Utabon Pediatric

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OXYMETAZOLINE

Available from:

J. Uraich & Cia S.A. Av. Cami Reial, 51-57, 08184 Palau- solita I Plegamans, Barcelona, Spain

ATC code:

R01AA05

INN (International Name):

OXYMETAZOLINE 0.25 mg/ml

Pharmaceutical form:

NASAL DROPS, SOLUTION

Composition:

OXYMETAZOLINE 0.25 mg/ml

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-07-07

Patient Information leaflet

 
UTABON 
OXYMETAZOLINE 
UTABON DECONGESTS AND CLEARS THE NOSE AND HAS A RAPID AND PROLONGED
EFFECT 

Congestion of the nasal mucosa is one of the most frequent and
troublesome symptoms affecting the processes 
of the upper respiratory tracts. 
The active ingredient of UTABON, oxymetazoline, produces
vasoconstriction and the decongestion of the nasal 
mucosa, and it has a quick action and prolonged effect. 

COMPOSITION 
100 ml contain : 

Adults   
    Pediatric 
Oxymetazoline HCI…… 

50 mg                     25 mg 
Excipients: benzalkonium chloride, disodium phosphate anhydrous,
sodium dihydrogen phosphate dehydrate, 
glycine, sorbitol, purified water. 

INDICATIONS 
UTABON affords local relief of the symptoms of nasal congestion in
patients suffering from colds, allergic 
rhinitis and other nasal infections such as sinusitis. 

CONTRA-INDICATIONS 
Do not administer to children under the age of six. 
Do not use in case of hypersensitivity to patients who are
excessively sensitive to any of its components or to 
adrenergic decongestants. 

DOSAGE 
Adults : In general, two nasal sprays per day will be sufficient. Due
to UTABON’s prolonged action, one nasal 
spray before going to bed will keep the nasal nostrils clear during
the entire night. 
Children : Two drops in each nostril, keeping the head of the child
tilted backward. The application may be 
repeated twice a day. 

PRECAUTION/WARNINGS 
UTABON -very rarely- increases, rather than reduces, the
symptoms of nasal congestion. If this happens, 
consult your physician. If insomnia occurs – very rarely – try to
avoid applying the treatment late in the evening 
or during the night. 
Do not exceed the recommended dose. Do not use orally. Do not use
for periods of more than three days 
without medical prescription. 

Ask your physician before using this product if you suffer
from diabetes, high blood pressure, heart disease or 
disease of the thyroid gland, g

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
Utabon Pediatric 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Oxymetazoline hydrochloride: 0.25 mg/ml. 
Excipients: see section 6.1 

3. PHARMACEUTICAL 
FORM 
Nasal drops, solution. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Local relief of the symptoms of nasal congestion in patients
suffering from colds, 
allergic rhinitis and other nasal disorders such as sinusitis. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Nasal use. 
Children over 6 years of age: two
drops in each nostril, keeping the head of the child 
tilted backward, maximum twice a day. 

After each use, clean the tip of the nozzle with a clean, moist
cloth before closing the 
flask. 

4.3  CONTRAINDICATIONS 

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. 

4.4  SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

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. 
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