Reaptan Side Effects

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

What is reaptan?

Reaptan contains the active ingredient Perindopril arginine.

• Active ingredient — Perindopril arginine
• Registration number — 52/7.1.3/0709; 52/7.1.3/0710; 52/7.1.3/0711
• Registration holder — Servier Laboratories SA (Pty) Ltd

It is approved for:

• Viacoram is a combination of two active ingredients, perindopril and amlodipine
• Both of these substances help to control your high blood pressure
• Perindopril is an ACE (Angiotensin Converting Enzyme) inhibitor
• Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines)

Common side effects of reaptan

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

• light-headedness, cough, oedema (fluid retention/swelling)
• high levels of blood potassium which can cause abnormal heart rhythm (hyperkalaemia), excess sugar in the blood (hyperglycaemia), tiredness. The following side effects have been reported with perindopril or amlodipine, and either not observed with Viacoram or observed with a higher frequency than with Viacoram. These side effects may also occur with Viacoram. If any of these causes you problems, you should contact your doctor
• oedema (fluid retention/swelling)
• headache, sleepiness (especially at the beginning of treatment), abnormal taste perception, numbness or tingling sensation in your limbs, vertigo, vision disturbances (including double vision), tinnitus (sensation of noises in the ears), palpitations (awareness of your heartbeat), flushing, shortness of breath (dyspnoea), abdominal pain, nausea (feeling sick), vomiting (being sick), dyspepsia or difficulty of digestion, change of bowel habit, constipation, diarrhoea, itching, skin rashes, redness of the skin, pruritus, ankle swelling, muscle cramps, tiredness, weakness
• increase in some white blood cells (eosinophilia), low sodium level in the blood (hyponatraemia), low sugar level in the blood (hypoglycaemia), mood swings, anxiety, sleeplessness, depression, sleep disturbances, syncope, loss of pain sensation, trembling, vasculitis (inflammation of blood vessels), rhinitis (blocked up or runny nose), dry mouth, increased sweating, hair loss, red patches on skin, skin discolouration, formation of blister clusters over the skin, sensitivity to light, back pain, muscle or joint pain, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine, kidney problems, impotence, discomfort or enlargement of the breasts in men, chest pain, feeling unwell, pain, weight increase or decrease, increased blood urea, increased blood creatinine, fall, fever

Less frequent side effects

• acute renal failure; symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion): dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion, and seizures; decreased or absent urine output; psoriasis worsening, high level of serum bilirubin, increased level of liver enzymes
• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets, increased muscle tension, disorders of the nerves which can cause weakness, tingling or numbness, eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, abdominal bloating (gastritis), yellowing of the skin (jaundice)
• trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk, discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon). 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 allergic (hypersensitive) to perindopril or any other ACE-inhibitor, or to amlodipine or any other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems (severe impairment of your kidney function)
• if you have serious liver problems with severe impairment of your liver functions)
• 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 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 have severe low blood pressure (hypotension)
• if you suffer from heart failure after a heart attack
• if you are pregnant or breastfeeding your baby
• 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, Viacoram 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 have taken or are currently taking 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

Use with care, and tell your doctor, if

• have hypertrophic cardiomyopathy (cardiac muscle disease)
• have heart failure
• have severe increase in blood pressure (hypertensive crisis)
• have any other heart problems
• have liver problems
• have kidney problems (including kidney transplantation)
• have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism)
• have collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma
• have diabetes
• are on a salt restricted diet or use salt substitutes which contain potassium (a well balanced potassium blood level is essential)
• are elderly and your dose needs to be increased
• 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. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals
• See also information under the heading “Do not take Viacoram”
• are of black origin since you may have a higher risk of angioedema and Viacoram may be less effective in lowering your blood pressure than in non-black patients
• are taking any of the following medicines, the risk of angioedema is increased
• sirolimus, everolimus, temsirolimus and other medicines 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). 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 perindopril. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Viacoram and see a doctor immediately. See also section 4. When you are taking Viacoram, you should also inform your doctor or the medical staff if you
• are going to have a general anaesthetic and/or major surgery
• have recently suffered from diarrhoea or vomiting (being sick)
• are to undergo LDL apheresis (the removal of cholesterol from your blood by a machine)
• are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings. Children and adolescents Viacoram should not be given to children and adolescents less than 18 years of age

Pregnancy and breastfeeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Viacoram
• Pregnancy You should not be treated with Viacoram if you are planning to become pregnant or are pregnant as Viacoram may cause serious harm to your unborn baby
• Breastfeeding You should not breastfeed your baby if you are on treatment with Viacoram
• Amlodipine has been shown to pass into breast milk in small amounts

Interactions and medicines to check

The approved leaflet names these interactions.

• lithium (used to treat mania or depression)
• estramustine (used in cancer therapy)
• 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 (medicine used to prevent blood clots), trimethoprim and co- trimoxazole also known as trimethoprim/sulfamethoxazole (for the treatment of infections) and ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection
• aliskiren (used to treat high blood pressure)
• angiotension II -receptor blockers (ARB) (used to treat high blood pressure) (e.g. valsartan, telmisartan, irbesartan…)
• dantrolene (infusion) (used to treat muscle stiffness in diseases such as multiple sclerosis or to treat malignant hyperthermia (very high body temperature which may be fatal) during anaesthesia, symptoms including very high fever and muscle stiffness)
• Sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take Viacoram” and “Warnings and precautions”. Treatment with Viacoram can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required
• other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys)
• medicines, which are most often 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”
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen) for pain relief or high dose aspirin
• medicines to treat diabetes (such as insulin, gliptins)
• medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics)
• 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)
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of an irregular heartbeat)
• vasodilators including nitrates (products that widen the blood vessels)
• ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma)
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis
• some antibiotics such as rifampicin, erythromycin, clarithromycin (for infection caused by bacteria)
• antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• itraconazole, ketoconazole (medicines used for treatment of fungal infections)
• alpha-blockers used for the treatment of enlarged prostate such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin
• amifostine (used to prevent or reduce side effects caused by other medicines or radiation therapy that are used to treat cancer)
• corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis)
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis)
• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
• potassium-sparing medicines used in the treatment of heart failure eplerenone and spironolactone at doses between 12,5 mg to 50 mg by day
• hypericum perforatum (St John’s wort, a herbal medicine used to treat depression). Contact your doctor to re-evaluate your treatment if you are treated with ACE- inhibitors/Angiotensin blockers together with a fluoroquinolone antibiotic. Viacoram with food and drink You should not consume grapefruit juice and grapefruit if you are taking Viacoram
• 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 Viacoram

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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