BISOPROLOL COR SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol Cor Sandoz 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.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only; do 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bisoprolol Cor Sandoz and what is it used for
2. What you need to know before taking Bisoprolol Cor Sandoz
3. How to take Bisoprolol Cor Sandoz
4. Possible side effects
5. Storage of Bisoprolol Cor Sandoz

1. Package Contents and Additional Information

1. What is Bisoprolol Cor Sandoz and what is it used for

Bisoprolol belongs to a group of medications called beta-blockers. This group of medications protects the heart when it is overactive.

Bisoprolol is used to treat:

• high blood pressure,
• chest pain (angina),
• heart failure that causes breathing difficulties when exerting oneself or fluid retention. In this case, bisoprolol can be used as additional treatment with other medications suitable for heart failure.

2. What you need to know before taking Bisoprolol Cor Sandoz

Do not take Bisoprolol Cor Sandoz

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medication (listed in section 6),
• if you have cardiogenic shock, which is a severe heart disease that produces a weak and rapid pulse; low blood pressure; cold and sweaty skin; weakness and fainting,
• if you have ever suffered from asthma or severe respiratory difficulties, as it may affect your breathing,
• if you have a slow heart rate (less than 60 beats per minute). Ask your doctor if you have any doubts,
• if you have very low blood pressure,
• if you have severe circulation problems (which can cause tingling in the fingers of the hands and feet or turn them pale or blue),
• if you have certain severe heart rhythm problems,
• if you have heart failure that has just occurred or if it is not stabilized and requires hospital treatment,
• if you have metabolic acidosis, which is a condition that occurs when there is an excessive accumulation of acid in the blood. Your doctor can advise you,
• if you suffer from untreated pheochromocytoma, which is a tumor of the adrenal gland.

Consult your doctor if you are unsure about having any of the above problems.

Warnings and Precautions

Tell your doctor before taking Bisoprolol Cor Sandoz

• if you have difficulty breathing (asthma). It should be administered at the same time as bronchodilator treatment. You may need a higher dose of the beta2 stimulant,
• if you have diabetes. This medication can mask the symptoms of low blood sugar (such as rapid heartbeat, palpitations, or sweating),
• if you are on a solid food diet,
• if you are receiving treatment for hypersensitivity reactions (allergic reactions). Bisoprolol can increase hypersensitivity to substances you are allergic to and the severity of such a reaction. Treatment with adrenaline may not have the desired effect. You may need a higher dose of adrenaline (epinephrine),
• with first-degree heart block (heart conduction disorders),
• if you have Prinzmetal's angina, which is a type of chest pain caused by spasms of the coronary arteries that supply the heart muscle,
• if you have any circulation problems in the extremities of your body, for example in the hands or feet,
• if you are going to undergo surgery with anesthesia: if you are going to see a doctor, go to the hospital or dentist for surgery with anesthesia, you must inform them that you are taking this medication,
• in combination with calcium antagonists, such as verapamil or diltiazem. Concomitant use is not recommended, see also "Use of Bisoprolol Cor Sandoz with other medications",
• if you have or have had psoriasis (a chronic skin disease that produces scaly lesions and dryness),
• in pheochromocytoma (adrenal gland tumor). Your doctor will treat this disease before prescribing bisoprolol,
• if you have a thyroid problem. This medication can mask the symptoms of hyperthyroidism.

So far, there is no therapeutic experience with the use of bisoprolol in the treatment of heart failure in patients with the following diseases and conditions:

• insulin-treated diabetes mellitus (type I),
• severe kidney disease,
• severe liver disease,
• certain heart diseases,
• heart attack in the last 3 months.

Treatment of heart failure with bisoprolol requires regular medical monitoring. This is absolutely necessary, especially at the start of treatment and after finishing treatment.

Do not stop taking bisoprolol abruptly unless there are compelling reasons.

Do not stop taking bisoprolol abruptly in patients with hypertension and angina pectoris accompanied by heart failure. The dose should be gradually reduced by half weekly.

Consult your doctor if you have or have had any of these situations.

Other Medications and Bisoprolol Cor Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Certain medications cannot be used at the same time, while others require specific changes (e.g., in dosage).

Tell your doctor if you are using or are being administered any of the following medications in addition to bisoprolol:

• medications for blood pressure control or medications used for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil),
• tranquilizers and treatment for psychosis (a mental illness), e.g., barbiturates (also used to treat epilepsy), phenothiazines (also used against vomiting and nausea),
• medications for depression, e.g., tricyclic antidepressants, MAO-A inhibitors,
• medications used during anesthesia (see also "Warnings and Precautions" section),
• medications for pain (e.g., acetylsalicylic acid, diclofenac, floctafenine, indomethacin, ibuprofen, naproxen),
• medications for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or for pupil dilation,
• medications used in the treatment of shock (e.g., adrenaline, dobutamine, noradrenaline),
• mefloquine, a medication against malaria,
• rifampicin, an antibiotic,
• ergotamine derivatives for the treatment of migraines.

All these medications, like bisoprolol, can modify blood pressure and/or heart function.

• Insulin or other diabetes medications. The glucose-lowering effect may increase. The symptoms of low blood sugar levels may be masked.

Taking Bisoprolol Cor Sandoz with Alcohol

The dizziness and headache that bisoprolol may cause can worsen if you consume alcohol. If this happens to you, avoid consuming alcohol.

Pregnancy and Breastfeeding

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.

Bisoprolol may have harmful effects on pregnancy and/or the fetus. There is a higher risk of premature birth, abortion, low blood sugar, and reduced heart rate in the newborn. It can also affect the growth of the baby. Therefore, bisoprolol should not be used during pregnancy.

It is not known if bisoprolol passes into breast milk, and its use is not recommended during breastfeeding.

Driving and Using Machines

This medication can make you feel tired, drowsy, or dizzy. If you have these side effects, do not drive or use machines. Be especially careful at the start of treatment, with dose changes, and in combination with alcohol.

Bisoprolol Cor Sandoz Contains Lactose and Sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1mmol of sodium (23 mg) per film-coated tablet; this is, essentially "sodium-free".

3. How to Take Bisoprolol Cor Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how many tablets to take. You should take this medication in the morning, before, during, or after breakfast. Swallow the tablets with the help of a glass of water and do not chew or crush them.

Hypertension/Angina Pectoris

Adults

The dose should be adjusted individually.

The recommended starting dose is 5 mg per day.

The usual dose for adults is 10 mg per day. Your doctor may increase or decrease the dose.

The maximum recommended daily dose is 20 mg per day.

Severe Renal or Hepatic Impairment

If you have severe renal or hepatic impairment, the maximum dose is 10 mg per day.

Elderly

Normally, no dose adjustment is necessary. Your doctor will start treatment with the lowest possible dose.

Heart Failure (Reduced Heart Pumping Strength)

When you start treatment with bisoprolol, you will already be using an ACE inhibitor, a diuretic, or a cardiac glycoside (heart medications or blood pressure medications).

The dose will be gradually increased until the most suitable dose for you is reached:

1.25 mg once a day for one week. If it is well tolerated, the dose can be increased to:

2.5 mg once a day for another week. If it is well tolerated, the dose can be increased to:

3.75 mg once a day for another week. If it is well tolerated, the dose can be increased to:

5 mg once a day for the next 4 weeks. If it is well tolerated, the dose can be increased to:

7.5 mg once a day for the next 4 weeks. If it is well tolerated, the dose can be increased to:

10 mg once a day as a maintenance dose.

The maximum daily dose is 10 mg of bisoprolol.

Your doctor will determine the optimal dose for you based on possible side effects, among other factors.

After the first dose of 1.25 mg, your doctor will monitor your blood pressure, heart rate, and heart function disorders.

Severe Renal or Hepatic Impairment

Dose increases should be made with greater caution.

Elderly

Normally, no dose adjustment is necessary.

If you think the effect of bisoprolol is too strong or too weak, inform your doctor or pharmacist.

Place the tablet on a solid and flat surface with the score line facing up.

Press with your thumb in the center of the tablet and it will break into two halves. If you press with your thumb in the center of each half, they will break and you will have four parts.

Duration of Treatment

Generally, treatment with bisoprolol is long-term.

Use in Children and Adolescents

There is no experience with bisoprolol in children and adolescents, so its use is not recommended in children, as no studies have been conducted on its effects in this group of patients.

If You Take More Bisoprolol Cor Sandoz Than You Should

If you have accidentally taken more doses than your doctor prescribed, consult your doctor or pharmacist immediately. Bring the remaining tablets or this package leaflet with you so that the medical team knows exactly what you have ingested.

The symptoms of an overdose may include dizziness, drowsiness, fatigue, and/or difficulty breathing.

Additionally, a reduction in heart rate, decrease in blood pressure, heart failure, and low blood sugar levels (which can cause hunger, sweating, and palpitations) may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Bisoprolol Cor Sandoz

Do not take a double dose to make up for forgotten doses.Take your dose as soon as you remember and then continue with your normal dose the next day.

If You Stop Taking Bisoprolol Cor Sandoz

Treatment with bisoprolol should not be stopped abruptly. If you suddenly stop taking this medication, your condition may worsen. Instead, the dose should be gradually reduced over a few weeks as your doctor indicates.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

To avoid serious reactions, talk to a doctor immediately if a serious side effect occurs suddenly or worsens rapidly.

The most serious side effects are related to heart function:

• decreased heart rate (may affect more than 1 in 10 people)
• worsening of pre-existing heart failure (may affect up to 1 in 10 people)
• slow or irregular heartbeats (may affect up to 1 in 100 people)

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

You should go to the doctor immediately if you experience severe allergic reactions, which can occur in the face, neck, tongue, mouth, or trachea, or difficulty breathing.

Other side effects are listed below according to their frequency:

Frequent, may affect up to 1 in 10 patients:

• Fatigue. This side effect is rare during treatment for hypertension or angina pectoris.
• Dizziness, tiredness, and headache (especially at the start of treatment in patients with hypertension or angina pectoris. These symptoms are usually mild and disappear after 1 or 2 weeks).
• Feeling of cold or numbness in the extremities (fingers of the hands or feet, ears, nose); more frequently, cramps or pain when walking.
• Very low blood pressure (hypotension), especially in patients with heart failure.
• Feeling of dizziness (nausea), vomiting.
• Diarrhea.
• Constipation.

Uncommon, may affect up to 1 in 100 patients:

• Fatigue. This side effect is common during treatment for heart failure.
• Feeling of dizziness, especially when standing up suddenly (orthostatic hypotension).
• Sleep disorders.
• Depression.
• Heart rhythm irregularities.
• Patients with asthma or a history of respiratory problems may have difficulty breathing.
• Muscle weakness and cramps.

Rare, may affect up to 1 in 1,000 patients:

• Nightmares.
• Hallucinations (imagining things).
• Fainting.
• Hearing problems.
• Inflammation of the nasal mucosa, causing nasal discharge with irritation.
• Allergic reactions on the skin (itching, redness, rash).
• Dry eyes due to reduced tear flow (this can be problematic if contact lenses are used).
• Liver inflammation (hepatitis), which causes abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the whites of the eyes and skin, and darkening of the urine.
• Reduced sexual performance (impotence).
• Increased levels of lipids in the blood (triglycerides) and liver enzymes.

Very rare, may affect up to 1 in 10,000 patients:

• Worsening of psoriasis or appearance of a rash similar to psoriasis with dry skin, scaling, and hair loss.
• Itching or redness of the eyes (conjunctivitis).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bisoprolol Cor Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

Do not use this medicine 6 months after opening the bottle.

Blister pack: This medicine does not require special storage conditions.

Bottle: This medicine does not require special storage conditions.

Storage conditions after opening the bottle: Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bisoprolol Cor Sandoz

• The active ingredient is bisoprolol fumarate. Each tablet contains 5 mg of bisoprolol in the form of bisoprolol fumarate.
• The other components (excipients) are:

anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).

Appearance of the product and package contents

Bisoprolol Cor Sandoz 5 mg are film-coated tablets, round, yellow in color, and marked with "BIS 5" on one side. The tablet can be divided into four equal doses.

The tablets are packaged in blister packs (OPA-Al-PVC/Al) or HDPE bottles with a PE cap.

Package sizes:

Blister pack: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 10x30 film-coated tablets.

Bottles: 10, 20, 30, 50, 60, 100, 250, 500 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

ROWA Pharmaceuticals Limited

Newtown, Bantry, Co. Cork

Ireland

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

Lek S.A

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

Lek S.A.

Ul. Podlipie 16 C,

95 010 Strykow

Poland

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Bisoprolol Sandoz 5 mg – Filmtabletten

Belgium: Bisosandoz 5 mg filmomhulde tabletten

Denmark: Bisoprolol Sandoz

Finland: Bisoprolol Sandoz

France: BISOPROLOL Sandoz 5 mg, comprimé pelliculé sécable

United Kingdom: Bisoprolol Fumarate 5 mg film-coated Tablets

Hungary: Bisoprolol Sandoz 5 mg filmtabletta

Italy: Bisoprololo Sandoz 5 mg compresse rivestite con film

Netherlands: Bisoprololfumaraat Sandoz Tablet 5 mg, filmomhulde tabletten

Norway: Bisoprolol Sandoz

Poland: Bibloc

Portugal: Bisoprolol Marpidum 5 mg Comprimidos Revestidos

Sweden: Bisoprolol Sandoz

Slovenia: Byol 5 mg filmsko oblozene tablete

Date of the last revision of this prospectus: March 2022

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