FEXALLEGRA NASALE SPRAY FL10ML

FEXALLEGRA NASALE 1 MG/ML + 3,55 MG/ML NASAL SPRAY DEAL

active ingredients

1 ml of solution contains: 1,18 mg weaveline weavezoline 1,01 mg, clorfeniramine maleate 5,05 mg equal to chlorfeniramine 3,55 mg (10 ml contain: plotzoline hydrochloride 11.8 mg, maleated chlorfeniramine 50,5 mg). Excipients with known effect: benzalconio chloride. For the full list of excipients, see paragraph 6.1

Excellent

benzalconio chloride, liquid sorbitol, citric acid, dihydrate dibasic phosphate sodium, chloride sodium, purified water.

Therapeutic indications

Symptomatic therapy of allergic rhinitis, such as hay cold.

Contraindications

Nasal fexallegra is contraindicated in the following cases: • Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. • Rinite sicca. • Heart disease and severe arterial hypertension. • Glaucoma with acute angle. • Hyperthyroidism, prostate hypertrophy. • Pregnancy and nursing. • After surgery performed nasally. • Children under the age of 12.

Population

Adults and children over 12 years: 1-2 nebulizations per nostril every 8-12 hours. Do not exceed the recommended doses. Duration of treatment: notify the patient who, in the absence of complete therapeutic response within a few days, should consult the doctor; in any case the treatment should not be protracted for over 4 days. Pediatric population: the medicinal product is contraindicated in children under 12 years old (see paragraph 4.3). Method of administration The bottle should be used by keeping it vertically, to obtain spray nebulizations. For proper use of the nebulizer follow the following: Remove the protective cap after blowing the nose, holding the head in normal position, introduce the olive in the nostril and nebulize evenly pressing the bottle one or two times with quick and energetic hits. After the nebulization inhale deeply in the closed mouth, pressing slightly with the index finger on the other nostril, in order to ensure a breakdown of the solution on the whole nasal mucosa. Then repeat the application in the other nostril. The vacuum space above the liquid is necessary for a perfect operation of the bottle as a nebulizer. After use it is recommended to clean the olive and put the protective cap.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Prolonged use of nasal topical vasoconstrictors can alter the normal function of nasal mucosa and paranasal breasts, causing chronic and atrophy inflammation; in addition, it may also induce drug addiction. The use, especially if prolonged, of topical products can give rise to phenomena of awareness. When the vasoconstrictor effect of the drug ceases, nasal mucosa edema may occur for reactive hyperemia. Mild and moderate arterial hypertension Because of the potential risk of systemic absorption, Fexallegra nasal should be used with caution in patients with mild to moderate arterial hypertension; In these patients, the use of nasal decongestants should be subjected to clinical evaluation from time to time. Diabetes Mellitus During the treatment with sympathetic medicinal products, an alteration of the regulation of glucose determined by the pharmacological interaction with antidiabetic drugs or the effect on glucidic metabolism can occur. For the potential risk of systemic absorption, nasal fexallegra should be used with caution in patients with diabetes mellitus. Phochromocytoma and porphyry For the potential risk of systemic absorption, nasal fexallegra should be used with caution in patients with feochromocytoma and porphyria. Seniors In the elderly, the medicine must be used with caution. The appearance of dizziness, sedation, confusion and hypotension can be more likely in older patients taking antihistamines. Elderly patients are particularly sensitive to anti-inflammatory side effects of antihistamines, such as dry mouth and urinary retention (especially in male patients). Improper use / Drug administration error The medicine should not be used by mouth. If accidentally ingested or used for a long period at excessive doses, it can cause toxic phenomena. Accidental ingestion in children can cause severe depression of the central nervous system with strong sedation (see paragraph 4.9). Liquid contact with eyes can cause irritations. Important information about some excipients Nasal fexallegra contains the preservative benzalconio chloride that can cause irritation and, especially if used for long periods, a persistent nasal congestion; in this case, a nasal medication without benzalconio chloride or, alternatively, another pharmaceutical form should be used.

Interactions

Antidepressant drugs and vasopressant drugs For the presence of the sympatomymetic agent weavezoline hydrochloride, nasal fexallegra should not be administered along with antidepressant drugs and in the two weeks following the administration of the latter. The administration of nasal fexallegra in conjunction with antidepressant drugs (MAO inhibitors or triceclic antidepressants) or vasopressor drugs, may result in increased blood pressure. Use in combination with tricyclic antidepressants can also cause arrhythmia. MAO inhibitors and tricyclic antidepressants can prolong and intensify the anticholinergic and depression effects of the central nervous system (SNC) of maleate chlorfeniramine. Drugs with depressive action on the SNC Alcoholics, sedatives, opioid analgesics, hypnotics can cause an increase in the effects of sedation due to antihistamine maleato. Fenitoin If taken in conjunction with phenytoin, maleate chlorfeniramine may result in a decrease in the elimination of phenytoin with increased risk of phenytoin toxicity. Antihypertensive drugs Interactions with antihypertensive drugs, especially those whose action involves the sympathetic nervous system, can be complex and lead to various cardiovascular effects.

Effects

The following Convention has been used for the classification of unwanted effects: very common (≥1/10), common (≥1/100, immune system disorders. Not known: hypersensitivity (edema of the skin, edema of the mucous membranes). Psychiatric disorders. Notable: hallucinations, insomnia, restlessness. Nervous system pathologies. Notable: drowsiness, sedation, headaches, dizziness, dysgeusia. Heart disease. Notable: arrhythmias, tachycardia, palpitations. Respiratory, thoracic and mediastinic pathologies. Do not note: epistaxes, nasal edema, nose burnings, nasal dryness, rhyrrhea, sneezing. Gastrointestinal disease. No note: nausea. Pathologies of skin and subcutaneous tissue. Note: rash, itching. Systemic pathologies and conditions for administration. Notable: fatigue. Diagnostic exams. Notable: increased blood pressure. 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

Synonyms An increase in blood pressure and tachycardia can, especially in children, be followed by a decrease in blood pressure, by temperatures under the norm, by shock and by reflected bradycardia. Similarly to other alpha-simpaticomimetic drugs, the clinical picture of an intoxication with nasal fexallegra can be confused, since phases of stimulation and depression of the Central Nervous System and the cardiovascular system can be alternated. Especially in children, intoxication produces effects on the Central Nervous System such as convulsions and coma, bradycardia, respiratory depression. Symptoms of Central Nervous System stimulation are anxiety, agitation, hallucinations and seizures. Symptoms of depression of the Central Nervous System are hypothermia, lethargy, drowsiness and coma. The following symptoms may also occur: midriasis, myosis, sweating, fever, pallor, cyanosis of the lips, cardiovascular dysfunctions, including cardiac arrest, respiratory dysfunctions, including respiratory failure and respiratory arrest, psychological alterations. Similarly to other antagonists H1 drugs, in case of acute intoxication by maleate chlorfeniramine, the greatest danger is represented by centrally-level excitation effects. The syndrome includes hallucinations, excitement, ataxia, athetosis and seizures. Dilated and fixed pupils can be found with reddened face, together with sinus tachycardia, urinary retention, dry mouth and fever. Therapy In case of nasal overdose wash or immediately clean nasal mucosa. Syntomatic treatment may be necessary.

Pregnancy The medicinal product is contraindicated in pregnancy (see paragraph 4.3). Food The medicinal product is contraindicated during feeding (see paragraph 4.3). Fertility Studies have not been conducted to investigate the effects on human fertility.

Source: Farmadati