Triplixam Side Effects

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

What is Triplixam?

Triplixam contains the active ingredient Perindopril arginine/ indapamide/ amlodipine.

• Active ingredient — Perindopril arginine/ indapamide/ amlodipine
• Registration number — 49/7.1.3/1245; 49/7.1.3/1246; 49/7.1.3/1247; 49/7.1.3/1248
• Registration holder — Servier Laboratories SA (Pty) Ltd

It is approved for:

• Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them
• Indapamide is a diuretic (which is a sulphonamide derivative). Diuretics increase the amount of urine produced by the kidneys. However, indapamide only causes a slight increase in the amount of urine produced
• Amlodipine is a calcium channel blocker s (which belongs to a class of medicines called dihydropyridines). It works by relaxing blood vessels, so blood passes through easily

Common side effects of Triplixam

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.

Reported side effects

• sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm)
• swelling of eyelids, face or lips
• swelling of the mouth, tongue and throat, which causes great difficulty breathing
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• severe dizziness or fainting
• heart attack, unusual fast or abnormal heart beat, or life-threatening irregular beat
• inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell
• muscle weakness, cramps, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown
• These are serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent side effects October 2023 Oedema, low potassium in the blood, headache, dizziness, palpitations (awareness of your heartbeat), flushing, vertigo, pins and needles, vision disturbances (including double vision), tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation, change of bowel habit), allergic reactions (such as skin rashes, itching), muscle spasms, cramps, feeling of tiredness, weakness, somnolence, ankle swelling (oedema). Less frequent side effects Mood swings, anxiety, depression, sleep disturbances, trembling, hives, fainting, loss of pain sensation, irregular and/or rapid heartbeat, rhinitis (blocked up or runny nose), altered bowel habits, hair loss, purpura (red pinpoints on skin), skin discoloration, itchy skin, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell (malaise), kidney problems, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine, impotence (inability to obtain or maintain an erection), fever or high temperature, discomfort or enlargement of the breasts in men, weight increase or decrease, increase in some white blood cells, high potassium levels in the blood, hypoglycaemia (very low blood sugar level), low sodium levels in the blood that may lead to dehydration and low blood pressure, rapid heartbeat, vasculitis (inflammation of blood vessels), photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA, blister clusters over the skin, swelling of hands, ankles or feet, blood creatinine increased and blood urea increase, fall, dry mouth. Confusional state, changes in laboratory parameters: low chloride in the blood, low magnesium in the blood, increased level of liver enzymes, high level of serum bilirubin and psoriasis worsen- ing, decrease or absence urine output, acute renal failure. Dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and seizures (fits). These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion). October 2023 Decreased numbers of white blood cells, decrease in the number of platelets (which causes easy bruising and nasal bleeding), anaemia (decrease in red blood cells), cardiovascular disorders (irregular heartbeat, angina pectoris (pains to the chest, jaw and back, brought on by physical effort, and due to problems with the blood flow to the heart), stroke, eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, severe skin reactions including intense skin rash, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs), bleeding, tender or enlarged gums, abnormal liver function, inflammation of the liver (hepatitis), severe kidney problems, yellowing of the skin (jaundice), abdominal bloating (gastritis), disorder of the nerves which can cause weakness, tingling or numbness, increased muscle tension, hyperglycaemia, high level of calcium in the blood, cerebrovascular accident (stroke) possibly secondary to excessive low blood pressure. Hepatic encephalopathy (disease of the brain caused by liver illness), abnormal ECG heart tracing, low potassium levels in the blood, if you suffer from systemic lupus erythematous (a type of collagen disease), this might get worse. Short sightedness (myopia), vision blurred, decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Trembling, rigid posture, mask like face, slow movements and a shuffling, unbalanced walk. Discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon). Changes in laboratory parameters (blood tests) can occur. Your doctor may request blood tests to monitor your condition. If you have these symptoms contact your doctor as soon as possible

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 perindopril or other ACE-inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or any of the other ingredients of Triplixam (listed in section 6)
• if you have experienced symptoms such as wheezing, with difficult breathing, 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), October 2023
• if you have a liver disease with moderate to severe impairment of your liver function or suffer from a condition called hepatic encephalopathy (disease of the brain caused by liver illness)
• if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing)
• if you are treated with medicines that may cause serious heart rhythm disturbances
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
• if you suffer from heart failure after a heart attack
• if you have severe low blood pressure (hypotension)
• if you have a low blood potassium level
• if you have severe kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis)
• if you have only one kidney
• if you are receiving dialysis or any other type of blood filtration. Depending on the machine that is used, Triplixam may not be suitable for you
• if you have moderate or severe impairment of your kidney function
• if you are pregnant or planning to become
• if you are breastfeeding your baby
• 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 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
• If you are treated with lithium
• If you are treated with potassium sparing diuretics (water pills that increase your blood potassium e.g. spironolactone, triamterene), October 2023
• If you are taking a fluoroquinolone (an antibiotic)

Use with care, and tell your doctor, if

• if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood)
• if you have heart failure or any other heart problems
• if you have a severe increase in blood pressure (hypertensive crisis)
• if you have liver disease/disorder
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma
• if you have atherosclerosis (hardening of the arteries)
• if you need to have a test to check how well your parathyroid gland is working
• if you suffer from gout
• if you have diabetes mellitus
• if you are on a salt restricted diet or use salt substitutes which contain potassium (a well- balanced potassium blood level is essential)
• if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Triplixam should be avoided
• if you are elderly and your dose needs to be increased
• if you have had photosensitivity reactions
• if you are of black origin the blood pressure lowering effect may be less and you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing)
• if you are on haemodialysis dialysed with high-flux membranes
• if you have a kidney disease/disorder or if you are receiving dialysis, October 2023
• 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 Triplixam. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy, you can be at higher risk of developing this
• if you have muscle disorders including muscle pain, tenderness, weakness or cramps
• if you have increased levels of a hormone called aldosterone in your blood (primary aldosteronism)
• if you have too much acid in blood, which may cause an increased rate of breathing
• if you have cerebral circulatory insufficiency (low blood pressure and blood flow in the brain)
• if you have swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), which can occur at any time during treatment, stop your treatment immediately and directly contact your doctor
• 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 medicines 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)
• 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. October 2023
• aliskiren. Your doctor may check your kidney function, blood pressure, and the concentration/levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Triplixam”. Your doctor may request laboratory blood tests to check if you have a low sodium level, a low or potassium level s or a high calcium level. When you are taking Triplixam, you should also inform your doctor or the medical staff:
• if you are to undergo anaesthesia and/or surgery
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated
• if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine)
• 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 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). Children and adolescents Triplixam should not be given to children and adolescents under the age of 18 years. October 2023

Pregnancy and breastfeeding

• You should not be treated with Triplixam if you think you are pregnant, if you are pregnant or plan to become pregnant, as Triplixam may cause serious harm to your unborn baby
• If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Triplixam
• Breastfeeding You should not breastfeed your baby if you are on treatment with Triplixam as harm to your baby cannot be excluded, and Triplixam may suppress or decrease the volume of breastmilk secreted
• Driving and using machinery Triplixam may affect your ability to drive or use machines
• You should not drive and use machines until you know how treatment with Triplixam is affecting you
• Triplixam may cause a low blood pressure, dizziness, nausea, vision disturbances, fatigue, tiredness and headache

Interactions and medicines to check

The approved leaflet names these interactions.

• lithium (used to treat some mental health disorders such as mania, manic depressive illness and recurrent depression)
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, 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)
• dantrolene (infusion) which is used to treat malignant hyperthermia during anaesthesia (symptoms including very high fever and muscle stiffness)
• estramustine (used in cancer therapy)
• medicines, which are used to treat diarrhoea (racecadotril) or to 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”
• sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take Triplixam” and “Warnings and precautions”
• other medicines used to treat high blood pressure: angiotensin-converting-enzyme inhibitor and angiotensin receptor blockers. Treatment with Triplixam can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:
• other medicines for treating high blood pressure, including angiotensin II receptor blocker (ARB), aliskiren, or diuretics (medicines which increase the amount of urine produced by the kidneys)
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12,5 mg to 50 mg per day
• anaesthetic medicines
• iodinated contrast medicines
• bepridil (used to treat angina pectoris)
• antibiotics used to treat bacterial infections (e.g rifampicin, erythromycin, clarithromycin, moxifloxacin, sparfloxacin
• methadone (used to treat addiction)
• medicines used for heart rythm problems (e.g. dofetilide, ibutilide, bretylium, cisapride, diphemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol
• verapamil, diltiazem (heart medicines)
• digoxin (for the treatment of heart problems)
• antifungal medicines (e.g itraconazole, ketoconazole, amphotericin B by injection)
• allopurinol (for the treatment of gout)
• antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine or astemizole)
• corticosteroids used to treat various conditions including severe asthma and rheumatoid ar- thritis, and non-steroidal anti-inflammatory medicines (e.g. ibuprofen) or high dose salicylates (e.g. acetylsalicylic acid an ingredient present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting)
• immunosuppressants (medicines used to control your body’s immune response) for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus)
• tetracosactide (to treat Crohn’s disease) October 2023
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis)
• halofantrine (used to treat certain types of malaria)
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis
• medicines to treat diabetes such as insulin or metformin
• calcium including calcium supplements
• stimulant laxatives (e.g. senna)
• medicines for the treatment of cancer
• vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss)
• medicines to treat mental health disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol))
• pentamidine (used to treat pneumonia)
• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
• hypericum perforatum (St. John’s Wort)
• trimethoprim (for the treatment of infections)
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline)
• nitroglycerin and other nitrates, or other vasodilators that may further reduce blood pressure. Contact your doctor to re-evaluate your treatment if you are treated with a fluoroquinolone antibiotic and you are also on treatment with Triplixam or an angiotensin receptor blocker for your hypertension. Athletes should be aware that Triplixam contains an active ingredient (indapamide) which is listed as a prohibited medicine for athletes to use (will give a positive test for prohibited substances). October 2023 Triplixam with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Triplixam
• This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Triplixam

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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