BISOPROLOL VIATRIS PHARMACEUTICALS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol Viatris Pharmaceuticals 10 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 experience 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 Viatris Pharmaceuticals and what is it used for.
2. What you need to know before you take Bisoprolol Viatris Pharmaceuticals.
3. How to take Bisoprolol Viatris Pharmaceuticals.
4. Possible side effects.

5 Storage of Bisoprolol Viatris Pharmaceuticals.

1. Contents of the pack and further information.

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

This medicine contains the active substance bisoprolol fumarate, which belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart against excessive activity.

Bisoprolol is used to treat:

• High blood pressure (hypertension).

Chest pain (angina pectoris, which is a pain in the chest caused by blockages in the arteries that supply the heart muscle).

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

Do not take Bisoprolol Viatris Pharmaceuticals 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 heartbeat. Consult your doctor if you are not sure.
• You have very low blood pressure.
• You have severe circulatory problems in your limbs (which can cause tingling in your fingers or 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 taking this medicine if:

• You have asthma or chronic lung disease.
• You have diabetes. Bisoprolol may mask the symptoms of hypoglycaemia.
• 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 Viatris Pharmaceuticals 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

Tell 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, asthma, or less severe asthma, inform your doctor immediately if you start experiencing breathing difficulties, cough, wheezing after exercise, etc. while 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 medicine in children.

Bisoprolol Viatris Pharmaceuticals and other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, as they may interact with your medicine.

• Medicines to control blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, nifedipine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medicines for depression, e.g., imipramine, amitriptyline, moclobemide.
• Medicines for mental illness, 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.
• Certain painkillers (e.g., 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 (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.
• All these medicines, 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 might take, any other medicines.

Pregnancy, breastfeeding, and fertility

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

Therefore, do notuse this medicine during pregnancy.

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 operate machinery. 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 medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

Bisoprolol Viatris Pharmaceuticals contains orange yellow S

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Bisoprolol Viatris Pharmaceuticals

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will monitor you closely 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 medicine.

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 medicine.

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

Generally, 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, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring the package 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 taking Bisoprolol Viatris Pharmaceuticals

If you stop taking Bisoprolol Viatris Pharmaceuticals suddenly, you may experience side effects. Your doctor will reduce your dose gradually 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:

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

• Slow heartbeat.
• 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, flushing, and skin rashes. Among the serious 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(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.
• Impotence (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, 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, 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 and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Viatris Pharmaceuticals

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 carton after EXP. The expiry date refers to 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 further information

Composition of Bisoprolol Viatris Pharmaceuticals

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are:

Tablet: Microcrystalline cellulose, butylhydroxyanisole, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, sodium croscarmellose (see section 2, 'Bisoprolol fumarate contains sodium'), iron oxide red (E-172). Coating: Titanium dioxide (E-171), talc, hypromellose (E-464), iron oxide yellow (E-172), orange yellow S (E-110) (see section 2 "Bisoprolol Viatris Pharmaceuticals contains orange yellow S").

Appearance of the product and pack contents

Light orange to bright orange, oval, biconvex film-coated tablets with lateral notches, engraved with "BL" and "6" on either side of the break 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 medicine from 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:

Date of last revision of this leaflet:May 2022

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