Indications
Short-term, symptomatic treatment of nasal obstruction caused by rhinitis or sinusitis.
Xylometazoline 123ratio, 1 mg/ml is intended for use in adults and children aged 10 years and over.
Xylometazoline 123ratio, 0.5 mg/ml is intended for use in children aged 2 to 10 years.
Active substance: Xylometazoline hydrochloride
Composition
Xylometazolin 123ratio, 1 mg/ml
Each spray dose (equivalent to 0.09 ml of nasal spray, solution) contains 0.09 mg of xylometazoline hydrochloride.
Xylometazolin 123ratio, 0.5 mg/ml
Each spray dose (equivalent to 0.09 ml of nasal spray, solution) contains 0.045 mg of xylometazoline hydrochloride.
For a full list of excipients, see section 6.1.
How to use
After removing the protective cap, place the applicator tip into the nostril and press the pump once. Breathe gently through the nose while administering the medication. After use, wipe the dispenser thoroughly with a clean tissue and replace the protective cap.
Action
It is a local decongestant that reduces nasal congestion and relieves the feeling of a “blocked” nose. The drug reduces swelling of the nasal mucosa.
Dosage
The medicinal product is intended for intranasal use. Xylometazoline 123ratio, 1 mg/ml:
Dosage in adults and children aged 10 years and older: 1-2 doses of Xylometazoline 123ratio, 1 mg/ml spray into each nostril, as needed, but up to 3 times a day. Do not use higher doses than recommended.
Xylometazoline 123ratio, 1 mg/ml is intended for both adults and children aged 10 years and over. The product must not be used in children under 10 years of age.
Xylometazolin 123ratio, 0.5 mg/ml:
Dosage in children aged 2 to 10 years: 1 dose of Xylometazoline 123ratio spray, 0.5 mg/ml in each nostril, as needed, but up to 3 times a day. Do not use higher doses than recommended.
Xylometazoline 123ratio, 0.5 mg/ml is intended for children aged 2 to 10 years. The product must not be used in children under 2 years of age.
Kids
Xylometazoline 123ratio, 1 mg/ml is intended for use in children aged 10 years and older, in accordance with the above recommendations.
Xylometazoline 123ratio, 1 mg/ml is contraindicated for use in children under 10 years of age. Other strengths of the medicinal product may be more appropriate for this group of patients.
Kids
Xylometazoline 123ratio, 0.5 mg/ml is intended for use in children aged 2 to 10 years, in accordance with the above recommendations.
Xylometazolin 123ratio, 0.5 mg/ml is not recommended for use in children under 2 years of age. The safety and efficacy of Xylometazolin 123ratio, 0.5 mg/ml in children under 2 years of age have not been established.
Duration of treatment
Xylometazolin 123ratio, 1 mg/ml / Xylometazolin 123ratio, 0.5 mg/ml must not be used for longer than 7 days, unless your doctor recommends otherwise.
If after 3 days of treatment the patient does not notice any improvement or feels a deterioration, the patient’s clinical condition should be reassessed. Prolonged and excessive use of the medicinal product may lead to secondary vasodilation and secondary rhinitis (see section 4.4). The recommended dose should not be exceeded.
You must wait a few days before using the medicinal product again.
In case of chronic rhinitis, the medicinal product may only be used under medical supervision due to the risk of atrophy of the nasal mucosa.
Method of administration
– Remove the protective cap.
– Before the first administration – and after a break in treatment of more than 15 days – press the pump several times until a fine mist appears. The next time you use it, the pump will be ready for immediate use.
– Place the nozzle into the nostril and administer the dose by pressing the pump once. Breathe calmly through your nose while administering the medicine.
– After use, wipe the dispenser thoroughly with a clean tissue and replace the protective cap.
Before using the medicinal product, patients are advised to thoroughly clean their nose. It is recommended to administer the last daily dose before going to bed.
For hygienic reasons and to avoid infection, each spray bottle should only be used by one person.
Contraindications
The medicinal product should not be used:
– if the patient is allergic to xylometazoline hydrochloride or any of the excipients,
– in persons after transsphenoidal pituitary removal or other surgical procedures involving exposure of the dura mater,
– in patients with dry inflammation of the nasal mucosa (rhinitis sicca) – with the exception of diagnostic tests to diagnose rhinitis sicca or atrophic rhinitis.
Xylometazoline 123ratio, 1 mg/ml is not intended for use in children under 10 years of age.
Xylometazoline 123ratio, 0.5 mg/ml is not intended for use in children under 2 years of age.
Contents: Xylometazolin Teva 1 mg/ml is a clear, almost colourless solution available in a brown glass bottle containing 10 ml (not less than 90 doses) of solution with a spray pump, a nasal applicator and a protective cap in a cardboard box.
Storage method: 15°C – 25°C
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