Answer the side-effect intent for synaleve 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 05/03/2025) and professional information (approved 05/03/2025) 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 Synaleve?
Which leaflet this comes from
There is no approved leaflet for Synaleve in SAHPRA’s public repository. The information below is from the approved leaflet for NUROFEN PLUS, another South African product containing Ibuprofen and Codeine Phosphate. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Synaleve contains the active ingredient Ibuprofen and Codeine Phosphate.
- Active ingredient — Ibuprofen and Codeine Phosphate
- Registration number — 37/2.7/0666
- Registration holder — Reckitt Benckiser Pharmaceuticals (Pty) Ltd
It is approved for:
- Nurofen Plus tablets have an analgesic (pain relieving), anti-inflammatory (inflammation reducing) and antipyretic (fever reducing) action
- The active ingredients are Ibuprofen and Codeine Phosphate
- Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs)
- Ibuprofen reduces inflammatory pain, swellings and fever
Common side effects of Synaleve
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
- Aspirin or other NSAIDs painkillers (eg naproxen, diclofenac)
- Within 14 days of taking monoamine oxidase inhibitors (MAOI’s) antidepressants such as moclobemide. Caution is advised during coadministration of Nurofen Plus with medicines listed below due to increased risk of side effects, consult your doctor or pharmacist if you are unsure:
- The use of other pain relievers or products containing aspirin, ibuprofen or other anti- inflammatory medicines can worsen the side-effects of Nurofen Plus
- Medicines for high blood pressure, e.g. water tablets
- Medicines for thinning the blood (anticoagulants e.g. warfarin)
- Methotrexate (anti-cancer medication)
- Lithium (mood stabiliser)
- Sleeping tablets, calming medicines etc
- Corticosteroids (medicines for treating severe allergies and skin problems)
- Anti-platelet agents (for treating blood clots)
- Medicines such as digoxin, quinidine and mexiletine these are used in the treatment of heart disorders (eg irregular heart rhythms)
- Medicines for treating or preventing organ transplant rejection, examples include tacrolimus and ciclosporin
- Mifepristone: used to end pregnancy
- Zidovudine: is used in the treatment of HIV infection and AIDS
- Quinoline antibiotics (for treating bacterial infection such as pneumonia or urinary and respiratory tract infections)
- Hydroxyzine (used to relieve allergies or itchiness)
- Loperamide and kaolin (medicines to treat runny tummy)
- Metoclopromide,cisapride or domperidone (for treating nausea and vomiting)
- Cimetidine (to treat stomach ulcers and heartburn)
- Naloxone (reverse opioid overdose) Nurofen Plus with food, drink, and alcohol Avoid alcoholic – may cause drowsiness. If affected do not drive or operate machinery. Pregnancy, breastfeeding and fertility If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. Do not take Nurofen Plus during pregnancy or while you are breastfeeding. Pregnancy: Use of Nurofen Plus during pregnancy is associated with the following complications:
- Foetal malformations, including serious damage to the kidneys of the unborn baby or foetus
- Maternal problems during birth, resulting in delayed or prolonged labour. Fertility: NSAIDs medicines such as Nurofen Plus may impair fertility in women, but this is reversible upon withdrawal of treatment. Driving and using machines:
- Nurofen Plus may cause visual disturbances and dizziness
- Do not drive because Nurofen Plus could interfere with your ability to drive
- Do not operate any tools or machines
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 Synaleve from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for Synaleve 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
- You are hypersensitive (allergic) to Ibuprofen & Codeine Phosphate or any of the other ingredients of Nurofen Plus (listed in section 6)
- You have or ever had a stomach ulcer
- You have had an allergic reaction to aspirin, anti-inflammatory drugs, codeine or any of the ingredients listed above
- You have a history of breathing difficulties or asthma, allergic rash or on itchy, runny nose when taking ibuprofen, aspirin or other anti-inflammatory medicines
- You suffer from chronic constipation
- You have difficulty breathing and swelling
- If you suffer from liver, kidney or heart problems
- If you have had gastrointestinal bleeding or perforation when previously taking NSAIDs
- If you are pregnant or breastfeeding
- If you are under 12 years old
- In children aged under 18 years old who had undergone tonsillectomy (surgical procedure for removal of tonsils) or adenoidectomy (surgical procedure for removal of adenoids due to breathing difficulties while sleeping) due to increased risk of respiratory problems
- If you are taking Monoamine Oxidase Inhibitors (MAOIs) or if you have taken them within the last 14 days (Antidepressants)
Use with care, and tell your doctor, if
- You suffer from low blood pressure
- You have a head injury
- You have a thyroid disorder
- You are in shock
- You have a bowel disorder
- If you have or have had asthma
- If you have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders
- If you have an infection You need to discontinue Nurofen Plus treatment and consult your doctor if these occur during treatment:
- Drug reaction with eosinophilia and systemic symptoms (DRESS): a life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abdominal heartbeat
- Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis: these are indicated by severe skin peeling, painful blisters and starts by flu-like illness
- Breathing difficulties whilst sleeping. You may experience increased sensitivity to pain due to Nurofen Plus, however, this may be resolved by discontinuing treatment or lowering your dose. Talk to your doctor if this applies to you. Care should be taken in elderly patients due to increased risk of adverse reactions
Interactions and medicines to check
The approved leaflet names these interactions.
- Always tell your health care provider if you are taking any other medicine
- (This includes complementary or traditional medicines) Do not use Nurofen Plus together with any of these medicines due to increased risk of
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
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-00048 · build rank 48 · Phase 1 · Tier 1. 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 1,500–2,200 words.