Leaflet: information for the user

Bisoprolol Normon 1.25 mg film-coated tablets EFG

bisoprolol fumarate

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Bisoprolol Normon

4. Possible side effects

5. Storage of Bisoprolol Normon

6. Contents of the pack and additional information

The active ingredient is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines act by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heartbeat and makes the heart more efficient, pumping blood throughout the body. At the same time, bisoprolol reduces the demand for oxygen and blood supply to the heart. 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 for:

- treating high blood pressure (hypertension).

- treating chronic stable angina.

- treating chronic stable heart failure. It is used in combination with other suitable medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

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

Do not take Bisoprolol Normon if you have one of the following heart problems:

Consult your doctor if you are unsure if 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 medication; your doctor may want to take special precautions (e.g. provide additional treatment or perform more frequent examinations):

– diabetes

– strict fasting

– certain heart conditions such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina)

– kidney or liver problems

– less severe circulatory problems in your extremities

– chronic lung disease or mild asthma

– history of scaly skin rash (psoriasis)

– adrenal gland tumor (phaeochromocytoma)

– thyroid disorder

During treatment

Inform your doctor if you are going to:

- desensitization treatment (e.g. for hay fever prevention), as bisoprolol may make you more likely to experience an allergic reaction, or that reaction may be more severe.

- anesthesia (e.g. for surgery), as bisoprolol may affect how your body reacts to this situation.

If you have chronic lung disease or mild asthma, inform your doctor immediately if you start experiencing new breathing difficulties, cough, wheezing after exercise, etc. while taking bisoprolol.

Taking Bisoprolol Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Do not take the following medications with Bisoprolol Normon without special advice from your doctor:

– certain medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone).

– certain medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem)

– certain medications used to treat high blood pressure such as clonidine, methyldopa, moxonidine, or rilmenidine. However, do not stop taking these medications without consulting your doctor first.

Consult your doctor before taking the following medications with Bisoprolol Normon, your doctor may need to monitor your condition more frequently:

– certain medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine)

– certain medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medications such as amiodarone)

– beta-blockers applied locally (such as eye drops of timolol for glaucoma treatment)

– certain medications used to treat, for example, Alzheimer's disease or for glaucoma treatment (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute cardiac problems (sympathomimetics such as isoprenaline and dobutamine)

– insulin or other medications for diabetes

– anesthetics (e.g. during surgery)

– digitalis, used to treat heart failure

– nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (e.g. ibuprofen or diclofenac)

– Medications for asthma or used for nasal congestion

– any medication that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital) or certain medications used to treat mental disorders characterized by loss of contact with reality (phenothiazines such as levomepromazine)

– mefloquine, used to prevent or treat malaria

– medications for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Bisoprolol may have harmful effects on the pregnancy and/or fetus. It may also affect the baby's growth. Therefore, bisoprolol should not be used during pregnancy.

The passage of bisoprolol into breast milk is unknown, 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 operating machinery

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medication. Be especially cautious 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 medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

Important information for athletes

Warning to athletes: this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts, 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 pectoris

Adults, including elderly patients

The maximum recommended dose is 20 mg once a day.

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, and this will usually be done in the following way:

- 1.25 mg of bisoprolol once a day for one week.

- 2.5 mg of bisoprolol once a day for one week.

- 3.75 mg of bisoprolol once a day for one week.

- 5 mg of bisoprolol once a day for four weeks.

- 7.5 mg of bisoprolol once a day for four weeks.

- 10 mg of bisoprolol once a day as maintenance therapy (continuation).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may decide to also prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose less than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do.

Use in patients with renal and/or hepatic insufficiency

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic insufficiency. In patients with severe renal insufficiency (creatinine clearance <20

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 bisoprolol tablets than you should, inform your doctor immediately. Your doctor will decide what measures are necessary.

The symptoms of an overdose may include a reduced heart rate, severe difficulty breathing, a feeling of dizziness, or tremors (due to decreased 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 medication and the amount ingested.

If you forgot to take Bisoprolol Normon

Do not take a double dose to compensate for the missed doses.Take your dose as soon as you remember, unless it is time to take the next dose.

If you interrupt treatment with Bisoprolol Normon

Treatment with bisoprolol should not be interrupted abruptly. If you stop taking this medication suddenly, your condition may worsen. Instead, the dose should be gradually reduced over a period of weeks as indicated by your doctor.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

To prevent serious adverse reactions, talk to your doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

Themost serious side effectsare related to heart function:

– Slowed 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:

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

• Depression.
• Respiratory problems in patients with asthma or chronic respiratory disease

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

• Inflammation of the liver that may cause yellowing of the skin or white of the eyes.

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

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

• Fatigue*.
• Headache*
• Sensation of coldness or numbness of hands and/or feet.
• Low blood pressure.
• Gastrointestinal 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.

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

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

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

• Ear problems.
• Allergic nasal discharge.
• Decreased tear production
• Abnormal results of blood tests for liver function or lipid levels.
• Reactions similar to allergic reactions such as itching, redness, and skin rashes.
• Erectile dysfunction
• Nightmares, hallucinations
• Passing out

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

• Eye irritation and redness (conjunctivitis)
• Loss of hair.
• Appearance or worsening of scaly skin rash (psoriasis);psoriasis-like rash

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bisoprolol Normon

Disodium anhydrous phosphate, microcrystalline cellulose, cornstarch, sodium croscarmellose, colloidal silica, vegetable magnesium stearate, hypromellose, talc, macrogol 6000, titanium dioxide (E171).

Appearance of the product and content of the packaging

Bisoprolol Normon 1.25 mg arefilm-coated, round, biconvex, and white or almost white tablets, with the imprint “B1.25” on one of their faces.They are available in blister packaging (PVC/Al or PVDC-PE/Al).

Blister containing 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: October 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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