Bisoprolol Normon 5 mg film-coated tablets EFG: detailed information

Brand name Bisoprolol Normon 5 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

BISOPROLOL HEMIFUMARATE · 5 mg

Prescription type Prescription Only Medicine. Long-Term Treatment

ATC code

C07A C07AB C07AB07

Registration number 65073

Manufacturer Laboratorios Normon S.A.

Bisoprolol Normon 5 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Bisoprolol NORMON is and what it is used for
2. What you need to know before taking Bisoprolol NORMON
3. How to take Bisoprolol NORMON
4. Possible adverse effects
5. Storage of Bisoprolol NORMON
6. Contents of the pack and other information
**Other presentations**

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol NORMON 5 mg film-coated tablets EFG

bisoprosol hemifumarate

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 others, 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 NORMON is and what it is used for

What you need to know before taking Bisoprolol NORMON
How to take Bisoprolol NORMON
Possible side effects
How to store Bisoprolol NORMON
Contents of the pack and other information

1. What Bisoprolol NORMON is and what it is 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 heartbeat and makes the heart more efficient at pumping blood throughout the body.

Bisoprolol is used for:

Treating high blood pressure (hypertension).
Treating chronic stable angina caused by insufficient oxygen supply to the heart muscle.
Treating chronic stable 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 taking Bisoprolol NORMON

Do not take Bisoprolol NORMON if you have any of the following conditions:
Allergy (hypersensitivity) to bisoprolol or to 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 may cause tingling in the fingers and toes or make them pale or blue.
Untreated pheochromocytoma, which is 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 heart failure requiring intravenous injection of medicines that increase the force of heart contraction.
Slow heart rate.
Low blood pressure.
Certain heart conditions causing very slow heart rate or irregular pulse.
Cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure.
Warnings and precautions

If you have any of the following conditions, inform your doctor before taking Bisoprolol NORMON; your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

Diabetes.
Strict fasting.
Certain heart diseases such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina).
Kidney or liver problems.
Less severe circulatory problems in the limbs.
Asthma or less severe chronic respiratory disease.
History of scaly skin rash (psoriasis).
Tumor of the adrenal gland (pheochromocytoma).
Thyroid disorder.
First-degree heart block (a condition in which nerve signals to the heart are altered, possibly causing occasional missed beats or irregular heartbeat).

Additionally, inform your doctor if you are undergoing:

Desensitization treatment (e.g., for prevention of hay fever), because Bisoprolol NORMON may make allergic reactions more likely or more severe.
Anesthesia (e.g., for surgery), because Bisoprolol NORMON may affect how your body responds to this situation.
Children and adolescents

The use of Bisoprolol NORMON is not recommended in children and adolescents.

Consult your doctor or pharmacist before starting to take Bisoprolol NORMON.

Taking Bisoprolol NORMON with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone).
Certain medicines used to treat high blood pressure, angina, 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 (calcium antagonists of the dihydropyridine type such as felodipine and amlodipine).
Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone).
Topically applied beta-blockers (such as timolol eye drops for the treatment of glaucoma).
Certain medicines used, for example, for Alzheimer's disease or for treating glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine).
Antidiabetic medicines, including insulin.
Anaesthetic agents (e.g., during surgery).
Digitalis, used to treat heart failure.
Non-steroidal anti-inflammatory drugs (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 either 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 used to treat mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine).
Mefloquine, used for 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is unknown whether 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 machinery may be affected depending on how well you tolerate the medicine. Be especially cautious at the beginning of treatment, when the dose is increased, when medication is changed, and also when combined with alcohol.

Important information for athletes

Athletes are advised 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; thus, it is essentially "sodium-free".

3. How to take Bisoprolol NORMON

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist.

Treatment with Bisoprolol NORMON requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment and during dose increases. 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 a maximum of 20 mg if necessary.

Treatment should never be stopped abruptly; 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 initiated at a low dose and gradually increased. Your doctor will decide how to increase the dose, and this will normally 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).

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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.

Your doctor will advise you what to do.

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

Renal or hepatic impairment

In patients with mild to moderate hepatic or renal disorders, dosage adjustment is usually not necessary. In patients with end-stage renal disease and in those with severe hepatic impairment, the daily dose should not exceed 10 mg.

Experience with bisoprolol in dialyzed patients is limited; however, to date, there is no evidence that the dosing regimen needs to be modified in these patients.

Elderly

Dosage adjustment is not required.

Paediatric population

There is no paediatric experience with bisoprolol, and therefore its use is not recommended in paediatric patients.

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 which measures are necessary.

Symptoms of overdose may include a slow heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

In case of overdose or accidental ingestion, contact 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 missed doses. Take your usual dose the following morning.

??If you stop taking Bisoprolol NORMON

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

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

4. Possible adverse effects

Like all medicines, Bisoprolol NORMON may cause adverse effects, although not everyone experiences them.

To prevent serious reactions, speak with a 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 the heart rate (affects more than 1 in 10 people).
Worsening of heart failure (affects less than 1 in 10 people).
Slow or irregular heartbeats (affects less than 1 in 100 people).

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

Other adverse effects listed below are categorized according to their possible frequency of occurrence:

Frequent (affects less than 1 in 10 people):

Fatigue, weakness, dizziness, headache.
Cold sensation 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 in 100 people):

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

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

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

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

Eye irritation and redness (conjunctivitis).
Hair loss.
Onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Inform your doctor or pharmacist if you notice any of the adverse effects listed above or any other undesired or unexpected effect.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 30 °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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 NORMON

The active substance is bisoprolol hemifumarate. Each tablet of Bisoprolol NORMON contains 5 mg of bisoprolol hemifumarate.

The other components are: microcrystalline cellulose, corn starch, colloidal silicon dioxide, hypromellose, sodium hydrogen phosphate, magnesium stearate, sodium croscarmellose, titanium dioxide (E-171), macrogol 6000, and yellow iron oxide (E-172).

Appearance of the medicine and contents of the pack

Bisoprolol NORMON are yellow, round, biconvex, film-coated tablets with a score line. They are available in packs containing 28, 30, 60 or 500 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)

Bisoprolol Normon 5 mg film-coated tablets EFG