BISOPROLOL VIATRIS PHARMACEUTICALS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol Viatris Pharmaceuticals 5 mg Film-Coated Tablets EFG

bisoprolol fumarate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bisoprolol Viatris Pharmaceuticals and what is it used for
2. What you need to know before taking Bisoprolol Viatris Pharmaceuticals
3. How to take Bisoprolol Viatris Pharmaceuticals
4. Possible side effects

5 Conservation of Bisoprolol Viatris Pharmaceuticals

1. Contents of the packaging and additional information

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

This medication contains the active ingredient bisoprolol fumarate, which belongs to the family of medications called beta-blockers. Beta-blockers protect the heart from excessive activity.

Bisoprolol is used to treat:

• High blood pressure (hypertension).

Chest pain (angina pectoris, pain in the chest caused by obstructions in the arteries that supply the heart muscle).

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

Do not take Bisoprolol Viatris Pharmaceuticals 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 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 may require hospital treatment.
• You have an excess of acid in the blood, a condition known as metabolic acidosis.
• You have 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 hypoglycemia.
• 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 disease. Concomitant use is not recommended, see also "Bisoprolol Viatris Pharmaceuticals and other medications".
• 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

Inform 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 a chronic lung disease, asthma, or less severe asthma, inform your doctor immediately if you start to experience breathing difficulties, cough, wheezing after exercise, etc. when using bisoprolol.
• Worsening of symptoms of obstruction of the main blood vessels in 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 Viatris Pharmaceuticals and other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, as they may interact with your medication.

• Medications to control blood pressure or medications for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, nifedipine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medications for depression, e.g., imipramine, amitriptyline, moclobemide.
• Medications for mental illness, 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 clinical shock (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication for malaria.
• All these medications, as well as bisoprolol, may affect blood pressure and/or heart function.

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

Pregnancy, breastfeeding, and fertility

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 whether bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during the use of this medication.

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 Viatris Pharmaceuticals contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

Bisoprolol Viatris Pharmaceuticals containsorange yellow S

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

3. How to take Bisoprolol Viatris Pharmaceuticals

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will closely monitor you at the start of treatment. Your doctor will increase the dose to obtain the best possible dosage for you.

The maximum recommended dose is 20 mg once a day.

Patients with kidney disease

Patients with severe kidney disease should not exceed 10 mg of bisoprolol once a day. Consult your doctor before starting to use this medication.

Patients with liver disease

Patients with severe liver disease should not exceed 10 mg of bisoprolol once a day. Consult your doctor before starting to use this medication.

Use in children and adolescents

Do notrecommend the use of bisoprolol since 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.

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 Viatris Pharmaceuticals than you should

If you take more Bisoprolol Viatris Pharmaceuticals than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 Viatris Pharmaceuticals

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 treatment with Bisoprolol Viatris Pharmaceuticals

If you suddenly stop treatment with Bisoprolol Viatris Pharmaceuticals, you may 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 experiences them.

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

Uncommon side effects(affect less than 1 in 100 people):

• Slow heart rate.
• Worsening of irregular heartbeats.
• Worsening of heart failure, causing increased difficulty breathing and/or fluid retention.
• Depression.
• Breathing problems in patients with asthma or chronic lung disease.

Rare side effects(affect less than 1 in 1,000 people):

• Liver inflammation (hepatitis), causing abdominal pain, loss of appetite, and jaundice, sometimes with 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, 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(affect less than 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(affect less than 1 in 100 people):

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

Rare side effects(affect less than 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, runny nose.
• Inability to achieve and maintain an erection (erectile dysfunction).
• Nightmares.
• Hallucinations.
• Fainting.

Very rare(affect less than 1 in 10,000 people):

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

• These symptoms occur especially at the start of treatment. They are usually mild and often disappear within 1 or 2 weeks.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package 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. Conservation of Bisoprolol Viatris Pharmaceuticals

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears 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 thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in 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 packaging and additional information

Composition of Bisoprolol Viatris Pharmaceuticals

• 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 section 2, "Bisoprolol Mylan Pharmaceuticals contains sodium"), yellow iron oxide (E-172).
• Coating: Titanium dioxide (E-171), hypromellose (E-464), quinoline yellow, carmine indigo (E-132), orange yellow S (E-110) (see section 2 "Bisoprolol Viatris Pharmaceuticals contains orange yellow S").

Appearance of the product and contents of the packaging

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 Viatris Pharmaceuticals is packaged in blisters containing 14, 28, 30, 50, 56, 60, 84, 98, 100, and 500 film-coated tablets. Bisoprolol Viatris Pharmaceuticals is packaged in bottles of 14, 28, 30, 50, 56, 60, 84, 98, 100, and 500 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

Mylan Hungary Kft.

H-2900, Komárom

Mylan útca.1

Hungary

You can request more information about this medication from 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:

Bulgaria Bisoprolol Mylan 5 mg film-coated tablets

Spain Bisoprolol Viatris Pharmaceuticals 5 mg film-coated tablets EFG

Portugal Bisoprolol Mylan 5 mg film-coated tablets

United Kingdom Bisoprolol fumarate 5 mg film-coated tablets

Date of the last revision of this package leaflet:May 2022.

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