• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to Bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• if you have a cardiogenic shock, a serious heart condition causing a rapid, weak pulse; low blood pressure; cold, clammy skin; weakness and fainting.
• if you have ever suffered from severe wheezing or severe asthma, as they can affect your breathing.
• if you have a slow heart rate (less than 60 beats per minute). Ask your doctor if you are not sure.
• if you have very low blood pressure.
• if you have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue).
• if you have certain serious heart rhythm problems.
• if you have heart failure which has just occurred or is not stabilised and is requiring hospital treatment.
• if you have a condition in which there is an accumulation of excessive acid in the body known as metabolic acidosis. Your doctor will be able to advise you.
• if you suffer from a tumour of the adrenal glands known as phaeochromocytoma which is untreated.

Tell your doctor if you are not sure about any of the above.

Talk to your doctor before taking Bisoprolol fumarate

• if you suffer from wheezing or difficulty breathing (asthma) Bronchodilating therapy should be given concomitantly. A higher dose of beta2-stimulants may be needed.
• if you have diabetes. The tablets can hide the symptoms of low blood sugar (such as accelerated heart beat rate, palpitations or sweating).
• if you are fasting from solid food
• if you are treated for hypersensitivity (allergic) reactions. Bisoprolol fumarate may increase the hypersensitivity to the substances you are allergic to and increase the severity of the hypersensitivity reactions. Treatment with adrenaline then may not have the desired result. A higher dose of adrenaline (epinephrine) may be needed.
• with 1st degree heart block (conduction disorder in the heart)
• if you suffer from Prinzmetal’s angina which is a type of chest pain caused by spasm of the coronary arteries that supply the heart muscle
• if you have any problems with the circulation to the extremities of the body such as hands and feet
• in case of surgery involving an anaesthetic. If you consult a doctor, attend hospital or the dentist for surgery involving anaesthetics, let them know what medicines you are taking
• in combination with calcium antagonists, such as verapamil and diltiazem. Concomitant use is not recommended, see also section“Other medicines and Bisoprolol fumarate”.
• if you suffer (or have suffered) from psoriasis (a recurrent skin disorder involving scaling and dry skin rash)
• if you suffer from phaeochromocytoma (tumour of the adrenal marrow). Your doctor will need to treat this before prescribing Bisoprolol fumarate for you.
• if you have a thyroid problem. The tablets can hide symptoms of an overactive thyroid.

There is so far no therapeutic experience of Bisoprolol fumarate treatment of heart failure in patients with the following diseases and conditions:

• diabetes mellitus treated with insulin (type I).
• severe kidney disease.
• severe liver disease.
• certain heart diseases.
• heart attack within 3 months.

Treatment of heart failure with Bisoprolol fumarate requires regular medical monitoring. This is absolutely necessary, particularly at the beginning of treatment, and upon stopping treatment.

Treatment with Bisoprolol fumarate must not be discontinued abruptly unless for compelling reasons.

For patients with hypertension and angina pectoris, accompanying heart failure treatment should not be stopped abruptly. The dosage should be diminished slowly by a weekly halving of the dose.

Consult your physician if one of the above warnings is applicable to you, or has been in the past.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. Certain medicines cannot be used at the same time, while other drugs require specific changes (in the dose, for example).

Always tell your doctor if you are using or receiving any of the following medicines in addition to Bisoprolol fumarate:

• Medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea).
• Medicines for depression e.g. tricyclic antidepressants, MAO-A inhibitors.
• Medicines used for anaesthesia during an operation (see also section “Warnings and precautions”).
• Certain pain killers (for instance acetyl salicylic acid, diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
• Certain medicines to treat shock (e. g. adrenaline, dobutamine, noradrenaline)
• Mefloquine, a medicine for malaria.
• The antibiotic rifampicin.
• Ergotamine derivatives for migraine.

All these drugs as well as Bisoprolol fumarate may influence the blood pressure and/or heart function.

• Insulin or other products for diabetes. The blood glucose reducing effect may be enhanced. Symptoms of low blood glucose levels can be masked.

The dizziness and light-headedness that may be caused by Bisoprolol fumarate can be made worse if you drink alcohol. If this happens to you, you should avoid drinking alcohol.

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. Bisoprolol fumarate may be harmful to the pregnancy and/or the unborn child. There is an increased possibility of premature birth, miscarriage, low blood sugar level and reduced heart rate of the child. The growth of the baby may also be affected. Therefore, bisoprolol should not be taken during pregnancy.

It is not known if bisoprolol is excreted in the breast milk and therefore it is not recommended while breast-feeding.

This medicine may make you feel tired, drowsy or dizzy. If you suffer from these side effects, do not operate vehicles and/or machines. Be aware of the possibility of these effects, particularly at the beginning of the treatment, with changes in medication and with use in combination with alcohol.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

Adults

The dose is determined individually.

The recommended starting dose is 5 mg once daily.

The usual dose for adults is once daily 10 mg. Your doctor may decide to increase or decrease the dose.

The maximum dose is once daily 20 mg.

Severe kidney or severe liver function disorders

If you suffer from a severe kidney or severe liver function disorder the maximum dose is 10 mg per day.

Elderly

Normally no dosage adjustment is required. Your doctor will start therapy with the lowest possible dose.

Before you start using Bisoprolol fumarate, you are already using an ACE-inhibitor, diuretic or heart glycoside (heart/ blood pressure product).

The dose will be increased gradually until the dose that is suitable for you has been found:

1.25 mg once daily for 1 week. If this is well tolerated, the dose may be increased to:

2.5 mg once daily during the next week. If this is well tolerated, the dose may be increased to:

3.75 mg once daily during the next week. If this is well tolerated, the dose may be increased to:

5 mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to:

7.5 mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to:

10 mg once daily as a maintenance dose.

Maximum dose is once daily 10 mg.

The doctor will determine the optimum dose for you amongst others based on possible side effects.

After the very first dose of 1.25 mg the doctor will check your blood pressure, heart rate and heart function disorders.

Liver or kidney function disorders

The doctor will be extra careful with the increasing of the dose.

Elderly:

Normally spoken an adjustment of the dose is not needed.

If you notice that the effect of Bisoprolol fumarate is too strong or not strong enough, please consult your doctor or pharmacist.

Place the tablet on a hard, flat surface with the scored side at the top.

Press with the thumb on the middle of the tablet and the tablet will break into two halves, press with the thumb in the middle of each half and you will have four parts.

Bisoprolol fumarate will usually be used long-term.

There is no experience with Bisoprolol fumarate in children and adolescents, therefore its use is not recommended in children.

If you have accidentally taken more than the prescribed dose, tell your doctor/pharmacist immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken. Symptoms of overdose may include dizziness, light-headedness, fatigue, breathlessness and/or wheezing. Also, there may be reduced heart rate, reduced blood pressure, insufficient action of the heart and a low blood glucose level (which may involve feelings of hunger, sweating and palpitations).

Do not take a double dose to make up for a forgotten dose. Take the normal dose as soon as you remember and then carry on with the usual dose the next day.

Treatment with Bisoprolol fumarate must not be stopped abruptly. If you suddenly stop taking this medicine your condition may get worse. Instead, it must be reduced gradually over a few weeks as advised by your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is bisoprolol fumarate.

Each film-coated tablet contains 5 mg of bisoprolol fumarate.

5mg film-coated tablets:

The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).

Each film-coated tablet contains 10 mg of bisoprolol fumarate.

10mg film-coated tablets:

The other ingredients are:

anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

• 5 mg film-coated tablets:
  Yellow coloured, round, scored film-coated tablets with a one-sided embossment „BIS 5".
  The tablet can be divided into four equal doses.
• 10 mg film-coated tablets:
  Apricot coloured, round, scored film-coated tablet with a one-sided embossment „BIS 10".
  The tablet can be divided into four equal doses.

The film-coated tablets are packed in OPA/Alu/PVC/Alu blisters and inserted in a carton, or are packed in a HDPE tablet bottle with PE cap.

Pack sizes:

Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x30, 500 film-coated tablets

Bottle: 10, 20, 30, 50, 60, 100, 250, 500 film-coated tablets

Not all pack sizes may be marketed.

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