Leaflet: Information for the user

Bisoprolol Kern Pharma 10 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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 Kern Pharma and what it is used for

2.What you need to know before starting to take Bisoprolol Kern Pharma

3.How to take Bisoprolol Kern Pharma

4.Possible side effects

5Storage of Bisoprolol Kern Pharma

6.Contents of the pack and additional information

The active ingredient is bisoprolol. Bisoprolol belongs to a group of medications called beta-blockers.

These medications 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 cardiac muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol Kern Pharma 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 medications for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

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 medication (listed in section 6).

-If you have severe asthma or severe chronic lung disease.

-If you have severe circulatory problems in your extremities (such as Raynaud's syndrome), which can cause numbness in your fingers and toes or make them pale or blue.

-If you have untreated phaeochromocytoma, 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 one of the following heart problems:

• Acute heart failure.
• Worsening heart failure that requires intravenous medication to increase heart contraction.
• Low blood pressure.
• Certain heart conditions that cause a very slow or irregular heart rate and you do not have a pacemaker.
• Slow heart rate.
• Cardiogenic shock, a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

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

• Diabetes,
• Fasting,
• Certain heart conditions such as arrhythmias, or severe chest pain at rest (Prinzmetal's angina),
• Kidney or liver problems,
• Milder circulatory problems in your extremities,
• Milder asthma or chronic lung disease,
• History of scaly skin rash (psoriasis),
• Adrenal gland tumor (pheochromocytoma),
• Thyroid disorder,
• First-degree heart block (a condition in which nerve signals to the heart are altered, causing occasional missed beats or irregular heartbeats).

Also, inform your doctor if you are going to:

• Undergo desensitization treatment (for example, for hay fever prevention), because bisoprolol may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe,
• Anesthesia (for example, for surgery), because this medication may affect how your body reacts to this situation.

Children and adolescents

Bisoprolol is not recommended for use in children and adolescents.

Taking Bisoprolol Kern Pharma with other medications

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 without special advice from your doctor:

• Certain medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone).
• Certain medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem).
• Certain medications used to treat high blood pressure such as clonidine, methyldopa, moxonidine, or rilmenidine. However,do not stop taking these medicationswithout consulting your doctor first.

Consult your doctor before taking the following medications with bisoprolol, your doctor may need to monitor your condition more frequently:

• Certain medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as nifedipine, felodipine, and amlodipine).
• Certain medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medications such as amiodarone).
• Topically applied beta-blockers (such as eye drops of timolol for glaucoma treatment).
• Certain 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 cardiac problems (sympathomimetics such as isoproterenol and dobutamine).
• Insulin or other medications for diabetes.
• Anesthetics (for example, during surgery)
• Digitals 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, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital) or certain 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 used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• Moxisilat, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding

There is a risk that the use of this medication during pregnancy may harm the baby. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take bisoprolol during pregnancy.

It is unknown whether this medication passes into breast milk 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.

Use in athletes

Inform patients that this medication contains bisoprolol, which may produce a positive result in doping control tests.

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.

Monitoring by your doctor is required for bisoprolol treatment. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of treatment.

The treatment with this medication 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

Bisoprolol treatment 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:

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 hypertension or angina pectoris and mild to moderate renal or hepatic insufficiency. In patients with severe renal insufficiency (creatinine clearance <20

Gradual dose adjustments in patients with chronic heart failure and deteriorated hepatic or renal function should be made with greater caution.

If you take more Bisoprolol Kern Pharma than you should

If you have taken more bisoprolol 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.

If you forgot to take Bisoprolol Kern Pharma

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

If you interrupt treatment with Bisoprolol Kern Pharma

Do not stop taking this medication 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 discontinuing treatment, your doctor will advise you on how to gradually reduce the dose.

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

Like all medications, this medication may 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:

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):

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

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

• Problems with hearing.
• Nasal discharge.
• Decreased tear production (dry eyes).
• Inflammation of the liver that may cause yellowing of the skin and 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.
• Fainting,

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medications.By doing so, you will help protect the environment.

Composition of Bisoprolol Kern Pharma

-The active ingredient is bisoprolol fumarate. Each tablet contains 10 mg of bisoprolol fumarate.

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

Appearance of the product and content of the container

The 10 mg tablets are white or almost white, round, biconvex, scored on one face, and with a “10” to the left of the score.

PVC/PVDC/aluminum or PVC/PCTFE/aluminum blisters.

It is presented in containers of 28, 30, and 60 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea – Co. Galway

Ireland

Last review date of this leaflet: June 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/