Package Insert: Information for the Patient

Bisoprolol Viatris Pharmaceuticals 5 mg Film-Coated Tablets

bisoprolol fumarate

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

- Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication 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 package insert. See section 4.

1. What is Bisoprolol Viatris Pharmaceuticals and how is it used

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

3. How to take Bisoprolol Viatris Pharmaceuticals

4. Possible adverse effects

5. Storage of Bisoprolol Viatris Pharmaceuticals

6. Contents of the package and additional information

This medication contains the active ingredientbisoprolol fumarate which belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart from excessive activity.

Bisoprolol is used to treat:

• High blood pressure (hypertension).

Angina pectoris (chest pain caused by blockages in the arteries that supply the heart muscle).

Do not take Bisoprolol Viatris Pharmaceuticals if:

• You are allergic to bisoprolol or to 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 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 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 circulatory problems in your limbs.
• You are taking verapamil or diltiazem, medications used to treat heart diseases. Concomitant use is not recommended, see also "Bisoprolol Viatris Pharmaceuticals and other medications".
• 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

Inform your doctor or pharmacist if:

• You are to receive general anesthesia during an operation – tell your doctor that you are taking bisoprolol.
• You receive treatment for hypersensitivity reactions (allergies). Bisoprolol may make your allergy worse or more difficult to treat.
• You have chronic lung disease, asthma, or mild 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 beginning of treatment.

Children and adolescents

No information is 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 used recently 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 used to treat 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.
• Some analgesics (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medications for asthma or medications used to decongest the nose.
• Medications used to treat certain eye disorders, such as glaucoma (increased pressure in the eye) or used to dilate the pupil of the eye.
• Some medications used to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication for malaria.
• All those medications, as well as bisoprolol, may affect blood pressure and/or heart function.

Inform your doctor or pharmacist what you are taking, have taken recently or might have to take any other medication.

Pregnancy, breastfeeding, and fertility

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

Thereforedo notuse this medication during pregnancy.

The excretion of bisoprolol in breast milk is unknown.Therefore, do not breastfeed during the use of this medication.

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

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

Bisoprolol Mylan Pharmaceuticals contains sodium

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

Bisoprolol Viatris Pharmaceuticals contains Yellow Iron Oxide S

This medication may cause adverse reactions because it contains Yellow Iron Oxide S (E-110).

Follow exactly the administration instructions of this medication 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 beginning 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

Nobisoprolol use is recommended since there is not enough experience with the use of this medication in children and adolescents.

Older adults

Generally, no dose adjustment is necessary. It is recommended to start with the lowest possible dose.

If you notice that the bisoprolol dose is too strong or not working 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 immediatelyyour doctor or pharmacist 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

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 Viatris Pharmaceuticals

If you suddenly interrupt treatment with Bisoprolol Viatris Pharmaceuticalsyou may experience adverse effects. Your doctor will gradually reduce your dose over 2 weeks.

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

Like all medications, this medication 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 you experience the following symptoms:

Less common side effects(affect fewer than1 in 100 people):

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

Rare side effects(affect fewer than1 in 1,000 people):

• Liver inflammation (hepatitis), causing abdominal pain, loss of appetite, and sometimes 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 have difficulty breathing, contact your doctor as soon as possible.

The following side effects have also been reported:

Common side effects(affect fewer than1 in 10 people):

• Chilly hands and/or feet.
• Numbness of hands and/or feet.
• Low blood pressure.
• Discomfort, vomiting, diarrhea, constipation.
• Tiredness*.
• Headache*.

Less common side effects(affect fewer than1 in 100 people):

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

Rare side effects(affect fewer than1 in 1,000 people):

• Changes in blood test results.
• Decreased tear flow (may be a problem if you wear contact lenses).
• Auditory disturbances.
• Nasal congestion, nasal discharge.
• Inability to achieve and maintain an erection (erectile dysfunction).
• Nightmares.
• Hallucinations.
• Passing out.

Very rare(affect fewer than1 in 10,000 people):

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

*These symptoms are especially common at the beginning of treatment. They are usually mild and often disappear within 1 or 2 weeks.

Reporting 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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 thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of 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 Viatris Pharmaceuticals Composition

• 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), talc, quinoline yellow, indigo carmine (E-132), yellow orange S (E-110) (see section 2 “Bisoprolol Viatris Pharmaceuticals contains yellow orange”).

Appearance of the product and contents of the package

Yellowish clear film-coated tablets, oval, biconvex, with lateral notches, engraved with “BL” and “4” on both sides of the notch of one of the faces 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 containing 14, 28, 30, 50, 56, 60, 84, 98, 100, and 500 film-coated tablets. Only some package 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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

BulgariaBisoprolol Mylan 5 mg film-coated tablets

SpainBisoprolol Viatris Pharmaceuticals 5 mg film-coated tablets EFG

PortugalBisoprolol Mylan 5 mg film-coated tablets

United KingdomBisoprolol fumarate 5 mg film-coated tablets

Last review date of this leaflet:May 2022.

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