BISOPROLOL FUMARATE ZENTIVA 5 MG TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

Bisoprolol fumarate 1.25 mg tablets

Bisoprolol fumarate 2.5 mg tablets

Bisoprolol fumarate 3.75 mg tablets

Bisoprolol fumarate 5 mg tablets

Bisoprolol fumarate 7.5 mg tablets

Bisoprolol fumarate 10 mg tablets

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 your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet

• 1. What Bisoprolol fumarate is and what it is used for

• 2. What you need to know before you take Bisoprolol fumarate

• 3. How to take Bisoprolol fumarate

• 4. Possible side effects

• 5. How to store Bisoprolol fumarate

• 6. Contents of the pack and other information

1. what bisoprolol fumarate is and what it is used for

The active substance is Bisoprolol fumarate. It belongs to a group of medicines called betablockers. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart _____ more efficient at pumping blood around the

body. At the same time, it reduces the amount of blood required by the heart, as well as its use of oxygen.

Bisoprolol fumarate is used to treat stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. It is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and heart glycosides).

In addition, Bisoprolol fumarate 5 mg and 10 mg are used to treat high blood pressure (hypertension) and heart pain due to impaired perfusion of the coronary vessels (ischemic heart disease, angina pectoris).

2. what you need to know before you take bisoprolol fumarate

Do not take Bisoprolol fumarate if you:

• are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6)
• have severe asthma
• have a late-stage vascular condition causing impaired perfusion of the arms and legs (peripheral arterial occlusive disease)
• have severe blood circulation problems in your limbs (such as Raynaud’s syn­drome); which may cause your fingers and toes to tingle or turn pale or blue
• have untreated phaeochromocytoma (a rare tumour of the adrenal gland)
• have metabolic acidosis (a condition when there is too much acid in the blood).

Do not take Bisoprolol fumarate if you have one of the following heart problems:

• acute heart failure
• worsening heart failure requiring the injection of medicines into a vein, that increase the force of contraction of the heart
• slow heart rate (less than 50 bpm)
• low blood pressure (systolic less than

90 mmHg)

• certain heart diseases causing a very slow heart rate or irregular heartbeat
• cardiogenic shock (an acute serious heart condition causing low blood pressure and circulatory failure).

Talk to your doctor about taking this medicine if you think that one of the conditions listed above applies to you.

Warnings and precautions

• Talk to your doctor or pharmacist before taking Bisoprolol fumarate if one of the following conditions applies to you. He or she may want to take special care (for example give additional treatment or perform more frequent checks): diabetes strict fasting certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s an­gina)
• kidney or liver problems
• less severe blood circulation problems in your limbs
• chronic lung disease or less severe asthma
• history of scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorders.

In addition, tell your doctor if you are going to have:

• desensitization therapy (for example for the prevention of hay fever), because Bisoprolol fumarate may make it more likely that you experience an allergic reaction, or the reaction may be more severe
• anaesthesia (for example for surgery), because Bisoprolol fumarate may influence how your body reacts to this situation.

If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties with breathing, coughing, wheezing after exercise, etc. when taking Bisoprolol fumarate.

Children and adolescents

Bisoprolol fumarate is not recommended for use in children or adolescents.

Other medicines and Bisoprolol fumarate

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 fumarate without special advice from your doctor:

• certain medicines used to treat an irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina pectoris or an irregular heartbeat (calcium antagonists such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with Bisoprolol fumarate; your doctor may need to check your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine
• certain medicines used to treat an irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)
• beta-blockers applied locally (such as timolol eye drops for glaucoma treatment)
• certain medicines used to treat, for example, Alzheimer’s disease or glaucoma (parasym-pathomimetics such as tacrine or carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such as isoprenaline, dobutamine and orciprenaline)
• antidiabetic medicines including insulin
• anaesthetic agents (for example during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or diclofenac)
• any medicine which can 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 anaesthesia (barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for the prevention or treatment of malaria
• medicines to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

There is a risk that use of Bisoprolol fumarate during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. He or she will decide whether you can take Bisoprolol fumarate during pregnancy. Breast-feeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during therapy with Bisoprolol fumarate.

Driving and using machines

Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Please be especially cautious at the start of treatment, when the dose is increased or the medication is changed, as well as in combination with alcohol.

Doping tests

The use of Bisoprolol fumarate may cause positive results in doping tests. The use of Bisoprolol fumarate as a doping substance may constitute a health hazard.

3. how to take bisoprolol fumarate

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment with Bisoprolol fumarate requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increases and when you stop treatment.

Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet. The score line is not intended for breaking the tablet.

Treatment with Bisoprolol fumarate is usually long-term.

Chronic heart failure

Adults including the elderly

Treatment with bisoprolol must be started at a low dose and increased gradually. Your doctor will decide how to increase the dose, and this will normally be done in the following way:

• 1.25 mg once daily for one week
• 2.5 mg nce daily for one week
• 3.75 mg once daily for one week
• 5 mg once daily for four weeks
• 7.5 mg once daily for four weeks
• 10 mg once daily for maintenance (on-going) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will tell you what to do.

If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.

High blood pressure (hypertension) Adults including the elderly

Unless prescribed otherwise, the recommended dose is 5 mg bisoprolol daily. In cases of only slightly elevated blood pressure (diastolic blood pressure of up to 105 mmHg), treatment with 2.5 mg once daily may be sufficient, using other medicinal products with appropriate strength. If the effect is insufficient, the dose can be increased to 10 mg bisoprolol daily.

Additional dose increases are justified only in exceptional cases.

The highest recommended dose is 20 mg once daily.

Ischemic heart disease (angina pectoris) Adults including the elderly

Unless prescribed otherwise, the recommended dose is 5 mg bisoprolol daily.

If the effect is insufficient, the dose can be increased to 10 mg bisoprolol daily. Additional dose increases are justified only in exceptional cases.

The highest recommended dose is 20 mg once daily.

High blood pressure (hypertension) and ischemic heart disease (angina pectoris) Dosing in case of hepatic or renal impairment In patients with mild to moderate hepatic or renal impairment, dosage adjustment is not normally necessary. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment, the daily dose should not exceed 10 mg bisoprolol fumarate.

If you take more Bisoprolol fumarate than you should

If you have taken more Bisoprolol fumarate tablets than you should, tell your doctor immediately. Your doctor will decide what measures are necessary.

Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar).

If you forget to take Bisoprolol fumarate Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

If you stop taking Bisoprolol fumarate Never stop taking Bisoprolol fumarate unless your doctor tells you to do so. Otherwise your condition could become much worse.

If you have any further questions on 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 reactions, speak to your doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.

The most serious side effects are related to the heart function:

• slowing of the heart rate

• – in patients with chronic heart failure (may affect more than 1 in 10 people)

• – in patients with hypertension or angina pectoris (may affect up to 1 in 100 people

• worsening of heart failure (may affect up to 1 in 10 people)
• slow or irregular heartbeat (may affect up to 1 in 100 people).

If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.

• Further side effects are listed below according to how frequently they may occur: Common (may affect up to 1 in 10 people): tiredness*, feeling weak (in patients with chronic heart failure), dizziness*, headache* feeling of coldness or numbness in hands or feet
• low blood pressure
• stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.

*These symptoms particularly occur at the start of treatment. They are generally mild and usually disappear within 1 to 2 weeks after start of treatment.

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

• feeling weak (in patients with hypertension or angina pectoris)
• sleep disturbances
• depression
• dizziness when standing up;
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.

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

• hearing problems
• allergic runny nose
• reduced tear flow (important if you use contact lenses)
• inflammation of the liver which can cause

yellowing of the skin or whites of the eyes

• certain blood test results for liver function or fat levels which differ from normal
• allergy-like reactions such as itching, flushing, rash. You should see your doctor straight away if you experience more severe allergic reactions, which may involve face, neck, tongue, mouth or throat swelling, or difficulty breathing
• impaired erection
• nightmares, hallucinations
• fainting.

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

• irritation and redness of the eye (conjunctivitis)
• hair loss
• developing, or worsening of a scaly skin rash (psoriasis); a psoriasis-like rash.

5. how to store bisoprolol fumarate

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 blister and the carton after EXP. The expiry date refers to the last date of that month.

The 1.25 mg tablets are packed in OPA/PVC/ Aluminium blisters:

Store below 30 °C. Store in the original package in order to protect from moisture.

The 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg tablets are packed in white PVC/PVdC/ Aluminium blisters: Store below 25 °C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Bisoprolol fumarate contains The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg, 2.5 mg, 3.75 mg, 5 mg 7.5 mg or 10 mg bisoprolol fumarate.

The other ingredients are cellulose, microcrystalline (PH 102); starch, pregelatinised; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate.

Bisoprolol fumarate 3.75 mg, 5 mg, 7.5 mg and 10 mg tablets also contain iron oxide yellow (E172 ).

Bisoprolol fumarate 3.75 mg tablets and 10 mg tablets also contain iron oxide brown (E172).

What Bisoprolol fumarate looks like and contents of the pack

Bisoprolol fumarate 1.25 mg tablets: White rounded tablets with 1.25 embossed and diameter 6 mm ± 0.3 mm.

Bisoprolol fumarate 2.5 mg tablets: White rounded tablets with 2.5 embossed, score line and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.

Bisoprolol fumarate 3.75 mg tablets : Off-white to light beige rounded tablets with 3.75 embossed and diameter 6 mm ± 0.3 mm.

Bisoprolol fumarate 5 mg tablets : Yellowish to light yellow rounded tablets with 5 embossed, score line and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet. Bisoprolol fumarate 7.5 mg tablets : Yellow to dark yellow rounded tablets with 7.5 embossed and with randomly distributed spots of colorant and diameter 6 mm ± 0.3 mm.

Bisoprolol fumarate 10 mg tablets : Ochre rounded tablets with 10 embossed, score line and with randomly distributed spots of colorants and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.

Pack sizes:

28, 30, 60, 90 or 100 tablets

Additional pack sizes:

1.25 mg: 20 tablets

2.5 mg: 15 tablets

3.75 mg and 7.5 mg: 50 tablets 5 mg and 10 mg: 50 and 56 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London EC4A 1JP, United Kingdom.

Manufacturer

ZENTIVA k. s.

U Kabelovny 130, Dolni' Mecholupy, 102 37 Prague 10, Czech Republic

This leaflet was last revised in February 2021.