Source: Medicines Authority (MT) Publisher: J Uriach and CIA S.A., Av. Camí Reial 51-57, 08184 Palau-Solitá i Plegamans, (Barcelona), Spain
Utabon is contraindicated in patients with a history of hypersensitivity to oxymetazoline or other decongestive adrenergic substances or any of the components of this medicinal product.
Do not use during periods longer than three days without medical prescription. This medicinal product should be used with caution if the patient suffers from diabetes mellitus, arterial hypertension, cardiovascular diseases, glaucoma, prostatic hypertrophy, hyperthyroidism or is taking adrenergic antidepressants or bronchodilators, phenothiazines or methyldopa.
In rare occasions, this medicinal product may increase the symptoms of nasal congestion instead of reducing them. This is because the effects of oxymetazoline are temporary and prolonged use may produce a rebound effect causing vasodilation, congestion and rhinitis.
Rarely, this product may cause insomnia. In this case this medicinal product should not be administered late in the evening or at night.
The use of the same flask by more than one person can be a source of infection.
Warning about excipients:
This medicinal product contains benzalkonium chloride, that may cause bronchospasm.
This medicinal product should not be administered together with monoaminoxidase inhibitors (MAOI), adrenergic bronchodilators, tricyclic antidepressants, phenothiazines, methyldopa and antiasthmatic products.
It is not advisable to use this medicinal product during pregnancy or lactation because oxymetazoline may be absorbed systemically. Therefore, if necessary, the benefits and/or risks involved should be assessed.
Although this kind of effects are not expected, if the patient undergoes drowsiness or dizziness driving is not recommended.
This product may cause the following undesirable effects:
Common (>1/100, <1/10): sneezing and irritation, dryness, or itching of the nasal mucosa. Excessive or prolonged use may result in rebound congestion.
Rare (>1/10000, <1/1000): excessive administration of this product may produce the following symptoms: headache, shivering, sleep disorders, excessive sweating, palpitations, nervousness.
Treatment should be discontinued If undesirable effects appears and it must be notified to the pharmacovigilance systems.
None known.
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