BISOPROLOL COR ALTER 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Bisoprolol Cor Alter 2.5 mg 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and further information

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

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

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

Bisoprolol is used to:

• Treat high blood pressure (hypertension)
• Treat chronic stable angina (chest pain caused by blockages in the arteries that supply the heart muscle).

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

2. What you need to know before you take Bisoprolol Cor Alter

Do not take Bisoprolol Cor Alter

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
• if you have severe asthma or severe chronic lung disease.
• if you have a slow or irregular heart rate. Consult your doctor if you are not sure.
• if you have very low blood pressure.
• if you have cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and circulatory failure.
• if you have severe circulatory problems (such as Raynaud's syndrome) that can cause tingling in the fingers and toes or turn them pale or blue.
• if you have heart failure that worsens suddenly and/or may require hospitalization.
• if you have excess acid in the blood, a disorder known as metabolic acidosis.
• if you have untreated pheochromocytoma, which is a rare tumor of the adrenal gland.

In case of doubt, consult your doctor.

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 levels.
• if you are on a solid food fast.
• if you are being treated for hypersensitivity reactions (allergy). Bisoprolol may worsen your allergy or make it more difficult to treat.
• if you have certain heart diseases such as rhythm disorders or severe chest pain at rest (Prinzmetal's angina).
• if you have any liver or kidney problems.
• if you have any problems with circulation in your limbs.
• if you are going to be given general anesthesia during surgery, inform your doctor that you are taking bisoprolol.
• if you are taking verapamil or diltiazem, medicines used to treat heart diseases. Concomitant use is not recommended, see also "Taking Bisoprolol Cor Alter with other medicines".
• if you have (or have had) psoriasis (a recurrent skin rash).
• if you have pheochromocytoma (an adrenal gland tumor). Your doctor will need to treat you 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 in the past.

Children and adolescents

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

Other medicines and Bisoprolol Cor Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

• Medicines used to control blood pressure or heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medicines used to treat depression, such as imipramine, amitriptyline, moclobemide.
• Medicines used to treat mental illnesses, such as phenothiazines, such as levomepromazine.
• Anesthetic medicines used during surgery (see also "Special warnings and precautions for use").
• Medicines used to treat epilepsy, such as barbiturates, such as phenobarbital.
• Certain anti-inflammatory medicines (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines used for asthma or nasal congestion.
• Medicines used for certain eye disorders, such as glaucoma (increased eye pressure) or used to dilate the pupils.
• Certain medicines used to treat clinical shock (e.g., adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine used to treat malaria.

All these medicines, as well as bisoprolol, can affect blood pressure and/or heart function.

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

• Insulin or other diabetes medicines. The effect of lowering blood sugar may be enhanced. The 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take bisoprolol if you are pregnant or planning 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 levels, and reduced heart rate in the child. It may also affect the growth of the baby.

Driving and using machines

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

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

Use in athletes

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

3. How to take Bisoprolol Cor Alter

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

Treatment with bisoprolol is usually long-term.

Chest pain and high blood pressure

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 medicines for heart failure, including some ACE inhibitors, diuretics, and cardiac glycosides (as an added possibility).

Treatment with bisoprolol should be started at a low dose and gradually increased.

Your doctor will decide how to increase the dose, and this will usually be done 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 medicine, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medicine, it may be necessary to reduce the dose again or stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do.

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

Use in patients with renal and/or hepatic impairment

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic impairment. In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, the dose should not exceed 10 mg of bisoprolol once a day.< p>

Use in children and adolescents

The use of bisoprolol is not recommended in children.

Elderly patients

In general, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 reduction in heart rate, severe difficulty breathing, feeling of dizziness or tremors (due to low blood sugar).

If you forget to take Bisoprolol Cor Alter

Do not take a double dose to make up for forgotten doses. Take your usual dose the next morning.

If you stop taking Bisoprolol Cor Alter

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The most serious side effects are related to heart function:

• Slow 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 start of treatment (frequency cannot be estimated from the 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:

Common (may affect up to 1 in 10 people)

• Fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*
• Feeling of cold or numbness in 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

Uncommon (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 high blood pressure or angina)

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

• Hearing problems
• Runny nose
• Decreased tear production (may be a problem if you wear contact lenses)
• Liver inflammation that can cause yellowing of the skin and the whites of the eyes, certain blood test results for liver function or abnormal fat levels
• Allergic reactions such as itching, redness, skin rash
• Erection problems
• Nightmares, hallucinations
• Fainting

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

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

• In the treatment of high blood pressure or angina, these symptoms may occur especially at the start of treatment, or if your dose changes. They are usually mild and frequently disappear within 1-2 weeks.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Bisoprolol Cor Alter

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bisoprolol Cor Alter

• The active substance is bisoprolol fumarate. Each tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium starch glycolate (type A), and magnesium stearate.

Appearance of the product and pack contents

White or almost 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 available in PVC/PVDC-Al or PVC/PCTFE-Al blister packs, in packs of 28 tablets.

Marketing authorization holder:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway

Ireland

Date of last revision of this leaflet: July 2017

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