RINOFLUIMUCIL SPRAY NAS 10ML

RINOFLUIMUCIL 1% + 0.5% NASAL SPRAY

active ingredients

100 ml of solution contain: Active ingredients N-Acetylcysteine: 1,000 g; Tuaminoeptano sulphate: 0.500 g. Excipients with known effects: benzalconio chloride Aroma mint containing d-limonene For the full list of excipients, see paragraph 6.1

Excellent

Benzalconio chloride, Ditiotreitol, Sodium edetato, Sodium phosphate bibasic, Sodium phosphate monobasic, Sodium hydroxide, Alcool, Ipromellosa, Sorbitol 70%, Natural mint aroma (containing d-limonene), purified water.

Therapeutic indications

- Acute and subacute rhinitis, especially with mucopurulent and slow resolution exudates. - Chronic and muco-crostose rhinitis. - Vasom renowns. - Sinusite.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients. - cardiovascular pathology, including hypertension. - Pregressed cerebrovascular pathology, including the presence of important risk factors (due to alpha-simpaticomimetic activity). - Pregressed seizures. - Glaucoma at a narrow angle. - Hyperthyroidism. - During and in the next two weeks to therapy with monoaminooxidase inhibitors (IMAO). - Children under the age of 12. - Feocromocytoma. - During the use of other sympathomimetic agents, including other nasal decongestants. - Hypofisectomy or surgery with exposure of the hard mother.

Population

The RINOFLUIMUCIL is used for applications in nasal cavities, using the appropriate dosing dispenser (see paragraph 6.6). ADULTS: 2 dispenses in each nostril 3-4 times a day. CHILDREN over 12 years: 1 delivery in every nostril 3-4 times a day. Do not exceed the doses indicated. The bottle, when opened, can be used for a period not exceeding 20 days.

Conservation

No details.

Warnings

Administer with precaution in subjects suffering from occlusive vascular disease, asthma, diabetes and in therapy with beta-blockers. Rinofluimucil should be administered with caution in pediatric age and is contraindicated in children under the age of 12. Protracted use of potassium-containing preparations can alter the normal function of the mucosa of the nose and of the paranasal breasts, also inducing the drug addiction. Repeating applications for long periods can therefore be harmful. Use the product with caution, for the risk of urinary retention, in the elderly and in the carriers of prostate hypertrophy. The use, especially if prolonged, of topical products can give rise to awareness: in this case it is necessary to stop treatment and, if necessary, to establish suitable therapy. However, in the absence of complete therapeutic response within a few days consult your doctor; in any case the treatment should not be protracted for over a week. The action of the preparation can be integrated, according to the doctor, with an appropriate antibacterial cover. It would be necessary to inform patients to stop the treatment if arterial hypertension, tachycardia, palpitations, heart rhythm disorders, nausea or any signal and neurological symptom (such as headache or worsening of headaches already present). Tuaminoeptano sulphate can determine positivity to the antidoping test. The preparation is not for ophthalmic use. Important information about some excipients: This medicine contains 0.005 mg of benzalconio chloride at each delivery. Prolonged use can cause nasal mucosa edema. The mint aroma present in this medicine contains d-limonene which can cause allergic reactions. In addition to allergic reactions in allergen-sensitive patients, nonsensical patients can become sensitive.

Interactions

Despite the poor systemic absorption of yourminoepthan administered intranasally, the following potential interactions should be considered: - monoamino oxidase inhibitors (IMAO), including reversible inhibitors of monoamino oxidase (RIMA): increased risk of hypertensive crisis; - antihypertensives (including adrenergic neuron blockers and beta blockers): can block hypotensive effects; - cardiac glycosides: can increase the risk of dysrithmia;- alkaloids of hergot: can increase the risk of ergotism; - antiparkinson drugs: they can increase the risk of cardiovascular toxicity; - oxytocin: can increase the risk of hypertension.

Effects

Security profile summary: Prolonged use can alter the normal functions of nasal and paranasal mucosa by causing nasal congestion and causing drug addiction. Summary table of adverse reactions: Frequently administered preparation at higher doses can cause side effects of sympathomimetic type (such as increased excitability, cardiopalm, tremor, etc.). Talora may occur dryness of the nose and throat, acne eruptions. Such effects completely disappear with the suspension of treatment. The following side effects can be associated with the use of Rinofluimucil:

Organ-systematic classification	Adverse reactions Frequency not known
Immune system disorders	Hypersensitivity
Psychiatric disorders	anxiety*, hallucination*, delusion*
Diseases of the nervous system	headache, restlessness, restlessness, insomnia, and tremor
Heart disease	palpitations*, tachycardia*, arrhythmia*
Vascular diseases	Hypertension
Respiratory, chest and mediastinic pathologies	nasal and throat dryness*, nasal discomfort*, nasal congestion*
Gastrointestinal diseases	Nausea
Pathologies of skin and subcutaneous tissue	Orthics, rash
Kidney and urinary pathologies	Urinary retention
Systemic pathologies and conditions for administration	irritability,* drug addiction*

° not known (can not be made an estimate from the available data) * Especially with prolonged and/or excessive use Pediatric population: The product is contraindicated in children under the age of 12 (see paragraph 4.3). 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of overdose in adults can appear arterial hypertension, photophobia, intense headache, chest oppression. Pediatric population In case of overdose in children can appear hypothermia with strong sedation. Treatment These events require the adoption of appropriate emergency measures.

Pregnancy

: Data relating to a limited number of pregnant women exposed to N-acetylcysteine did not indicate any negative effects on pregnancy itself or on the health of fetus/neonate. At present, no further important epidemiological data are available. Animal studies with N-acetylcysteine showed no direct or indirect harmful effects on reproductive toxicity. There are no data about pregnant women exposed or animal studies with yourminoeptano or N-acetylcysteine + yourminoeptano. The product is not recommended in pregnancy.

Food

: There is no information available on the excretion of N-acetylcysteine and yourminoepthan in breast milk. You cannot exclude a risk for the infant. The product should not be used by nursing mothers.

Fertility:

Animal studies on fertility with N-acetylcysteine + youraminoeptano are not available. Human data is not available.

Source: Farmadati