Answer the side-effect intent for amuco without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 25/11/2025) and professional information (approved 25/11/2025) for this product: patient information leaflet, professional information. Retrieved 2026-09-03. Where this page and the approved leaflet differ, the leaflet is correct.
What is Amuco?
Which leaflet this comes from
There is no approved leaflet for Amuco in SAHPRA’s public repository. The information below is from the approved leaflet for TUSSMUCO 600, another South African product containing Acetylcysteine. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Amuco contains the active ingredient Acetylcysteine.
- Active ingredient — Acetylcysteine
- Registration number — 59/10.3/0104
- Registration holder — Pharmacare Ltd
It is approved for:
- What you need to know before you take TUSSMUCO 600 3
- How to take TUSSMUCO 600 4
- Possible side effects 5
- How to store TUSSMUCO 600 6
Common side effects of Amuco
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.
About these frequency terms
This leaflet groups effects on the very common/common/uncommon scale.
Reported side effects
- If you have asthma. Children and adolescents
- TUSSMUCO 600, should not be used in children less than 14 years of age. Other medicines and TUSSMUCO 600 Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:
- Any cough suppressant medicines
- Any antibiotics especially antibiotics called ‘tetracyclines’. TUSSMUCO 600 and these antibiotics should be taken 2 hours apart
- Nitroglycerine or glyceryl trinitrate, which is used in heart failure, high blood pressure and to reduce pain associated with chest pains due to reduced blood
- As TUSSMUCO 600 liquifies thick phlegm, the amount of phlegm will increase. If you are unable to cough up this phlegm, consult your doctor to ensure effective steps are taken to remove this phlegm especially during the start of treatment with TUSSMUCO 600
- This is of particular concern if you are an elderly or frail patient
- If you suffer from histamine intolerance as TUSSMUCO 600 affects how your body breaks down histamine. General symptoms of histamine intolerance are usually headaches, runny nose and itching
- If you have kidney or liver problems. TUSSMUCO 600 with food and drink TUSSMUCO 600 should be taken dissolved in a glass of water after meals. Pregnancy, breastfeeding and fertility You should not take TUSSMUCO 600 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 TUSSMUCO 600. Driving and using machines It is not always possible to predict to what extent TUSSMUCO 600 may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which TUSSMUCO 600 affects you. TUSSMUCO 600 contains glucose: If you have been told that you have an intolerance to some sugars, you should not take TUSSMUCO 600. flow also known as angina. Your doctor will need to monitor you, especially if you develop headaches
- Blood pressure lowering medication especially a medicine classified as a ‘angiotensin converting enzyme inhibitor (ACE inhibitor)
- Activated charcoal. Do not share medicines prescribed for you with any other person. Always take TUSSMUCO 600 exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Adults and adolescents from 14 years of age: The usual dose of TUSSMUCO 600 is half (1/2) of an effervescent tablet taken twice daily or one (1) effervescent tablet taken once daily (equivalent to 600 mg acetylcysteine per day) fully dissolved in a glass of water taken after meals. A clear solution is produced when TUSSMUCO 600 effervescent tablet is dissolved in a glass of water. If a TUSSMUCO 600 effervescent tablet is not fully dissolved, it may cause choking and aspiration, particularly to elderly patients. TUSSMUCO 600 effervescent tablets should not be taken for more than 14 days without medical advice. Children Due to the high content of active substance (acetylcysteine 600 mg per tablet), TUSSMUCO 600 should not be used in children less than 14 years of age. If you take more TUSSMUCO 600 than you should
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
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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.
Evidence required before publish — source the following for Amuco from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for Amuco says about how long specific effects last
- Whether the source describes any effect as usually temporary, or as needing review if it persists
- Whether any effect is described as continuing after the product is stopped
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 acetylcysteine or any of the other ingredients of TUSSMUCO 600 (listed in section 6)
- If you are pregnant or planning to become pregnant
- If you have a history of stomach ulcers
Use with care, and tell your doctor, if
- If you develop a hypersensitivity reaction which may include but is not limited to severe blisters and bleeding of the lips, eyes, mouth, nose and genitals or fever, chills, aching muscles and generally feeling unwell (these are associated with skin conditions such as Stevens-Johnson syndrome or Lyell’s syndrome) (see
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
Do not stop a prescribed treatment on your own
Stopping some treatments suddenly causes its own problems, and the condition being treated may get worse. If you want to stop, ask a pharmacist or doctor how to do it safely — they can usually offer an alternative.
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.
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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
If you are having thoughts of harming yourself
Help is available in South Africa. The SADAG helpline is 0800 567 567, or you can go to your nearest emergency department. You do not have to wait until it feels like an emergency.
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
Reporting is not a substitute for medical care
If someone is unwell now, get medical help first and report afterwards. Urgent symptoms always take precedence over paperwork.
For a fuller walkthrough see how to report an adverse drug reaction.
Related pages
← Back to more medicine side effects.
Report a side effect
If you think you have had a side effect, you can report a suspected side effect in South Africa. Report a suspected side effect through the appropriate SAHPRA pathway where relevant.
Information only
This page gives general medicine-safety information for people in South Africa. It is not a diagnosis and not personalised medical advice. It cannot tell you whether a symptom you are having is caused by a particular product. Speak to a pharmacist or doctor about your own situation, and do not stop or change a prescribed treatment on the basis of a web page.
Editorial status: draft — not for publication
Brief SE-00550 · build rank 550 · Phase 2 · Tier 2. Every evidence slot on this page must be completed from the SAHPRA-approved source and the page signed off by a qualified clinical or pharmacy reviewer before it is published. Target length 1,300–2,000 words.