Active ingredients: Ephedrine
ARGOTONE 1% + 0.9% NASAL DROPS, solution
Why is Argotone used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Nasal decongestant for topical use.
THERAPEUTIC INDICATIONS
Nasal antiseptic and decongestant.
Contraindications When Argotone should not be used
Hypersensitivity to the active ingredients, to sympathomimetic amines in general or to any of the excipients; heart disease and severe arterial hypertension. Glaucoma, prostatic hypertrophy, hyperthyroidism.
Do not administer during or in the two weeks following monoamine oxidase inhibitor therapy (MAOIs).
The drug can not be taken by children under the age of 12.
Precautions for use What you need to know before taking Argotone
The use of topical products, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, to institute a suitable therapy. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be continued for more than a week.
Follow the recommended doses scrupulously. The medicine, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena.
Interactions Which drugs or foods can modify the effect of Argotone
Ask your doctor or pharmacist for advice before taking any medicine.
Ephedrine reduces the plasma half-life of corticosteroids.
Warnings It is important to know that:
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 prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can, therefore, be harmful.
Use with caution in diabetics and for the danger of urinary retention, in elderly subjects.
Consult your doctor before taking this medicine if you have a history of heart disease, irregular heart rhythm or angina.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
It is advisable not to use the drug in pregnancy for prolonged periods.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
It is forbidden to "take a different dose, by dosage and by route of administration, from those reported.
Dosage and method of use How to use Argotone: Dosage
Adults and children over 12 years: 3 drops in each nostril 2-3 times a day.
Good results are also obtained if Argotone is administered by aerosol.
Overdose What to do if you have taken an overdose of Argotone
In the event of an overdose (e.g. accidental oral intake), central depression and sedation, or episodes of excitement with agitation, hypertensive crisis and congestion of the face may appear in children.
In case of accidental intake of an excessive dose of Argotone, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF ARGOTONE, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Argotone
Like all medicines, Argotone can cause side effects, although not everybody gets them.
The drug can locally determine phenomena of sensitization or congestion of the rebound mucous membranes. Especially for high-dose or prolonged treatments beyond the recommended limit, the ephedrine absorbed through the inflamed mucous membranes and the digestive mucosa can cause systemic effects consisting, in general, in tachycardia, hypertension, headache, urination disturbances, insomnia, restlessness.
Although it is not known exactly how often this occurs, some people may occasionally experience chest pain (due to heart problems, such as angina). Tell your doctor immediately if you get these symptoms while taking Argotone.
Compliance with the instructions in the package leaflet reduces the risk of side effects.If any of the side effects gets serious or you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
WARNING: do not use the medicine beyond the expiration date indicated on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
NOTE - Argotone stains on handkerchiefs will be easily removed by washing them in warm water with any type of detergent. Boiling water should not be used as it would make the stains indelible.
In compliance with the current provisions of the Ministry of Health, the ARGOTONE is packaged in a child-resistant, difficult-to-open package. Therefore, TO OPEN THE BOTTLE, YOU MUST PRESS THE CAP AND SIMULTANEOUSLY UNscrew it. To close it, simply screw it tightly.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
Composition and pharmaceutical form
COMPOSITION
100 ml of solution contain:
Active principles:
Ephedrine hydrochloride g 0.9
Calved silver g 1.0
Excipients: sodium chloride, purified water, anhydrous sodium thiosulfate.
PHARMACEUTICAL FORM AND CONTENT
Nasal drops, solution. Bottle of 20 ml.
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
ARGOTONE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:
Calved silver 1 g
Ephedrine hydrochloride 0.9 g.
03.0 PHARMACEUTICAL FORM
Nasal drops.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Nasal antiseptic and decongestant.
04.2 Posology and method of administration
Adults and children over 12 years old: 3 drops in each nostril 2-3 times a day.
Good results are also obtained if ARGOTONE is administered by aerosol.
04.3 Contraindications
Known hypersensitivity to the product and sympathomimetic amines in general, heart disease and severe arterial hypertension. Glaucoma, prostatic hypertrophy, hyperthyroidism. Do not administer during or in the two weeks following monoamine oxidase inhibitor therapy (MAOIs). The drug is contraindicated in children under 12 years of age.
04.4 Special warnings and appropriate precautions for use
In patients with cardiovascular diseases, and especially in hypertensive patients, the use of nasal decongestants must be subjected to the judgment of the doctor from time to time. The prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, inducing also drug addiction. Repeating applications for long periods can therefore be harmful. Use with caution in diabetics and, due to the danger of urinary retention, in the elderly.
The use of topical products, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, to institute a suitable therapy. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be continued for more than a week.
Follow the recommended doses scrupulously. The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Ephedrine reduces the plasma half-life of corticosteroids.
04.6 Pregnancy and lactation
It is advisable not to use the drug in pregnancy for prolonged periods.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
The product may locally determine sensitization or congestion of the rebound mucous membranes. Especially for high dose or prolonged treatments beyond the recommended limit, the Ephedrine absorbed through the inflamed mucous membranes and the digestive mucosa can cause systemic effects consisting, generally, in tachycardia, hypertension, headache, urination disturbances, insomnia, restlessness.
04.9 Overdose
In the event of an overdose (e.g. accidental oral intake), central depression and sedation, or episodes of excitement with agitation, hypertensive crisis and congestion of the face, may occur in children.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Argotone has a local decongestant action due to the vasoconstrictor activity of Ephedrine hydrochloride and antiseptic action due to the presence of Vitellinate Silver.
05.2 Pharmacokinetic properties
The silver vitellin is not absorbed
05.3 Preclinical safety data
The LD50 was evaluated for Ephedrine hydrochloride: in the rat (iv137 mg / kg; sc 600 mg / kg); in the rabbit (iv 60 mg / kg; ip 355 mg / kg; sc 360 mg / kg; im 340 mg / kg; os 590 mg / kg) and in dogs (iv 72.5 mg / kg; sc 220 mg / kg).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium chloride;
sodium thiosulfate anhydrous;
demineralized water.
06.2 Incompatibility
None.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in ordinary environmental conditions.
06.5 Nature of the immediate packaging and contents of the package
Glass bottle with hard-to-open cap containing 20 ml.
06.6 Instructions for use and handling
See point 4.2.
07.0 MARKETING AUTHORIZATION HOLDER
Bracco S.p.A. - Via Folli, 50 - 20134 MILAN
08.0 MARKETING AUTHORIZATION NUMBER
1% + 0.9% Nasal drops - 20 ml bottle AIC n 003950019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization date: 29 September 1950
Renewal: June 1, 2000
10.0 DATE OF REVISION OF THE TEXT
01/07/2007
