FAQ (Frequently Asked Question) - Reporting of Side Effects”

What is a side effect?

A side effect is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product.

This can be any unfavourable and unintended sign, symptom, or disease associated with the use of the product.

Why should you report side effects to Ferozsons?

Although medicinal products are tested extensively in clinical trials before they are authorised, not everything is known about their side effects or drug related safety until they have been used by many people over time.

By reporting side effects for Ferozsons product, you are giving us important feedback which ultimately will help us take appropriate actions and to provide better instructions for how to use our products.

Your information will also enable Ferozsons to fulfill its reporting responsibilities to health authorities, who will also analyse the data.

What should I do if I think I may have experienced a side effect?

If you are concerned that you have had a suspected side effect to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the Ferozsons.

Anyone can report issues relating to the safety of medicines to the Ferozsons. This includes patients, care takers, other members of the public and healthcare professionals.

How do I report an adverse reaction?

You can report a suspected side effect in a number of ways:

    • To your doctor, pharmacist or nurse who can then notify the Ferozsons.
    • By using our online form.
    • By downloading a copy of our adverse reaction report form (Word version). You can e-mail completed forms to pharmacovigilance@ferozsons-labs.com
    • By calling us on +92 042 36026700 Ext. 710

When do I need to report a side effect?

You need to report safety information immediately or within 24 hours of becoming aware of event.

What types of events should I report?

You should report any adverse event that happens after getting a Ferozsons’s product, even if you are not sure that the medicine caused the adverse event. All serious and non-serious side effects must be reported. These include but not limited to:

  • Fatal i.e. results in death
  • Life threatening
  • Requires in-patient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability / incapacity
  • Leads to a congenital anomaly / birth defect
  • Important medical events which may jeopardize patient or may require intervention to prevent one or the other outcomes.
  • Pregnancy reports (Maternal pregnancy and Partner pregnancy)
  • Safety information of infants due to exposure via breastfeeding
  • Inappropriate use of medicine (e.g. abuse, misuse, medication error, Off-Label Use)
  • Overdose
  • Lack of Effect
  • Occupational Exposure
  • Drug interactions
  • Medical device incident
  • Unexpected benefits
  • Counterfeit or falsified medicines
  • Transmission of infectious agents via the product

Permission to contact Health Care professional (HCP)

As Ferozsons has an obligation to seek additional information from a Health Care Professional with knowledge about the side effect, please confirm whether Ferozsons can contact your doctor?

If “Yes”, please provide your doctor´s contact details (once clicked field will be opened i.e. Name of doctor, contact number, email address, mailing address)

If “No”, Ferozsons will respect that and not contact your doctor but we suggest to discuss any safety related concern to your prescribing physician.

All personal information related to the reporting of a side effect is processed in accordance with the data protection legislation.