Reporting Suspected Product Side Effects

What is a product side effect, and why do we report them?

A side effect is any unwanted or unexpected medical occurrence that a patient experiences, where they have been given a pharmaceutical product. This may or may not have been a result of receiving treatment with the product. Side effects are also referred to as adverse events or adverse reactions. Side effects can present as any unexpected and / or unfavourable symptom, sign or sickness which is associated with use of a product.

Reporting a suspected side effect for Biocelect products helps us ensure the safety of our patients and products. This also allows Biocelect to fulfill its reporting requirements to the relevant health authorities. This is important even in the cases where a relationship between the product and the side effect is not apparent.

To report a suspected side effect, adverse event or product complaint with one of our products please contact us and provide the following information:

Product Details:
- Name of product
- When patient began use of the product
- Dose strength & dose frequency - amount & how often it was taken (e.g. 100mg taken once daily)
- Any action / changes while taking medication (e.g. lowered dose, stopped using medication) and if this impacted the side effect
Description of the suspected side effect associated with product:
- What signs or symptoms were experienced?
- Was any treatment required?
  - Who was the healthcare provider who provided the treatment? (Name & contact details)
Information about the patient who experienced the suspected side effect
- Initials, gender & age of patient
- Any other ongoing & current medical condition
- Any other medications currently taken (Name of other medication, dose strength, dose frequency, when patient began other medication)

patientsafety@biocelect.com | + 61 1300 848 628.

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