BISOPROLOL KERN PHARMA 5 mg TABLETS

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

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

• If you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
• If you have severe asthma or severe chronic lung disease.
• If you have severe circulatory problems in your limbs (such as Raynaud's syndrome), which can cause tingling in your fingers or toes or turn them pale or blue.
• If you have an untreated pheochromocytoma, which is a rare tumor of the adrenal gland.
• If you have metabolic acidosis, which is 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 of heart failure that requires intravenous injection of medications 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.
• Slow heart rate.
• Cardiogenic shock, which is 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 medicine; 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 your limbs,
• mild 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 the nerve signals to the heart are altered, likely causing you to miss a beat from time to time, or beat irregularly).

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

• desensitization treatment (e.g., for hay fever prevention), because bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe,
• anesthesia (e.g., for surgery), because this medicine 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 medicines

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 without special advice from your doctor:

• Certain medicines used to treat irregular or abnormal heartbeats (Class I anti-arrhythmic 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 medicineswithout consulting your doctor first.

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

• Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as nifedipine, felodipine, and amlodipine).
• Certain medicines used to treat irregular or abnormal heartbeats (Class III anti-arrhythmic medicines such as amiodarone).
• Beta-blockers applied locally (such as eye drops containing timolol for glaucoma treatment).
• Certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine).
• Insulin or other diabetes medicines.
• Anesthetic 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 the prevention or treatment of malaria.
• Medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
• Moxisylate, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy and breastfeeding

There is a risk that the use of 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 not known 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 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.

Use in athletes

Patients should be warned that this medicine contains bisoprolol, which may produce a positive result in doping tests.

3. How to take Bisoprolol Kern Pharma

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

Treatment with this medicine is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

The recommended initial 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 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 (continuing).

The maximum recommended daily 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 hypertension or angina pectoris and 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.< p>

Gradual dose adjustments in patients with chronic heart failure and impaired 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, feeling dizzy, or trembling (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 ingested.

If you forget to take Bisoprolol Kern Pharma

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

If you stop taking Bisoprolol Kern Pharma

Do not stop taking this medicine unless your doctor tells you to. Otherwise, your condition could worsen significantly. Treatment should not be stopped abruptly, especially in patients with 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 on the use of this product, 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, occurs suddenly, or worsens rapidly.

The most serious side effects are related to heart function:

• slow 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.

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

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

• Fatigue, weakness, dizziness, headache:
• Feeling cold or numbness in hands and/or feet.
• Low blood pressure.
• Stomach or intestinal problems such as nausea, vomiting, diarrhea, constipation.

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

• Sleep disturbances.
• Depression.
• Dizziness when standing up.
• 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.
• Decreased tear production (dry eyes).
• Liver inflammation that can cause yellowing of the skin and the whites of the eyes.
• Certain blood test results for liver function or fat levels being abnormal.
• Allergic reaction-like symptoms such as itching, redness, and skin rashes.
• Erection problems.
• 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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Bisoprolol Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bisoprolol Kern Pharma

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

Appearance of the product and contents of the pack

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

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

It is available in packs of 28, 30, and 60 tablets.

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 last revision of this leaflet: June 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/