ARGOTONE "1% + 0.9% NASAL DROPS" 1 BOTTLE OF 20 ML"

Name
ARGOTONE 1%/0.9% nasal drops, solution
Vitellinate silver/Ephedrine hydrochloride


What is it and what is it used for?
ARGOTONE contains the active ingredients vitellinate silver, responsible for the antiseptic action, and ephedrine hydrochloride, responsible for the nasal decongestant action, and belongs to the group of nasal decongestant medicines for topical (local) use.

ARGOTONE, therefore, acts as an antiseptic and nasal decongestant.

Talk to your doctor if you do not feel better or if you feel worse.


What you need to know before taking the medicine
Do not use ARGOTONE
- if you are allergic to vitellinated silver, ephedrine hydrochloride, sympathomimetic amines in general or to any of the other ingredients of this medicine (listed in section 6).
- If the patient is a child under 12 years of age.
- If you suffer from heart disease and severe high blood pressure.
- If you suffer from glaucoma (increased pressure inside the eye).
- If you suffer from prostatic hypertrophy (enlargement of the prostate).
- If you suffer from hyperthyroidism (increased thyroid function).
- If you suffer from pheochromocytoma (tumor of the adrenal gland).

Do not administer during or within two weeks of treatment with monoamine oxidase inhibitors (MAOIs), medicines used against depression.


Warnings and precautions
Talk to your doctor or pharmacist before using ARGOTONE.

In patients with cardiovascular disease, and in hypertensive patients, the use of nasal decongestants must be subject to the doctor's judgment on a case-by-case basis.

Cardiovascular effects may be observed with the use of Argotone; rare cases of myocardial ischemia have been reported in association with the use of beta agonists.
Prolonged use of vasoconstrictors, i.e., medications that cause blood vessels to narrow, resulting in increased blood pressure, can disrupt the normal function of the nasal and sinus mucosa, possibly leading to drug tolerance. Repeated use for longer periods than recommended can therefore be harmful.
Use with caution in diabetics and, due to the risk of urinary retention, in elderly subjects.
Consult your doctor if you experience symptoms such as chest pain and difficulty breathing.
Use of topical products, especially if prolonged, may cause sensitization. In this case, discontinue treatment and, if necessary, initiate appropriate therapy. If a complete therapeutic response is not seen within a few days, consult your doctor; in any case, treatment should not be continued for more than a week.
Strictly adhere to the recommended dose. If accidentally ingested or if used excessively for a long time, the medicine may cause toxicity.

The medicine should not be used orally.
Avoid contact of the liquid with eyes.
"Attention for athletes: this medicinal product contains substances prohibited for doping. Any use other than those listed, in terms of dosage schedule and route of administration, is prohibited."
Ephedrine can be a substance of abuse.

Children and adolescents
The medicine cannot be taken by children under 12 years of age (see section "Do not use Argotone").


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The medicine may cause local sensitization or congestion of the mucous membranes,
rebound phenomenon, that is, the opposite of the desired one.
The following side effects have been reported with the use of systemic ephedrine and may occur following the use of ephedrine nose drops.
The following adverse reactions have been reported in post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Nervous system disorders
Not known: Headache, restlessness, insomnia, intolerance
Heart disease
Not known: Tachycardia (increased heart rate), palpitations, myocardial ischemia
Vascular pathologies
Not known: Hypertension (increased blood pressure)
Respiratory, thoracic and mediastinal disorders
Not known: Dyspnoea (difficulty breathing)
Kidney and urinary tract diseases
Not known: Nocturia (frequent urination at night) in patients with prostatic hyperplasia (enlargement of the prostate gland), urinary retention (difficulty passing urine)
Skin and subcutaneous tissue disorders
Not known: Hyperhidrosis (excessive sweating), rash (temporary skin eruption)
Immune system disorders
Not known: Hypersensitivity

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.