Argotone 1% + 0.9% 20 ml nasal drops solution

Argotone 1% + 0.9% 20 ml nasal drops solution is an antiseptic and nasal decongestant medicine indicated for the treatment of stuffy nose and nasal congestion typical of colds and other upper respiratory tract conditions. Its formulation combines vitelline silver (1%) and ephedrine hydrochloride (0.9%), two active ingredients known for their effectiveness in clearing the nose and promoting easier breathing. The product is available in a practical 20 ml bottle, ideal for topical use and easily transportable.

Thanks to the presence of vitellinated silver , Argotone has an antiseptic action that helps to counteract the proliferation of microorganisms in the nasal mucosa, while ephedrine hydrochloride acts as a decongestant , reducing swelling of the mucous membranes and facilitating the passage of air. This nasal solution is particularly suitable for adults and children over 12 years of age who need an effective nasal treatment against the symptoms of colds and congestion.

Argotone 1% + 0.9% is a SOP (non-prescription) medicine and is a reliable choice for those looking for a practical and safe medical device . Its targeted action helps to quickly clear a stuffy nose , improving the quality of breathing and daily well-being.

ACTIVE INGREDIENTS

Active ingredients contained in Argotone 1% + 0.9% 20 ml nasal drops solution - What is the active ingredient of Argotone 1% + 0.9% 20 ml nasal drops solution?

100 ml of solution contain: - Vitellinate silver 1 g - Ephedrine hydrochloride 0.9 g For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Argotone 1% + 0.9% 20 ml nasal drops solution - What does Argotone 1% + 0.9% 20 ml nasal drops solution contain?

- Sodium chloride - Anhydrous sodium thiosulfate - Purified water

DIRECTIONS

Therapeutic indications Argotone 1% + 0.9% 20 ml nasal drops solution - Why is Argotone 1% + 0.9% 20 ml nasal drops solution used? What is it used for?

Antiseptic and nasal decongestant.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Argotone 1% + 0.9% 20 ml nasal drops solution - When should Argotone 1% + 0.9% 20 ml nasal drops solution not be used?

Hypersensitivity to the active substances, to sympathomimetic amines in general or to any of the excipients listed in paragraph 6.1, Cardiac disease and severe arterial hypertension, Glaucoma, Prostatic hypertrophy, Hyperthyroidism, Pheochromocytoma. Do not administer during or within two weeks of therapy with monoamine oxidase inhibitors (MAOIs). The drug is contraindicated in children under 12 years of age.

DOSAGE

Quantity and method of taking Argotone 1% + 0.9% 20 ml nasal drops solution - How to take Argotone 1% + 0.9% 20 ml nasal drops solution?

Adults and children over 12 years: 3 drops in each nostril 2-3 times a day. Treatment should not be continued for more than 7 days. Strictly follow the recommended doses. A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects.

CONSERVATION

Storage Argotone 1% + 0.9% 20 ml nasal drops solution - How do you store Argotone 1% + 0.9% 20 ml nasal drops solution?

THIS MEDICINAL PRODUCT DOES NOT REQUIRE ANY SPECIAL STORAGE CONDITIONS. For storage conditions after first opening, see section 6.3.

WARNINGS

Warnings Argotone 1% + 0.9% 20 ml nasal drops solution - About Argotone 1% + 0.9% 20 ml nasal drops solution it is important to know that:

In patients with cardiovascular disease, and in hypertensive patients, the use of nasal decongestants should be subject to the physician's judgment from time to time. Cardiovascular effects may be observed with the use of sympathomimetic drugs, such as Argotone. There is evidence, from post-marketing data and published literature, of rare cases of myocardial ischemia in association with the use of beta agonists. Patients taking Argotone should be advised to contact their physician if they experience chest pain or other symptoms of worsening of a pre-existing cardiac disease. Attention should be paid to the evaluation of symptoms such as dyspnea and chest pain, as they may be of respiratory or cardiac origin. Prolonged use of vasoconstrictors may alter the normal function of the nasal mucosa and paranasal sinuses, also inducing addiction to the drug. Repeating applications for periods longer than recommended may, therefore, be harmful. Use with caution in diabetics and, due to the risk of urinary retention, in elderly subjects. 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. Scrupulously adhere to the recommended doses. The medicine, if accidentally ingested or if used for a long period at excessive doses, can cause toxic phenomena. It should be kept out of the reach of children. It should not be used orally. Avoid contact of the liquid with the eyes.

INTERACTIONS

Interactions Argotone 1% + 0.9% 20 ml nasal drops solution - Which medicines or foods can modify the effect of Argotone 1% + 0.9% 20 ml nasal drops solution?

Ephedrine reduces the plasma half-life of corticosteroids. Asthmatic patients treated with such drugs should therefore avoid taking ephedrine-based products. Ephedrine contained in ARGOTONE may interact negatively with monoamine oxidase inhibitors (MAOIs). Consequently, administration of the product during or within two weeks of antidepressant drug therapy is contraindicated. Ephedrine may reduce the pharmacological efficacy of antihypertensive drugs; associated with clonidine, it may cause an increase in noradrenaline levels and an increase in blood pressure with an increased risk of arrhythmias. The urinary excretion of ephedrine is pH dependent; acetazolamide, antacids, ammonium chloride and sodium bicarbonate are able to alkalinize the urine, and consequently slow the elimination of ephedrine. The concomitant use of ephedrine with digoxin, phenylpropanolamine, cyclopropane and pseudoephedrine is associated with an increased risk of cardiovascular adverse events (increased risk of arrhythmias). Reserpine, by causing noradrenaline depletion, may reduce the efficacy of ephedrine. Theophylline may cause an increased incidence of central and gastrointestinal adverse effects, which occur following the administration of ephedrine. Thyroid hormones: Caution is advised in the concomitant use of sympathomimetics and thyroid hormones. Volatile anaesthetics: Ephedrine should be avoided in patients undergoing anaesthetic treatment with halogenated anaesthetics.

SIDE EFFECTS

Like all medicines, Argotone 1% + 0.9% 20 ml nasal drops solution can cause side effects - What are the side effects of Argotone 1% + 0.9% 20 ml nasal drops solution?

The medicinal product may cause local rebound sensitization or congestion of the mucous membranes. The following undesirable effects have been reported with the use of systemic ephedrine and may arise following the use of ephedrine-based nasal drops. The undesirable effects are described according to the MedDRA system organ class and on the basis of the frequency estimated from 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 (frequency cannot be estimated from the available data). Nervous system disorders Not known: Headache, restlessness, insomnia, tolerance Cardiac disorders Not known: Tachycardia, palpitations, myocardial ischemia Vascular disorders Not known: Hypertension Respiratory, thoracic and mediastinal disorders Not known: Dyspnoea Renal and urinary disorders Not known: Nocturia in patients with prostatic hyperplasia, urinary retention Skin and subcutaneous tissue disorders Not known: Hyperhidrosis, rash Immune system disorders Not known: Hypersensitivity Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

OVERDOSE

Overdose Argotone 1% + 0.9% 20 ml nasal drops solution - What are the risks of Argotone 1% + 0.9% 20 ml nasal drops solution in case of overdose?

In case of overdose (e.g. accidental oral intake), central depression and sedation may appear in children, i.e. episodes of excitement with agitation, hypertensive crisis and facial congestion.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Argotone 1% + 0.9% 20 ml nasal drops solution.

It is advisable not to use the drug during pregnancy or while breastfeeding. Pregnancy Ephedrine crosses the placental barrier and has been associated with increased fetal heart rate. Breastfeeding Ephedrine is present in breast milk. The effects on infants are not known: it has been reported that ephedrine can cause irritability and disturbed sleep in newborns when used during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Argotone 1% + 0.9% 20 ml nasal drops solution before driving or using machines - Does Argotone 1% + 0.9% 20 ml nasal drops solution affect driving or using machines?

Not known.