BISOPROLOL UXA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Uxa 5mg 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 Uxa and what is it used for

1. What you need to know before you take Bisoprolol Uxa
2. How to take Bisoprolol Uxa
3. Possible side effects
4. Storage of Bisoprolol Uxa
5. Contents of the pack and other information

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

The active substance is bisoprolol fumarate. 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 heart rate and makes the heart more efficient, pumping blood throughout the body.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol Uxa is used to:

• treat high blood pressure (hypertension)
• treat coronary heart disease and chronic stable angina pectoris caused by a lack of oxygen in the heart muscle.
• treat chronic stable heart failure. Bisoprolol is used in combination with other suitable medications for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

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

Do not take Bisoprolol Uxa

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

• allergy (hypersensitivity) to bisoprolol or any of the other ingredients (see section 6 "Composition of Bisoprolol Uxa")
• 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 Uxa if you have any of the following heart problems:

• acute heart failure
• worsening of heart failure that requires intravenous injection of medications that increase the heart's contractile force
• slow heart rate
• 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

Warnings and precautions

If you have any of the following problems, consult your doctor before starting to take this medication; 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 your limbs
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• adrenal gland tumor (pheochromocytoma) or currently being treated for adrenal gland tumor.
• thyroid disorder.

In addition, inform your doctor if you are going to undergo:

• desensitization treatment (e.g., for the prevention of hay fever), because this medication may make you more likely to experience an allergic reaction, or such a reaction may be more severe
• anesthesia (e.g., for surgery), because this medication 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 notice breathing difficulties, coughing, wheezing after exercise, etc. while using this medication.

Taking Bisoprolol Uxa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take the following medicines with Bisoprolol Uxa 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 pectoris, 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 medicineswithout consulting your doctor first.

Consult your doctor before taking the following medicines with Bisoprolol Uxa; your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (calcium antagonists of the dihydropyridine type such as nifedipine, felodipine, and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeat (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)
• antidiabetic medicines, including insulin
• anesthetic 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.
• Mefloquine, used for the prevention or treatment of malaria.
• 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 amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines for treating mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine)
• medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

Pregnancy

Bisoprolol is not recommended during pregnancy. There is a risk that the use of Bisoprolol Uxa during pregnancy may harm the baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, inform your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take bisoprolol during pregnancy.

Breastfeeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

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.

Use in athletes

This medicine contains bisoprolol, which may produce a positive result in doping tests.

3. How to take Bisoprolol Uxa

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Treatment with Bisoprolol Uxa requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when stopping treatment.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet.

Treatment with Bisoprolol Uxa is usually long-term.

Adults, includingelderly patients

Hypertension and angina pectoris

The maximum recommended dose is 20 mg once daily.

Chronic stable heart failure

Treatment should be carried out by a doctor with experience in the treatment of chronic heart failure.

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 maximum recommended daily dose is 10mg 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.

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

Use in patients with renal and/or hepatic impairment

In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, the dose of bisoprolol should not exceed 10 mg once daily.< p>

Use in children and adolescents

The use of Bisoprolol Uxa is not recommended in children or adolescents.

If you take more Bisoprolol Uxa than you should

If you have taken more tablets of Bisoprolol Uxa than you should, inform your doctor immediately. Your doctor will decide what measures are necessary. 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 taken.

The symptoms of an overdose may include a reduction in heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

If you forget to take Bisoprolol Uxa

If you forget to take a dose, take it as soon as you remember, unless it is time to take the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Bisoprolol Uxa

Never stop taking this medicine except on the advice of your doctor. Otherwise, your condition could worsen significantly. If you are considering stopping treatment, your doctor will tell you how to gradually reduce the dose to avoid any adverse effects.

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

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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 a doctor immediately if a side effect is severe, occurs suddenly, or worsens rapidly.

The most serious side effects are 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 are mentioned below according to their possible frequency of occurrence:

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

• fatigue*
• headache*
• feeling of cold or numbness in hands 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 pectoris. They are usually mild and disappear within 1-2 weeks.

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

• sleep disorders
• depression
• dizziness when standing up
• changes in normal heart rhythm
• respiratory problems in patients with asthma or chronic respiratory disease
• muscle weakness, muscle cramps.

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

• hearing problems
• runny nose
• decreased tear production
• inflammation of the liver that can cause yellowing of the skin or the whites of the eyes
• certain blood test results for liver function or fat levels outside the normal range
• allergic reactions such as itching, redness, rash
• erectile 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); rash similar to psoriasis.

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Uxa

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

No special storage conditions are required.

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

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6. Contents of the pack and other information

Composition of Bisoprolol Uxa

The active substance is bisoprolol fumarate.

Each tablet contains 5 mg of bisoprolol fumarate.

The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized maize starch, crospovidone, anhydrous colloidal silica, magnesium stearate, and Opadry yellow 03B82846 (composed of HPMC 2910/hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172), and macrogol/PEG 400)

Appearance of the product and pack contents

Bisoprolol Uxa is presented in the form of round, biconvex, white-yellowish film-coated tablets, marked with "C" and scored on one side and marked with "39" on the other, in aluminum/aluminum blister packs containing 28 and 60 tablets.

The score line is only for breaking and facilitating swallowing but not for dividing into equal doses.

Marketing authorization holder

Uxa Farma S.A.

Avda. San Francisco Javier, 24

41018 SEVILLA

Spain

Manufacturer

Netpharmalab Consulting Services Carretera de Fuencarral 22

Alcobendas

28108 Madrid

Date of last revision of this leaflet: January 2020

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.gob.es/.