Risopet Side Effects

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

What is Risopet?

Risopet contains the active ingredient Rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride.

• Active ingredient — Rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride
• Registration number — A42/20.2.3/0890
• Registration holder — Pharma Dynamics (Pty) Limited

It is approved for:

• RISOPET contains four different medicines called isoniazid, rifampicin, pyrazinamide and ethambutol hydrochloride
• They all belong to a group of medicines called antituberculosis medicines
• They work by killing the bacteria that cause tuberculosis (also known as TB)
• RISOPET is used for the treatment and re-treatment of tuberculosis (TB) in adult patients and children

Common side effects of Risopet

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, numbness, tiredness, drowsiness, light-headedness, dizziness, lack of co-ordination
• eye irritation, blurred vision, conjunctivitis
• nausea, vomiting, diarrhoea
• reddish-orange discoloration of urine, faeces, saliva, sputum, sweat and tears, fever, chills
• blood tests may show changes in the way your liver or kidneys are working
• tingling sensation in your hands, feet or lips (“pins and needles), feeling unwell
• limb weakness or numbness, loss of memory, vision, and/or intellect, uncontrollable obsessive and/or compulsive behaviours, delusions, headache, cognitive and behavioural problems and sexual dysfunction (symptoms of neurotoxicity)
• polyneuritis (paralysis and loss of reflexes, usually in the leg)
• constipation, dry mouth, stomach cramps, loss of weight, anorexia, metallic taste
• pain or inflammation in the large and small joints, bone pain, muscle pain, twitching or weakness 16 April 2024
• fever, a general feeling of discomfort, illness, or unease

Less frequent side effects

• sore mouth or tongue (due to fungal infection such as thrush)
• blood tests showing low white blood cell count
• low blood pressure, low blood levels of sugar and high blood levels of potassium in Addison patients
• skin rashes or other skin conditions, such as flushing, hives, itching, acne, hair loss
• angioedema (painless swelling under the skin)
• gouty arthritis (chills, pain and swelling of joints, especially big toe, ankle or knee, tense hot skin over affected joints). The following side effects have been reported but the frequency for them to occur is not known:
• flu-like symptoms (chills, difficult breathing, dizziness, fever, headache, muscle and bone pain, fatigue and shivering)
• decreased appetite
• permanent discolouration of soft contact lenses
• tooth discolouration
• muscle weakness, bone pain, muscle pain
• severe vaginal bleeding after childbirth, transfer of foetal blood into the maternal circulation during pregnancy
• painful or abnormal menstruation 16 April 2024
• worsening of porphyria
• Cushing syndrome (fatty hump between the shoulders, a rounded face and pink or purple stretch marks), early puberty, difficult controllable diabetes
• pellagra (a disease caused by low levels of niacin, also known as vitamin B3 with symptoms such as dementia, diarrhoea, and dermatitis), hyperglycaemia (high blood glucose), metabolic acidosis (too much acid in the body)
• increased seizure frequency in epileptics, hyperactivity, euphoria, insomnia, delusions, dulled or completely suspended sense or sensibility
• ringing in the ears (tinnitus), loss of balance (vertigo)
• enlargement of a man’s breasts
• swelling of the lymph glands
• aggravation of peptic ulcer
• painful or difficult urination
• urine tests showing excess uric acid in the urine

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 rifampicin, isoniazid, pyrazinamide, ethambutol, or to any of the ingredients of RISOPET
• if you have a liver disease (jaundice)
• if you have severe kidney disease
• If you have optic neuritis (inflammation of the nerves in your eye)
• if you are pregnant, planning to become pregnant or breast feeding your baby (see

Use with care, and tell your doctor, if

• your doctor will need to check your blood before you take RISOPET. This will help your doctor to know if any changes happen to your blood after taking this medicine, as well as to check how your liver is working as each of the four components of RISOPET are known to affect the liver
• you experience any effects of hypersensitivity such as shock, kidney failure, anaemia, difficult or laboured breathing and asthma-like attacks, bleeding into the tissues, bruising, slow blood clotting after injury, fever, uncontrolled hay fever, develop eczema or if you develop any other form of rash after using RISOPET or rifampicin
• it is very important that you take RISOPET exactly as your doctor has told you. There is a chance of you developing a severe and dangerous reaction if you do not take your tablets every day. You must keep taking this medicine until your doctor tells you to stop
• if you have a liver disease, are an elderly patient, or suffer from or have suffered from alcoholism as RISOPET may cause liver damage. Do not use RISOPET if you experience the following symptoms: yellowing of the skin or eyes, rash, fever 16 April 2024
• if you have any of the following conditions: neuropathy (a disease that affects the nervous system), vitamin B6 deficiency, diabetes (high blood sugar), are malnourished, an alcoholic or infected with HIV virus (AIDS) as your doctor may prescribe pyridoxine (vitamin B6) to be taken during the course of your treatment
• if you have kidney problems as your dose of RISOPET may need to be adjusted
• if you have a history with gout your doctor may need to monitor the levels of uric acid in your blood. RISOPET treatment may be discontinued should the effects of gout reappear or worsen
• do not use RISOPET if you have a blood disorder called thrombocytopenia (a condition in which there is a decreased number of circulating platelets), purpura (bleedings in the skin and mucous membranes that result in the appearance of purplish spots or patches) or shock
• you have diabetes. Your diabetes may become more difficult to control while taking this medicine
• if you have epilepsy (seizures or fits) as RISOPET may trigger fits
• if you have a psychiatric disorder
• if you experience any vision disturbances whilst taking RISOPET (e.g. blurred vision), stop taking RISOPET and immediately inform your doctor. You may be required to have an eye test done regularly during treatment
• if you are using oral birth control tablets to prevent pregnancies, you should use additional forms of birth control
• if you are taking antacids (for indigestion) you will need to take your dose of RISOPET an hour before taking the antacid. Preparations containing bentonite 16 April 2024 should be taken 8 hours after taking RISOPET
• be aware that rifampicin as contained in RISOPET may stain soft contact lenses irreversibly. The use of soft contact lenses when taking RISOPET is not recommended
• RISOPET treatment may lead to reddish-orange colouration of faeces, saliva, urine, tears and sweat

Pregnancy and breastfeeding

• • RISOPET should not be used in children under 13 years of age
• • if you are taking a combination of medicines called protease inhibitors, saquinavir and ritonavir (medicines used in the treatment of HIV) except ritonavir when given at full dose or 600 mg twice daily 16 April 2024 • if you are taking voriconazole (medicine used to treat fungal infections) • if you have porphyria (a rare hereditary disease affecting the blood pigment with symptoms such as dark urine and extreme sensitivity of the skin to light)

Interactions and medicines to check

The approved leaflet names these interactions.

• you are taking voriconazole (to treat fungal infections) or protease inhibitors (used in the treatment of HIV) as the combination may result in liver damage. Taking the combination of saquinavir (used in the treatment of HIV) and ritonavir whilst taking RISOPET may result in liver damage, therefore RISOPET should not be taken with these medicines. The following combinations are not recommended with RISOPET:
• nevirapine, ritonavir (to treat HIV infection), simvastatin (used in patients with high 16 April 2024 cholesterol) and oral contraceptives
• halothane (used in anaesthetics). Your doctor may either change or adjust your dose of the following medicines:
• paracetamol, alfentanil, methadone, morphine etoricoxib, rofecoxib (painkillers)
• atovaquone (used for pneumonia), quinine (anti-malaria medicines)
• ciclosporin, tacrolimus and azathioprine (immunosuppressant medicines used in organ transplantation and in the treatment of autoimmune diseases such as rheumatoid arthritis – inflammation of the joints and surrounding tissues), pemphigus (a disease characterised by blistering of the skin and mucous membranes), Crohn’s disease (a type of inflammatory bowel disease, affecting the small intestines), ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine and rectum) and multiple sclerosis (a disease that affects the brain and spinal cord)
• chloramphenicol, doxycycline, cycloserine, clarithromycin, telithromycin, linezolid and fluoroquinolones (antibiotics used to treat certain infections)
• anti-cancer medicines including irinotecan, imatinib, gefitinib
• cimetidine (used in the treatment of heartburn and peptic ulcers)
• clofibrate and statins (used to treat high cholesterol), corticosteroids (anti- inflammatory)
• coumarin anticoagulants (e.g. warfarin used to prevent blood clots), ciclosporin (used to reduce the risk of organ rejection after organ transplant)
• dapsone, clofazimine, co-trimoxazole (used to treat certain infections) 16 April 2024
• benzodiazepines (e.g. diazepam, triazolam) and benzodiazepine-related medicines (used to treat anxiety, convulsions [seizures/fits], sleeping disturbances and muscle spasms), including zopiclone and zolpidem
• azole antifungals, such as voriconazole, fluconazole, itraconazole, ketoconazole (used to treat fungal infections)
• haloperidol, clozapine, aripiprazole (used in psychiatric disorders)
• oral medicines used to treat diabetes (high blood sugar)
• phenytoin, carbamazepine, primidone, ethosuximide (used to treat seizures or fits)
• sulfasalazine (used as an anti-inflammatory agent in the treatment of inflammatory bowel disease as well as for rheumatoid arthritis – it is not a pain killer)
• thyroxine (used in the treatment of an inactive thyroid gland)
• theophylline (used in therapy for respiratory diseases such as asthma)
• antiretroviral medicines, such as zidovudine, delavirdine, indinavir, efavirenz, nevirapine and protease inhibitors (used in the treatment of HIV infection (AIDS))
• medicines to help you sleep (barbiturates, e.g. hexobarbitone)
• beta-blockers such as those used for the management of cardiac dysrhythmias (abnormal electrical activity in the heart), protection of the heart after a heart attack, and hypertension)
• digoxin, antidysrhythmic medicines (such as disopyramide, mexiletine, quinidine, propafenone, tocainide and verapamil), calcium channel blockers (such as diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine, 16 April 2024 amlodipine), used to treat cardiac disease and losartan, eplerenone (used to treat water retention and cardiac disease)
• female hormonal medicines that reduce estrogen levels and are also used for treating breast cancer, such as tamoxifen, gestrinone and toremifene
• birth control tablets (containing estrogens) used to prevent unwanted pregnancies
• chlorzoxazone (used to treat muscle spasms)
• allopurinol, colchicine, probenecid, sulfinpyrazone (used in the therapy of gout)
• hormonal preparations used to treat thyroid (goitre) problems, such as levothyroxine
• ondansetron, used for the treatment of nausea
• enalapril (to treat high blood pressure)
• disulfiram (to treat alcohol abuse)
• enflurane (general anaesthetic)
• antacids containing aluminium
• other antituberculosis medicines (e.g. cycloserine, para-aminosalicylic acid (PAS))
• tricyclic antidepressants (e.g. amitriptyline). Avoid alcohol consumption when taking RISOPET. RISOPET may interfere with the results of certain medical tests, including blood tests for folate and vitamin B12 and copper sulphate urine glucose test. 16 April 2024 Tell your healthcare professional, who performs such tests that you are taking RISOPET. This medicine may influence contrast media used for gallbladder tests, therefore, these tests should be performed before the morning dose of RISOPET. RISOPET with food and drink RISOPET should be taken with a full glass of water 1 hour before or 2 hours after a meal. If you experience stomach disturbances, the tablet may be taken with food. If you are taking antacids containing aluminium, use RISOPET 1 hour after taking antacids. Ingestion of certain types of cheese (e.g. Swiss or Cheshire), or fish (e.g. tuna, skipjack, other tropical fish, salmon, mackerel), red wine or beer may result in itching of the skin, rapid or pounding heart, sweating, flushing, low blood pressure, chills or headache. These foods should be avoided while taking RISOET. Using alcohol while you are being treated with RISOPET can increase your risk of developing liver disease or problems. Pregnancy, breastfeeding and fertility 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 provider for advice before using RISOPET. 16 April 2024 DO NOT take RISOPET if you are pregnant or suspect that you are pregnant. DO NOT take RISOPET if you are breastfeeding your baby

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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