Esonide Nasal Spray

Esonide is indicated for:
treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children (over 6 years old) and for the treatment of the perennial non allergic rhinitis only in adults.
Treatment of nasal polyps.

This drug is indicated only for your disease. Do not use it for any other situation, except if recommended by your Physician.
Do not give your drug to anybody else.
Unreasonable dosage or long-term therapy with glucocorticosteroids, may lead to the appearance of symptoms or signs of
corticosteroids overdose, suppression of HPA axis and/or growth delay in children.
Physicians should regularly monitor the growth rate of children using any kind of corticosteroids for long-term treatment, and
they should evaluate the benefits of the therapy against the growth delay risk.
Reduced hepatic function affects the corticosteroid elimination. You should inform your physician if you have any hepatic
dysfunction. Caution in the use of corticosteroids is recommended in case of patients that suffer of pulmonary tuberculosis.
Also, caution is recommended in case of patients with nasal diseases caused by fungi and virus or bacterial antritis,
which should be treated adequately. Children under immunosuppressant therapy are more susceptible compared with the
healthy ones, i.e. diseases as chickenpox or morbilli could be expressed with more severe forms in children that are under
glucocorticosteroid treatment. Children or adults that are not immune to these diseases, should avoid to be exposed and if
exposed they should seek urgently a medical advice. Special care is demanded in treatment of patients transferred from oral
steroids to ESONDE® nasal spray. In case that an inhaler corticosteroid is used, the sum of the nasal and inhaler dosage should
be adjusted, in order that possible side-effects of corticosteroids should be avoided, especially for children. In case of long-
term treatment, the nasal mucosa should be examined every 6 months. Long - term therapy in children is not recommended
at least until to obtain more experience in this sector.
Moreover during ESONIDE® treatment the general precautions of all corticosteroids should be taken into consideration: Long-term
therapy with corticosteroids leads, as already mentioned, to HPA axis suppression. The rate of this suppression depends on the dose,
strength, frequency and time of administration during 24 hours of the corticosteroid drug as well as on the half-life of the drug in
the tissues and the whole duration of the therapy. The dose is adjusted according to the disease exacerbation or suppression, the
individual patient response to the therapy and his exposition to emotional or physical stress (diseases, operations, trauma etc.).
2. Elderly patients: there are not any particular instructions. Dosage is adjusted in each case separately.
3. Pregnancy: Administration during pregnancy is not recommended unless, according to physician's evaluation, the benefits
for the pregnant woman compensate the risks for the foetus.
4. Lactation: ESONDE® nasal spray could be administrated during lactation only, according to physician's evaluation, when the
benefits for the pregnant woman compensate the risks for the foetus. In case of unexpected pregnancy while you are under
corticosteroid therapy, you should contact your physician the soonest possible.
5. Children: the results of the long-term use of corticosteroids for nasal use are not completely known. Read carefully the
paragraph of the dosage for children.
6. Affects in driving ability and in ability to operating machines: ESONIDE® nasal does not affect the ability to drive and
operate machinery.
7. Special warnings for the excipients: There are not any special warnings for the excipients.
8. Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as
blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation
of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR)
which have been reported after use of systemic and topical corticosteroids.

Store at room temperature below 25 degree C in a dry place. Keep out of the sight and reach of children. For nasal use.