Bisoprolol Kern Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bisoprolol Kern Pharma 5 mg tablets EFG

Bisoprolol fumarate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Bisoprolol Kern Pharma is and what it is 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 down 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 Kern Pharma 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 appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking Bisoprolol Kern Pharma

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

• If you are allergic to bisoprolol or to any of the other components of this medicine (listed in section 6).
• If you have severe asthma or severe chronic lung disease.
• If you have 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.
• If you have untreated pheochromocytoma, which is a rare tumor of the adrenal gland.
• If you have metabolic acidosis, a condition that occurs when there is too much acid in the blood.

Do not take Bisoprolol Kern Pharma if you have any of the following heart problems:

• Acute heart failure.
• Worsening heart failure requiring intravenous administration of medicines that increase the heart's contraction force.
• Low blood pressure.
• Certain heart conditions causing a very slow heart rate or irregular pulse, and you do not have a pacemaker.
• Slow heart rate.
• Cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting bisoprolol. If you have any of the following conditions, consult your doctor before taking this medicine; your doctor may wish to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• diabetes,
• strict fasting,
• certain heart diseases 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,
• less severe asthma or chronic lung disease,
• history of scaly skin rash (psoriasis),
• tumor of the adrenal gland (pheochromocytoma),
• thyroid disorder,
• first-degree heart block (a condition in which nerve signals to the heart are disturbed, possibly causing occasional missed beats or irregular heartbeat).

In addition, inform your doctor if you are undergoing:

• desensitization treatment (e.g., for hay fever prevention), because bisoprolol may make allergic reactions more likely or more severe,
• anesthesia (e.g., for surgery), because this medicine may affect how your body responds to this situation.

Children and adolescents

Bisoprolol is not recommended for use in children and adolescents.

Taking Bisoprolol Kern Pharma with other medicines

Inform 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 without specific medical advice:

• 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, 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, as your doctor may need to monitor your condition more frequently:

• Certain medicines used to treat high blood pressure or angina (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).
• Topically applied beta-blockers (such as timolol eye drops for glaucoma treatment).
• Certain medicines used, for example, in Alzheimer's disease or glaucoma treatment (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 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 prevention or treatment of malaria.
• Medicines for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• Moxisylylate, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding

There is a risk that using this medicine during pregnancy may harm the baby. 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. Your doctor will decide whether you can take bisoprolol during pregnancy.

It is unknown whether this medicine 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 cautious at the beginning of treatment, when the dose is increased, when medication is changed, and also when combined with alcohol.

Use in athletes

Patients should be advised that this medicine contains bisoprolol, which may result in a positive doping test.

3. How to take Bisoprolol Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increases, and when stopping treatment.

Treatment with this medicine 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 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 normally 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).

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 tell you what to do.

Normally, if treatment needs 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 hypertension or angina pectoris who have 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, it is recommended not to exceed 10 mg of bisoprolol once daily.

Dose titration in patients with chronic heart failure and impaired hepatic or renal function should be performed with increased caution.

If you take more Bisoprolol Kern Pharma than you should

If you have taken more bisoprolol tablets than prescribed, inform your doctor immediately. Your doctor will decide which measures are necessary.

Symptoms of overdose may include a slow 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, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Kern Pharma

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

If you stop taking Bisoprolol Kern Pharma

Do not stop taking this medicine unless instructed by your doctor. Otherwise, your condition could worsen significantly. Treatment must not be stopped suddenly, especially in patients with systemic heart failure. If you are considering stopping treatment, your doctor will advise you on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can 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 up to 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, listed below according to their possible frequency of occurrence:

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

• Tiredness, weakness, dizziness, headache
• Cold sensation or numbness in hands and/or feet
• Low blood pressure
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea, 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 and muscle cramps

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

• Hearing problems
• Runny nose
• Reduced tear production (dry eyes)
• Liver inflammation that may cause yellowing of the skin and 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Kern Pharma

Keep this medicine out of 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Kern Pharma

• The active substance is bisoprolol fumarate. Each tablet contains 5 mg of bisoprolol fumarate.
• The other components are: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, sodium carboxymethyl starch (type A) (from potato), magnesium stearate.

Appearance of the product and contents of the pack

The 5 mg tablets are white or almost white, round, biconvex, with a score line on one side and a "5" marked to the left of the score.

Packs of 28, 30 and 60 tablets in PVC/PVDC/aluminum or PVC/PCTFE/aluminum blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea – Co. Galway

Ireland

Date of the most recent review of this leaflet: June 2017

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