Prexum Side Effects

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

What is Prexum?

Prexum contains the active ingredient Perindopril arginine salt.

• Active ingredient — Perindopril arginine salt
• Registration number — A39/7.1.3/0232; A39/7.1.3/0233
• Registration holder — Servier Laboratories SA (Pty) Ltd

It is approved for:

• to treat high blood pressure (hypertension)
• 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 Prexum

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

• headache
• dizziness
• vertigo
• pins and needles
• vision disturbances
• tinnitus (sensation of noises in the ears)
• cough
• shortness of breath (dyspnoea)
• gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation)
• allergic reactions (such as skin rashes, itching)
• muscle cramps
• feeling of tiredness

Less frequent side effects

• depression
• mood swings
• sleep disturbances
• dry mouth
• intense itching or severe skin rashes)
• formation of blister clusters over the skin
• kidney problems
• impotence
• sweating
• excess of eosinophils (a type of white blood cells)
• somnolence
• fainting
• palpitations
• tachycardia
• vasculitis (inflammation of blood vessels)
• photosensitivity reaction (increased sensitivity of the skin to sun)
• arthralgia (joint pain)
• myalgia (muscle pain)
• chest pain
• malaise
• peripheral oedema
• fever
• fall
• change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine
• acute renal failure
• dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion)
• decreased or absent urine output
• flushing
• worsening of psoriasis
• changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin
• confusion
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked up or runny nose)
• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets
• If you have these symptoms contact your doctor as soon as possible
• Frequency not known (cannot be estimated from available data): Discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

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

• you are allergic to perindopril, or to any other ACE-inhibitor or to any of the ingredients of Prexum (listed in Section 6)
• you are pregnant or trying to become pregnant
• you are breastfeeding or plan to breastfeed
• you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE-inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (This rare condition is known as angioedema)
• If you have porphyria
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
• if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Prexum may not be suitable for you
• if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis)
• if you are being treated with sacubitril/valsartan, a medicine for heart failure as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see
• If you take fluoroquinolones (antibiotics)

Use with care, and tell your doctor, if

• If you are undergoing desensitisation treatment, or have had an allergic reaction during previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom)
• are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine)
• If you are to undergo anaesthesia and/or surgery
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated
• You have any other health problems, including: Kidney disease or if you are receiving dialysis. Liver disease. Diabetes. Heart disease
• Contact your doctor to re-evaluate your treatment if you are treated with ACE- inhibitors/Angiotensin receptor blockers together with a fluoroquinolone antibiotic
• if you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism)
• If you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery suppling the kidney with blood)
• If you have been told by your doctor that you have an intolerance to some sugars
• If you suffer from a collagen vascular disease such as systemic lupus erythematosus or scleroderma
• if you are on a salt restricted diet or use salt substitutes which contain potassium
• 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
• if you are taking aliskiren (medicines used to treat hypertension). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals
• if you are of black origin since you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black patients
• if you are taking any of the following medicines, the risk of angioedema is increased:
• racecadotril (used to treat diarrhoea)
• sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs and for cancer)
• sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the class of the also called gliptins (used to treat diabetes). Angioedema Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) has been reported in patients treated with ACE-inhibitors, including Prexum. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Prexum and see a doctor immediately. (Also You must tell your doctor if you think that you are (or might become) pregnant. Prexum is not recommended as it may cause serious harm to your baby. Children and adolescents Prexum is not recommended for children and adolescents

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine
• You must tell your doctor if you think that you are (or might become) pregnant
• Prexum should not be taken while pregnant or breastfeeding
• Should you become pregnant while using Prexum the medicine must immediately be stopped and consult your doctor without delay
• Breastfeeding Tell your doctor if you are breastfeeding or about to start breastfeeding
• Prexum is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely

Interactions and medicines to check

The approved leaflet names these interactions.

• Non steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin, a substance presents in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting
• Lithium medications (used to treat mood swings and some types of depression/mania)
• Potassium-sparing diuretics (e.g. triamterene, amiloride), sources of potassium, like potassium tablets and salt substitutes containing potassium, other medicines which can increase potassium in your body (such as heparin, a medicine used to thin blood to prevent clots, trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections caused by bacteria)
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12,5 mg to 50 mg by day
• other medicines for treating high blood pressure, including angiotensin II receptor blocker (ARB) or aliskiren or diuretics (medicines which increase the amount of urine produced by the kidneys)
• medicines used to treat diabetes (tablets and insulin)
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis)
• medicines to treat mental disorders such as depression, anxiety, schizophrenia (i.e. tricyclic antidepressants, antipsychotics)
• immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus)
• trimethoprim (for the treatment of infections)
• estramustine (used in cancer therapy)
• medicines, which are most often used to treat diarrhoea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section Warnings and precautions
• sacubitril/valsartan (used to treat long-term heart failure). See “Do not take Prexum and Warnings and precautions”
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of irregular heartbeat)
• vasodilators including nitrates (products that make the blood vessels become wider)
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline)
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis). It is a good idea to remind your doctor of all other medicines you take. Your doctor or pharmacist has more information on medicines that you need to be careful with or avoid while taking Prexum. Prexum with food and drink It is preferable to take Prexum before 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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