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


What it is and what it is used for
ARGOTONE contains the active ingredients vitellinated 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 therapy 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 subjected to the doctor's judgment from time to time.

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. drugs that cause blood vessels to narrow, resulting in increased blood pressure, can alter the normal function of the nasal mucosa and paranasal sinuses, also leading to drug addiction. Repeating applications 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.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, institute an appropriate therapy. 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.
Strictly follow the recommended doses. The medicine, if accidentally ingested or if used for a long period at excessive doses, can cause toxic phenomena.

The medicine should not be used orally.
Avoid contact of the liquid with eyes.
"Attention for those who practice sports: the medicinal product contains substances prohibited for doping. It is forbidden to take it in a different way, in terms of dosage schedule and administration route, from those reported."
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 locally cause 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 undesirable effects have been reported in post-marketing experience. The 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 (cannot be estimated from the available data).
Nervous system disorders
Not known: Headache, restlessness, insomnia, tolerance
Heart disease
Not known: Tachycardia (increased heart rate), palpitations, myocardial ischemia
Vascular pathologies
Not known: Hypertension (increased blood pressure)
Respiratory, thoracic and mediastinal pathologies
Not known: Dyspnoea (difficulty breathing)
Kidney and urinary disorders
Not known: Nocturia (frequent urination during the night) in patients with prostatic hyperplasia (enlargement of the prostate gland), urinary retention (difficulty in 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.