Gedeon Richter Updates Product Information for Aertal Cream in Russia

Gedeon Richter Plc. has submitted revised product information for its locally applied Aertal cream (aceclofenac) for regulatory review in Russia. These updates aim to provide clearer guidance on the cream's indications and usage.

The revised instructions specify the approved uses of the cream, which are for treating local pain associated with musculoskeletal injuries and inflammatory conditions. Aertal cream is indicated for conditions such as sprains, strains, bruises, injuries to ligaments and muscles, and tendonitis. The pharmaceutical company also notes its utility in managing lower back pain (lumbago), stiff neck (torticollis), and inflammation around joints (periarthritis).

Application guidelines have also been clarified. The cream should be massaged into the affected area three times daily. The dosage depends on the size of the affected area, typically 1.5–2 grams of cream (approximately a 5–7 cm strip). It is crucial for users to wash their hands after application, unless the hands are the site of application. The product should not come into contact with eyes or mouth.

Further clarifications have been made regarding contraindications and precautions. The cream is not recommended for use during pregnancy or breastfeeding, or for individuals under the age of 18. Application is also contraindicated on damaged skin, such as open wounds.

Gedeon Richter Plc. is a Hungarian pharmaceutical company specializing in drug development and manufacturing. The company offers a broad range of products across multiple therapeutic areas and operates globally.