BISOPROLOL STADA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Stada 10 mg 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, as it may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bisoprolol Stada and what is it used for
2. What you need to know before you take Bisoprolol Stada
3. How to take Bisoprolol Stada
4. Possible side effects
5. Storage of Bisoprolol Stada
6. Contents of the pack and other information

1. What is Bisoprolol Stada 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 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. At the same time, bisoprolol reduces the heart's demand 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 Stada is used to:

• treat high blood pressure (hypertension).
• treat chronic stable angina pectoris.

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 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 substance 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 Stada 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 and you do not have a pacemaker.
  • cardiogenic shock, which is a severe and acute heart disease that causes low 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 (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
• first-degree heart block (a condition in which the nerve signals to the heart are altered, capable of producing an occasional skipped beat or an irregular heartbeat)

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

• desensitization treatment (e.g., to prevent hay fever), as Bisoprolol Stada may make you more likely to experience an allergic reaction, or such a reaction may be more severe.
• Anesthesia (e.g., for surgery), as Bisoprolol Stada 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.

Children and adolescents

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

Other medicines and Bisoprolol Stada

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 Stada 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 pectoris, 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 first consulting your doctor.

Consult your doctor before taking the following medicines with Bisoprolol Stada, as 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 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 to treat 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)
• 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 used to treat 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, 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 medicine.

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

It is not known whether bisoprolol passes into breast milk, and 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.

Bisoprolol Stada contains sodium

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

3. How to take Bisoprolol Stada

Follow exactly the administration instructions of this medicine given 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.

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

Treatment with Bisoprolol Stada is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

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

The maximum recommended 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 maximum daily recommended 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.

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

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 of bisoprolol should not exceed 10 mg once daily.< p>

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 tablets of Bisoprolol Stada 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 taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Bisoprolol Stada

Do not take a double dose to make up for forgotten doses. Take your usual dose the next morning.

If you stop taking Bisoprolol Stada

Do not stop taking Bisoprolol Stada unless your doctor tells you to. Otherwise, your condition could worsen significantly. Treatment should not be stopped abruptly, especially in patients with chronic heart failure. If you are considering stopping treatment, your doctor will tell you how to gradually reduce the dose.

If you have any further questions about the use of this medicine, 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, sudden, 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.

Below are mentioned other side effects according to their frequency of possible occurrence:

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

• fatigue, weakness, dizziness, 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.

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

• sleep disorders
• depression
• dizziness when standing up
• breathing 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
• reduced tear production (dry eyes)
• inflammation of the liver that can cause yellowing of the skin or the whites of the eyes
• certain abnormal blood test results for liver function or fat levels
• allergic reactions such as itching, redness, and skin rashes
• 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); psoriasis-like rash

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 Stada

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 is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. 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 Stada

• The active substance is bisoprolol fumarate.

Each tablet contains 10 mg of bisoprolol fumarate.

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

Appearance of the product and contents of the pack

White to almost white, round, biconvex tablet, scored with a "10" to the left of the score line and smooth on the other side.

The tablet can be divided into equal doses.

Bisoprolol Stada is available in packs containing 28, 30, and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

Co. Galway

Ireland.

This leaflet was approved in:July 2017

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/