They (nasal drops as well as nasal sprays) are used for various types of colds. It is designed to be applied in the nostrils, where it exerts a vasoconstricting effect thereby decongesting the mucosae of the nose and the throat. This effect allows patients with colds to breathe more easily through the nose. The action of these products is felt within a few minutes and lasts for several hours. They contain ingredients which help prevent the nasal mucosa drying out.  

Unless otherwise prescribed by the doctor, you must keep to the following dosage recommendations:

Infants and children under 2 years old, only under medical prescription, and children under 6 years old under adult supervision: 0.05% nasal drops and metered dose spray:

1-2 drops of solution or 1 spray puff with the 0.05% metered dose spray 1-2 times a day in each nostril are usually sufficient. Do not exceed 3 applications per day.

Adults and children over 6 years: 0.1% nasal drops and metered dose spray: 2-3 drops of solution or 1 spray puff from 0.1% metered dose spray in each nostril generally 4 applications per day are sufficient. The last application will usually take place shortly before bedtime.

Method for using the metered dose spray:

Remove protective cap. Before using for the first time, pump several times until an even mist appears. Place the nozzle of the device in the nostril and exert pressure firmly, once only, on the collar of the metered dose nasal spray.

For subsequent applications, the metered-dose spray is instantly ready for use without prior pumping. Replace the protective cap after use. Please keep to the doses which appear in the package leaflet or prescribed by your doctor. If you feel that the medicinal product is not effective enough or on the contrary, it is too effective, please consult your doctor, or pharmacist. 

As with other medicinal products for colds, Decozal can lead to sleep and vision problems or episodes of dizziness which are evidence of oversensitivity to the product. Please consult the doctor if:

- These effects are very disruptive.

- The cold persists or gets worse.

- Other problems appear.

Decozal must be used with care in the case of hypertension, cardio-vascular disease, thyroid hyperactivity, or diabetes (Diabetes mellitus).

Decozal must not be used for more than a week without medical advice because over a longer period of use, rebound congestion of the nasal mucosa (rhinitis medicamentosa) may appear. This would be very similar to the symptoms of a cold. Do not use the 0.1% drops or metered dose spray in children under 6 years old.

Decozal 0.05% nasal drop and metered dose spray must not be used without a medical prescription in children under 2 years old and must be administered under adults supervision in children under 6 years old.

The doctor must be informed if the patient suffer from another medical condition, allergy or if the patient is already taking or using other medicinal products either internally or externally (even as self-medication).

As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.

No fetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Decozal during pregnancy.

Label warning: If you are pregnant or taking any other medicines, or are under a doctor's care, consult him before using Decozal.             

No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Decozal should be used only on prescription whilst breastfeeding.

None.

Using Decozal can cause the following side-effects: occasionally, a burning sensation in the nose and throat, local irritation, nausea, headaches and dryness of the nasal mucosa. In very rare cases insomnia or allergic reactions with respiratory problems may also appear.

In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness.

There is no specific treatment. Appropriate supportive measures should be initiated.

Decozal contains Xylometazoline which is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighboring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Decozal begins within a few minutes and lasts for up to 10 hours. Decozal is generally well tolerated and does not impair the function of ciliated epithelium.

In a double-blind, saline solution controlled study in patients with common cold, the decongestant effect of Decozal was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

Systemic absorption may occur following nasal application of Xylometazoline hydrochloride solutions. It is not used systemically.

Not applicable.

For Nasal Drops:

o   Sodium phosphate monobasic

o   Sodium phosphate dibasic

o   Sodium edetate

o   Sodium chloride

o   Tween 80

o   Benzalkonium chloride

o   Highly purified water

For Nasal Spray:

o   Sodium chloride

o   Sodium phosphate dibasic

o   Sodium phosphate monobasic

o   Hypermelose

o   Benzalkonium chloride

o   Highly purified water

Not applicable.

Nasal Drops: Store up to 30 °C.

Nasal Spray: Don't store above 30 °C, Protect from heat.

Nasal Drops: LDPE bottle with HDPE cap.

Nasal Spray: High density polyethylene bottle with a metered dose pump and polypropylene nozzle with cap.

Content: 10 ml.

- Do not use if cap seal is broken