Properties/Effects: Xylometazoline is an arylalkyl imidazoline. Decozal must be
administered into the nasal cavities, where it exerts a vasoconstrictive effect leading
to decongestion of the nasal and pharyngeal mucosa. Decozal thus makes it easier to
breathe through the nose when suffering from a cold or a chill. Decozal contains
ingredients which should prevent the drying of nasal mucous membrane. The effect of
Decozal is felt within a few minutes and lasts for up to 10 hours. Even when the
mucous membranes are sensitive, Decozal is well tolerated and does not impair the
function of the ciliated epithelium.

Indications/Possible uses:
Colds of various types.
To aid drainage of secretions in sinus conditions.
In otitis media, as an adjuvant to decongest the nasopharyngeal mucosa. To facilitate
rhinoscopy.

Contraindications:
Like other vasoconstrictors, Decozal should not be used after a transsphenoidal
hypophysectomy (nor after transnasal or transoral surgery in which the dura mater
has been exposed), nor should it be used in case of dry rhinitis, acute angle glaucoma,
or known hypersensitivity to substances contained in the product.
Precautions: Like all products belonging to the same class of active ingredients,
Decozal should be used with caution in patients suffering from hypertension,
cardiovascular diseases and hyperthyroidism, diabetes mellitus and in case of
excessive reactions to sympathomimetics agents, evidenced by insomnia, dizziness,
etc. As with other local vasoconstrictors, continued and prolonged treatment of more
than one week with Decozal , e.g. in chronic rhinitis, is not advisable without medical
advice. Drug-induced rhinitis accompanied by congestion of the nasal mucosa, with
symptoms closely resembling those of a cold, may occur.
Pregnancy, breast feeding: Considering its vasoconstrictive properties, as a
precaution, Decozal should be avoided during pregnancy.
It should be used while breast feeding only if prescribed by a doctor. Studies in
women or in animals are not available. Consequently, the medicine should be
administered only if the potential benefit justifies the potential risk to the foetus.
Effect on the ability to drive and Use machines: The possibility of systemic effects
with cardiovascular manifestations cannot be excluded when cold remedies based on
xylometazoline are used long term and at high dose.

Dosage/Directions for use:
Nasal drops 0.05% for infants and small children up to 6 years of age: Usually, 1 or 2
drops of 0.05% solution, 1 to 2 times a day into each nostril, are sufficient. Do not
exceed 3 applications a day.
Nasal drops 0.1% for adults and children over 6 years of age only:
2-3 drops of 0.1% solution into each nostril per application; 4 applications a day are
usually sufficient.

Metered dose nasal spray 0.05% for infants and small children up to 6 years of age:
One spray puff into each nostril. Repeat the administrations as required; but do not
exceed 3 applications a day.
Metered dose nasal spray 0.1% for adults and children over 6 years of age: One spray
puff into each nostril. Repeat the administration as required; 3 - 4 applications a day
are usually sufficient.
Use of the metered dose nasal spray: Remove the protective cap. Before using for
the first time, pump several times (fig. 1) until an even spray mist emerges.
For subsequent applications, the metered-dose nasal spray will then be ready for
instant use. Insert the nozzle of the metered dose nasal spray into the nostril and press
once firmly on the spray head (fig. 2), then withdraw the nozzle before releasing the
pressure.
Optimal distribution of the spray is achieved by inhaling gently through the nose
during the spraying process. Replace the protective cap after each use.
Restrictions on use

Respiratory tract: Decozal may cause short- lived irritation (burning or dry sensation
of the nasal mucosa), particularly in sensitive patients. In isolated cases, more marked
congestion of the mucous membrane may occur when the effect diminishes (reactive
hyperaemia). The prolonged or repeated use of xylometazoline as well as its use in
high doses may cause a burning or dry sensation of the nasal mucosa and also reactive congestion with drug-induced rhinitis. This effect may appear after only 5 to 7 days of
treatment and cause permanent damage to the mucous membrane with crusting (dry
rhinitis) if use is continued.
Nervous system: Headache, insomnia or fatigue have been reported in very rare or
isolated cases.
Heart and circulation: During local intranasal use, systemic sympathomimetic effects,
such as palpitations, racing pulse or raised blood pressure for example, are rare or
even occasional.
Immune system: Very rare cases of allergic reactions with dyspnoea and angioedema.
Interactions: If used as recommended, systemic effects are negligible. However, some
systemic effects of Decozal may be enhanced if tri- or tetracyclic antidepressants,
MAOI or other products which may raise blood pressure are taken at the same time,
especially in case of overdose.
Overdosage: No cases of overdosage in adults have yet been reported. In rare
instances of accidental poisoning in children, the clinical picture was dominated by
the following symptoms: accelerated or irregular pulse, increased blood pressure and
sometimes clouding of consciousness.
If necessary, symptomatic treatment under medical supervision is indicated.

Decozal nasal drops: Store between 15-25oC.
Decozal metered dose nasal spray: Do not store above 30oC.
Protect from heat.
Medicines should be kept out of the reach of children. For external use only.