The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Poor Growth: While poor growth can result from ICS, poorly controlled asthma can also lead to poor growth in children. In general, low and medium doses of ICS are potentially associated with small, non-progressive but reversible declines in growth of children. As a result, you and your asthma provider should not only carefully monitor growth, but try to use the lowest possible dose that gets good control of your child's asthma. You must weigh the potential benefits of good asthma control with the small but real possible side effect of slowed growth.
The most commonly reported side effects were: oral thrush , nausea , headache , and pain in the pharynx or larynx . More rarely reported side effects (occurring in <1% of patients during the clinical trial) include: tachycardia , palpitations , dry mouth , allergic reaction ( bronchospasm , dermatitis , hives ), pharyngitis , muscle spasms , tremor , dizziness , insomnia , nervousness , and hypertension . Patients experiencing an allergic reaction or increase in difficulty breathing while using this medication should immediately discontinue its use and contact their physician.