Package Insert: Information for the Patient

Bisoprolol Cor Sandoz 10 mg Film-Coated Tablets

Bisoprolol Fumarate

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. Contents of the package and additional information

Bisoprolol belongs to a group of medicines called beta-blockers. This group of medicines protects the heart when it has too much activity.

Bisoprolol is used to treat:

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

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, a severe heart disease that produces a weak and rapid pulse; low blood pressure; cold and sweaty skin; weakness and dizziness,
• if you have ever suffered from 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 can cause numbness in your hands and feet or make them pale or blue),
• if you have certain severe heart rhythm problems,
• if you have heart failure, which has just occurred or is not stabilized and requires hospital treatment,
• if you have metabolic acidosis, a condition that occurs when there is an excessive accumulation of acid in the blood. Your doctor will be able to advise you,
• if you have untreated phaeochromocytoma, a tumor of the adrenal gland.

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

Warnings and precautions

Inform your doctor before taking Bisoprolol Cor Sandoz

• if you have breathing difficulties (asthma). It should be taken at the same time as bronchodilator treatment. You may need a higher dose of beta 2 stimulant,
• if you have diabetes. This medication may mask the symptoms of low blood sugar (such as rapid pulse, palpitations, or sweating),
• if you are on a low-calorie 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 the reaction. Treatment with adrenaline may not be effective. You may need 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 of the coronary arteries that supply the heart muscle,
• if you have severe circulation problems in your limbs, for example in your hands or feet,
• if you are undergoing surgery with anesthesia: if you are going to see a doctor, hospital, or dentist for surgery with anesthesia, inform them of the medications you are taking,
• in combination with calcium channel blockers, such as verapamil or diltiazem. Its 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 phaeochromocytoma (adrenal gland tumor). Your doctor will treat this condition before prescribing bisoprolol,
• if you have a thyroid problem. This medication may mask the 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:

• type 1 diabetes treated with insulin,
• severe kidney disease,
• severe liver disease,
• certain heart diseases,
• recent myocardial infarction.

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

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

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

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

Other medications and Bisoprolol Cor Sandoz

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

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

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

• blood pressure medications 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 psychosis treatment (a mental illness), e.g., barbiturates (also used for epilepsy treatment), phenothiazines (also used for vomiting and nausea),
• depression medications, e.g., tricyclic antidepressants, MAO-A inhibitors,
• anesthesia medications (see also "Warnings and precautions"),
• pain medications (e.g., aspirin, diclofenac, flurbiprofen, indomethacin, ibuprofen, naproxen),
• asthma medications, nasal congestion medications, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation,
• shock medications (e.g., adrenaline, dobutamine, noradrenaline),
• mefloquine, an antimalarial medication,
• rifampicin, an antibiotic,
• ergotamine derivatives for migraine treatment.

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

• Insulin or other diabetes medications. The blood sugar-lowering effect may increase. 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, avoid consuming alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The passage of bisoprolol into breast milk is unknown, and its use is not recommended during breastfeeding.

Driving and operating machinery

This medication may cause drowsiness, dizziness, or lightheadedness. If you experience these side effects, do not drive or operate machinery. Be especially cautious at the beginning 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 are intolerant to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor.

If you have any doubts, 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 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 liver or kidney failure

If you have severe liver or kidney failure, the maximum dose is 10 mg per day.

Advanced age

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

Heart failure (reduced heart pumping force)

When starting treatment with bisoprolol, you are already using an ACE inhibitor, a diuretic, or a cardiac glycoside (heart or blood pressure medication).

The dose will be gradually increased to reach the most suitable dose for you:

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

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

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

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

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

10 mg once a day as maintenance dose.

The maximum daily dose is 10 mg of bisoprolol.

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

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

Severe liver or kidney failure

Dose increases should be made with greater caution.

Advanced age

Normally, no dose adjustment is required.

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

Place the tablet on a solid and flat surface with the groove 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, it will break into four parts.

Treatment duration

Generally, bisoprolol treatment is long-term.

Use in children and adolescents

Bisoprolol is not recommended for use in children, as there have been no studies 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 leaflet with you so that the medical team knows exactly what you have ingested.

The symptoms of an overdose may include dizziness, vertigo,fatigue, and/or difficulty breathing. Additionally, it may cause a reduction in heart rate, low blood pressure, heart failure, and low blood glucose levels (which may cause hunger, sweating, and palpitations).

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 compensate for the missed doses.Take your dose as soon as you remember and then continue with the normal daily dose the next day.

If you interrupt treatment with Bisoprolol Cor Sandoz

Bisoprolol treatment should not be stopped abruptly. If you stop suddenly, your condition may worsen. Instead, the dose should be gradually reduced over several weeks as indicated by your doctor.

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

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

The side effects that may occur are:

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

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 must see a doctor immediately if you experience severe allergic reactions, which may occur on the face, neck, tongue, mouth, or trachea, or difficulty breathing.

Other side effects are listed below according to the frequency with which they may occur:

Frequent, may affect up to 1 in 10 patients:

• Fatigue. This side effect is rare during hypertension or angina treatment.
• Dizziness, fatigue, and headache (especially at the beginning of treatment in patients with hypertension or angina. These symptoms are usually mild and usually disappear after 1 or 2 weeks).
• Sensation of coldness 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.
• Sensation of dizziness (nausea), vomiting.
• Diarrhea.
• Constipation.

Rare, may affect up to 1 in 100 patients:

• Fatigue. This side effect is frequent during heart failure treatment.
• Sensation of dizziness, especially when standing up suddenly (orthostatic hypotension).
• Sleep disturbances.
• Depression.
• Irregular heart rhythms.
• 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.
• Problems with hearing.
• Inflammation of the nasal mucosa, causing nasal mucus with irritation.
• Allergic reactions on the skin (itching, redness, skin rash).
• Dry eyes due to reduced tear flow (this may be problematic if contact lenses are used).
• Inflammation of the liver (hepatitis), which causes abdominal pain, loss of appetite, and sometimes jaundice with yellow discoloration of the white of the eyes and skin, and darkening of the urine.
• Reduced sexual performance (alterations in potency).
• 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 psoriasis-like rash with dry skin, scaling, and hair loss.
• Itching or redness of the eyes (conjunctivitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Blister: This medication does not require special storage conditions.

Bottle: This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Bisoprolol Cor Sandoz Composition

• The active ingredient is bisoprolol fumarate. Each tablet contains 10 mg of bisoprolol in the form of bisoprolol fumarate.
• The other components (excipients) are:

calcium hydrogen phosphate anhydrous, microcrystalline cellulose, pregelatinized cornstarch, 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 product and contents of the package

Bisoprolol Cor Sandoz 10 mg are round, orange-coated tablets with the imprint “BIS 10” on one of their faces. The tablet can be divided into four equal doses.

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

Package 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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) with 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 oblozene tablete

Last review date of this leaflet: March 2022

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