BISOPROLOL NORMON 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol NORMON 2.5 mg film-coated tablets EFG

bisoprolol hemifumarate

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

1. What is Bisoprolol NORMON and what is it used for
2. What you need to know before you take Bisoprolol NORMON
3. How to take Bisoprolol NORMON
4. Possible side effects
5. Storage of Bisoprolol NORMON
6. Contents of the pack and other information

1. What is Bisoprolol NORMON and what is it used for

Bisoprolol belongs to a group of medicines called beta-blockers. 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 at pumping blood throughout the body.

Bisoprolol is used to:

• Treat high blood pressure (hypertension).
• Treat chronic angina pectoris caused by a lack of oxygen in the heart muscle.
• Treat stable chronic heart failure. It is used in combination with other medicines. Heart failure is the inability of the heart to pump enough blood to meet the body's needs.

2. What you need to know before you take Bisoprolol NORMON

• Do not take bisoprolol NORMON if you have any of the following conditions:

• Allergy (hypersensitivity) to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
• Severe asthma or severe chronic lung disease.
• Severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling in the fingers or toes or turn them pale or blue.
• Untreated pheochromocytoma, a rare tumor of the adrenal gland.
• Metabolic acidosis, a condition that occurs when there is too much acid in the blood.

• Do not take bisoprolol NORMON if you have any of the following heart problems:

• Acute heart failure.
• Worsening of heart failure that requires intravenous injection of medicines that increase the heart's contractile force.
• Slow heart rate.
• Low blood pressure.
• Certain heart conditions that cause a very slow or irregular heart rate.
• Cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.

• Warnings and precautions

If you have any of the following problems, inform your doctor before taking Bisoprolol NORMON; your doctor may want to take special precautions (such as providing additional treatment or performing more frequent tests):

• Diabetes.
• Strict fasting.
• Certain heart diseases such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina).
• Kidney or liver problems.
• Less severe circulatory problems in the limbs.
• Mild asthma or chronic respiratory disease.
• History of scaly skin rash (psoriasis).
• Adrenal gland tumor (pheochromocytoma).
• Thyroid disorder.
• First-degree heart block (a condition in which the nerve signals to the heart are altered, probably causing an occasional skipped beat or irregular heartbeat).

Also, inform your doctor if you are going to undergo:

• Desensitization treatment (e.g., to prevent hay fever), because bisoprolol NORMON may make you more likely to experience an allergic reaction, or that reaction may be more severe.
• Anesthesia (e.g., for surgery), because bisoprolol NORMON may affect how your body reacts to this situation.

• Children and adolescents

Bisoprolol NORMON is not recommended for use in children and adolescents.

Consult your doctor or pharmacist before starting treatment with Bisoprolol NORMON.

• Taking Bisoprolol NORMON with other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicines.

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

• Certain medicines used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone).
• Certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem).
• Certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines with Bisoprolol NORMON; your doctor may need to monitor your condition more frequently:

• Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists such as felodipine and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medicines such as amiodarone).
• Locally applied beta-blockers (such as timolol eye drops for glaucoma treatment).
• Certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• Antidiabetic medicines, including insulin.
• Anesthetic agents (e.g., during surgery).
• Digitalis, used to treat heart failure.
• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac).
• Epinephrine, a medicine used to treat severe allergic reactions and cardiac arrest.
• Any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines for mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine).
• Mefloquine, used for the prevention or treatment of malaria.
• Medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

• 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.

There is a risk that the use of Bisoprolol NORMON during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide if you can take Bisoprolol NORMON during pregnancy.

It is not known if bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoprolol NORMON.

• Driving and using machines:

Your ability to drive or use machines may be affected depending on how well you tolerate the medicine. Be especially careful at the start of treatment, when the dose is increased, or the medication is changed, and also in combination with alcohol.

• Important information for athletes

Athletes are warned that this medicine contains a component that may result in a positive doping test.

• Bisoprolol Normon contains sodium

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

3. How to take Bisoprolol NORMON

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

Treatment with bisoprolol NORMON requires regular monitoring by your doctor. This is particularly necessary at the start of treatment and during dose increase.

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

Treatment with Bisoprolol NORMON is usually long-term.

Adults:

For the treatment of hypertension and angina pectoris

The initial dose is 5 mg once daily.

Your doctor may increase the dose in small increments (usually every few weeks) to 10 mg or up to 20 mg as needed.

Treatment should never be stopped abruptly, but the dose should be gradually reduced over a period of 1-2 weeks.

For the treatment of stable chronic heart failure

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 (continuing).

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.

Normally, if you need to stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise, your condition may worsen.

Renal or hepatic impairment

In patients with mild to moderate hepatic or renal disorders, it is usually not necessary to adjust the dose of the medicine. In patients with terminal renal insufficiency and in patients with severe hepatic insufficiency, the daily dose should not exceed 10 mg.

Experience with bisoprolol in dialysis patients is limited; however, to date, it has not been shown that the dosage regimen needs to be modified in these patients.

Elderly

No dose adjustment is necessary.

Pediatric population

There is no pediatric experience with bisoprolol, so its use is not recommended in the pediatric population.

• If you take more Bisoprolol NORMON than you should

If you have taken more tablets of Bisoprolol NORMON 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, dizziness, or tremors (due to low blood sugar).

In case of overdose or accidental ingestion, consult the Toxicology Information Service (Tel. 91 562 04 20), indicating the product and the amount ingested.

• If you forget to take Bisoprolol NORMON

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

• If you stop taking Bisoprolol NORMON

Never stop taking Bisoprolol NORMON except on the advice of your doctor. Otherwise, your condition may worsen significantly.

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

4. Possible side effects

Like all medicines, Bisoprolol NORMON can cause side effects, although not everybody gets them.

To prevent serious side effects, talk to a 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 (affects more than 1 person in 10).
• Worsening of heart failure (affects less than 1 person in 10).
• Slow or irregular heartbeats (affects less than 1 person in 100).

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

Other side effects are mentioned below according to their frequency of possible occurrence:

Common(affects less than 1 person in 10):

• Fatigue, weakness, dizziness, headache.
• Feeling of cold or numbness in hands or feet.
• Low blood pressure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

Uncommon(affects less than 1 person in 100):

• Sleep disturbances.
• Depression.
• Dizziness when standing up.
• Breathing problems in patients with asthma or chronic respiratory disease.
• Muscle weakness, muscle cramps.

Rare(affects less than 1 person in 1,000):

• Hearing problems.
• Allergic nasal congestion.
• Decreased tear production.
• Liver inflammation that can cause yellowing of the skin or the whites of the eyes. Elevated levels of liver enzymes (laboratory tests (ALAT or ASAT)).
• Certain abnormal blood test results for liver function or fat levels.
• Allergic reactions such as itching, redness, skin rash.
• Erection problems.
• Nightmares, hallucinations.
• Fainting.

Very rare(affects less than 1 person in 10,000):

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

Tell your doctor or pharmacist if you notice any of the side effects mentioned above or any other unwanted or unexpected effect.

Reporting of side effects

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

5. Storage of Bisoprolol NORMON

Keep out of sight and reach of children.

Do not store above 25°C.

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 should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol NORMON

The active substance is bisoprolol hemifumarate. Each Bisoprolol NORMON tablet contains 2.5 mg of bisoprolol hemifumarate.

The other ingredients are microcrystalline cellulose, cornstarch, sodium croscarmellose, colloidal silicon dioxide, hypromellose, magnesium stearate, sodium hydrogen phosphate, titanium dioxide (E-171), macrogol 6000.

Appearance of the product and packaging contents

Bisoprolol NORMON 2.5 mg film-coated tablets, are presented as white or almost white, round, and scored tablets. They are available in packs of 28 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos, Madrid (SPAIN)

OTHER PRESENTATIONS

BISOPROLOL NORMON 5 mg FILM-COATED TABLETS EFG

BISOPROLOL NORMON 10 mg FILM-COATED TABLETS EFG

Date of the last revision of this leaflet

July-2014

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72163/P_72163.html