Bisoprolol Fumarate 5 mg film-coated tablets

• 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 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

• are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• have severe asthma or severe chronic lung disease
• have a slow or irregular heart rate. Ask your doctor if you are not sure
• have very low blood pressure
• have severe blood circulation problems (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue
• have heart failure that suddenly becomes worse and/ or may require hospital treatment
• Cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure.
• have excess acid in the blood, a condition known as metabolic acidosis
• have untreated phaeochromocytoma, a rare tumour of the adrenal gland (medulla)

Tell your doctor if you are not sure about any of the above: your doctor will be able to advise you.

Talk to your doctor or pharmacist before taking Bisoprolol Fumarate. He or she may want to take special care (for example give additional treatment or perform more frequent checks) if you have any of the following conditions if you:

• have asthma or chronic lung disease
• have diabetes. Bisoprolol fumarate can hide the symptoms of low blood sugar
• are fasting from solid food
• are treated for hypersensitivity (allergic) reactions. Bisoprolol may make your allergy worse or often difficult to treat.
• have certain heart disease such as disturbance in heart rhythm or severe chest pain at rest (Prinzmetal’s angina)
• have any liver or kidney problems
• have any problems with the circulation in your limbs
• are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended, see also “taking other medicines”
• have (or have had) psoriasis (a recurring skin rash)
• have phaeochromocytoma (tumour of the adrenal gland). Your doctor will need to treat this before prescribing bisoprolol for you
• have a thyroid problem. The tablets can hide symptoms of an overactive thyroid

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

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 as allergic reaction or such reaction may be more severe.
• Anesthesia (for example for surgery) because this medicine may influence how your body react to this situation.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain medicines cannot be used at the same time, while other drugs require specific changes (to the dose, for example).

Do not take the following medicines with Bisoprolol Fumarate without special advice from your doctor:

• 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)
• Medicines for depression e.g. imipramine, amitriptyline, moclobemide
• Medicines to treat mental illness e.g. phenothiazines such as levomepromazine
• Medicines used for anaesthesia during an operation (see also “Warnings and precautions”)
• Medicines used to treat epilepsy e.g. barbiturates such as phenobarbital
• Certain pain killers (for instance acetyl salicylic acid, diclofenac, indomethacin, ibuprofen, naproxen)
• Medicines for asthma or medicines used for a blocked nose
• Medicines used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to widen the pupil of the eye.
• Certain medicines to treat clinical shock (e. g. adrenaline, dobutamine, noradrenaline)
• Mefloquine, a medicine for malaria

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

• Rifampicin for the treatment of infections
• medicines to treat severe headaches or migraines (ergotamine derivatives).

It is also especially important to speak with your doctor if you are taking:

• Insulin or other products for diabetes including sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide). Bisoprolol could increase the risk of severely low blood glucose levels when used with these medicines.

Bisoprolol Fumarate may be taken with or without food and should be swallowed whole with a drink of water.

Do not take bisoprolol if you are pregnant or may be pregnant. 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.

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

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

These tablets 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.

Your doctor will take extra care when adjusting the dose of Bisoprolol Fumarate.

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

In general adjustment of the dose is not needed. It is recommended to start with lowest possible dose.

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

Bisoprolol Fumarate will usually be used long-term.

The tablet can be divided into equal halves

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. The dose of bisoprolol must be reduced gradually over a few weeks as advised by your doctor.

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

• Tiredness*, feeling weak, (In patient with chronic heart failure), dizziness*, headache*
• Feeling of coldness or numbness in hands or feet
• low blood pressure, especially in patient with heart failure.
• Stomach or intestine problem such as nausea, vomiting, diarrhoea or constipation

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

• Sleep disturbances
• Depression
• Breathing problems in patients with asthma or chronic lung disease
• Muscle weakness, muscle cramps
• feeling weak (In patient with hypertension or angina pectoris)

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

• Hearing problems
• Inflammation of the lining of the nose, causing a runny nose with irritation
• Allergic reactions (itching, flushed appearance, 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.
• Dry eyes from reduced tear flow (can be very troublesome if you use contact lenses)
• Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite and sometimes jaundice with yellowing of the whites of the eyes and skin and dark urine
• Reduced sexual performance (impaired erection)
• certain blood test results for liver function or fat levels differing from normal
• fainting

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

• Irritation and redness of eye (conjunctivitis)
• Hair loss
• Appearance or worsening of scaly skin rash (psoriasis): Psoriasis like rash.

* if treated for high blood pressure or angina then these symptom occur especially at beginning of treatment, or if your dosage changes. They are generally mild or often disappear within 1 to 2 weeks.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is bisoprolol fumarate. Each tablet contains 2.5 mg, 3.75 mg, 5 mg, 7.5 mg or 10 mg bisoprolol fumarate.
  The other ingredients are: Cellulose microcrystalline, calcium hydrogen phosphate, silica colloidal anhydrous, crospovidone (Type A), magnesium stearate.
  Tablet coat: Hypromellose 6cP (E464), Titanium Dioxide (E171), Macrogol 400.

Bisoprolol Fumarate 2.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and breakline on one side and ‘2’ on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 3.75 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and breakline on one side and ‘3’ on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and breakline on one side and ‘5’ on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 7.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and breakline on one side and ‘7’ on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 10 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and breakline on one side and ‘10’ on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate film-coated tablets are available in cold form Polyamide/Aluminum/PVC-Aluminum blisters and HDPE bottle packs.

Pack sizes:

Blister pack: 20, 28, 30, 50, 90, 100 film-coated tablets

Bottle pack: 30, 500 film-coated tablets

Not all pack sizes may be marketed.

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