Bisbeta 2.5 mg/5 mg/10 mg Tablets

The active substance is bisoprolol fumarate. BISBETA 2.5 mg: Each film-coated tablet contains bisoprolol fumarate (2:1) 2.5 mg. Sugar free. BISBETA 5 mg: Each film-coated tablet contains bisoprolol fumarate (2:1) 5 mg. Sugar free. BISBETA 10 mg: Each film-coated tablet contains bisoprolol fumarate (2:1) 10 mg. Sugar free. The other ingredients of BISBETA are calcium hydrogen phosphate; cellulose microcrystalline; crospovidone; magnesium stearate and silica colloidal anhydrous. The coating material of BISBETA contains hypromellose; macrogol / PEG 400 and titanium dioxide (C.I. No: 77891).

BISBETA belongs to a group of medicines called beta-blockers. BISBETA are used in combination with other medicines to treat stable chronic (long-term) moderate to severe heart failure. Read all of this leaflet carefully before you start taking BISBETA.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• BISBETA have been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

Do not take BISBETA:

• If you are hypersensitive (allergic) to bisoprolol, or any of the other ingredients of BISBETA.
• If you are in acute heart failure of if you require injection of inotropic medicines (medicines which increase the force of contraction of the heart).
• If you have had cardiac shock (inadequate heart function).
• If you suffer from heart block and do not have a pacemaker.
• If you suffer from very slow heartbeats (less than 50/minute) or sick sinus syndrome (a syndrome of slow heart beats with rapid dysrhythmics).
• If you suffer from sinoatrial block (interference of impulse to heart chamber).
• If you have very poor circulation or Raynaud’s syndrome.
• If you have low blood pressure.
• If you suffer from an untreated phaeochromocytoma (a tumour on the adrenal glands).
• If you suffer from severe bronchial asthma, bronchitis or have severe breathing difficulties.
• If you are pregnant or breast-feeding.
• If you suffer from an overactive thyroid gland producing an excessive amount of thyroid hormones.
• If you have metabolic acidosis (a condition that occurs when the body produces too much acid or when the kidneys are not removing enough acid from the body).
• In children.

Take special care with BISBETA:

Before taking BISBETA, tell your doctor if you suffer from any of the following:

• asthma or any other lung disease.
• diabetes mellitus (taking BISBETA can make it harder for you to tell when you have low blood sugar).
• you are having desensitisation therapy for allergies.
• heart block.
• Prinzmetal’s angina (a form of unstable angina).
• poor circulation.
• psoriasis.
• kidney disease – If you have severe kidney problems, your doctor will adjust the dosage of BISBETA.
• a phaeochromocytoma (a tumour on the adrenal glands).

Also tell your doctor if:

• you are fasting.
• you are taking or receiving any other medicines such as anaesthetics, calcium antagonists, medicines used to treat heart disease and irregular heart beat such as disopyramide and verapamil, and clonidine (medicine used to treat high blood pressure, migraine and menopausal flushing).

Care is required if you are being transferred from clonidine to BISBETA. If you are taking BISBETA and clonidine together, the clonidine should not be stopped until several days after BISBETA have been withdrawn.

You need to have any type of surgery. Tell the surgeon and anaesthetist ahead of time that you are using BISBETA.

BISBETA may mask the signs of thyroid overactivity.

Your doctor will monitor you regularly when you start taking BISBETA.

If you have a history of severe allergic reactions that have required adrenaline, BISBETA may make your system unresponsive to the usual effective dose of adrenaline.

Stopping treatment with BISBETA: Do not stop treatment suddenly without talking to your doctor first.

Taking BISBETA with food and drink:

• BISBETA can be taken with food.
• Swallow the tablets with liquid.

Always take BISBETA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of BISBETA is too strong or too weak, talk to your doctor or pharmacist.

• Your doctor will tell you how many tablets to take. You should take BISBETA in the morning. BISBETA can be taken with food.
• Swallow the tablet/s with some liquid and do not chew or crush them.
• Adults and the elderly: When you first start taking BISBETA your doctor will increase the strength of the tablets you take gradually, until you receive the dose that suits you best. Your doctor will usually start your treatment with: BISBETA 1.25 mg, once daily. If you need a stronger dose, he will put you on: after one week: BISBETA 2.5 mg, once daily, after another week, BISBETA 3.75 mg, once daily, after a further week, BISBETA 5 mg, once daily, after another four weeks: BISBETA 10 mg, once daily (maximum dose).
• After starting treatment with BISBETA 1.25 mg, your doctor may observe you over a period of about 4 hours in order to monitor your blood pressure, heart rate and look for signs of worsening of heart failure.
• Your doctor may interrupt treatment or decrease the dosage step by step, if he considers it necessary.
• Treatment of stable chronic heart failure with BISBETA is generally a long-term treatment.

If you take more BISBETA than you should:

Overdose symptoms may include slow heart rate and severe low blood pressure. Wheezing or shortness of breath and heart failure may occur. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take BISBETA:

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

Effects when treatment with BISBETA is stopped:

Stopping treatment with BISBETA: Do not stop treatment suddenly or change the recommended dose without talking to your doctor first. If you need to stop treatment, it is usually done gradually, to avoid side effects.

BISBETA can have side effects. Get emergency medical help if you have any of these signs of an allergic reaction:

• Hives / rash; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• Slow, fast or pounding heartbeats.
• Chest pain.
• Dizziness, lightheadedness or fainting.
• Feeling short of breath, even with mild exertion.
• Swelling of ankles, feet, or lower legs.
• Unusual bleeding or bruising.
• Hallucinations (false perceptions), loss of contact with reality.
• Numbness, tingling, or cold feeling in your hands and feet.

You may notice tiredness, exhaustion, dizziness and headache, especially during the first two weeks of treatment. Other side effects include: too few white blood cells; lack of energy, fatigue, lethargy; mild headache; difficulty in sleeping; depression; problems with vision; sweating; skin reactions (rash, itching); loss of hair; low blood pressure; high blood pressure; restlessness; nausea (queasiness, feeling that one is about to vomit); vomiting; diarrhoea (frequent or loose watery stools); constipation; inflammation of the mouth; problems with hearing; muscle cramps; muscle weakness; weight gain; low blood sugar; increased levels of uric acid in the blood; increased blood levels of some fats; dizziness, lightheadedness or fainting (especially when getting up from a lying down position); nightmares; bronchospasm (constriction of air passages causing difficulty in breathing); hepatitis (inflammation of the liver) and increased liver enzymes (you would notice a yellowing of your skin or the whites of your eyes); impotence (loss of male sexual ability); runny nose; dry eyes and conjunctivitis.

Tell your doctor if any of the above side effects are severe, bothersome, do not go away or about any concerns you have while taking BISBETA.