Bisoprolol Cor Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bisoprolol Cor Sandoz 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 and must not be given to other people, even if they have the same symptoms as you. It could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bisoprolol Cor Sandoz is and what it is 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. How to store Bisoprolol Cor Sandoz

6. Contents of the pack and other information

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

Bisoprolol belongs to a group of medicines called beta-blockers. This group of medicines helps protect the heart when it is overactive.

Bisoprolol is used to treat:

• high blood pressure,
• angina pectoris (chest pain),
• heart failure causing breathlessness during exertion or fluid retention. In this case, bisoprolol may be used as additional treatment alongside other appropriate medicines 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 medicine (listed in section 6),
• if you have cardiogenic shock, a serious heart condition causing weak and rapid pulse; low blood pressure; cold, sweaty skin; weakness and fainting,
• if you have ever had asthma or severe breathing difficulties, as this medicine may affect your breathing,
• if you have a slow heart rate (less than 60 beats per minute). Ask your doctor if you are unsure,
• if you have very low blood pressure,
• if you have severe circulation problems (which may cause tingling in fingers and toes, or make them pale or blue),
• if you have certain serious heart rhythm disorders,
• if you have heart failure that has just occurred or is unstable and requires hospital treatment,
• if you suffer from metabolic acidosis, a condition caused by excessive buildup of acid in the blood. Your doctor can advise you,
• if you have untreated phaeochromocytoma, a tumor of the adrenal gland.

Consult your doctor if you are unsure whether you have any of the above conditions.

Warnings and precautions

Tell your doctor before taking Bisoprolol Cor Sandoz

• if you have difficulty breathing (asthma). It should be given together with bronchodilator therapy. You may require a higher dose of beta2-stimulants,
• if you have diabetes. This medicine may mask symptoms of low blood sugar (such as rapid pulse, palpitations, or sweating),
• if you are on a solid food diet,
• if you are receiving treatment for hypersensitivity reactions (allergic reactions). Bisoprolol may increase your sensitivity to substances you are allergic to and the severity of such reactions. Treatment with adrenaline may not produce the desired effect. You may require a higher dose of adrenaline (epinephrine),
• if you have first-degree heart block (cardiac conduction disorders),
• if you have Prinzmetal's angina, a type of chest pain caused by spasms in the coronary arteries supplying the heart muscle,
• if you have circulation problems in your limbs, for example in your hands or feet,
• if you are undergoing surgery with anesthesia: if you visit your doctor, hospital, or dentist for surgery under anesthesia, you must inform them of all medicines you are taking,
• when used concomitantly with calcium antagonists such as verapamil or diltiazem. Their combined use is not recommended; see also “Use of Bisoprolol Cor Sandoz with other medicines”,
• if you have or have had psoriasis (a chronic skin disease causing scaly lesions and dryness),
• in phaeochromocytoma (a tumor of the adrenal gland). Your doctor will treat this condition before prescribing bisoprolol,
• if you have a thyroid disorder. This medicine may mask symptoms of hyperthyroidism.

There is currently no therapeutic experience with 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 within the last 3 months.

Treatment of heart failure with bisoprolol requires regular medical monitoring. This is absolutely necessary especially at the beginning and at the end of treatment.

Do not stop treatment with bisoprolol abruptly unless there are compelling reasons.

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

Consult your doctor if you currently have or have previously had any of these conditions.

Other medicines and Bisoprolol Cor Sandoz

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

Some medicines cannot be used together, while others require specific adjustments (e.g., in dosage).

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

• medicines for blood pressure control or for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil),
• tranquilizers and treatments for psychosis (a mental illness), e.g., barbiturates (also used for epilepsy treatment), phenothiazines (also used for nausea and vomiting),
• medicines for depression, e.g., tricyclic antidepressants, MAO-A inhibitors,
• medicines used during anesthesia (see also section “Warnings and precautions”),
• painkillers (e.g., acetylsalicylic acid, diclofenac, floctafennine, indometacin, ibuprofen, naproxen),
• medicines for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or for pupil dilation,
• medicines used in the treatment of shock (e.g., adrenaline, dobutamine, noradrenaline),
• mefloquine, an antimalarial medicine,
• rifampicin, an antibiotic,
• ergotamine derivatives for the treatment of migraine.

All of these medicines, like bisoprolol, may affect blood pressure and/or heart function.

• Insulin or other medicines for diabetes. The blood glucose-lowering effect may be enhanced. Symptoms of low blood sugar may be masked.

Taking Bisoprolol Cor Sandoz with alcohol

Dizziness and headache caused by bisoprolol may worsen if you drink alcohol. If this occurs, avoid alcohol consumption.

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 medicine.

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

It is unknown whether bisoprolol passes into human milk, and therefore its use is not recommended during breastfeeding.

Driving and using machines

This medicine may cause tiredness, drowsiness, or dizziness. If you experience these side effects, do not drive or operate machinery. Be especially cautious at the start of treatment, when doses are changed, and when taking alcohol.

Bisoprolol Cor Sandoz contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Bisoprolol Cor Sandoz

Follow exactly the administration instructions for this medicine as given by your doctor.

If in doubt, please consult your doctor or pharmacist again. Your doctor will tell you how many tablets to take. Bisoprolol should be taken in the morning, before, during, or after breakfast. Swallow the tablets whole with a glass of water and do not chew or crush them.

Hypertension/Angina pectoris

Adults

The dose should be individually adjusted.

The recommended starting dose is 5 mg once daily.

The usual adult dose is 10 mg daily. Your doctor may increase or decrease the dose.

The maximum recommended daily dose is 20 mg.

Hepatic or renal impairment

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

Elderly

Dose adjustment is usually not required. Your doctor will start treatment with the lowest possible dose.

Heart failure (reduced pumping function of the heart)

When starting treatment with bisoprolol, you will already be taking an ACE inhibitor, a diuretic, or a cardiac glycoside (medicines for heart or blood pressure conditions).

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

1.25 mg once daily for one week. If well tolerated, the dose may be increased to:

2.5 mg once daily for another week. If well tolerated, the dose may be increased to:

3.75 mg once daily for another week. If well tolerated, the dose may be increased to:

5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to:

7.5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to:

10 mg once daily as the maintenance dose.

The maximum daily dose is 10 mg of bisoprolol.

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

After the first 1.25 mg dose, your doctor will monitor your blood pressure, heart rate, and any disturbances in heart function.

Hepatic or renal impairment

Dose increases should be made with greater caution.

Elderly

Dose adjustment is usually not necessary.

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

Place the tablet on a solid, flat surface with the score line facing upwards.

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

Duration of treatment

Generally, treatment with bisoprolol is long-term.

Use in children and adolescents

The use of bisoprolol is not recommended in children, as studies on its effects have not been conducted in this patient group.

If you take more Bisoprolol Cor Sandoz than you should

If you have accidentally taken more than the dose prescribed by your doctor, contact your doctor or pharmacist immediately. Take the remaining tablets or this leaflet with you so that the medical team knows exactly what you have ingested.

Symptoms of overdose may include dizziness, lightheadedness, fatigue and/or difficulty breathing. In addition, a reduced heart rate, low blood pressure, heart failure, and decreased blood glucose levels (which may cause feelings of hunger, sweating, and palpitations) may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Cor Sandoz

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

If you stop taking Bisoprolol Cor Sandoz

Treatment with bisoprolol must not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. Instead, the dose should be gradually reduced over several weeks, as directed by your doctor.

If you have any further questions about the use of this product, 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 possible adverse effects are:

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

The most serious side effects are related to heart function:

• Slowing of the 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 must seek immediate medical attention if you experience severe allergic reactions, which may involve the face, neck, tongue, mouth, or trachea, or if you have difficulty breathing.

Other side effects are listed below according to how frequently they may occur:

Frequent, may affect up to 1 in 10 patients:

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

Uncommon, may affect up to 1 in 100 patients:

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

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

• Nightmares.
• Hallucinations (seeing or imagining things).
• Fainting.
• Hearing problems.
• Inflammation of the nasal mucosa, causing nasal discharge with irritation.
• Skin allergic reactions (itching, redness, skin rash).
• Dry eyes due to reduced tear flow (this may be problematic if you wear contact lenses).
• Liver inflammation (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.
• Reduced sexual performance (impotence disorders).
• Increased levels of lipids in the blood (triglycerides) and of liver enzymes.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Sandoz

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

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

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

Blister: 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. Dispose of unused medicines and their containers at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Cor Sandoz

• The active substance is bisoprolol fumarate. Each tablet contains 10 mg of bisoprolol as bisoprolol fumarate.
• The other components (excipients) are:

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

Appearance of the medicinal product and contents of the pack

Bisoprolol Cor Sandoz 10 mg are round, orange, film-coated tablets marked with "BIS 10" on one side. The tablet can be divided into four equal doses.

The tablets are packed in blisters (OPA-Al-PVC/Al) or in HDPE bottles with PE caps.

Pack sizes:

Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x30 and 500 film-coated tablets.

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

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

Lek Pharmaceuticals

Trimlini 2d

9220 Lendava

Slovenia

This medicinal product 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 10 mg – Filmtabletten

Belgium: Bisosandoz 10 mg filmomhulde tabletten

Denmark: Bisoprolol Sandoz

Finland: Bisoprolol Sandoz

France: BISOPROLOL Sandoz 10 mg, comprimé pelliculé sécable

United Kingdom (Northern Ireland): Bisoprolol Fumarate 10 mg film-coated Tablets

Hungary: Bisoprolol Sandoz 10 mg filmtabletta

Italy: Bisoprololo Sandoz 10 mg compresse rivestite con film

Netherlands: Bisoprololfumaraat Sandoz Tablet 10 mg, filmomhulde tabletten

Norway: Bisoprolol Sandoz

Poland: Bibloc

Portugal: Bisoprolol Marpidum 5 mg Comprimidos Revestidos

Sweden: Bisoprolol Sandoz

Slovenia: Byol 10 mg filmsko obložene tablete

Date of the most recent revision of this leaflet: March 2022

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