Bisoprolol Viatris Pharmaceuticals 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bisoprolol Viatris Pharmaceuticals 10 mg film-coated tablets EFG

bisoprolol fumarate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.

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

Contents of the leaflet

1. What Bisoprolol Viatris Pharmaceuticals is and what it is 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. Storage of Bisoprolol Viatris Pharmaceuticals.

6. Contents of the pack and other 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 family 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) caused by blockages in the arteries supplying 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 to 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 unsure.
• You have very low blood pressure.
• You have severe circulatory problems in the limbs (which may cause tingling in the fingers and toes or make them pale or blue).
• You have heart failure that suddenly worsens and/or may require hospital treatment.
• You have excess acid in the blood, a condition known as metabolic acidosis.
• You have untreated phaeochromocytoma, a rare tumour 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 the limbs.
• You are taking verapamil or diltiazem, medicines used to treat heart conditions. 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 phaeochromocytoma (a rare tumour of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol.
• You have a thyroid disorder. The tablets may mask symptoms of hyperthyroidism.

During treatment

Inform your doctor or pharmacist if:

• You are going to receive general anaesthesia during surgery – tell your doctor that you are taking bisoprolol.
• You are receiving treatment for hypersensitivity reactions (allergy). Bisoprolol may worsen your allergy or make it harder to treat.
• You have chronic lung disease, asthma, or less severe asthma, and experience breathing difficulties, cough, wheezing after exercise, etc., while taking bisoprolol – inform your doctor immediately.
• You notice worsening symptoms of blockage in the main blood vessels of the legs, especially at the beginning of treatment.

Children and adolescents

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

Bisoprolol Viatris Pharmaceuticals and other medicines

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

• Medicines to control blood pressure or 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 used to treat mental illness, e.g., phenothiazines such as levomepromazine.
• Medicines used for anaesthesia during surgery (see also “Warnings and precautions”).
• Medicines used to treat epilepsy, e.g., barbiturates such as phenobarbital.
• Some painkillers (e.g., acetylsalicylic acid, diclofenac, indometacin, 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.
• Some medicines used to treat 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 about any other medicines you are taking, have recently taken, or might need to take.

Pregnancy, breast-feeding and fertility

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

Therefore, do not use this medicine during pregnancy.

It is unknown whether bisoprolol is excreted in breast milk. Therefore, breast-feeding is not recommended during treatment with this medicine.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Bisoprolol may occasionally cause dizziness or fatigue (see "Possible side effects"). If you experience any of these side effects, do not drive or operate machinery. These side effects are most likely to occur at the start of treatment or when the dose of bisoprolol is changed.

Bisoprolol Mylan Pharmaceuticals contains sodium

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

Bisoprolol Viatris Pharmaceuticals contains sunset yellow

This medicine may cause allergic reactions as it contains sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Bisoprolol Viatris Pharmaceuticals

Follow exactly the instructions for use of this medicine as given 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 monitor you closely at the beginning of treatment. Your doctor will increase your dose to achieve the best possible dosage for you.

The maximum recommended dose is 20 mg once daily.

Patients with renal impairment

Patients with severe renal disease must not exceed 10 mg of bisoprolol once daily. Consult your doctor before starting to use this medicine.

Patients with hepatic impairment

Patients with severe hepatic disease must not exceed 10 mg of bisoprolol once daily. Consult your doctor before starting to use this medicine.

Use in children and adolescents

Bisoprolol is not recommended as there is insufficient experience with the use of this medicine in children and adolescents.

Elderly patients

In general, 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 not effective 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 must not be chewed.
• The tablets may 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 Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Take the container and any remaining tablets with you.

If you forget to take Bisoprolol Viatris Pharmaceuticals

Do not take a double dose to make up for forgotten doses. Take the next dose at the scheduled time. If you miss several doses, consult your doctor.

If you stop taking Bisoprolol Viatris Pharmaceuticals

If you stop treatment with Bisoprolol Viatris Pharmaceuticals suddenly, you are likely to experience adverse effects. Your doctor will gradually reduce your dose over a period of 2 weeks.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects are important and will require immediate action if you experience them. You must stop taking bisoprolol and consult your doctor immediately if any of the following symptoms occur:

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

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

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

• Inflammation of the liver (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. Severe allergic reactions may include swelling of the face, neck, tongue, or throat, or breathing difficulties.

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

The following adverse effects have also been reported:

Common adverse effects (affect less than 1 in 10 people):

• Coldness of hands and/or feet.
• Numbness of hands and/or feet.
• Low blood pressure.
• Nausea, vomiting, diarrhoea, constipation.
• Fatigue*.
• Headache*.

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

• Sleep disorders.
• Dizziness upon standing.
• Muscle weakness, muscle cramps.

Rare adverse 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):

• Inflammation of the eye (conjunctivitis).

• Worsening of psoriasis or appearance of a dry, scaly rash.

• Hair loss.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Blister pack: Store below 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Viatris Pharmaceuticals

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

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

Nature of the product and contents of the pack

Light orange to bright orange film-coated tablets, oval-shaped, biconvex, with side notches, marked with "BL" and "6" on either side of the score line on one side 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 also packaged in bottles containing 14, 28, 30, 50, 56, 60, 84, 98, 100 and 500 film-coated tablets. Only certain pack sizes may be commercially available.

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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the 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 of Medicines and Medical Devices (AEMPS): http://aemps.gob.es/