Active ingredients: Xylometazoline (xylometazoline hydrochloride)
Argotone Nasal Decongestant 0.1% solution to be nebulized
Why is Argotone Nasal Decongestant used? What is it for?
What is it
Nasal decongestant that helps to clear the stuffy nose.
Why is it used
Argotone Nasal Decongestant is used as a nasal decongestant for rhinitis, colds, sinusitis.
Contraindications When Argotone Nasal Decongestant should not be used
When it should not be used
- Hypersensitivity to components or other closely related substances from a chemical point of view.
- Heart disease and severe arterial hypertension
- Glaucoma
- Prostatic hypertrophy and hyperthyroidism
- During and in the two weeks following therapy with antidepressant drugs
- Children under the age of 12
When it can only be used after consulting your doctor
- Pregnancy and breastfeeding: see "What to do during pregnancy and" breastfeeding ".
- Patients with cardiovascular diseases, especially those with hypertension
- Elderly, due to the danger of urinary retention
It is also advisable to consult your doctor in cases where these disorders have occurred in the past
What to do during pregnancy and breastfeeding
Use with caution in the first months of pregnancy.
During pregnancy and lactation Argotone Nasal Decongestant should be used only after consulting the Doctor and having evaluated with him the risk / benefit ratio in your case.
Consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.
Precautions for use What you need to know before taking Argotone Nasal Decongestant
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and produce undesirable effects; in this case it is necessary to stop the treatment and consult your doctor.
Do not use for prolonged treatments. After a short period of treatment, of no more than 4 days, without appreciable results, consult your doctor.
Interactions Which drugs or foods can modify the effect of Argotone Nasal Decongestant
Not to be used at the same time or in the two weeks following "taking antidepressant drugs (see" When it should not be used ")
If you are using other medicines, ask your doctor or pharmacist for advice
Warnings It is important to know that:
The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena (see "What to do if you have taken an excessive dose of medicine").
The repeated use of the drug for long periods can be harmful. The prolonged use of vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, also inducing addiction to the drug.
Dose, Method and Time of Administration How to use Argotone Nasal Decongestant: Dosage
How many
Adults: 1-2 sprays per nostril, 2-3 times a day Children over 12 years: for each administration halve the quantities indicated for adults In the case of elderly patients, consult a doctor.
Warning: never exceed the indicated doses without the advice of the doctorWhen and for how long
Adults: 2-3 times a day
Children over 12 years: 1-2 times a day
Do not use for more than 4 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics
Like
To nebulize the preparation, press the bottle holding the package between the index, middle and thumb.
When using the pack for the first time, press 2 or 3 times without pressure (not in the nostril), for regular nebulisation
Overdose What to do if you have taken too much Argotone Nasal Decongestant
In the event of an overdose, there may be an increase in blood pressure, and a decrease in heartbeat, discomfort due to bright light, intense headache, a feeling of tightness in the chest and, in children, lowering of body temperature and marked sedation, which require adoption. adequate measures of urgency.
In case of accidental ingestion / intake of an excessive dose of Argotone Nasal Decongestant, immediately notify your doctor or go to the nearest hospital
Side Effects What are the side effects of Argotone Nasal Decongestant
The product can locally determine sensitization phenomena and, by rebound, congestion of the mucous membrane. Due to the rapid absorption of the product through the inflamed mucous membranes, systemic effects may occur such as increase in blood pressure, slow heartbeat, headache, urination disturbances.
Compliance with the instructions in the package leaflet reduces the risk of side effects. These side effects are usually transient. However, when they arise, it is advisable to consult the doctor or pharmacist.
It is important to inform the doctor or pharmacist of the appearance of undesirable effects not described in the package leaflet.
Request and fill in the Undesirable Effects report form available at the pharmacy (form B).
Expiry and Retention
Expiry: 36 months from the date of preparation
Warning: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach and sight of children
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
Composition
100 g of solution to be sprayed contain:
Active ingredient: xylometazoline hydrochloride 100 mg
Excipients: Monopotassium phosphate, sodium chloride, disodium phosphate dihydrate, nonylphenoxy polyethoxyethanol, disodium edetate, eucalyptol, Neroli essential oil, benzalkonium chloride, purified water.
How it looks
Argotone Nasal Decongestant comes in the form of a solution to be nebulized for nasal use. The contents of the package is a 15 g nebulizer bottle with dosing valve.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
NASAL DECONGESTANT ARGOTONE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of solution to be sprayed contain, active principle: xylometazoline hydrochloride 100 mg.
See point 6.1
03.0 PHARMACEUTICAL FORM
Nebulizer solution, nasal use.
15 g nebulizer bottle.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Nasal decongestant for rhinitis, colds, sinusitis
04.2 Posology and method of administration
Adults: 1 or 2 sprays per nostril, 2-3 times a day.
Children over 12 years old: 1 spray per nostril, 1 or 2 times a day.
To nebulize the preparation press the bottle holding the package between the index, middle and thumb. At the beginning press 2-3 times without pressure (not in the nostril), to have a regular nebulization.
04.3 Contraindications
Hypersensitivity to product components or other closely related substances from an organic point of view; heart disease and severe hypertension, glaucoma, prostatic hypertrophy and hyperthyroidism. Not to be used during and in the last two weeks following antidepressant drug therapy.
Do not use in children under 12 years of age.
04.4 Special warnings and appropriate precautions for use
Use with caution, due to the risk of urinary retention, in the elderly and in subjects with prostatic hypertrophy. In patients with cardiovascular diseases, especially those with hypertension, the use of nasal decongestants must in any case be subjected to the judgment of the physician from time to time.
The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena (see "Overdose").
The repeated use of the drug for long periods can be harmful. The prolonged use of vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, also inducing addiction to the drug.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and produce undesirable effects; in this case it is necessary to interrupt the treatment and, if necessary, to institute a suitable therapy. In any case, the treatment is not must be continued for more than 4 days.
04.5 Interactions with other medicinal products and other forms of interaction
Not to be used in conjunction with antidepressant drugs (see "Contraindications")
04.6 Pregnancy and lactation
Use with caution in the first months of pregnancy.
04.7 Effects on ability to drive and use machines
You don't notice.
04.8 Undesirable effects
The product can locally determine sensitization phenomena and, by rebound, congestion of the mucous membranes. Due to the rapid absorption of the product through the inflamed mucous membranes, systemic effects may occur such as arterial hypertension, reflex bradycardia, headache, urination disturbances.
04.9 Overdose
In case of overdose, arterial hypertension, bradycardia, photophobia, intense headache, chest tightness and, in children, hypothermia and severe depression of the central nervous system with marked sedation may appear, which require the adoption of adequate emergency measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: R01AA
Xylometazoline hydrochloride is a selective alpha-adrenergic agonist of the imidazoline type which exerts, via nasal inhalation, a rapid and prolonged vasoconstrictor activity in the mucosa. This effect causes a resolution of edema, promotes drainage of the sinuses, and improves nasal ventilation.
05.2 Pharmacokinetic properties
After nasal inhalation, the effect of xylometazoline is manifest in about 5-10 minutes and lasts for 5-6 hours. Although the compound is generally not absorbed, after inhalations of higher than recommended doses, absorption can occur. systemic from both the nasal mucosa and the gastrointestinal tract, especially in children and the elderly.
05.3 Preclinical safety data
The oral LD50 of xylometazoline is 230 mg / kg in the rat and 75 mg / kg in the mouse.
No teratogenic or carcinogenic effects of the substance have been documented.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Monopotassium phosphate, sodium chloride, disodium phosphate dihydrate, nonylphenoxy polyethoxyethanol, disodium edetate, eucalyptol, Neroli essential oil, benzalkonium chloride, purified water.
06.2 Incompatibility
There are no known incompatibilities.
06.3 Period of validity
36 months from the date of preparation.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Rhinological nebulizer, solution in 15 g plastic bottle with dosing valve.
06.6 Instructions for use and handling
Not relevant.
07.0 MARKETING AUTHORIZATION HOLDER
BRACCO s.p.a., Via E. Folli, 50 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 033184019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
25/11/2000
10.0 DATE OF REVISION OF THE TEXT
October 2008
