Colds of various types. For easing the flow of secretions when the paranasal sinuses are inflamed. For otitis media as an adjuvant to mucosal decongestant in the nasopharynx. To facilitate rhinoscopy. 
 

Children aged between 2-11 years: use under the supervision of adults. 
 
Metered-Dose Spray 0.05% for children aged 2 years or over Normally 1 spray in each nostril 1−2 times per day is sufficient, whereby there should be no more than 3 applications per day. 
 
Metered-Dose Spray 0.1% only for adults and teenagers from 12 years old 1 spray in each nostril. Repeat if necessary; 3−4 applications per day are usually sufficient. 
 
How to use the metered-dose spray 

The nose should be thoroughly cleaned before use (by blowing the nose). Remove the protective cap. Before using for the first time pump a few times until an even, fine mist is produced. For further applications, the metered-dose spray is ready for use immediately. Place the nozzle of the spray into the nostril and press once firmly on the spray head; withdraw the spray nozzle before releasing the pressure. To ensure optimum distribution of the spray mist the patient should breathe in gently through the nose while applying the spray. Put the protective cap back on after use. 

XyloAcino should be used with caution in patients 
− with high blood pressure, cardiovascular disease, 
− with hyperthyroidism, diabetes mellitus or phaeochromocytoma, 
− with prostatic hypertrophy, 
− being treated with or having received MAO inhibitors within the last 14 days (see “Interactions”),

- who have an intense reaction to sympathomimetic substances, with signs of sleeplessness, vertigo, etc.

As with other topical vasoconstrictive agents, XyloAcino should not be used continuously for more than one week since rhinitis medicamentosa can occur with swelling of the nasal mucosa, which is very similar in its symptoms to a cold. The recommended dosage should not be exceeded, especially in children and elderly patients. 
 

MAO inhibitors

Xylometazoline can potentiate the effect of MAO inhibitors and cause a hypertensive crisis. Xylometazoline is not recommended in patients taking or having taken MAO inhibitors within the last 14 days (see “Warnings and precautions”). 

Tri- or tetracyclic antidepressants

Concomitant use of tri- or tetracyclic antidepressants with sympathomimetic agents can lead to potentiation of the sympathomimetic effect of xylometazoline and is therefore not recommended. 
 

Pregnancy

In view of its vasoconstrictive properties, as a precaution XyloAcino should not be used during pregnancy. 
 
Lactation

It is unknown whether xylometazolineis excreted in human milk. XyloAcino should not be used while breastfeeding unless instructed by a physician. 
 
Fertility

No relevant data are available on the effect of XyloAcino on fertility and no controlled studies on animals are available. As systemic exposure to xylometazoline is very low, effects on fertility are highly unlikely. 
 

If xylometazoline-containing medicinal products for rhinitis are used for a long time or at high doses, systemic effects with cardiovascular events cannot be ruled out. 

The following section lists undesirable effects presented by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Immune system disorders Very rare: hypersensitivity reactions (angioedema, rash, pruritus). 
 
Nervous system disorders Common: headache. 

Eye disorders Very rare: transient visual disturbances. 
 
Cardiac disorders Very rare: irregular and increased heart rate; hypertension, arrhythmias. 
 
Respiratory, thoracic and mediastinal disorders Common: dry nose, nasal discomfort, burning, rhinitismedicamentosa. 
 
Gastrointestinal disorders Common: nausea. 
 
General disorders and administration site conditions Common: burning at the administration site. 

To report any side effects: 
The National Pharmacovigilance and Drug Safety Centre (NPC)  • Fax: +966-11-205-7662  • Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. • Toll free phone: 8002490000  • E-mail: npc.drug@sfda.gov.sa  • Website: www.sfda.gov.sa/npc  
 

Excessive use of topical xylometazoline or accidental ingestion may cause sympatholytic effects, including CNS depression (such as drowsiness, coma), hypertension or hypotension, as well as tachycardia and bradycardia. Gastrointestinal symptoms such as nausea and vomiting may also occur. Further symptoms are pallor, excessive sweating, hypothermia, miosis, respiratory depression, ataxia and restlessness. Severe symptoms after accidental exposure have not been observed; however, in one neonate (2 weeks old), the use of 1 drop of a 0.1% solution in each nostril resulted in coma. In young children, ingestion of up to 0.5 mg/kg body weight did not lead to any clinically relevant symptoms. Due to a lack of data, severe symptoms cannot be excluded after ingestion of more than 0.5 mg/kg body weight. In such cases, medical surveillance and administration of a single dose of activated charcoal are indicated after consultation with a physician or a Poison Centre. There is no specific antidote. Treatment is symptomatic; bradycardia can be treated with atropine. 

ATC code: R01AA07

Mechanism of action

Xylometazoline is a sympathomimetic agent and acts on the alpha-adrenergic receptors of the nasal mucosa. Following application in the nose, the blood vessels are constricted, thereby resulting in decongestion of the mucosa in the nose and the surrounding area of the nasopharynx. Breathing through the nose is facilitated. The effect begins within a few minutes and lasts for up to ten hours. XyloAcino does not impair the function of the ciliated epithelium. 
 

After nasal application, the plasma concentrations of xylometazoline in humans are generally low and close to the limit of detection. 
 

Xylometazoline has no mutagenic effect. After subcutaneous administration of xylometazoline to mice and rats, no teratogenic effects were observed. 

Citric acid monohydrate, sodium citrate, glycerol 85%, water for injections. 

Not applicable. 

Do not store above 30°C. Keep out of the sight and reach of children.  Xylo Acino should not be used for more than 12 months after first opening the metered-dose spray. 
 

The solution is packed in 10 ml bottle, sealed with a pump with a nose adapter and amounted protecting cup. 

XyloAcino 0.05% Metered-Dose Spray without preservatives for children: 10 mL metereddose spray.  

XyloAcino 0.1% Metered-Dose Spray without preservatives for adults: 10 mL metered-dose spray.