Introduction

Leaflet: information for the user

Bisoprolol Stada 2.5 mg tablets EFG

Bisoprolol fumarate

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, ask 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 Stada and for what it is used

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

3.How to take Bisoprolol Stada

4.Possible side effects

5.Storage of Bisoprolol Stada

6.Contents of the pack and additional informationinformation

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

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 Stada 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).

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

Do not take Bisoprolol Stada:

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

if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)
severe asthma
severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause numbness in the fingers and toes or make them pale or blue
untreated phaeochromocytoma, 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 Stada if you have any of the following heart problems:

acute heart failure.
- exacerbation of heart failure that requires intravenous medication to increase the heart's contraction force.
- low blood pressure
- specific heart conditions that cause a very slow or irregular heart rate and you are not a pacemaker carrier.
- cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.
- slow heart rate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol Stada.

If you have any of the following conditions, consult your doctor before taking Bisoprolol Stada; your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

diabetes
strict fasting
specific heart conditions such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina)
kidney or liver problems
milder circulatory problems in the extremities
chronic lung disease or milder asthma
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, capable of causing occasional omission of the beat or irregular heartbeat)

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

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

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

Children and adolescents

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

Other medications and Bisoprolol Stada

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

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

specific medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone).
specific medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem)
specific 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 Stada, your doctor may need to monitor your condition more frequently:

specific medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine)
specific 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) – specific 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 conditions (sympathomimetics such as isoproterenol and dobutamine)
insulin or other medications for diabetes
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)
any medication that can lower blood pressure as a desired or undesired effect, such as antihypertensives, specific medications for depression (tricyclic antidepressants such as imipramine or amitriptyline), specific medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital) or specific 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, breastfeeding, and fertility

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

There is a risk that using Bisoprolol Stada during pregnancy may harm the baby. Your doctor will decide if you can take bisoprolol during pregnancy.

The passage of bisoprolol into breast milk is unknown, and therefore breastfeeding is not recommended during treatment with bisoprolol.

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.

Bisoprolol Stada contains sodium

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

3. How to Take Bisoprolol Stada

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

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 Stada requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase and at the end of treatment.

The treatment with Bisoprolol Stada is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

The recommended starting dose is 5 mg once a day. If necessary, the dose can be increased to 10 mg per day.

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 as follows:

-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 (continue).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may also decide to 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 reduce the dose gradually, as otherwise your condition may worsen.

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 Stada is not recommended in children.

The tablet can be divided into equal doses

If you take more Bisoprolol Stada than you should

If you have taken more Bisoprolol Stada 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Bisoprolol Stada

Do not take a double dose to compensate for the missed doses. Take your usual dose the next morning.

If you interrupt treatment with Bisoprolol Stada

Do not stop taking Bisoprolol Stada unless your doctor tells you to. Otherwise, your condition may worsen significantly. Treatment should not be interrupted suddenly, especially in patients with systemic heart failure. If you are considering interrupting treatment, your doctor will advise you on how to gradually reduce the dose.

If you haveany other questionsabout the use of this medication,ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can 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.

The most serious side effects are related to heart function:

slowing of 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 listed below according to their frequency of possible occurrence:

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

fatigue, weakness, dizziness, headache
sensation of coldness or numbness in hands and/or feet
low blood pressure.
gastrointestinal problems such as nausea, vomiting, diarrhea, or constipation.

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

sleep disturbances
depression
dizziness when standing
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
nasal discharge
decreased tear production (dry eyes)
inflammation of the liver that may cause yellowing of the skin or the white of the eyes
abnormal results of blood tests for liver function or abnormal levels of fat
allergic-like reactions such as itching, redness, and rashes on the skin
erectile dysfunction
nightmares, hallucinations
syncope

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 any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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.

5. Conservation of Bisoprolol Stada

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

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Bisoprolol Stada

The active ingredient is bisoprolol fumarate.

Each tablet contains 2.5 mg of bisoprolol fumarate.

The other components are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium carboxymethylcellulose (type A) (derived from potato starch) and magnesium stearate.

Appearance of the product and contents of the packaging

White to almost white, round, biconvex tablet, engraved with “2”, scored, “5” and smooth on the other side.

The tablet can be divided into equal doses.

Bisoprolol Stada is presented in packaging containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible for manufacturing:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

Co. Galway

Ireland.

This leaflet has been approved in:July 2017

The 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/