Pharmapress Side Effects

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

What is Pharmapress?

Pharmapress contains the active ingredient Enalapril maleate.

• Active ingredient — Enalapril maleate
• Registration number — 33/7.1.3/0479; 33/7.1.3/0480
• Registration holder — PHARMACARE LIMITED

It is approved for:

• treat high blood pressure (hypertension) including renovascular hypertension (caused by high blood pressure due to narrowing of the arteries that carry blood to the kidneys)
• the treatment of heart failure (weakening of the heart function), usually combined with other medicines used for high blood pressure (diuretics) and medicine used to treat heart rhythm problems (digoxin)
• the treatment of a form of heart failure with no symptoms (asymptomatic left ventricular dysfunction). PHARMAPRESS decreases the rate of development of heart failure with symptoms and decreases the incidence of hospitalisation for heart failure

Common side effects of Pharmapress

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

• Persistent feeling of sadness and loss of interest (depression)
• dizziness, headache, taste distortion
• blurred vision
• fast heartbeat (tachycardia), change in the way your heart beats (rhythm disturbance)
• low blood pressure or a fall in blood pressure on standing up which causes dizziness, light-headedness, or fainting (orthostatic hypotension)
• cough, difficulty breathing (dyspnoea)
• loose stools (diarrhoea), feeling sick (nausea), stomach pain
• feeling very tired (fatigue), abnormal physical weakness, or lack of energy (asthenia)
• change in blood results showing how your kidneys are working

Less frequent side effects

• Swelling of the immune system glands due to an infection (lymphadenopathy)
• disease in which the body’s immune system attacks healthy cells (autoimmune diseases)
• low blood levels of sodium which can cause tiredness, confusion, muscle twitching, fits and coma (hyponatraemia), low blood sugar levels (hypoglycaemia), decreased weight which may be cause anorexia
• confusion, sleep disorders, extreme sleepiness, nervousness, sleeplessness (insomnia), dream abnormality
• numbness or tingling pressure of the skin (paraesthesia), spinning sensation (vertigo)
• ringing in the ears (tinnitus)
• feeling that your heart is pounding or racing (palpitations)
• flushing, discolouration of the fingers and/or toes due to an abnormal spasm of the blood vessel after exposure to changes in temperature (hot or cold) or emotional events (Raynaud’s phenomenon)
• asthma, tightening of chest muscles (bronchospasm), swelling and irritation inside the nose (rhinitis), runny nose (rhinorrhoea), sore throat and change in pitch or quality of voice (hoarseness)
• presence of some unusual substance in the lungs (pulmonary infiltrates)
• bloating while or after eating (dyspepsia), dry mouth, vomiting (being sick), constipation, stomach irritations, ulcers on the inside lining of your stomach and the upper portion of your small intestine (peptic ulcers), inflammation of the tongue (glossitis), inflammation and shallow sores inside the mouth or at the base of the gums (stomatitis)
• hives (urticaria), increased sweating (diaphoresis), hair loss (alopecia), widespread reddening and inflammation of the skin (erythroderma)
• muscle cramps
• decreased urine output (oliguria)
• high level of protein in your urine (proteinuria)
• loss of male sexual ability (impotence), enlargement of male breast tissue (gynaecomastia)
• fever, a general feeling of discomfort or illness (malaise)
• increase of urea (a waste product that your kidneys remove from your blood), bilirubin and liver enzymes in blood results. Side effects with an unknown frequency:
• A condition in which high levels of hormone cause the body to retain water known as syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• sensitivity of the skin to light (photosensitivity)

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 maleate, to any other medicine belonging to the same group (ACE inhibitors) or any of the other ingredients of PHARMAPRESS (listed in section 6)
• if you ever had swelling of the face, mouth, throat, lips, eyes, or tongue which caused difficulty in swallowing or breathing (angioedema or hereditary or idiopathic angioedema) related to taking ACE-inhibitor therapy or angiotensin receptor blockers (ARBs) before or due to an unknown cause. You should never receive PHARMAPRESS again
• if you have heart problems which cause narrowing of the vessels in the heart (aortic stenosis)
• if you have heart problems which cause hardening of the heart muscles (hypertrophic obstructive cardiomyopathy)
• if you have severe kidney problems
• if you have high blood pressure caused by the kidney and you have only one kidney (renal artery stenosis)
• if you have a condition where the arteries from both your kidneys are narrowed resulting in increased blood pressure (bilateral renal artery stenosis)
• if you are taking medicines to treat high blood pressure such as spironolactone, triamterene, amiloride (potassium-sparing diuretics)
• if you have kidney problems and/or are elderly and you are taking medicine used to treat bacterial infections (antibiotics) belonging to the fluoroquinolone group. Contact your doctor to re-evaluate treatment if you are treated with PHARMAPRESS together with a fluoroquinolone antibiotic
• if you are taking lithium, which is used to treat mental illnesses
• if you have porphyria
• if you have diabetes or kidney problems and you are taking a medicine containing aliskiren, used to lower blood pressure
• if you are taking medicine containing sacubitril and valsartan used to treat heart failure
• if you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• If you have ever had an allergic reaction, ‘angioedema’. The signs include itching, red marks on the hands, feet, and throat, swelling of the face, around the eyes, lips, tongue, or throat with difficulty in swallowing or breathing
• if your ethnicity is black, as you may have a higher risk of developing side effects, PHARMAPRESS may also be less effective in lowering your blood pressure than in the non-black population
• if you are undergoing treatment to reduce your response to bee or wasp stings (hymenoptera venom desensitisation). You may have to stop PHARMAPRESS while undergoing this treatment
• if you are taking a medication called dextran sulfate to lower your cholesterol
• if you have low blood pressure (you may notice this as fainting or dizziness, especially when standing up)
• if you are on a diet that restricts your salt intake or if you have low levels of sodium in your blood (hyponatraemia)
• if you have experienced excessive vomiting or diarrhoea recently or if you are dehydrated
• if you are receiving dialysis
• if you have an obstruction of blood flow across the aortic or mitral valve in the heart
• if you have any type of kidney
• You may need a lower dose of PHARMAPRESS and may be at risk of developing high levels of potassium in your blood or low blood pressure
• if you have had a kidney transplant
• if you have liver problems
• if you have low levels of white blood cells (neutropenia/agranulocytosis), a low platelet count (thrombocytopenia) or fewer red blood cells (anaemia). Symptoms may include increased susceptibility to infections, fever, tiredness, excessive bruising, prolonged bleeding, shortness of breath, light-headedness, dizziness, or a fast heartbeat
• if you are taking antibiotics called fluoroquinolones as these could cause damage to the kidneys
• if you have a problem with blood flow to the heart (ischaemic heart disease) or brain (ischaemic cerebrovascular disease) the narrowing of arteries by plaque
• if you have diabetes and you are using medicine to control your blood sugar. You should monitor your blood for low blood sugar levels, especially during the first month of treatment. The level of potassium in your blood can also be higher (hyperkalaemia)
• if you are going to undergo major surgery or if you are going to receive anaesthesia
• if you develop a persistent cough without phlegm after starting PHARMAPRESS
• if you are taking medicines such as racecadotril (medicine used in the treatment of diarrhoea), sirolimus, everolimus, temsirolimus (used in the treatment of some cancers) or vildagliptin (used in the treatment of diabetes) as these may cause angioedema. The safe use of PHARMAPRESS in children has not been established

Pregnancy and breastfeeding

• You should not take PHARMAPRESS if you are pregnant or breastfeeding your baby
• 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
• If you become pregnant while taking PHARMAPRESS, you must contact your doctor immediately
• Your doctor will stop PHARMAPRESS immediately and change you to a different medicine which is safe to use during pregnancy
• Babies who have been exposed to PHARMAPRESS while their mother was pregnant, will be closely monitored by a doctor

Interactions and medicines to check

The approved leaflet names these interactions.

• Fluoroquinolones (e.g. ciprofloxacin, ofloxacin, moxifloxacin, levofloxacin): medicines used to treat specific bacterial infections
• Antihypertensive medicines such vasodilators (e.g. nitroglycerine, nitrates), aliskiren, sacubitril/valsartan, angiotensin II receptor blockers (ARBs) (e.g. losartan, valsartan, telmisartan), diuretics (e.g. hydrochlorothiazide, furosemide, spironolactone, triamterene, eplerenone, amiloride), calcium channel blockers (e.g. amlodipine diltiazem), beta blockers (e.g. propranolol), methyldopa, ganglionic blocking medicines (e.g hexamethonium): medicines used to treat high blood pressure and sometimes heart failure
• Non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors (e.g. indomethacin, ibuprofen, diclofenac, celecoxib, aspirin): medicine used to treat pain, swelling and inflammation
• Thrombolytics (e.g. streptokinase): medicine used to dissolve blood clots
• Potassium supplements (e.g. potassium chloride): medicine used to supplement the amount of potassium in the body
• Salt substitutes that contain potassium
• Immunosuppressant medicines (e.g. ciclosporin, temsirolimus, sirolimus, everolimus): medicines used to treat certain types of cancer or to prevent the body’s immune system for rejecting a transplanted organ
• Anticoagulants (e.g. heparin): medicine used to thin the blood to treat and prevent blood clots from forming in the body
• Lithium: medicine used to treat mental illnesses
• Antidepressants (e.g. amitriptyline): medicine used to treat depression
• Racecadotril: medicine used to treat diarrhoea
• Gold (e.g. sodium aurothiomalate): medicine used to treat rheumatoid arthritis
• Sympathomimetic medicines: medicines used in certain cough and cold medicines or weight loss medicines
• Antidiabetic medicines (e.g. insulin, vildagliptin, metformin): medicine used to treat high blood sugar in diabetic patients
• Anaesthetics: medicine used during surgery to induce sleep
• Antipsychotics: medicine used to treat mental illnesses such as schizophrenia
• Allopurinol: medicine used to treat gout
• Procainamide: medicine used to treat heart rhythm problems
• Narcotics (e.g.codeine): medicines used for pain relief. PHARMAPRESS with food and drink PHARMAPRESS may be taken with or without food, preferably at the same time each day. Avoid drinking alcohol as the use of alcohol may cause low blood pressure

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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