Enalapril Side Effects

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

Part of cardiovascular side effects.

What is enalapril?

Enalapril contains the active ingredient Enalapril maleate.

• Active ingredient — Enalapril maleate
• Registration number — 34/7.1.3/0010; 34/7.1.3/0011; 34/7.1.3/0012
• Registration holder — Ranbaxy Pharmaceuticals (Pty) Ltd

It is approved for:

• Enalapril belongs to a class of medicines called ACE inhibitors
• Enalapril Unicorn is used to treat high blood pressure and to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs)

Common side effects of enalapril

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

• Cough, difficulty in breathing
• Headache, depression
• Blurred vision
• Feeling dizzy, lightheadedness, fainting
• Chest pain, irregular heartbeat, fast heart beat
• Feeling sick (nausea), diarrhoea, stomach pain, disturbances in taste
• Skin rash
• Unusual tiredness or weakness

Less frequent side effects

• Vomiting, indigestion, constipation, loss of appetite, dry mouth, blockage in the bowel (constipation), stomach ulcer, irritated stomach; swollen, red, sore tongue; mouth ulcers and cold sores, dark stools, swelling of your intestine
• Muscle cramps
• Asthma, runny nose, sore throat or hoarseness
• Kidney or urination problems, infection in urinary passage, kidney failure
• Sudden fall in blood pressure, palpitations
• Heart attack or stroke (possibly due to very low blood pressure in high-risk patients)
• Changes in blood values such as a lower number of white and red blood cells, lower hemoglobin, lower number of blood platelets
• ‘Raynaud’s phenomenon’ where your hands and feet may become very cold and white due to low blood flow
• Hepatitis or jaundice (yellow eyes or skin), liver failure, higher levels of liver enzymes or bilirubin (measured in a blood test)
• Inflammation of the cheeks, gums, tongue, lips, throat
• Confusion, sleepiness, trouble in sleeping, nervousness, sleep disorders, strange dreams
• Numbness or weakness of the arms and legs
• Impotence, enlargement of the mammary glands in males
• Flushing, generally feeling unwell (malaise), high temperature (fever), ringing in the ears, loss of smell, swollen runny eyes, dry eyes, tearing, flank pain
• Excessive sweating, itching, hives, hair loss
• A rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals and other skin related problems
• Low level of blood sugar or sodium, high level of creatinine, potassium, urea in blood (all measured in a blood test)

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 enalapril, or to any of the other ingredients of Enalapril Unicorn TABLETS (listed in section 6)
• if you have previously been treated with a medication in the same group of medicines as Enalapril Unicorn (ACE inhibitors) or with a medication in the group of medicines known as angiotensin receptor blockers and have had allergic reactions with swelling of the face, lips, tongue, and or throat with difficulty in swallowing or breathing
• if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited
• if you have severe kidney dysfunction
• if you have kidney problems, where the blood supply to your kidney is reduced (renal artery stenosis)
• if you are also taking potassium sparing diuretics such as spironolactone, triamterene, amiloride
• if you are also receiving lithium therapy: Administration together with ENALAPRIL UNICORN may lead to toxic blood concentrations of lithium
• if you have a hereditary condition called porphyria
• if you are pregnant or breast-feeding
• if you are taking aliskiren containing products
• if you are taking antibiotics belonging to fluoroquinolone family (eg. Ciprofloxacin, levofloxacin etc.)

Use with care, and tell your doctor, if

• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems
• aliskiren
• if you are at risk of low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• if you have been very sick (excessive vomiting) or had bad diarrhoea recently
• if you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents (such as spironolactone, triamterene, amiloride), or potassium-containing salt substitutes
• if you have any heart problem or heart disease
• if you have any other kidney problems (including kidney transplantation). These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your blood level of potassium
• if you are an elderly person (over 65 years of age)
• if you are on dialysis
• if you have liver problems
• if you have a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red cells (anaemia)
• if you have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors such as Enalapril Unicorn. Signs of swelling of the face or arms and legs or difficulty in swallowing or breathing require immediate medical attention because of the risk of angioedema
• if you have lupus, rheumatoid arthritis, scleroderma, or if you are on therapy that suppresses your immune system
• if you are taking the medicines allopurinol for gout or any combinations of these
• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher
• The safety and efficacy of Enalapril Unicorn in children have not been established. Your doctor will conduct some blood tests before and during the treatment to examine if your kidneys are working properly. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril Unicorn. If you are about to have a procedure If you are about to have any of the following, tell your doctor that you are taking Enalapril Unicorn:
• Any surgery or receive anaesthetics (even at the dentist)
• A treatment to remove cholesterol from your blood called “LDL apheresis”
• A desensitization treatment, to lower the effect of an allergy to bee or wasp stings. If any of the above applies to you, talk to your doctor or dentist before the procedure

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 health care provider for advice before taking this medicine
• You must not take Enalapril Unicorn if you are pregnant or breast-feeding
• If you are pregnant or become pregnant while taking Enalapril Unicorn, stop taking Enalapril Unicorn and talk to your doctor as soon as possible
• If you are a woman of childbearing age, ensure that you take adequate contraceptive measures
• If you are pregnant or breast-feeding your baby, please consult your health care provider for advice before taking Enalapril Unicorn
• Driving and using machinery Caution is necessary when driving or performing tasks requiring alertness, as some people may feel dizzy or sleepy during treatment with Enalapril Unicorn

Interactions and medicines to check

The approved leaflet names these interactions.

• Angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan) or aliskiren
• Medicines containing potassium (including dietary salt supplements)
• Medicines for diabetes (including oral antidiabetic medicines and insulin)
• Lithium (a medicine used to treat a certain kind of depression)
• Medicines for depression called “tricyclic antidepressants”
• Medicines for mental problems called “antipsychotics”
• Other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics), such as furosemide, hydrochlorothiazide, spironolactone, triamterene or amiloride
• Medicines used for arthritis or gout (allopurinol, cytostatic or immune-suppressive agents, systemic corticosteroids)
• Gold therapy such as sodium aurothiomalate, which can lead to flushing of your face, feeling sick (nausea or vomiting) and low blood pressure
• Ciclosporin (medicine used for organ transplant, arthritis or psoriasis)
• Non-steroidal anti-inflammatory medicines (NSAIDs), e.g. ibuprofen, including COX-2-inhibitors, e.g. celecoxib (medicines that reduce inflammation, and can be used to help relieve pain)
• Certain cough and cold medicines and cold medicines and weight reducing medicines which contain an ingredient called a “sympathomimetic agent”
• Alcohol
• Fluoroquinolones eg. Ciprofloxacin, levofloxacin [see also information under the headings “Do not take Enalapril Unicorn and Take special care with Enalapril Unicorn”). Enalapril Unicorn with food and drink Enalapril Unicorn can be taken before, during or after a meal

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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