Bilocor Side Effects

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Answer the side-effect intent for bilocor without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Bilocor?

Bilocor contains the active ingredient Bisoprolol fumarate.

• Active ingredient — Bisoprolol fumarate
• Registration number — A38/5.2/0051; A38/5.2/0053
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• The active substance in BILOCOR is bisoprolol
• Bisoprolol belongs to a group of medicines called beta-blockers
• 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

Common side effects of Bilocor

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• drowsiness, unusual tiredness or weakness, dizziness, mild headache
• slow or irregular heart rate
• feeling of coldness or numbness in hands or feet, low blood pressure
• nausea, vomiting, diarrhoea, constipation
• abnormal physical weakness or lack of energy, feeling of constant tiredness or weakness (fatigue)

Less frequent side effects

• blood disorders such as low white blood cell count (leucopenia characterised by frequent infections, infections that don’t resolve fatigue, feeling unwell), low blood platelet count (thrombocytopenia characterised by easy or excessive bruising, bleeding gums, rash of pinpoint-sized reddish-purple spots usually on lower legs, prolonged bleeding)
• sleeping problems, depression, nightmares, hallucinations, vivid dreams, confusion
• anxiety, nervousness, fainting
• dry, sore eyes, irritation and redness of the eye (conjunctivitis), reduced tear flow (can be a problem if you wear contact lenses)
• feeling faint or dizzy when standing up from a sitting or lying position
• breathing problems in patients with asthma or chronic lung disease, stuffy nose (nasal congestion), allergic runny nose (blocked or runny nose)
• skin rash, itching of skin, appearance or worsening of scaly skin rash (psoriasis), swelling under the skin (angioedema), hair loss
• back pain, joint pain or chest pain, muscle cramps, muscle weakness
• impaired erection (reduced sexual performance), problems during sexual intercourse (sexual dysfunction)
• some blood test for liver function and fat content are different from normal value. The following side effects have been reported but the frequency for them to occur is not known:
• low blood sugar levels, increased uric acid levels in the blood, high cholesterol levels
• hallucinations, delusions, confused and disturbed thoughts (symptoms of psychosis)
• restlessness, lack of energy, abnormal sensation, typically tingling or pricking (‘pins and needles’)
• problems seeing
• temporary loss of hearing
• dizziness, palpitations, fatigue, chest pressure or pain, shortness of breath, fainting spells (symptoms of heart block), fluid retention
• weight gain, painful swelling and sores inside the mouth (stomatitis)
• sweating
• disorder affecting the muscles that control voluntary movement in the body (myopathy)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to bisoprolol or any of the other ingredients of BILOCOR
• if you suffer from severe asthma or from other severe breathing difficulties
• if you suffer from acute heart failure or if you are receiving therapy for a weak heart
• if you have a weak, irregular or slow heartbeat
• if you have cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure
• if you have low blood pressure
• if you are pregnant or breastfeeding your baby
• if you suffer from metabolic acidosis, which is a condition when there is too much acid in the blood (this sometimes occurs as an acute complication of diabetes)
• if you suffer from late stage peripheral arterial occlusive disease, including severe forms of Raynaud’s syndrome (a condition where the blood supply to the tips of the fingers or toes may become restricted as to cause tissue damage)
• if you suffer from phaeochromocytoma, which is a rare tumour of the adrenal gland (marked by high blood pressure, raised heart rate and headache)
• if you have a thyroid problem, as BILOCOR may hide symptoms of an overactive thyroid
• do not use BILOCOR in children as safety and efficacy have not been proven

Use with care, and tell your doctor, if

• if you suffer from asthma or from any other breathing difficulties
• if you suffer from less severe blood circulation problems in your limbs (resulting in temporary discoloration of the skin and numbness of the fingers or toes)
• if you suffer from diabetes mellitus as BILOCOR may mask low blood sugar levels
• if you experience sudden onset of chest pain, or if you already suffer from a mild form of angina or heart conditions as BILOCOR may make your angina worse if you stop taking it abruptly
• if you are due to have an operation; you should inform the hospital doctor that you are taking BILOCOR 5 or BILOCOR 10 because it may influence how your body reacts to this situation
• if you have liver or kidney problems
• if you are following a strict fasting program
• if you are receiving ongoing desensitisation therapy. BILOCOR may increase both the sensitivity to allergens and the severity of anaphylactic reactions
• if you have any heart problems such as disturbances in heart rhythm, or severe chest pain or severe chest pain at rest (Prinzmetal’s angina), or heart failure
• if you suffer from or have suffered from psoriasis (marked by severe skin rashes)
• if you suffer from phaeochromocytoma (marked by high blood pressure, raised heart rate and headache); this condition should be treated first, prior to taking BILOCOR 5 or BILOCOR 10. In addition, tell your doctor if:
• you are due to receive an anaesthetic (for example for an operation)
• you are going to have desensitisation therapy (for example to prevent hay fever), since BILOCOR may make it more likely that you will experience an allergic reaction, or more severe reaction. Children and adolescents Safety and efficacy of BILOCOR have not been established in children

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine
• Pregnancy You should not take BILOCOR if you are pregnant or suspect that you are pregnant
• There is a risk that BILOCOR may harm the baby
• Contact you doctor or healthcare provider immediately
• Breastfeeding You should not take BILOCOR if you are breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as verapamil and diltiazem)
• medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first. Check with your doctor before taking the following medicines with BILOCOR as they may interact with BILOCOR, and your doctor may need to check your condition more frequently:
• medicines used to treat high blood pressure or angina pectoris (dihydropyridine- type calcium antagonists such as felodipine and amlodipine)
• medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone), as you may have depression of the heart muscle
• beta-blockers applied locally (such as timolol eye drops for glaucoma treatment)
• medicines used to treat for example Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or carbachol that stimulate or suppress your nervous system)
• oral blood sugar lowering medicine or insulin, as you may experience extremely low blood sugar levels when taking BILOCOR
• anaesthetic medicines, as BILOCOR may lower the heart’s reflex response to a decrease in blood pressure and reduce your blood pressure. If you are due to have an operation, tell the anaesthetist or the medical staff you are taking BILOCOR
• digitalis glycosides such as digoxin (used improve the strength and efficiency of the heart or control the rate and rhythm of the heart) may be used with BILOCOR. Your doctor should monitor your pulse rate and response regularly
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or diclofenac as they may decrease the effect of BILOCOR
• medicines in the beta-adrenoceptor agonist class used to treat acute heart problems (such as isoprenaline, dobutamine) may stop BILOCOR from working correctly
• sympathomimetics such as epinephrine and norepinephrine which are used in the treatment of heart attack and low blood pressure. Epinephrine is also used to treat allergic reactions. Higher doses of adrenaline may be necessary for treatment of allergic reactions if BILOCOR is taken at the same time
• using the medicines reserpine or guanethidine with BILOCOR may cause life- threatening vasoconstriction (constricting of the blood vessels)
• medicines which can lower blood pressure such as other antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbitone), or certain medicines to treat mental illness characterised by a loss of contact with reality (phenothiazines such as levomepromazine). These medicines used with BILOCOR may lower your blood pressure further
• mefloquine, used for prevention or treatment of malaria may slow your heart rate when taken with BILOCOR
• medicines to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide as they may increase the effect of BILOCOR or cause a severe increase in blood pressure
• ergotamine derivatives, used to treat severe, throbbing headaches, such as migraine and cluster headaches may affect the way both medicines work. BILOCOR with food and drink The tablets can be taken with or without food

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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