Rinofluimucil 1% + 0.5% nasal spray - acute and subacute rhinitis - 10 ml solution

Product Description

Fluidifying and decongestant nasal spray useful for acute and subacute rhinitis.

Active ingredients

100 ml of solution contain: Active ingredients N-Acetylcysteine ​​1.000 g Tuaminoheptane sulfate 0.500 g For the full list of excipients, see section 6.1

Excipients

Benzalkonium chloride, Dithiothreitol, Sodium edetate, Dibasic sodium phosphate, Monobasic sodium phosphate, Sodium hydroxide, Alcohol, Hypromellose, Sorbitol 70%, Natural mint flavouring, Purified water.

Therapeutic indications

- Acute and subacute rhinitis, especially with mucopurulent and slowly resolving exudates. - Chronic and mucous-crusted rhinitis. - Vasomotor rhinitis. - Sinusitis.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Narrow-angle glaucoma. Hyperthyroidism. During and in the two weeks following therapy with monoamine oxidase inhibitors (MAOIs). Children under 12 years of age. Pheochromocytoma. During use of other sympathomimetic agents, including other nasal decongestants. Hypophysectomy or surgical interventions with exposure of the dura mater.

Dosage

RINOFLUIMUCIL is used for applications in the nasal cavities, using the appropriate metered-dose dispenser (see section 6.6). ADULTS: 2 sprays in each nostril 3-4 times a day. CHILDREN over 12 years of age: 1 spray in each nostril 3-4 times a day. Do not exceed the indicated dose. Once opened, the bottle can be used for a period not exceeding 20 days.

Warnings and precautions

In patients with cardiovascular disease, and especially in hypertensive patients, the use of nasal decongestants should be subject to the doctor's judgment. Administer with caution in patients with occlusive vascular disease, asthma, diabetes, and those undergoing treatment with beta-blockers. Rinofluimucil should be administered with caution in pediatric patients and is contraindicated in children under 12 years of age. Prolonged use of preparations containing vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, also leading to drug addiction. Repeated applications for long periods can therefore be harmful. Use the product with caution, due to the risk of urinary retention, in the elderly and in those with prostatic hypertrophy. The use, especially if prolonged, of topical products may give rise to sensitization phenomena: in this case, it is necessary to discontinue treatment and, if necessary, institute appropriate therapy. However, if a complete therapeutic response is not achieved within a few days, consult your doctor; in any case, treatment should not be continued for more than a week. The action of the preparation may be supplemented, at the doctor's discretion, with an appropriate antibacterial coverage. Tuaminoheptane sulfate may cause a positive anti-doping test. The preparation is not for ophthalmic use. Important information about some excipients: The preservative benzalkonium chloride may cause allergic reactions. cause skin reactions or bronchospasm.

Interactions

Despite the poor systemic absorption of intranasally administered tuaminoheptane, the following potential interactions should be taken into consideration: - monoamine oxidase inhibitors (MAOIs), including reversible monoamine oxidase inhibitors (RIMAs): increased risk of hypertensive crisis, - antihypertensives (including adrenergic neuron blockers and beta blockers): may block hypotensive effects, - cardiac glycosides: may increase the risk of dysrhythmia, - ergot alkaloids: may increase the risk of ergotism, - antiparkinsonian drugs: may increase the risk of cardiovascular toxicity, - oxytocin: may increase the risk of hypertension.

Undesirable effects

Frequent administration of the preparation at the highest doses may increase the risk of hypertension. High doses may cause sympathomimetic side effects (such as increased excitability, palpitations, tremors, etc.). Dryness of the nose and throat, acne rashes, may sometimes occur. These effects disappear completely when treatment is stopped. The following side effects may be associated with the use of Rinofluimucil; the frequency of these side effects is unknown (cannot be estimated from the available data):

Pregnancy and breastfeeding

Pregnancy Data on a limited number of pregnant women exposed to N-acetylcysteine ​​have not indicated any negative effects on the pregnancy itself or on the health of the fetus/newborn. At present, no further relevant epidemiological data are available. Animal studies have not shown direct or indirect harmful effects with regard to reproductive toxicity. There are no data on pregnant women exposed to tuoaminoheptane or animal studies with tuoamonoheptane. Rinofluimucil is not recommended during pregnancy. Breastfeeding There is no information available on the excretion of N-acetylcysteine ​​and tuaminoheptane in breast milk, therefore the product should not be used by breastfeeding mothers.