Bisoprolol Normon 1.25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol Normon 1.25 mg film-coated 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, ask 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.

Contents of the leaflet

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 side effects
5. How to store Bisoprolol Normon
6. Contents of the pack and other information

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

The active substance is bisoprolol. 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 down 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 Normon is used to:

• treat high blood pressure (hypertension).
• treat chronic stable angina pectoris.
• treat chronic stable heart failure. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before starting to take Bisoprolol Normon

Do not take Bisoprolol Normon if you have any of the following conditions:

• if you are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6),
• severe asthma
• severe circulation problems in the limbs (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or turn them pale or blue
• untreated phaeochromocytoma, 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 one of the following heart problems:

• acute heart failure
• worsening heart failure requiring intravenous injection of medicines that increase the force of the heart's contraction
• low blood pressure
• certain heart conditions causing a very slow heart rate or irregular pulse
• cardiogenic shock, a severe and acute heart condition causing low blood pressure and circulatory failure
• slow heart rate

Consult your doctor if you are unsure whether you have any of the above conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bisoprolol. If you have any of the following conditions, consult your doctor before taking this medicine; your doctor may wish to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• diabetes
• strict fasting
• certain heart diseases such as cardiac arrhythmias, or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• less severe circulatory problems in your limbs
• chronic lung disease or mild asthma
• history of scaly skin rash (psoriasis)
• tumor of the adrenal gland (pheochromocytoma)
• thyroid disorder

During treatment

Also, inform your doctor if you are undergoing:

• desensitization treatment (for example, to prevent hay fever), because bisoprolol may make it more likely that you experience an allergic reaction, or that such a reaction may be more severe.
• anesthesia (for example, for surgery), because bisoprolol may influence how your body reacts to this situation.

If you have chronic lung disease or mild asthma, inform your doctor immediately if you begin to experience new breathing difficulties, coughing, wheezing after exercise, etc., while taking bisoprolol.

Taking Bisoprolol Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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 agents such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone)
• certain medicines used to treat high blood pressure, angina, or irregular heartbeats (calcium antagonists such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, or 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 (dihydropyridine-type calcium antagonists such as nifedipine, felodipine, and amlodipine)
• certain medicines used to treat irregular or abnormal heart rhythms (Class III antiarrhythmic agents such as amiodarone)
• locally applied beta-blockers (such as timolol eye drops used to treat glaucoma)
• certain medicines used, for example, in the treatment of Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine)
• insulin or other medicines used to treat diabetes
• 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)

– Medicines for asthma or used for nasal congestion

• any medicine that may lower blood pressure as either a desired or undesired effect, such as antihypertensives, certain medicines used for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (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 the prevention or treatment of malaria
• medicines used to treat depression called monoamine oxidase inhibitors (excluding 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. Bisoprolol may have harmful effects during pregnancy and/or on the fetus. It may also affect the baby's growth. Therefore, bisoprolol should not be used during pregnancy.

It is unknown whether bisoprolol passes into breast milk, and therefore its use is not recommended during breastfeeding.

Children and adolescents

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

Driving and use of machines

Your ability to drive or operate machinery may be impaired depending on how well you tolerate the medicine. Exercise particular caution at the beginning of treatment, when the dose is increased or the medication is changed, and also when combined with alcohol.

Information about excipients

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

Important information for athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to take Bisoprolol Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. Your doctor will tell you how many tablets to take. Bisoprolol should be taken in the morning, before, during, or after breakfast.

Swallow the tablets whole with a glass of water and do not chew or crush them.

High blood pressure and angina pectoris

Adults, including elderly patients

The maximum recommended dose is 20 mg once daily.

Chronic stable heart failure

Adults, including elderly patients

Treatment with bisoprolol should be initiated at a low dose and gradually increased. Your doctor will decide how to increase the dose, which 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 tell you what to do.

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

Bisoprolol is not recommended for use in children or adolescents.

If you take more Bisoprolol Normon than you should

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 dose as soon as you remember, unless it is almost time for your next dose.

If treatment with Bisoprolol Normon is interrupted

Treatment with bisoprolol should not be stopped abruptly. If you suddenly stop taking this medicine, your condition may worsen. Instead, the dose should be gradually reduced over several weeks, as directed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 the 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)

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

Other adverse effects that may occur are:

Uncommon (may affect up to 1 in 100 patients):

• Depression
• Breathing problems in patients with asthma or chronic respiratory disease

Rare (may affect up to 1 in 1,000 patients):

• Inflammation of the liver which may cause yellowing of the skin or whites of the eyes.

The following are other adverse effects listed according to their possible frequency of occurrence:

Common (may affect up to 1 in 10 people):

• Tiredness*
• Headache*
• Feeling cold or numbness in hands and/or feet
• Low blood pressure
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation

*These symptoms occur at the beginning of treatment in patients with hypertension or angina pectoris. They are usually mild and disappear within 1–2 weeks.

Uncommon (may affect up to 1 in 100 people):

• Sleep disorders
• Changes in normal heart rhythm
• Muscle weakness and cramps
• Dizziness upon standing

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

• Hearing problems
• Allergic nasal discharge
• Reduced tear production
• Certain abnormal blood test results for liver function or fat levels
• Allergy-like reactions such as itching, redness, and skin rashes
• Erectile problems
• 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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Normon

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

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

Store below 30 °C in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Normon

• The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg of bisoprolol in the form of bisoprolol fumarate.
• The other components (excipients) are:

Anhydrous disodium phosphate, microcrystalline cellulose, corn starch, sodium croscarmellose, colloidal silica, vegetable magnesium stearate, hypromellose, talc, macrogol 6000, titanium dioxide (E171).

Appearance of the product and contents of the pack

Bisoprolol Normon 1.25 mg are round, biconvex, film-coated tablets that are white or almost white, with the imprint “B1.25” on one side. They are available in blister packs (PVC/Al or PVDC-PE/Al).

Blister pack containing 20 tablets.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: October 2019

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84589/P_84589.html