Biloblok 5 mg/10 mg Film-Coated Tablets

BILOBLOK contains a medicine called bisoprolol fumarate, which belongs to a group of medicines called beta-blockers. BILOBLOK is used to treat the following conditions:

• High blood pressure (hypertension)
• A type of chest pain caused by reduced blood flow to the heart (angina pectoris).

Do not take BILOBLOK if:

• you are hypersensitive (allergic) to bisoprolol fumarate or any of the other ingredients of BILOBLOK (see section 6 What BILOBLOK contains).
• you have the following conditions:
• asthma, bronchitis or any other chronic lung disease
• 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
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland (medulla)
• metabolic acidosis, which is a condition when there is too much acid in the blood
• acute heart failure or heart failure that suddenly becomes worse and/or that may require hospital treatment.
• you have one of the following heart problems:
• heart failure
• slow heart rate
• certain heart conditions causing a very slow heart rate or irregular heartbeat
• cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure.
• you are pregnant or breastfeeding.
• BILOBLOK should not be given to children.

Warnings and precautions

Take special care with BILOBLOK if you:

• have chronic lung disease or less severe asthma.
• have diabetes.
• are on strict fasting.
• have certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal's angina).
• have less severe blood circulation problems in your limbs.
• have kidney or liver problems.
• have a history of a scaly skin rash (psoriasis).
• have a tumour of the adrenal gland (pheochromocytoma).
• have a thyroid disorder.
• are taking the following medicines:
• medicines to treat irregular heartbeat such as disopyramide
• calcium antagonist e.g. verapamil (for high blood pressure)
• clonidine (for high blood pressure).

Do not share medicines prescribed for you with any other person.

Always take BILOBLOK exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. The usual dose is one 5 mg film-coated tablet once daily in the morning. If necessary, your doctor may increase the dosage to 10 mg or 20 mg in the morning. Your doctor will tell you how long your treatment with BILOBLOK will last. Do not stop treatment early. If you have the impression that the effect of BILOBLOK is too strong or too weak, talk to your doctor or pharmacist.

Take BILOBLOK once a day in the morning on an empty stomach or with breakfast. Swallow each tablet with a glass of water. Do not crush or chew the tablets.

If you take more BILOBLOK than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing, low blood pressure and heart failure.

If you forget to take BILOBLOK

It is important to take your BILOBLOK regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for forgotten individual doses.

If you stop taking BILOBLOK

Do not stop taking BILOBLOK tablets just because you feel better. Take BILOBLOK for as long as your doctor recommends. Do not stop taking BILOBLOK unless your doctor tells you to. 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.

BILOBLOK can have side effects. Not all side effects reported for BILOBLOK are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BILOBLOK, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking BILOBLOK and tell your doctor immediately or go to the casualty department of your nearest hospital:

• Sudden signs of allergy – including skin rash, itching or hives; swelling of the face, lips or tongue, shortness of breath or difficulty breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to BILOBLOK. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• Slowing of heart rate, worsening of heart failure, slow or irregular heartbeat. Symptoms include feeling dizzy or weak, or have breathing difficulties.
• 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.
• The development of gangrene, a serious medical condition in which lack of blood supply to body tissues causes the tissue to die. Although any body tissues can be affected, gangrene most commonly starts in the fingers, toes, hands and feet. Gangrene can be fatal if left untreated.
• Hypoglycaemia - low sugar (glucose) levels in the blood. Symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat.
• Breathing difficulties if you have asthma or chronic lung disease.
• Tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes (symptoms of abnormal liver function or hepatitis). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• dizziness, headache, pins and needles in the hands and feet
• feeling of coldness or numbness in hands or feet
• low blood pressure
• nausea, vomiting, diarrhoea, constipation, mouth sores or ulcers
• weakness, tiredness, swelling of the hands and feet.

Less frequent side effects

• a decrease in the number of white blood cells
• reduction in number of red blood cells (anaemia)
• depression, sleep disturbances, nightmares, hallucinations, restlessness, mental illness
• weight gain
• fainting
• reduced tear flow (use suitable lubricating eye drops if you wear contact lenses), irritation and redness of the eye (conjunctivitis), disturbances of vision
• hearing problems
• dizziness when standing up, high blood pressure
• allergic runny nose
• skin rash, hair loss, perspiration, appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash
• muscle weakness, muscle cramps
• difficulty maintaining an erection in men
• laboratory test may show the following:
• blood test results for liver function or fat levels differing from normal

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BILOBLOK.

Store all medicines out of reach of children. Store at or below 25 °C in the original package. Protect from light. Keep blisters in the carton until required for use. Do not use BILOBLOK after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).