ADMINISTRATION AND DOSAGE
Dosage
Adults
1 ampoule once daily.
Children
Children 12 years old and over: 1 ampoule once daily.
Children under 12 years old: This product is not
recommended for children under 12 years of age.
Intermittent allergic rhinitis (presence of symptoms for
less than 4 days per week or for less than 4 weeks) should
be managed in accordance with the evaluation of
patient's disease history and the treatment could be
discontinued after symptoms are resolved and reinitiated
upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for
4 days or more per week and for more than 4 weeks),
continued treatment may be proposed to the patients during
the allergen exposure periods.
Administration
BOSTANEX is administered orally. The dose can be taken
with or without food.
CONTRAINDICATIONS
Hypersensitivity to the desloratadine, to any of the
excipients or to loratadine.
WARNINGS AND PRECAUTIONS
In the case of severe renal insufficiency, desloratadine
should be used with caution.
This medicinal product contains sorbitol. Patients with
rare hereditary problems of fructose intolerance should
not take this medicine.
This medicine contains sucrose. Patients with rare
hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase
insufficiency should not take this medicine.
PREGNANCY AND LACTATION
Pregnancy
A large amount of data on pregnant women (more than 1,000
pregnancy outcomes) indicate no malformative nor
foeto/neonatal toxicity of desloratadine. Animal studies
do not indicate direct or indirect harmful effects with
respect to reproductive toxicity. As a precautionary
measure, it is preferable to avoid the use of
desloratadine during pregnancy.
Lactation
The effect of desloratadine on newborns/infants is
unknown. A decision must be made whether to discontinue
breast-feeding or to abstain from desloratadine therapy
taking into account the benefit of breast feeding for the
child and the benefit of therapy for the woman.
SHELF-LIFE
24 months from the manufacturing date. Do not use after
the expiry date.