Natrixam Side Effects

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

What is Natrixam?

Natrixam contains the active ingredient Perindopril tosilate and indapamide.

• Active ingredient — Perindopril tosilate and indapamide
• Registration number — 48/7.1.3/1168; 48/7.1.3/1169
• Registration holder — Teva Pharmaceuticals (Pty) Ltd

It is approved for:

• S3 TREXEVA PLUS is an anti-hypertensive medicine containing two active ingredients, perindopril and indapamide
• It is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension) in adults
• Perindopril belongs to a class of medicines called ACE inhibitors
• These work by widening the blood vessels, which makes it easier for your heart to pump blood through them

Common side effects of Natrixam

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

• hypokalaemia (low potassium in the blood)
• headache
• feelings of dizziness
• pins and needles
• taste disturbances
• visual impairment
• vertigo (spinning of head)
• tinnitus (sensation of noises in the ears)
• cough
• shortness of breath (dyspnoea)
• abdominal pain
• constipation
• diarrhoea
• indigestion
• nausea, vomiting
• allergic reactions (skin rashes, itching)
• muscle cramps
• feeling of tiredness

Less frequent side effects

• runny nose
• 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)
• unusual bruising or easy bleeding, feeling generally tired or lethargic, pale skin, signs of infection such as sore throat, fever and chills (these may indicate changes or damage to your blood cells including a lower number of white and red blood cells, lower number of blood platelets and an excess of eosinophils (a type of white blood cell)
• hypoglycaemia (very low blood sugar level)
• changes in blood composition (levels of potassium, sodium, chloride, magnesium and calcium) that have the following symptoms: tiredness or weakness, nausea and vomiting, irregular heartbeats, confusion, seizures, loss of appetite, abdominal pain, disorientation
• depression
• mood swings, sleep disturbances
• confusion
• sleeplessness
• inflammation of blood vessels that results in a reddish rash, fever, loss of appetite and fatigue
• flushing
• eosinophilic pneumonia (a rare type of pneumonia)
• dry mouth
• abnormal hepatic function (skin and eyes appear yellowish, abdominal pain, dark urine colour)
• hives
• red pinpoints on skin
• excessive sweating
• photosensitivity reactions (increased sensitivity of the skin to sun)
• rare autoimmune conditions that cause blistering and rashes on the skin and mucous membranes
• flare-ups of psoriasis
• joint pain
• muscle pain
• kidney problems
• acute renal failure
• decreased or absent urine output
• impotence (inability to obtain or maintain an erection)
• chest pain, fever, general feeling of discomfort
• swelling of the lower legs and arms (peripheral oedema)
• tiredness or fatigue
• changes in blood values and laboratory parameters: increased blood urea, increased blood creatinine, increased level of liver enzymes, high level of serum bilirubin and lower haemoglobin
• fall

Frequency not known side effects

• short sightedness (myopia), blurred vision
• decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer on the eye (choroidal effusion) or acute angle-closure glaucoma)
• numbness and pain in fingers or toes (Raynaud’s phenomenon)
• worsening of a disease called systemic lupus erythematosus (a type of collagen disease that causes severe fatigue, joint pain and swelling, rash on the cheeks and nose called a “butterfly rash”)
• incorrect results for heart tests (ECG)
• high uric acid levels in the blood that cause fever, chills, fatigue, joint inflammation (called “gout”)
• high sugar levels in the blood that causes increased thirst, frequent urination, fatigue. Disorders of the blood, kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition

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 to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients (listed in section 6)
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, 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 (a condition called angioedema)
• if you have recurrent episodes of swelling (angioedema)
• if you have hypertrophic cardiomyopathy (cardiac muscle disease)
• if you have renal artery stenosis (narrowing of the artery supplying the kidney with blood) or if you have only one kidney functioning
• if you are pregnant or breastfeeding your baby
• if you have a severe kidney disease or if you are receiving dialysis
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
• if you have taken or are currently taking 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
• if a method of achieving poison removal, either by dialysis or by a non-dialytic technique, such as hemoperfusion is used
• if you have severe liver impairment
• if you have low or high blood potassium
• if you have aortic stenosis (narrowing of the main blood vessel leading from the heart or if your heart’s aortic valve narrows)
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)
• if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with TREXEVA PLUS should be avoided
• if you have porphyria
• if you are taking anti-dysrhythmic medicines for your heart that can cause torsades de pointes
• if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing)
• if you are taking fluoroquinolones (antibiotics)

Use with care, and tell your doctor, if

• if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking TREXEVA PLUS before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of TREXEVA PLUS
• 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 supplying the kidney with blood)
• 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 take lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements as their use with TREXEVA PLUS should be avoided
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma
• if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema). This may occur at any time during treatment. If you develop such symptoms, you should stop taking the treatment and see a doctor immediately
• 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)
• 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)
• if you are a haemodialysis patient dialysed with high-flux membranes
• if you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism)
• if you have liver problems the use of TREXEVA PLUS may cause loss of brain function and TREXEVA PLUS should be stopped immediately
• if you have had photosensitivity reactions
• if you have kidney problems, or if you are receiving dialysis
• if you start coughing – your doctor will prescribe a different class of anti-hypertensive medicine
• if you are on a salt restricted diet or use salt substitutes which contain potassium
• if you are elderly
• if you have atherosclerosis (hardening of the arteries)
• if you have heart failure or any other heart problems
• if you have diabetes
• if you have liver problems
• if you have muscle disorders including muscle pain, tenderness, weakness or cramps
• if you suffer from hyperparathyroidism (overactive parathyroid gland)
• if you suffer from gout
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking TREXEVA PLUS. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. When you are taking TREXEVA PLUS, you should also inform your doctor or the medical staff:
• if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings
• if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine)
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated
• if you are to undergo anaesthesia and/or surgery
• if you have changes in your vision or pain in one or both of your eyes while taking TREXEVA PLUS. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue TREXEVA PLUS treatment and seek medical attention
• if you are to undergo a medical test that requires injection of an iodinated contrast medicine (a substance that makes organs like kidney or stomach visible on an X-ray) Athletes should be aware that TREXEVA PLUS contains an active ingredient (indapamide) which may give a positive reaction in drug tests Children and adolescents: TREXEVA PLUS is not for use in children and adolescents under 18 years

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 TREXEVA PLUS
• You should not take TREXEVA PLUS if you are pregnant or breastfeeding your baby
• Effects on fertility by perindopril or indapamide in humans are not known

Interactions and medicines to check

The approved leaflet names these interactions.

• lithium (used to treat mania or depression)
• aliskiren (medicine used to treat hypertension) if you have no diabetes mellitus or kidney problems
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, including angiotensin II receptor blocker (ARB) or diuretics (medicines which increase the amount of urine produced by the kidneys)
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium salts, other medicines which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections caused by bacteria)
• sacubitril/valsartan (used to treat long-term heart failure)
• 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 medicines belonging to the class of so-called mTor inhibitors). See section Warnings and precautions
• fluoroquinolones (as antibiotic). Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:
• baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin) (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting)
• medicines to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol))
• medicines to treat diabetes such as insulin, metformin or gliptins
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg to 50 mg per day
• allopurinol (for the treatment of gout)
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
• immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin)
• procainamide (for the treatment of an irregular heartbeat)
• anaesthetic medicines
• injectable gold (used to treat rheumatoid polyarthritis)
• medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)
• vasodilators including nitrates (medicines that make the blood vessels become wider)
• digoxin or other cardiac glycosides (for the treatment of heart problems)
• sultopride (for the treatment of psychoses)
• cisapride, diphemanil (used to treat gastric and digestive problems)
• bepridil (used to treat angina pectoris)
• erythromycin by injection (an antibiotic)
• moxifloxacin, sparfloxacin (antibiotic: medicine used to treat infection)
• methadone (used to treat addiction)
• vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss)
• halofantrine (used to treat certain types of malaria)
• terfenadine, mizolastine or astemizole (antihistamines for hay fever or allergies)
• pentamidine (used to treat pneumonia)
• amphotericin B by injection (to treat severe fungal disease)
• stimulant laxatives (e.g. senna)
• tetracosactide (to treat Crohn’s disease)
• iodinated contrast medicine
• calcium including calcium supplements
• trimethoprim (for the treatment of infections) TREXEVA PLUS with food and drink: It is preferable to take TREXEVA PLUS in the morning 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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