Bisoprolol cor Sandoz 1.25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bisoprolol Cor Sandoz 1.25 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 you should not give it 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 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:

Heart failure causing breathlessness on exertion or fluid retention. In this case, bisoprolol may be used as additional treatment alongside other medicines for heart failure.

2. What you need to know before starting to take 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, which is a serious heart condition causing weak and rapid pulse; low blood pressure; cold and sweaty skin; weakness and fainting,
• if you have ever had asthma or severe breathing 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 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 accumulation of acid in the blood. Your doctor can advise you,
• if you have untreated pheochromocytoma, 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 administered together with bronchodilator treatment. 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 hypersensitivity 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),
• with 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 the extremities of your body, for example in the 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 the medicines you are taking,
• if you have or have had psoriasis (a chronic skin disease causing scaly lesions and dryness),
• in pheochromocytoma (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 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 within the last 3 months.

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

Bisoprolol treatment must not be stopped abruptly unless there are compelling reasons.

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

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

• medicines for controlling blood pressure or 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 treatments for psychosis (a mental illness), e.g., barbiturates (also used for treating epilepsy), 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 (enlargement),
• medicines used in the treatment of shock (e.g., adrenaline, dobutamine, noradrenaline),
• mefloquine, a medicine for malaria,
• 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 consume 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 make you feel tired, drowsy, or dizzy. 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 diagnosed you with 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; this is essentially “sodium-free”.

3. How to take Bisoprolol Cor Sandoz

Follow exactly the instructions for use of 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. You should take this medicine in the morning, before, during, or after breakfast. Swallow the tablets with a glass of water and do not chew or crush them.

The recommended dose is:

Heart failure (reduced heart pumping function)

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

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 maintenance dose.

The maximum daily dose is 10 mg of bisoprolol.

Your doctor will determine the optimal dose for you, based among other factors on any 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 carried out 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.

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; therefore, its use is not recommended in children.

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 taken. Symptoms of overdose may include dizziness, lightheadedness, fatigue and/or difficulty breathing.

In addition, a reduced heart rate, low blood pressure, heart failure, and low blood sugar levels (which may cause 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 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, and then continue with your normal dose 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.

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:

• decrease in 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 occur in 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, exhaustion.
• Dizziness.
• Headache.
• Cold sensation or numbness in the extremities (fingers or toes, ears, or nose); more frequently, cramps or pain when walking.
• Very low blood pressure (hypotension), particularly in patients with heart failure.
• Feeling of dizziness (nausea), vomiting.
• Diarrhea.
• Constipation.

Uncommon, may affect up to 1 in 100 patients:

• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting.
• 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 (imagining things).
• Fainting.
• Hearing problems.
• Inflammation of the nasal mucosa, causing nasal discharge with irritation.
• Allergic skin reactions (itching, redness, skin rash).
• Dry eyes due to reduced tear flow (this may be problematic if wearing 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).
• Increase in blood lipid levels (triglycerides) and liver enzymes.

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

• Worsening of psoriasis or development 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 side effects 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 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 6 months after opening the bottle.

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

Bottle: Store below 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps 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 1.25 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).

Nature of the product and pack sizes

Bisoprolol Cor Sandoz 1.25 mg are white, round, film-coated tablets, marked with “BIS 1.25” on one side.

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

Pack sizes:

Blister packs: 7, 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x20 and 10x30 film-coated tablets.

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

Only certain pack 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

LEK PHARMACEUTICAL COMPANY D.D.
Verovskova, 57
Ljubljana – 1526
Slovenia

SALUTAS PHARMA GMBH
Otto Von Guericke Alle, 1
Barleben D-39179
Germany

ROWA PHARMACEUTICALS LIMITED
Newtown (Bantry, Co Cork)
Ireland

LEK, S.A.
Ul Domaniewska 50 C
Warsaw - PL02-672
Poland

LEK S.A.
Ul Podlipie, 16
Strykow
Poland

Lek Pharmaceuticals
Trimlini 2d
9220 Lendava
Slovenia

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Bisoprolol Sandoz 1,25 mg – Filmtabletten
Germany: Bisoprolol Sandoz 1,25 mg Filmtabletten
France: BISOPROLOL Sandoz 1,25 mg, comprimé pelliculé sécable
United Kingdom (Northern Ireland): Bisoprolol Fumarate 1,25 mg film-coated Tablets
Italy: Bisoprolol Sandoz 1,25 mg compresse rivestite con film
Netherlands: Bisoprolol fumaraat Sandoz Tablet 1,25 mg, filmomhulde tabletten
Norway: Bisoprolol Sandoz
Poland: Bibloc
Sweden: Bisoprolol Sandoz
Slovenia: Byol 1,25 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