Fexallegra Nasal 1 mg/ml + 3, 55 mg/ml 10 ml nasal spray solution

Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution is a nasal medicine specifically formulated to provide rapid and targeted treatment of the symptoms of allergic rhinitis , such as hay fever and seasonal allergies . Thanks to the combination of tramazoline hydrochloride (decongestant) and chlorpheniramine maleate (antihistamine), this nasal spray works effectively to clear a blocked nose , reducing congestion and relieving the discomfort associated with nasal allergies .

The nasal solution Fexallegra Nasal is indicated for the symptomatic treatment of allergic rhinitis , offering a rapid and prolonged effect directly on the nasal mucosa. Its combined action allows to counteract both inflammation and congestion, ensuring immediate relief from nasal disorders such as sneezing, itching, runny nose and obstruction. The practical 10 ml bottle with nebulizer ensures easy application and uniform distribution of the solution, ideal for daily use during periods of greater exposure to allergens.

Fexallegra Nasal is the ideal choice for those looking for a drug for stuffy nose and nasal congestion caused by allergies , with a fast and localized action . An effective solution for the treatment of nasal symptoms related to allergies, improving breathing and quality of life throughout the year.

ACTIVE INGREDIENTS

Active ingredients contained in Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - What is the active ingredient of Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution?

1 ml of solution contains: tramazoline hydrochloride 1.18 mg equivalent to tramazoline 1.01 mg, chlorpheniramine maleate 5.05 mg equivalent to chlorpheniramine 3.55 mg (10 ml contain: tramazoline hydrochloride 11.8 mg, chlorpheniramine maleate 50.5 mg). Excipients with known effect: benzalkonium chloride. For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - What does Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution contain?

benzalkonium chloride , liquid sorbitol, citric acid, disodium phosphate dihydrate, sodium chloride, purified water.

DIRECTIONS

Therapeutic indications Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - Why is Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution used? What is it used for?

Symptomatic therapy of allergic rhinitis, such as hay fever.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - When should Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution not be used?

Fexallegra nasal is contraindicated in the following cases: • Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. • Dry rhinitis. • Heart disease and severe arterial hypertension. • Acute angle glaucoma. • Hyperthyroidism, prostatic hypertrophy. • Pregnancy and breastfeeding. • After cranial surgery performed via the nasal route. • Children under 12 years of age.

DOSAGE

Quantity and method of taking Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - How is Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution taken?

Adults and children over 12 years: 1-2 sprays per nostril every 8-12 hours. Do not exceed the recommended doses. Duration of treatment: advise the patient that, in the absence of a complete therapeutic response within a few days, he/she should consult his/her doctor; in any case, treatment should not be continued for more than 4 days. Paediatric population: the medicinal product is contraindicated in children under 12 years of age (see section 4.3). Method of administration The bottle should be used by holding it vertically, to obtain spray nebulisations. For correct use of the nebuliser, follow the instructions below: Remove the protective cap after blowing your nose, keeping your head in a normal position, insert the olive into the nostril and nebulise by pressing the bottle evenly once or twice with quick and forceful strokes. After nebulisation, inhale deeply with your mouth closed, pressing lightly with your index finger on the other nostril, in order to ensure distribution of the solution over the entire nasal mucosa. Then repeat the application in the other nostril. The empty space above the liquid is necessary for the bottle to function perfectly as a nebulizer. After use, it is recommended to clean the olive and put the protective cap on.

CONSERVATION

Storage Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - How is Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - About Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution it is important to know that:

Prolonged use of topical nasal vasoconstrictors may alter the normal function of the nasal mucosa and paranasal sinuses, causing chronic inflammation and atrophy; it may also lead to drug addiction. Use, especially if prolonged, of topical products may give rise to sensitization phenomena. When the vasoconstrictor effect of the drug ceases, nasal mucosal edema may occur due to reactive hyperemia. Mild and moderate arterial hypertension Due to the potential risk of systemic absorption, Fexallegra nasal should be used with caution in patients with mild-moderate arterial hypertension; in these patients, the use of nasal decongestants should in any case be subjected to clinical evaluation from time to time. Diabetes Mellitus During treatment with sympathomimetic drugs, an alteration in glucose regulation may occur due to the pharmacological interaction with antidiabetic drugs or the effect on glucose metabolism. Due to the potential risk of systemic absorption, Fexallegra nasal should be used with caution in patients with diabetes mellitus. Phaeochromocytoma and porphyria Due to the potential risk of systemic absorption, Fexallegra nasal should be used with caution in patients with phaeochromocytoma and porphyria. Elderly The medicinal product should be used with caution in elderly patients. Dizziness, sedation, confusion and hypotension may be more likely to occur in elderly patients taking antihistamines. Elderly patients are particularly sensitive to the anticholinergic side effects of antihistamines, such as dry mouth and urinary retention (especially in male patients). Misuse / Drug administration error The medicinal product should not be used orally. If accidentally ingested or if 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 marked sedation (see section 4.9). Contact of the liquid with the eyes may cause irritation. Important information about some of the excipients Fexallegra nasal contains the preservative benzalkonium chloride which can cause irritation and, especially if used for long periods, persistent nasal congestion; in this case, a nasal medicine without benzalkonium chloride or, alternatively, another pharmaceutical form must be used.

INTERACTIONS

Interactions Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - Which medicines or foods can modify the effect of Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution?

Antidepressant drugs and vasopressor drugs Due to the presence of the sympathomimetic agent tramazoline hydrochloride, Fexallegra nasal should not be administered together with antidepressant drugs and within two weeks of their administration. The administration of Fexallegra nasal in conjunction with antidepressant drugs (MAO inhibitors or tricyclic antidepressants) or vasopressor drugs may cause an increase in blood pressure. Use in combination with tricyclic antidepressants may also cause arrhythmias. MAO inhibitors and tricyclic antidepressants may prolong and intensify the anticholinergic and central nervous system (CNS) depressant effects of chlorpheniramine maleate. Drugs with a depressant action on the CNS Alcohol, sedatives, opioid analgesics, hypnotics may cause an increase in the sedative effects due to the antihistamine chlorpheniramine maleate. Phenytoin When taken concomitantly with phenytoin, chlorpheniramine maleate may result in decreased phenytoin elimination 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.

SIDE EFFECTS

Like all medicines, Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution can cause side effects - What are the side effects of Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution?

The following convention has been used for the classification of undesirable effects: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). The following undesirable effects may occur following the use of Fexallegra nasal: Immune system disorders. Not known: hypersensitivity (skin oedema, mucosal oedema). Psychiatric disorders. Not known: hallucinations, insomnia, restlessness. Nervous system disorders. Not known: somnolence, sedation, headache, dizziness, dysgeusia. Cardiac disorders. Not known: arrhythmias, tachycardia, palpitations. Respiratory, thoracic and mediastinal disorders. Not known: epistaxis, nasal edema, burning nose, nasal dryness, rhinorrhea, sneezing. Gastrointestinal disorders. Not known: nausea. Skin and subcutaneous tissue disorders. Not known: rash, pruritus. General disorders and administration site conditions. Not known: fatigue. Diagnostic tests. Not known: increased blood pressure. 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 www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution - What are the risks of Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution in case of overdose?

Symptoms An increase in blood pressure and tachycardia may, especially in children, be followed by a drop in blood pressure, subnormal temperatures, shock and reflex bradycardia. Similar to other alpha-sympathomimetic drugs, the clinical picture of intoxication with Fexallegra nasal can be confusing, since phases of stimulation and depression of the Central Nervous System and the cardiovascular system can alternate. Especially in children, intoxications produce effects on the Central Nervous System such as convulsions and coma, bradycardia, respiratory depression. Symptoms of stimulation of the Central Nervous System are anxiety, agitation, hallucinations and convulsions. Symptoms of depression of the Central Nervous System are hypothermia, lethargy, drowsiness and coma. In addition, the following symptoms may occur: mydriasis, miosis, sweating, fever, pallor, cyanosis of the lips, cardiovascular dysfunction, including cardiac arrest, respiratory dysfunction, including respiratory failure and respiratory arrest, psychological changes. As with other H1 antagonist drugs, in case of acute intoxication with chlorpheniramine maleate, the greatest danger is represented by central excitatory effects. The syndrome includes hallucinations, excitation, ataxia, athetosis and convulsions. Dilated and fixed pupils with a red face may be observed, together with sinus tachycardia, urinary retention, dry mouth and fever. Therapy In case of nasal overdose, immediately wash or clean the nasal mucosa thoroughly. Symptomatic treatment may be necessary.

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 Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution.

Pregnancy The medicinal product is contraindicated during pregnancy (see section 4.3). Breastfeeding The medicinal product is contraindicated during breastfeeding (see section 4.3). Fertility No studies have been conducted to investigate the effects on human fertility.

DRIVING AND USE OF MACHINERY

Taking Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution before driving or using machines - Does Fexallegra Nasal 1 mg/ml + 3.55 mg/ml 10 ml nasal spray solution affect driving or using machines?

No studies have been performed to investigate the effects of Fexallegra nasal on the ability to drive or use machines. However, patients are advised that undesirable effects such as hallucinations, drowsiness, sedation, dizziness and tiredness may occur during treatment with Fexallegra nasal. Chlorpheniramine maleate may cause drowsiness that may persist the following day. Concomitant ingestion of alcohol or other CNS depressant drugs produces an additive effect that impairs motor skills. Alcohol consumption should be avoided during treatment. Therefore, caution is recommended when driving or using machines. If patients experience the above-mentioned side effects, they should avoid activities in which loss of attention could be potentially dangerous, such as driving or using machines.