Rinofluimucil 1% + 0.5% nasal spray solution 10ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

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 mucosa of the nose 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 a suitable therapy. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case the treatment must not be continued for more than a week. The action of the preparation can be integrated, in the doctor's opinion, with an appropriate antibacterial covering. Patients should be advised to discontinue treatment if they develop arterial hypertension, tachycardia, palpitations, heart rhythm disturbances, nausea or any neurological signs and symptoms (such as headache or worsening of existing headache). Tuaminoheptane sulfate can cause a positive anti-doping test. The preparation is not for ophthalmic use. Important information about some excipients: This medicine contains 0.005 mg of benzalkonium chloride in each actuation. Prolonged use may cause edema of the nasal mucosa. The mint flavoring 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

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

SIDE EFFECTS

Security profile summary: Prolonged use can alter the normal functionality of the nasal and paranasal mucosa, causing nasal congestion and inducing addiction to the drug. Summary table of adverse reactions: Frequent administration of the preparation at higher doses can cause sympathomimetic side effects (such as increased excitability, heart palpitations, tremor, etc.). Sometimes dryness of the nose and throat, acne rashes may occur. These effects disappear completely when treatment is discontinued. The following side effects may be associated with the use of Rinofluimucil:

Organ-systemic classification | Adverse reactions Frequency not known°

Immune system disorders | Hypersensitivity

Psychiatric disorders | anxiety*, hallucination*, delirium*

Nervous system disorders | headache*, restlessness*, agitation*, insomnia*, tremor*

Cardiac disorders | palpitations*, tachycardia*, arrhythmia*

Vascular pathologies | Hypertension

Respiratory, thoracic and mediastinal disorders | dry nose and throat*, nasal discomfort*, nasal congestion*

Gastrointestinal disorders | Nausea

Skin and subcutaneous tissue disorders | Urticaria, rash

Renal and urinary disorders | Urinary retention

Systemic disorders and conditions relating to the administration site | irritability,* drug addiction*

° not known (cannot be estimated from available data) * Particularly with prolonged and/or excessive use Pediatric 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 authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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.