If you have lost the leaflet that came with your medicine, or want to read it before collecting a prescription, SAHPRA publishes approved product information for registered South African medicines in its PI and PIL repository.
Two documents exist for most registered products, and the distinction is worth knowing:
- Professional Information (PI). Written for healthcare professionals. More technical and more complete, covering pharmacology, full contraindications and detailed dosing.
- Patient Information Leaflet (PIL). Written for the person taking the medicine, in plainer language. This is the leaflet inside the box.
Both are approved documents rather than marketing material, which makes them the most authoritative source for a specific product. See package insert compared with patient information leaflet.
Quick answer: when and how to report a suspected side effect
What information to record
The leaflet is where to check whether an effect you are having is already recognised for your medicine. An effect that is not listed is particularly worth reporting, because unexpected reactions are what the safety system most needs to hear about.
Where reporting fits into medicine safety
Leaflets are not static. When enough reports accumulate, the approved information is updated, which is why the repository version may differ from an older printed leaflet you have kept.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone. Take the product name and strength from the pack, and match it in the repository. See who can report.
Where reporting fits into medicine safety
Search by the product name on the box. Generic versions from different manufacturers each have their own approved documents, so match the name on your pack rather than a similar one.
What information should you collect before reporting?
What information to record
Product name, strength, dose form, batch number and expiry date, the dates involved, what happened, and everything else being taken. Reading the leaflet first helps you describe the effect in terms that match how it is usually recorded.
Where reporting fits into medicine safety
Reading the leaflet does not mean tolerating what it lists. A listed effect can still be worth changing treatment over. See how to read the side effects section.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- SAHPRA online reporting via the reporting routes listed on SAHPRA’s health products vigilance page
- The Med Safety App
- The ADR and quality problem form
- Through a doctor or pharmacist, or the company marketing the product
Where reporting fits into medicine safety
See the PI and PIL repository guide and medicine package inserts in South Africa.
What counts as a serious or unexpected side effect?
Red-flag symptoms
A reaction counts as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is otherwise medically important. Unexpected means it is not described in the approved product information.
Difficulty breathing, facial or throat swelling, chest pain, seizures or a blistering rash need emergency care. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
The leaflet frequency bands describe how often something was seen in studies, not how serious it is or how likely it is for you. A rare effect can still be an emergency.
What happens after a report is submitted?
What information to record
Keep a copy of your report and note which version of the leaflet you read.
Where reporting fits into medicine safety
Leaflet updates are one of the most common outcomes of pharmacovigilance. The effects listed in any leaflet today are there partly because people reported them. See what pharmacovigilance means.
Medical Disclaimer: This content is for informational and educational purposes only and does not constitute medical diagnosis, prescription, or professional advice. Always read the patient information leaflet and consult a qualified doctor or pharmacist regarding any medicine or health concern.