It has been considered that the risk-benefit of terfenadine 60 mg tablet formulations is acceptable and the Marketing Authorisations should be maintained provided that: -the indications are restricted to adults and children over 12 years and 50 kg of body weight to avoid the likelihood of overdose in children. -the Summaries of Product Characteristics (SPCs) are revised with emphasis on contraindications due to hepatic or cardiac diseases and pharmacokinetic or pharmacodynamic interactions between terfenadine and other substances as stated in Annex I.