ARGOTONE GTT RINO 20ML 1%+0.9%

ARGOTONE 1% +0.9% NASAL GOCCE, DEVELOPMENT

active ingredients

100 ml of solution contain: - Silver vitellinate g 1 - Efedrina hydrochloride g 0.9 For the full list of excipients, see paragraph 6.1.

Excellent

- Sodium chloride - Sodium tiosolfato anidro - Purified water

Therapeutic indications

Nasal antiseptic and decongestant.

Contraindications

Hypersensitivity to active ingredients, sympathomimetic amines in general or any of the excipients listed in paragraph 6.1, heart disease and severe arterial hypertension, Glaucoma, prostate hypertrophy, Hyperthyroidism, Feocromocytoma. Do not administer during or in the two weeks following therapy with mono-aminooxidase inhibitors (IMAO). The drug is contraindicated in children under the age of 12.

Population

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

Conservation

MEDICINAL THIS IS NOT REQUEST A PARTICULAR CONDITION For storage conditions after first opening see paragraph 6.3

Warnings

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 can be observed with the use of sympathetic 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 agonisti. Patients taking Argotone should be advised to contact the doctor if they experience chest pain or other symptoms of worsening of a pre-existing heart disease. It must be paid attention to the evaluation of symptoms such as dispersion and chest pain, as they may be both of respiratory and cardiac origin. The protracted use of vasoconstrictors can alter the normal function of the mucosa of the nose and of the paranasal breasts, also causing assuefation to the drug. Repeat applications for longer periods than recommended can therefore be harmful. Carefully use in diabetics and, for the risk of urinary retention, in elderly individuals. The use, especially if the topical products are prolonged, can give rise to awareness-raising phenomena; in this case it is necessary to stop the treatment and, if necessary, establish suitable therapy. In the absence of a complete therapeutic response within a few days, consult your doctor; in any case, treatment should not be protracted for over a week. Strictly adhere to the recommended doses. The medicinal product, if accidentally ingested or used for a long period at excessive doses, can determine toxic phenomena. It must be kept away from the reach of children. It should not be used orally. Avoid liquid contact with eyes.

Interactions

Ephedrine reduces the plasma half-life of corticosteroids. Asthmatic patients in treatment with such drugs should therefore avoid taking ephedrine-based products. Ephedrine contained in ARGOTONE can interact negatively with mono-aminooxidase inhibitors (IMAO). It is therefore contraindicated the administration of the product during or in the two weeks following antidepressant drug therapy. Ephedrine can reduce the pharmacological effectiveness of antihypertensive drugs; associated with clonidine, it can cause increased noradrenaline levels and increased blood pressure with increased risk of arrhythmias. Ephedrine urinary excretion is dependent pH; acetazolamide, antacids, ammonium chloride and sodium bicarbonate are able to alkaline the urine, and consequently slow the elimination of ephedrine. The contemporary association of ephedrine with digoxin, phenylpropanolamin, cyclopropane and pseudoefedrine is associated with a greater risk of cardiovascular adverse events (increased risk of arrhythmias). Reserpine, causing norepinephrine depletion, can reduce the effectiveness of ephedrine. Theophylline can cause greater incidence of central and gastrointestinal adverse effects, which occur as a result of ephedrine administration. Thyroid hormones: caution is required in the concomitant use of sympathetics and thyroid hormones. Volatile anesthetics: ephedrine should be avoided in patients subjected to anesthetic treatment with halogenated anesthetics.

Effects

The medicinal product can determine locally phenomena of sensitization or congestion of rebound mucosa. The following side effects have been reported using ephedrine by systemic means and may arise as a result of the use of ephedrine-based nasal drops. The side effects are described according to the classification for systems and organs according to MedDRA and based on the frequency estimated by post-marketing experience. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, Diseases of the nervous system Not known: Kefalea, restlessness, insomnia, tolerance Heart disease Notable: Tachycardia, palpitations, myocardial ischemia Vascular diseases Notable: Hypertension Respiratory, chest and mediastinic pathologies Notable: Dispense Kidney and urinary pathologies Notable: Nicturia in patients with prostate hyperplasia, urinary retention Pathologies of skin and subcutaneous tissue Notable: Hyperhidrosis, rash Immune system disorders Notable: Hypersensitivity Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

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

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

Source: Farmadati