FROBEN RAFFREDDORE 15ML 0,05%

FROBEN REFREDDOUR 0.05% NASAL SPRAY, DEAL

active ingredients

100 ml of product contain: Active ingredient: oxytazoline hydrochloride 50 mg. A spray corresponds to 0.1 ml of solution and contains 0.05 mg of oxytazoline. For the full list of excipients, see paragraph 6.1.

Excellent

Sorbitol, hydrogen phosphate potassium, sodium phosphate dibasic dodecaidrate, chlorhexidine diacetate, purified water.

Therapeutic indications

Decongestant of the nasal mucosa (free the closed nose), especially in case of cold.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 - Prostatic hypertrophy - Heart disease and severe arterial hypertension - Glaucoma - Hyperthyroidism - Inflammation or lesions of the oral mucosa or skin around the nostrils. Do not administer in patients in treatment with antidepressant drugs, during and in the two weeks following therapy. In particular, concomitant use with monoaminoxydase inhibitors (IMAO) can cause increased blood pressure or hypertensive crisis (see paragraph 4.5); The drug is contraindicated in children under the age of 12.

Population

Population Adults and children over twelve years A spray for nostril every 6 - 12 hours, if necessary. Do not exceed 4 days of treatment unless otherwise indicated by your doctor. Do not exceed the recommended doses. Method of administration For use remove the plastic cap, introduce the end of the bottle in the nostril and press with fast and decisive motion, breathing deeply with the nose.

Conservation

Store at a temperature below 25°C. Don't refrigerate.

Warnings

In patients with cardiovascular diseases, especially in hypertensives, the use of nasal decongestants must nevertheless be subjected to the medical examination. Patients with thyroid pathologies, diabetes, or difficulty in urination by enlarged prostate should not take oxytazoline, unless otherwise indicated by the doctor. Temporary discomforts such as burning, pinching, sneezing or increased nasal secretion may occur. The frequent or protracted use of vasoconstrictors may alter the normal function of mucosa of the nose and paranasal breasts, also causing drug addiction. Repeating applications for long periods may result dannoso.Impiegare with caution in the elderly for the danger of urinary retention. The use, especially if prolonged, of topical medicines can give rise to phenomena of sensitization and reduction of the effectiveness of the drug administered (tachyphylaxis): in such case it is necessary to stop the treatment and establish suitable therapy. If symptoms persist or worsen, or new symptoms appear, patients must stop using and consult a doctor; in any case the treatment should not be protracted for over 4 days to avoid a rebound effect and rhinitis phenomena induced by the drug. Strictly adhere to the recommended doses. It should not be used orally. The medicinal product, if accidentally ingested or if used for a long time in excessive doses may cause toxic phenomena. It must be kept away from the reach of children, since accidental ingestion can prove severe sedation. Avoid liquid contact with eyes. Attention for sportsmen: the product contains substances prohibited for doping. A different intake is prohibited, by a posological scheme and by way of administration, from those indicated.

Interactions

Do not administer during and in the two weeks following antidepressant medication therapy. Oxytazoline exercises its vasoconstrictoral properties by stimulating adrenergic receptors and encouraging the release of norepinephrine from neuronal storage sites. Monoaminoxydase inhibitors (IMAO), hinder the metabolism of sympathomimetic amines by increasing the availability of releasing norepinephrine in the nervous system, can enhance the diary effect of oxytazoline. In medical literature, acute hypertensive crises were reported due to the concomitant use of IMAO and sympathomimetic amines. Oxytazoline could reduce the effectiveness of beta-blockers, methyl dopa or other antihypertensive drugs. Hypertension and arrhythmia phenomena may occur when antidepressants are administered with sympathomimetic drugs such as oxytazoline. An increase in cardiovascular toxicity may occur when sympathomimetic drugs are administered in conjunction with antiparchinsonian drugs such as bromocriptine.

Effects

Below are the adverse reactions identified during the post marketing experience with oxytazoline, divided according to the incidence of spontaneous signalling and according to the frequency categories using the following convention: Very common (≥1/10); Common (≥1/100,

The medicinal product can determine locally phenomena of sensitization and congestion of rebound mucosa. 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 the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

In case of overdose, following excessive use, alternating periods of stimulation and depression of the cardiopulmonary system and central nervous system may occur, causing symptoms such as, but not limited to: arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression and, in children, hypothermia and severe depression of the central nervous system with strong sedation, requiring adoption. Oral ingestion, especially in children, can cause symptoms such as nausea, vomiting, letargy, tachycardia, decreased breathing, bradycardia, hypotension, hypertension, sedation, drowsiness, midriasis, astonishment, hypothermia, salivation, coma. You can observe local irritation and congestion of bounce mucosa. Treatment Treatment should only be symptomatic. In serious cases, intubation and artificial breathing is required.

There are no adequate and controlled clinical studies on pregnant or nursing women for oxytazoline. This medicine should not be used during pregnancy or breastfeeding unless the potential benefit of the treatment for the mother is greater than possible risks to the developing fetus or infant breastfeeding. It is not known whether oxytazoline and its metabolites are excreted in human milk.

Source: Farmadati