

Appearance and packaging of the product

White or almost white, oval, biconvex film-coated tablets with lateral notches, engraved with “BL” and “2” 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 medicine 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 under the following names:

Spain Bisoprolol COR Viatris 2.5 mg film-coated tablets EFG

Ireland Bisoprolol Mylan 2.5 mg film-coated tablets

United Kingdom (Northern Ireland)

Bisoprolol fumarate 2.5 mg film-coated tablets

Sweden Bisomyl 2.5 mg film-coated tablets

Date of last revision of this leaflet:July 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/