Package Insert: Information for the Patient

Bisoprolol Cor Alter 2.5 mg Tablets EFG

Bisoprolol fumarate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to 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 who 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.

Contents of the package and additional information

Bisoprolol Cor Alter contains bisoprolol fumarate as the active ingredient.Bisoprolol belongs to a group of medications called beta-blockers. Beta-blockers protect the heart from excessive activity. These medications act by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and blood supply.

Heart failure appears when the cardiac muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol is used for:

• Treating high blood pressure (hypertension)
• Treating chronic and stable angina pectoris (chest pain caused by blockages in the arteries that irrigate the cardiac muscle).

Treating chronic stable heart failure, in combination with other medications (such as ACE inhibitors, diuretics, and cardiac glycosides).

Do not take Bisoprolol Cor Alter

• if you are allergic to bisoprolol or any of the other components of this medication (listed in section 6).
• if you have severe asthma or chronic severe lung disease.
• if you have a slow or irregular heartbeat. Consult your doctor if you are unsure.
• if you have very low blood pressure.
• if you have cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.
• if you have severe circulatory problems (such as Raynaud's syndrome) that can cause tingling in your hands and feet or make them pale or blue.
• if you have heart failure that worsens suddenly and/or may require hospitalization.
• if you have metabolic acidosis, a condition characterized by excess acid in the blood.
• if you have untreated phaeochromocytoma, a rare tumor of the adrenal gland.

Consult your doctor if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol Cor Alter:

• if you have asthma or chronic lung disease.
• if you have diabetes. Bisoprolol may mask the symptoms of low blood sugar.
• if you are fasting from solid food.
• if you are undergoing hypersensitivity reactions (allergy) treatment. Bisoprolol may worsen your allergy or make it harder to treat.
• if you have certain heart conditions such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina).
• if you have any liver or kidney problems.
• if you have any circulation problems in your extremities.
• if you are to receive general anesthesia during surgery, inform your doctor that you are taking bisoprolol.
• if you are taking verapamil or diltiazem, medications for heart disease. Concomitant use is not recommended, see also "Taking Bisoprolol Cor Alter with other medications".
• if you have (or have had) psoriasis (a recurring skin eruption).
• if you have phaeochromocytoma (an adrenal gland tumor). Your doctor will need to treat it before prescribing bisoprolol.
• if you have a thyroid disorder. Bisoprolol tablets may mask the symptoms of hyperthyroidism.

Consult your doctor if any of the above warnings apply to you or have applied to you previously.

Children and adolescents

Bisoprolol Cor Alter is not recommended for use in children and adolescents.

Other medications and Bisoprolol Cor Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Do not take the following medications with Bisoprolol Cor Alter without special advice from your doctor:

• Medications used to control blood pressure or medications for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medications used to treat depression, for example imipramine, amitriptyline, moclobemide.
• Medications for mental health disorders, for example phenothiazines such as levomepromazine.
• Medications used for anesthesia during surgery (see also "Be especially careful with Bisoprolol Cor Alter").
• Medications used to treat epilepsy, for example barbiturates such as phenobarbital.
• Some anti-inflammatory medications (for example, acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medications used for asthma or for nasal congestion.
• Medications used for some eye disorders such as glaucoma (increased intraocular pressure) or used to dilate pupils.
• Some medications used to treat clinical shock (for example, adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medication used to treat malaria.

All these medications, as well as bisoprolol, may affect blood pressure and/or cardiac function.

It is also especially important to talk to your doctor if you are using:

• Insulin or other diabetes medications. The effect of low blood sugar may be potentiated. Symptoms of low blood sugar may be masked.

Taking Bisoprolol Cor Alter with food and drinks

Bisoprolol tablets can be taken with or without food and should be swallowed with a glass of water.

Pregnancy, breastfeeding, and 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 medication.

Do not take bisoprolol if you are pregnant or plan to become pregnant. Bisoprolol Cor Alter may be harmful to the pregnancy and/or the fetus. There is a higher risk of premature birth, spontaneous abortion, low blood sugar, and reduced heart rate in the child. It may also affect the baby's growth.

Driving and operating machinery

These tablets may make you feel tired, drowsy, or dizzy.

If you experience these adverse effects, do not drive or operate machinery. Be aware of the possibility of these effects, especially at the beginning of treatment, when the medication is changed, and with the use in combination with alcohol.

Use in athletes

This medication contains bisoprolol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The treatment with Bisoprolol Cor Alter requires regular monitoring by your doctor. This is especially necessary at the beginning of treatment, during dose increase and when interrupting treatment.

Take the tablets with a little water in the morning, with or without food. Do not crush or chew the tablets.

The treatment with bisoprolol is usually long-term.

Chest pain and hypertension

Adults

The recommended starting dose is 5 mg once a day. If necessary, the dose can be increased to 10 mg per day.

The maximum recommended dose is 20 mg once a day.

Heart failure

Adults

Before starting to use bisoprolol, you should have taken other medications for heart failure, including some beta-blockers, diuretics and cardiac glycosides (as an added possibility).

The treatment with bisoprolol should be initiated at a low dose and gradually increased.

Your doctor will decide how to increase the dose, and this will be done normally as follows:

• 1.25 mg of bisoprolol once a day for one week.
• 2.5 mg of bisoprolol once a day for one week.
• 3.75 mg of bisoprolol once a day for one week.
• 5 mg of bisoprolol once a day for four weeks.
• 7.5 mg of bisoprolol once a day for four weeks.
• 10 mg of bisoprolol once a day as maintenance therapy (continuous).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose less than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do.

If you have to discontinue treatment completely, your doctor will usually recommend reducing the dose gradually, as otherwise your condition may worsen.

Use in patients with renal and/or hepatic insufficiency

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic insufficiency. In patients with severe renal insufficiency (creatinine clearance <20

Use in children and adolescents

The use of bisoprolol is not recommended in children.

Older patients

Generally, no dose adjustment is required. It is recommended to start with the lowest possible dose. If you consider that the effect of bisoprolol is too strong or too weak, inform your doctor or pharmacist.

If you take more Bisoprolol Cor Alter than you should

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

If you have taken more tablets than you should, inform your doctor immediately. Your doctor will decide what measures are necessary.

The symptoms of an overdose may include a reduced heart rate, severe difficulty breathing, feeling of dizziness or tremors (due to decreased blood sugar).

If you forgot to take Bisoprolol Cor Alter

Do not take a double dose to compensate for the missed doses. Take the usual dose the next morning.

If you interrupt treatment with Bisoprolol Cor Alter

Do not stop taking this medication unless your doctor tells you to. Otherwise, your condition may worsen. Treatment should not be interrupted suddenly, especially in patients with systemic heart failure. If you are considering interrupting treatment, your doctor will indicate how to reduce the dose gradually.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

To prevent serious adverse reactions, talk to your doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

The most serious side effects are related to heart function:

• Slowing of heart rate (may affect more than 1 in 10 people)
• Worsening of heart failure (may affect up to 1 in 10 people)
• Slow or irregular heartbeats (may affect up to 1 in 100 people)
• Worsening of symptoms of blockage of the main blood vessels in the legs, especially at the beginning of treatment (frequency cannot be estimated from available data). If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

Other side effects are listed below, according to frequency of occurrence:

Frequent (may affect up to 1 in 10 people)

• Tiredness*, weakness (in patients with chronic heart failure), dizziness*, headache*
• Sensation of coldness or numbness of hands and/or feet
• Low blood pressure, especially in patients with chronic heart failure
• Stomach or intestinal problems, such as nausea, vomiting, diarrhea, or constipation

Rare (may affect up to 1 in 100 people)

• Sleep disturbances
• Depression
• Respiratory problems in patients with asthma or chronic respiratory disease
• Muscle weakness, muscle cramps
• Weakness (in patients with hypertension or angina)

Rare (may affect up to 1 in 1,000 people)

• Auditory problems
• Nasal discharge
• Decreased tear production (may be a problem if you wear contact lenses)
• Liver inflammation that may cause yellowing of the skin and eyes Determined abnormal liver function test results or abnormal levels of fat
• Allergic-like reactions such as itching, redness, skin rash
• Erectile dysfunction
• Nightmares, hallucinations
• Fainting

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

• Irritation and redness of the eyes (conjunctivitis)
• Hair loss
• Appearance or worsening of scaly skin rash (psoriasis); rash similar to psoriasis.

* In the case of treatment for high blood pressure or angina, these symptoms may appear especially at the beginning of treatment, or if your dose changes. They are usually mild symptoms that often disappear within 1-2 weeks.

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 Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Bisoprolol Cor Alter

• The active ingredient is bisoprolol fumarate. Each tablet contains 2.5 mg of bisoprolol fumarate.
• The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethylstarch (type A) from potato, and magnesium stearate.

Appearance of the product and content of the container

White or off-white, round, biconvex, scored, tablets engraved with “2” on one side of the score and “5” on the other side on one face and smooth on the other face. The tablet can be divided into equal doses.

Bisoprolol Cor Alter 2.5 mg is presented in PVC/PVDC-Al blisters or PVC/PCTFE-Al blisters, in containers of 28 tablets.

Holder of the marketing authorization:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway

Ireland

Date of the last review of this leaflet: July 2017

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