News & insights

Saudi Arabia: Notice to Pharmaceutical Companies

April 8, 2011

The Saudi Food and Drug Authority has revised on April 4, 2011 the patient information leaflet requirements for all drugs sold in the country containing paracetamol.

The leaflet should now include the following precautions:

– To warn patients not to exceed the stated dose if they are allergic to Paracetamol.
– To ask patients to consult their doctor before using a product containing Paracetamol in case they have severe liver or kidney problems.
– To warn patients not to take other products containing Paracetamol at the same time.

The pharmaceutical companies are also recommended to mention the risk of drug interactions in addition to the over-dosage cases when the paracetamol quantity exceeds 10g.

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