Bisoprolol Cor Alter 2.5 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Bisoprolol Cor Alter 2.5 mg 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, consult 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 Alter is and what it is used for
2. What you need to know before taking Bisoprolol Cor Alter
3. How to take Bisoprolol Cor Alter
4. Possible side effects
5. How to store Bisoprolol Cor Alter

Pack contents and additional information

1. What Bisoprolol Cor Alter is and what it is 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 excessive activity. These medicines work by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows the heartbeat and makes the heart more effective at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and its 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 supplying 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 starting to 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 heartbeat. Consult your doctor if you are unsure.
• if you have very low blood pressure.
• if you have cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure.
• if you have severe circulatory problems (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make 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 condition known as metabolic acidosis.
• if you have untreated pheochromocytoma, a rare tumor of the adrenal gland.

If in doubt, consult your doctor.

Warnings and precautions

Talk to 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 symptoms of low blood sugar.
• if you are fasting from solid food.
• if you are undergoing treatment for hypersensitivity reactions (allergy). 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 liver or kidney problems.
• if you have circulation problems in your limbs.
• if you are going to receive general anesthesia during surgery, inform your doctor that you are taking bisoprolol.
• if you are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended; see also "Taking Bisoprolol Cor Alter with other medicines".
• if you have (or have had) psoriasis (a recurring skin rash).
• if you have pheochromocytoma (a tumor of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol.
• if you have a thyroid disorder. Bisoprolol tablets may mask symptoms of an overactive thyroid.

Consult your doctor if any of the above warnings apply to you or have applied to you 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 need to take any other medicines.

Some medicines cannot be taken at the same time, while others may require specific adjustments (for example, 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 for heart problems (for example, amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Medicines used to treat depression, for example imipramine, amitriptyline, moclobemide.
• Medicines used to treat mental illnesses, for example phenothiazines such as levomepromazine.
• Anaesthetic medicines used during surgery (see also "Take special care with Bisoprolol Cor Alter").
• Medicines used to treat epilepsy, for example, barbiturates such as phenobarbital.
• Some anti-inflammatory medicines (for example, acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines used for asthma or nasal congestion.
• Medicines used for certain eye conditions such as glaucoma (increased eye pressure) or to dilate the pupils.
• Some medicines used to treat clinical shock (for example, adrenaline, dobutamine, noradrenaline).
• Mefloquine, a medicine used to treat malaria.

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

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

• 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 Alter with food and drink

Bisoprolol tablets may 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 medicine.

Do not take bisoprolol if you are pregnant or planning to become pregnant. Bisoprolol Cor Alter may be harmful to pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and reduced heart rate in the newborn. The baby's growth may also be affected.

Driving and using machines

These tablets may make you feel tired, drowsy, 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 beginning of treatment, when the dose is changed, and when used together with alcohol.

Use in athletes

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

3. How to take Bisoprolol Cor Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Treatment with Bisoprolol Cor Alter requires regular monitoring by your doctor. This is especially important at the beginning of treatment, when increasing the dose, and when stopping treatment.

Take the tablets with a glass of 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 daily. If necessary, the dose may be increased to 10 mg daily.

The maximum recommended dose is 20 mg once daily.

Heart failure

Adults

Before starting bisoprolol, you should already be taking other medications for heart failure, including an ACE inhibitor, diuretics, and cardiac glycosides (if indicated).

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 daily for one week.
• 2.5 mg of bisoprolol once daily for one week.
• 3.75 mg of bisoprolol once daily for one week.
• 5 mg of bisoprolol once daily for four weeks.
• 7.5 mg of bisoprolol once daily for four weeks.
• 10 mg of bisoprolol once daily as maintenance therapy (ongoing treatment).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 advise you accordingly.

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

Dose adjustment is normally not 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 daily.

Use in children and adolescents

The use of bisoprolol is not recommended in children.

Elderly patients

In general, dose adjustment is not required. It is recommended to start with the lowest possible dose. If you feel 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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.

Symptoms of overdose may include a slow heart rate, severe difficulty breathing, 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 missed 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 systemic heart failure. If you are considering stopping treatment, your doctor will advise you on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

To prevent serious reactions, speak to your doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly.

The most serious adverse 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 in the main blood vessels of 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 adverse effects are listed below, according to frequency of occurrence:

Frequent (may affect up to 1 in 10 people)

• Fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*
• Cold sensation 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, diarrhoea, or constipation

Uncommon (may affect up to 1 in 100 people)

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

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

• Hearing problems
• Runny nose
• Decreased tear production (may be problematic if you wear contact lenses)
• Liver inflammation, which may cause yellowing of the skin and whites of the eyes; certain blood test results showing abnormal liver function or abnormal fat levels
• Allergy-like reactions such as itching, redness, skin rash
• Erectile dysfunction
• Nightmares, hallucinations
• Fainting

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

• Eye irritation and redness (conjunctivitis)

• Hair loss

• Onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash

• When treating high blood pressure or angina, these symptoms may occur especially at the beginning of treatment or if your dose is changed. Usually, they are mild symptoms that often disappear within 1–2 weeks.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Alter

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Cor Alter

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

Description of the product and contents of the pack

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 opposite 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 blisters, 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 the most recent revision of this leaflet: July 2017

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