Leaflet: information for the user

Bisoprolol NORMON 5 mg film-coated tablets EFG

bisoprolol hemifumarate

Read this 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; do 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 is Bisoprolol NORMON 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. Storage of Bisoprolol NORMON

6. Contents of the pack and additional informationl

Bisoprolol belongs to a group of medications called beta-blockers. These medications act by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient, pumping blood throughout the body.

Bisoprolol is used for:

- Treating high blood pressure (hypertension).

- Treating chronic stable angina caused by a lack of oxygen in the heart muscle.

- Treating chronic stable heart failure. It is used in combination with other medications. Heart failure is the inability of the heart to pump enough blood to meet the body's needs.

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

- Allergy (hypersensitivity) to bisoprolol or to any of the other components of this medication (listed in section 6).

- Severe asthma or severe chronic lung disease.

- Severe circulatory problems in the extremities (such as Raynaud's syndrome), which may cause tingling in the fingers of the hands and feet or make them pale or blue.

- Untreated phaeochromocytoma, 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 one of the following heart problems:

- Acute heart failure.

- Worsening of heart failure that requires intravenous injection of medications that increase the heart's contraction force.

- Slow heart rate.

- Low blood pressure.

- Certain heart conditions that produce a very slow or irregular heart rate.

- Cardiogenic shock, which is 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, 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 conditions such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina).

- Kidney or liver problems.

- Less severe circulatory problems in the extremities.

- Less severe asthma or chronic respiratory disease.

- History of scaly skin rash (psoriasis).

- Adrenal gland tumor (phaeochromocytoma).

- Thyroid disorder.

- First-degree heart block (a condition in which nerve signals to the heart are altered, causing occasional missed beats or irregular heartbeats).

Also, inform your doctor if you are going to:

- Undergo desensitization treatment (for example, for hay fever prevention), as bisoprolol NORMON may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe.

- Anesthesia (for example, for surgery), as bisoprolol NORMON may affect how your body reacts to this situation.

• Children and adolescents

Bisoprolol NORMON is not recommended for children or adolescents.

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

• Taking Bisoprolol NORMON with other medications:

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication

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, propafenone).

- Certain medications used to treat high blood pressure, chest pain, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem).

- Certain medications used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. However,do not stop taking these medicationswithout consulting your doctor first.

Consult with 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 chest pain (calcium channel blockers of the dihydropyridine type such as 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 heart problems (sympathomimetics such as isoprenaline and dobutamine).

- Antidiabetic medications including insulin.

- Anesthetic agents (for example, during surgery).

- Digitalis, used to treat heart failure.

- Nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac).

- Epinephrine, a medication used to treat severe allergic reactions and cardiac arrest.

- Any medication that can 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 treating depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

• Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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.

The passage of bisoprolol to human breast milk is unknown. Therefore, breastfeeding is not recommended during treatment with Bisoprolol NORMON.

• 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.

• Important information for athletes

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

• Bisoprolol Normon contains sodium

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

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

The 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. The treatment with Bisoprolol NORMON is usually long-term.

Adults:

Treating hypertension and angina pectoris

?The initial dose is 5 mg once a day.

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

The treatment should never be interrupted abruptly, but rather the dose should be gradually reduced over a period of 1 – 2 weeks

Treating chronic stable heart failure

The 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 be done in the following manner:

?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.

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

Renal or hepatic insufficiency

In patients with mild to moderate hepatic or renal impairment, the dose of the medication usually does not need to be adjusted. In patients with terminal renal failure and in patients with severe hepatic insufficiency, the daily dose should not exceed 10 mg.

The experience with bisoprolol in patients undergoing dialysis is limited, but so far, it has not been demonstrated that the dosing regimen needs to be modified in these patients.

Geriatric patients

No adjustment of the dose is necessary.

Pediatric population

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

• If you take more Bisoprolol NORMON than you should

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

In case of overdose or accidental ingestion, consult the Toxicological 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 compensate for the missed doses. Take your usual dose the next morning.

??If you discontinue treatment with Bisoprolol NORMON

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

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

Like all medications, Bisoprolol NORMON may cause side effects, although not everyone will experience them.

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

The most serious side effects are related to heart function:

-Slowed 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 feeling dizzy or weak, or having difficulty breathing, contact a doctor as soon as possible.

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

Frequent(affects less than 1 in 10):

-Fatigue, weakness, dizziness, headache.

-Sensation of coldness or numbness in hands or feet.

-Low blood pressure.

-Stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

Infrequent(affects less than 1 in 100):

-Sleep disturbances.

-Depression.

-Dizziness when standing.

-Respiratory problems in patients with asthma or chronic respiratory disease.

-Muscle weakness, muscle cramps.

Rare(affects less than 1 in 1000):

-Auditory problems.

-Allergic nasal mucositis.

-Decreased tear production.

-Jaundice that may cause yellowing of the skin or white of the eyes. Elevated liver enzymes (laboratory tests (ALAT or ASAT)).

-Determined blood test results for liver function or abnormal levels of fat.

-Allergic reactions similar to those of type such as itching, redness, skin rash.

-Erectile dysfunction.

-Nightmares, hallucinations.

-Loss of consciousness.

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

-Eye irritation and redness (conjunctivitis).

-Loss of hair.

-Appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Inform a doctor or pharmacist if any of the above side effects are experienced or any other unwanted or unexpected effect.

Reporting of side effects

If any type of side effect is experienced, consult a doctor or pharmacist, even if it is not listed in this prospectus. Side effects can also be reported directly through the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not store at a temperature above 30 °C.

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

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

Composition of Bisoprolol NORMON

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

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

Appearance of the product and content of the packaging

Bisoprolol NORMON are film-coated tablets, yellow in color, round, biconvex, and scored. They are presented in packaging with 28, 30, 60, or 500 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Other presentations

BISOPROLOL NORMON 2.5 mg FILM-COATED TABLETS

BISOPROLOL NORMON 10 mg FILM-COATED TABLETS

Last review date of this prospectus

July-2014

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65073/P_65073.html