Actifed decongestant 1mg/ml nasal spray solution 10ml

Actifed decongestant 1mg/ml nasal spray 10ml solution is an effective treatment for the temporary relief of nasal congestion associated with rhinitis or sinusitis. Formulated with xylometazoline hydrochloride , an active ingredient known for its decongestant properties, this nasal spray works quickly to reduce swelling of the nasal mucosa, making breathing easier. Each 140 mcg spray-dose ensures precise and targeted dosing, optimising the effectiveness of the treatment. The solution is enriched with excipients such as sodium hyaluronate and glycerol , which help maintain the hydration of the nasal mucosa, reducing dryness. Actifed decongestant is ideal for adults and children over 12 years old, offering a practical and convenient option for managing the symptoms of colds and seasonal allergies.

ACTIVE INGREDIENTS

Active ingredients contained in Actifed decongestant 1mg/ml nasal spray solution 10ml - What is the active ingredient of Actifed decongestant 1mg/ml nasal spray solution 10ml?

Xylometazoline hydrochloride 1 mg in 1 ml of solution: Each spray-dose (140mcl) contains 140 mcg of xylometazoline hydrochloride. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Actifed decongestant 1mg/ml nasal spray solution 10ml - What does Actifed decongestant 1mg/ml nasal spray solution 10ml contain?

Sodium hyaluronate, Sorbitol (E420), Glycerol (E422), Sodium dihydrogen phosphate dihydrate, Disodium phosphate dihydrate, Sodium chloride, Water for injections.

DIRECTIONS

Therapeutic indications Actifed decongestant 1mg/ml nasal spray solution 10ml - Why is Actifed decongestant 1mg/ml nasal spray solution 10ml used? What is it used for?

Temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Actifed decongestant 1mg/ml nasal spray solution 10ml - When should Actifed decongestant 1mg/ml nasal spray solution 10ml not be used?

ACTIFED DECONGESTIONANTE must not be used: - in patients with hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; - in patients with high intraocular pressure, particularly in the presence of narrow-angle glaucoma; - in patients with "dry" inflammation of the nasal mucosa ( Rhinitis sicca ); - in children under 12 years of age; - after transsphenoidal hypophysectomy or other transnasal / transoral surgery with exposure of the dura mater; - in patients treated with monoamine oxidase inhibitors (MAOIs) or who have used these drugs in the previous 2 weeks, or in patients taking other medicinal products with potential hypertensive effect; - in patients with atrophic or vasomotor rhinitis.

DOSAGE

Quantity and method of taking Actifed decongestant 1mg/ml nasal spray solution 10ml - How do you take Actifed decongestant 1mg/ml nasal spray solution 10ml?

For nasal use. Adults and children over 12 years : One spray in each nostril no more than three times a day. This medicine should be used for a maximum of 7 days, unless otherwise prescribed by your doctor. To minimize the risk of infections, the product should not be used by more than one person and the nozzle should be cleaned after each use. Children : ACTIFED DECONGESTANT is contraindicated in children under 12 years (see section 4.3). Elderly : Same dosage as for adults.

CONSERVATION

Storage Actifed decongestant 1mg/ml nasal spray solution 10ml - How is Actifed decongestant 1mg/ml nasal spray solution 10ml stored?

Do not store above 25°C.

WARNINGS

Warnings Actifed decongestant 1mg/ml nasal spray solution 10ml - About Actifed decongestant 1mg/ml nasal spray solution 10ml it is important to know that:

Xylometazoline, like other drugs belonging to the same pharmacological class, should be administered with caution in patients with a marked reaction to sympathomimetic substances. The use of substances of this type can cause a series of disorders in these patients, such as insomnia, dizziness, tremors, arrhythmia or increased blood pressure. Particular caution is required in patients with cardiovascular disease, hypertension, hyperthyroidism or diabetes, as well as in patients with prostatic hypertrophy and pheochromocytoma. Patients with long QT syndrome treated with xylometazoline may be exposed to an increased risk of serious ventricular arrhythmias. In case of prolonged treatment with xylometazoline, the reappearance of symptoms of rhinitis and mucous membrane edema is sometimes observed when the therapy is stopped. In these cases, it may also be a so-called "rebound" phenomenon caused by the drug itself, which progresses to chronic oedema and atrophy of the nasal mucosa ( Rhinitis medicamentosa and Rhinitis sicca) . To avoid this, the duration of treatment should be as short as possible (see section 4.2). Nasal and paranasal inflammations of bacterial origin should be treated appropriately. For the treatment of allergic rhinitis, this product can only be used temporarily as supportive therapy.

INTERACTIONS

Interactions Actifed decongestant 1mg/ml nasal spray solution 10ml - Which medicines or foods can modify the effect of Actifed decongestant 1mg/ml nasal spray solution 10ml?

The use of the product is not recommended in conjunction with tricyclic or tetracyclic antidepressant drugs or monoamine oxidase inhibitors (MAOIs), or within two weeks of using MAO inhibitors.

SIDE EFFECTS

Like all medicines, Actifed decongestant 1mg/ml nasal spray solution 10ml can cause side effects - What are the side effects of Actifed decongestant 1mg/ml nasal spray solution 10ml?

The most frequently reported side effects of this medicine are tingling or burning of the nose and throat and dryness of the nasal mucosa. Based on their frequency, the side effects have been divided into the following categories: Very common ≥1/10; Common from ≥1/100 to <1/10; Uncommon from ≥1/1000 to <1/100; Rare from ≥1/10,000 to <1/1000; Very rare <1/10,000 including isolated reports; Not known: frequency cannot be estimated from the available data.

	Common	Uncommon	Rare	Not known
Immune System Disorders			Systemic allergic reactions
Psychiatric disorders			Nervousness, insomnia
Pathology of the nervous system			Headache, dizziness
Eye pathologies			Transient visual disturbances
Heart disease			Palpitation
Vascular pathologies			Blood pressure increase
Respiratory, thoracic and mediastinal pathologies	Itching and burning in the nose and throat and dryness of the nasal mucosa	Epistaxis		Rebound effect
Gastrointestinal disorders			Nausea

Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. 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 Actifed decongestant 1mg/ml nasal spray solution 10ml - What are the risks of Actifed decongestant 1mg/ml nasal spray solution 10ml in case of overdose?

As an imidazoline, systemic overdose of xylometazoline can cause a wide range of symptoms related to cardiac and nervous system stimulation or depression. Cases of overdose have been mainly related to the use of the drug in children. Symptoms of intoxication reported include severe paralysis of the central nervous system, sedation, dry mouth and sweating, as well as symptoms caused by stimulation of the sympathetic nervous system (tachycardia, irregular pulse and increased blood pressure). One drop (single dose) of the adult preparation of xylometazoline (1 mg/ml) administered intranasally caused a 4-hour coma in a 15-day-old neonate. During follow-up, the neonate completely recovered. Treatment of intoxication is nosotropic and may include administration of charcoal, gastric lavage and inhalation of oxygen. To reduce blood pressure, 5 mg of phentolamine in saline solution is administered slowly intravenously or 100 mg orally. If necessary, antipyretics and anticonvulsants are administered. The use of vasopressors is contraindicated.

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 Actifed decongestant 1mg/ml nasal spray solution 10ml

There are no data on the transplacental passage of xylometazoline, nor on its secretion in breast milk. Due to the potential systemic vascular constriction effect, this medicinal product should not be used during pregnancy. During breastfeeding, this medicinal product should be used with caution as it is not known whether or not the active substance is transferred into breast milk.

DRIVING AND USE OF MACHINERY

Taking Actifed decongestant 1mg/ml nasal spray solution 10ml before driving or using machines - Does Actifed decongestant 1mg/ml nasal spray solution 10ml affect driving or using machines?

When used correctly, xylometazoline does not appear to have any influence on the ability to drive or use machines.