Rinofluimucil 1% + 0.5% nasal spray solution 10ml

Rinofluimucil 1% + 0.5% Nasal Spray is a nasal decongestant and mucolytic indicated for the treatment of acute and chronic rhinitis and sinusitis . Thanks to the combination of acetylcysteine ​​and tuaminoheptane , it helps to thin out thick and stubborn mucus, quickly clearing the nasal passages and reducing congestion.

The nasal spray formulation allows for targeted application and rapid action, promoting freer breathing after just a few applications. Ideal for those suffering from colds, vasomotor rhinitis or sinusitis , Rinofluimucil is an excellent solution for reducing inflammation and improving respiratory well-being. The 10ml format is practical and easy to carry.

ACTIVE INGREDIENTS

Active ingredients contained in Rinofluimucil 1% + 0.5% nasal spray solution 10ml - What is the active ingredient of Rinofluimucil 1% + 0.5% nasal spray solution 10ml?

100 ml of solution contains: Active ingredients N-Acetylcysteine: 1,000 g; Tuaminoheptane sulphate: 0,500 g. Excipients with known effect: benzalkonium chloride Mint flavour containing d-limonene For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Rinofluimucil 1% + 0.5% nasal spray solution 10ml - What does Rinofluimucil 1% + 0.5% nasal spray solution 10ml contain?

Benzalkonium chloride, Dithiothreitol, Sodium edetate, Disodium phosphate, Monobasic sodium phosphate, Sodium hydroxide, Alcohol, Hypromellose, Sorbitol 70%, Natural mint flavour (containing d-limonene), Purified water.

DIRECTIONS

Therapeutic indications Rinofluimucil 1% + 0.5% nasal spray solution 10ml - Why is Rinofluimucil 1% + 0.5% nasal spray solution 10ml used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Rinofluimucil 1% + 0.5% nasal spray solution 10ml - When should Rinofluimucil 1% + 0.5% nasal spray solution 10ml not be used?

- Hypersensitivity to the active substance or to any of the excipients. - Cardiovascular disease, including hypertension. - Previous cerebrovascular disease, including the presence of important risk factors (due to alpha-sympathomimetic activity). - Previous seizures. - Narrow-angle glaucoma. - Hyperthyroidism. - During and within two weeks of therapy with monoamine oxidase inhibitors (MAOIs). - Children under 12 years of age. - Phaeochromocytoma. - During use of other sympathomimetic agents, including other nasal decongestants. - Hypophysectomy or surgery exposing the dura mater.

DOSAGE

Quantity and method of taking Rinofluimucil 1% + 0.5% nasal spray solution 10ml - How to take Rinofluimucil 1% + 0.5% nasal spray solution 10ml?

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

CONSERVATION

Storage Rinofluimucil 1% + 0.5% nasal spray solution 10ml - How is Rinofluimucil 1% + 0.5% nasal spray solution 10ml stored?

Nothing in particular.

WARNINGS

Warnings Rinofluimucil 1% + 0.5% nasal spray solution 10ml - About Rinofluimucil 1% + 0.5% nasal spray solution 10ml it is important to know that:

Administer with caution in subjects suffering from occlusive vascular disease, asthma, diabetes and in therapy with beta-blocking drugs. Rinofluimucil should be administered with caution in pediatric age and is in any case 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 inducing addiction to the drug. Repeating 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 can give rise to sensitization phenomena: in this case it is necessary to interrupt the treatment and, if necessary, institute appropriate therapy. However, in the absence of a complete therapeutic response 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 can be integrated, at the discretion of the doctor, with an appropriate antibacterial coverage. Patients should be informed to stop the treatment if they experience arterial hypertension, tachycardia, palpitations, heart rhythm disturbances, nausea or any neurological signs and symptoms (such as headache or worsening of an existing headache). Tuaminoheptane sulphate may cause a positive anti-doping test. The preparation is not for ophthalmic use. Important information about some of the excipients : This medicine contains 0.005 mg of benzalkonium chloride per spray. Prolonged use may cause edema of the nasal mucosa. The mint flavour present in this medicine contains d-limonene which may cause allergic reactions. In addition to allergic reactions in patients sensitive to the allergen, non-sensitive patients may become sensitive.

INTERACTIONS

Interactions Rinofluimucil 1% + 0.5% nasal spray solution 10ml - Which medicines or foods can modify the effect of Rinofluimucil 1% + 0.5% nasal spray solution 10ml?

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.

SIDE EFFECTS

Like all medicines, Rinofluimucil 1% + 0.5% nasal spray solution 10ml can cause side effects - What are the side effects of Rinofluimucil 1% + 0.5% nasal spray solution 10ml?

Summary of safety profile: Prolonged use may alter the normal function of the nasal and paranasal mucosa, causing nasal congestion and inducing drug addiction. Summary table of adverse reactions: Frequent administration of the preparation at higher doses may cause sympathomimetic side effects (such as increased excitability, palpitations, tremors, etc.). Dryness of the nose and throat, acne eruptions may sometimes occur. These effects disappear completely when treatment is suspended. The following side effects may be associated with the use of Rinofluimucil:

° not known (cannot be estimated from the available data) * Particularly with prolonged and/or excessive use Paediatric population: The product is contraindicated in children under 12 years of age (see section 4.3). Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Rinofluimucil 1% + 0.5% nasal spray solution 10ml - What are the risks of Rinofluimucil 1% + 0.5% nasal spray solution 10ml in case of overdose?

In case of overdose in adults, arterial hypertension, photophobia, severe headache, chest tightness may occur. Paediatric population In case of overdose in children, hypothermia with marked sedation may occur. Treatment These events require the adoption of adequate emergency measures.

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 Rinofluimucil 1% + 0.5% nasal spray solution 10ml.

Pregnancy : Data on a limited number of pregnant women exposed to N-acetylcysteine ​​do not indicate any negative effect on pregnancy or on the health of the fetus/newborn. At present, no further relevant epidemiological data are available. Animal studies with N-acetylcysteine ​​have not shown direct or indirect harmful effects with respect to reproductive toxicity. There are no data on exposed pregnant women or animal studies with tuaminoheptane or N-acetylcysteine ​​+ tuaminoheptane. The product is not recommended during pregnancy. Breastfeeding : There is no information available on the excretion of N-acetylcysteine ​​and tuaminoheptane in human milk. A risk to the infant cannot be excluded. The product should not be used by breastfeeding mothers. Fertility: There are no animal studies on fertility with N-acetylcysteine ​​+ tuaminoheptane. There are also no data available on humans.

DRIVING AND USE OF MACHINERY

Taking Rinofluimucil 1% + 0.5% nasal spray solution 10ml before driving or using machinery - Does Rinofluimucil 1% + 0.5% nasal spray solution 10ml affect driving or using machinery?

There are no presuppositions or evidence that the drug can modify the attentional capacities and reaction times. Patients should however be informed that effects such as hallucinations have been reported.