BISOPROLOL NORMON 1.25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Normon 1.25 mg film-coated 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

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

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 some 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. At the same time, bisoprolol reduces the heart's need 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 Normon is used to:

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

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

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

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6),
• severe asthma
• 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, which is a rare tumor of the adrenal gland
• metabolic acidosis, which is 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.
• low blood pressure
• certain heart conditions that cause a very slow or irregular heartbeat.
• cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and circulatory failure.
• slow heart rate.

Consult your doctor if you are not sure if you have any of the above problems.

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 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
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• adrenal gland tumor (pheochromocytoma)
• thyroid disorder

During treatment

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

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

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

Taking Bisoprolol Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 medicines 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 consulting your doctor first.

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 calcium antagonists such as nifedipine, felodipine, and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medicines such as amiodarone)
• beta-blockers applied locally (such as eye drops of timolol for the treatment of glaucoma)
• certain medicines used to treat, for example, Alzheimer's disease or for the treatment of glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• insulin or other medicines for diabetes
• 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)

–Medicines for asthma or used for nasal congestion

• 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 amitriptiline), 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. Bisoprolol may have harmful effects on pregnancy and/or the fetus. It may also affect the growth of the baby. Therefore, bisoprolol should not be used during pregnancy.

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

Children and adolescents

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

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.

Information on excipients

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

Important information for athletes

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

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 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 the help of a glass of water and do not chew or crush them.

Hypertension and angina

Adults, including elderly patients

The recommended maximum dose is 20 mg once daily.

Chronic stable heart failure

Adults, including elderly patients

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 recommended maximum 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.

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 daily.< p>

Use in children and adolescents

The use of bisoprolol is not recommended in children or adolescents.

If you take more Bisoprolol Normon than you should

If you have taken more tablets of bisoprolol 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 your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 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 forgotten doses.Take your dose as soon as you remember, unless it is time to take the next dose.

If you stop taking Bisoprolol Normon

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 a few weeks, as your doctor will indicate.

If you have any further questions on the use of this product, 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 effectsare 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)

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

Other side 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 that can cause yellowing of the skin or the whites of the eyes.

The following side effects are also reported:

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

• Fatigue*.
• Headache*
• Feeling of 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 start of treatment in patients with hypertension or angina. 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 when standing up.

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

• Hearing problems.
• Runny nose due to allergy.
• Decreased tear production
• Certain abnormal blood test results for liver function or fat levels.
• Allergic reactions such as itching, redness, and skin rashes.
• Sexual dysfunction
• Nightmares, hallucinations
• Fainting

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

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

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 to the Spanish Medicines Agency's website: https://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 this medicine out of the sight and reach of children.

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

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

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 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 ingredients (excipients) are:

Sodium phosphate anhydrous, microcrystalline cellulose, corn starch, sodium croscarmellose, colloidal silicon dioxide, vegetable magnesium stearate, hypromellose, talc, macrogol 6000, titanium dioxide (E171).

Appearance of the product and pack contents

Bisoprolol Normon 1.25 mg are film-coated tablets, round, biconvex, and 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 manufacturer

Marketing authorization holder

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet: October 2019

Detailed and updated information on this medicine 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 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/84589/P_84589.html