Revised SPC: Granpidam (sildenafil) 20 mg film-coated tablets

SPC advises that sildenafil should not be used in neonates with persistent pulmonary hypertension of the newborn as risks outweigh the benefits. The safety and efficacy of sildenafil in other conditions in children below 1 year of age has not been established.

Source:

electronic Medicines compendium