Bisoprolol Cor Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Bisoprolol COR Viatris 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 as 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine contains the active substance bisoprolol fumarate, which belongs to a family 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 properly throughout the body. This results in difficulty breathing and swelling.

Bisoprolol slows down the heartbeat and makes the heart more effective at pumping blood around the body.

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

Do not take Bisoprolol COR Viatris 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 circulation 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 that 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

Talk to 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 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 the limbs.
• You are taking verapamil or diltiazem, medicines used to treat heart conditions. 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 phaeochromocytoma (a rare tumour of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol to you.
• You have a thyroid problem. The tablets may mask the symptoms of hyperthyroidism.

During treatment

Talk to your doctor or pharmacist if:

• You are due 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 or less severe asthma; inform your doctor immediately if, while taking bisoprolol, you begin to experience difficulty breathing, coughing, wheezing after exercise, etc.
• There is a worsening of symptoms due to blockage of the main blood vessels to the legs, especially at the beginning of treatment.

Children and adolescents

No information is 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 using 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, e.g., imipramine, amitriptyline, moclobemide.
• Medicines used to treat mental illnesses, 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.
• Any 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 need to take any other medicines.

Fertility, pregnancy and breastfeeding

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

Therefore, do not use this medicine during pregnancy.

It is not known whether bisoprolol is excreted in breast milk. Breastfeeding during treatment with this medicine is not recommended.

There is no available information on the effects of bisoprolol on fertility.

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

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 beginning of treatment or after a change in your bisoprolol dose.

Bisoprolol COR Viatris contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

Bisoprolol COR Viatris contains sunset yellow

This medicine may cause adverse reactions because it contains sunset yellow FCF (E-110).

3. How to take Bisoprolol COR Viatris

Before starting Bisoprolol COR Viatris, you should already be taking other medications for heart failure, including an ACE inhibitor, a diuretic, and (as an additional option) a cardiac glycoside.

Always follow exactly the instructions given by your doctor for taking this medicine. If 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, usually as follows:

• 1.25 mg of bisoprolol once daily for one week.
• 2.5 mg of bisoprolol once daily for one week.
• 3.75 mg of bisoprolol once daily for one week.
• 5 mg of bisoprolol once daily for four weeks.
• 7.5 mg of bisoprolol once daily for four weeks.
• 10 mg of bisoprolol once daily as maintenance therapy (ongoing treatment).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.

Your doctor will advise you accordingly.

Patients with liver or kidney problems

Your doctor will take special care when adjusting the dose of bisoprolol.

Use in children and adolescents

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.
• Do not chew the tablets.
• 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 immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested. Bring the packaging and any remaining tablets with you.

If you forget to take Bisoprolol COR Viatris

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

If you stop taking Bisoprolol COR Viatris

If you stop treatment with Bisoprolol COR Viatris, you may 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:

Very common adverse effects (may affect more than 1 in 10 people):

• Slow heartbeat.

Common adverse effects (may affect up to 1 in 10 people):

• Worsening of heart failure, causing increased shortness of breath and/or fluid retention.

Uncommon adverse 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 adverse effects (may affect up to 1 in 1,000 people):

• Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite and, sometimes, jaundice 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 severe allergic reactions may occur swelling of the face, neck, tongue or throat, or breathing difficulties.

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

The following adverse effects have also been reported:

Common adverse effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (may affect up to 1 in 100 people):

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

Rare adverse 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.
• Decreased sexual appetite.
• Inability to achieve and maintain an erection (erectile dysfunction).
• Nightmares.
• Hallucinations (seeing or imagining things).
• Fainting.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Inflammation of the eye (conjunctivitis).
• Worsening of psoriasis or appearance of a similar dry, scaly rash.
• Hair loss.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 COR Viatris

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 refers to 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This 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 10 mg of bisoprolol fumarate.

The other components are:
Tablet: microcrystalline cellulose, butylhydroxyanisole, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulphate, sodium croscarmellose (see section 2, ‘Bisoprolol fumarate contains sodium’), iron oxide red (E-172).
Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), macrogol, iron oxide yellow (E-172), sunset yellow FCF (E-110) (see section 2 “Bisoprolol COR Viatris contains sunset yellow”).

Nature of the product and pack sizes

Film-coated tablets, light orange to bright orange in colour, oval-shaped, biconvex, with side notches, engraved with “BL” and “6” on either side of the break line on one side 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 also packaged in bottles containing 10, 28, 30, 50, 56, 84, 98, 100, 500 and 1,000 film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Spain: Bisoprolol COR Viatris 10 mg film-coated tablets EFG
Ireland: Bisoprolol Mylan 10 mg film-coated tablets
United Kingdom: Bisoprolol fumarate 10 mg film-coated tablets (Northern Ireland)
Sweden: Bisomyl 10 mg film-coated tablets

Date of the most recent revision of this leaflet: July 2021

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