Bisoprolol STADA 10 mg tablets EFG

Package leaflet: Information for the user

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 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bisoprolol Stada is and what it is used for
2. What you need to know before taking Bisoprolol Stada
3. How to take Bisoprolol Stada
4. Possible side effects
5. How to store 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, particularly in the heart. As a result, bisoprolol slows the heartbeat and makes the heart more efficient at pumping blood throughout the body. At the same time, bisoprolol reduces the heart's demand for oxygen and its 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 for:

• treating high blood pressure (hypertension).
• treating chronic stable angina pectoris.
• treating chronic stable heart failure. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking 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 to 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 may cause tingling in the fingers and toes or make them pale or blue
• untreated phaeochromocytoma, which is a rare tumour 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
  • worsening heart failure requiring intravenous injection of medicines that increase the heart's pumping strength
  • low blood pressure
  • certain heart conditions causing a very slow heart rate or irregular pulse, and you do not have a pacemaker
  • cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure
  • slow heart rate

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 check-ups):

• diabetes
• strict fasting
• certain heart conditions such as heart rhythm disorders, 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)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder
• first-degree heart block (a condition in which nerve signals to the heart are disrupted, potentially causing occasional missed beats or irregular heartbeat)

In addition, inform your doctor if you are undergoing:

• desensitisation treatment (e.g. for prevention of hay fever), as Bisoprolol Stada may make allergic reactions more likely or more severe.
• anaesthesia (e.g. for surgery), as Bisoprolol Stada may affect how your body responds to this.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you develop 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 medicines and Bisoprolol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide or propafenone).
• certain medicines used to treat high blood pressure, angina, 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; your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as nifedipine, felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmics such as amiodarone)
• locally applied beta-blockers (such as timolol eye drops for glaucoma treatment) – certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• insulin or other medicines for treating diabetes
• anaesthetic 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)
• any medicine that may lower blood pressure as either 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 anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterised by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• medicines for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is a risk that using 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 operate machinery may be affected depending on how well you tolerate the medicine. Be especially careful at the start of treatment, when the dose is increased, when medication is changed, and also when combined 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 instructions for use of this medicine as given by your doctor. If in 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 increases, and when stopping treatment.

Treatment with Bisoprolol Stada is usually long-term.

High blood pressure and angina pectoris

Adults, including elderly patients

The recommended starting dose is 5 mg once daily. If necessary, the dose may 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 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 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 (ongoing treatment).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will advise you what to do.

Normally, if treatment has to be completely discontinued, 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

Dose adjustment is usually not 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 should not exceed 10 mg of bisoprolol once daily.

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 which measures are necessary.

Symptoms of overdose may include a reduced heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Bisoprolol Stada

Do not take a double dose to make up for missed doses. Take your usual dose the following 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 suddenly, especially in patients with systemic heart failure. If you are considering stopping treatment, your doctor will advise 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 adverse effects

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

To prevent serious reactions, speak with your doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly.

The most serious adverse effects are related to heart function:

• Slowing of the 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 adverse effects are listed below according to their possible frequency of occurrence:

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

• Fatigue, weakness, dizziness, headache
• Cold sensation 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 disturbances
• Depression
• Dizziness upon standing
• 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
• Decreased tear production (dry eyes)
• Liver inflammation that may cause yellowing of the skin or whites of the eyes
• Certain abnormal blood test results for liver function or fat levels
• Allergy-like reactions such as itching, redness, and skin rashes
• Erectile dysfunction
• Nightmares, hallucinations
• Fainting

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

• Eye irritation and redness (conjunctivitis)
• Hair loss
• Onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Stada

Keep this medicine out of sight and reach of children.

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components 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, engraved with a “10” to the left of the breakline, 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.

Only certain 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/