Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays)

Rinoclenil 100 µg 30 ml nasal spray suspension is a nasal spray based on beclometasone dipropionate , a powerful nasal cortisone belonging to the glucocorticoid class, specifically formulated for the treatment and prophylaxis of seasonal and perennial allergic rhinitis , as well as vasomotor rhinitis . Each 30 ml bottle guarantees up to 200 precise sprays , with a dose of 100 micrograms of active ingredient per spray , ensuring a constant and targeted dosage directly on the nasal mucosa.

Thanks to its local anti-inflammatory action , Rinoclenil helps to quickly reduce the typical symptoms of nasal allergies such as congestion, itching, sneezing and nasal discharge, improving the quality of breathing and daily well-being. The nasal suspension is designed for topical use and acts directly on the inflamed areas, limiting systemic absorption and reducing the risk of side effects compared to oral corticosteroids.

Rinoclenil is indicated as a nasal decongestant for adults and children over 6 years of age, proving particularly effective both in the acute phase and in the prevention of recurrences of rhinitis. The formulation contains selected excipients to ensure homogeneous distribution of the drug and easy nebulization , making application simple and comfortable. Ideal for those suffering from nasal inflammation due to seasonal or perennial allergies or vasomotor rhinitis , Rinoclenil represents a reliable and proven effective solution for the treatment of rhinitis and the control of nasal allergic symptoms .

ACTIVE INGREDIENTS

Active substances contained in Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - What is the active substance of Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays)?

100 ml of suspension contains: Active ingredient: Beclometasone dipropionate 77 mg. Each spray delivers 100 micrograms of beclometasone dipropionate. Excipients with known effect : Benzalkonium chloride 27 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - What does Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) contain?

Polysorbate 20, microcrystalline cellulose and sodium carboxymethylcellulose, benzalkonium chloride, phenylethyl alcohol, dextrose (glucose) monohydrate, purified water.

DIRECTIONS

Therapeutic indications Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - Why is Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) used? What is it used for?

Prophylaxis and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - When should Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; Local viral and tubercular infections; Contraindicated in children under 6 years of age.

DOSAGE

Quantity and method of taking Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - How is Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) taken?

Rinoclenil must be administered exclusively by the nasal route. Dosage Adults and children over 6 years : two sprays in each nostril once a day. In children, if deemed appropriate, a schedule of administration in divided doses can be maintained, carrying out a single spray in each nostril twice a day. The onset of the effect is not immediate and for a complete therapeutic benefit it is advisable to use the product regularly and for several days. Children under 6 years : the product must not be administered to children under 6 years of age. Method of administration Shake the bottle vigorously before each administration. Furthermore, before starting the therapy it is advisable to remove the protective cap, the protective ring and activate the dosing pump several times to activate the nebulization mechanism. Proceed with the spraying as follows : 1) Thoroughly clean the nose. 2) Remove the protective cap. 3) Remove the protective ring that blocks the pump from the side. 4) Hold the bottle between your fingers. To activate the nebulization mechanism, activate the dosing pump several times until you obtain a visible spray. 5) Place the nasal tip on one nostril, closing the other nostril with a finger. Inhale and simultaneously press the base of the nasal tip. This will dispense a single dose of the active ingredient in exactly the right amount. Repeat the same operation on the other nostril. 6) After use, replace the protective cap and the protective ring. If the dispenser is blocked, wash it thoroughly with warm water, without touching the hole with sharp objects.

CONSERVATION

Storage Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - How should Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) be stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - It is important to know that Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays):

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses for prolonged periods. In all cases, treatment should be discontinued and appropriate therapy instituted. These effects are less likely to occur than with oral corticosteroids and may vary in individual patients and between corticosteroid preparations. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, reduction in bone mineral density, cataract, glaucoma and, more rarely, a range of psychological or behavioural effects including sleep disorders, anxiety, depression or aggression (particularly in children) or neurological effects such as psychomotor hyperactivity. It is recommended that the height of children receiving prolonged treatment with intranasal corticosteroids is regularly monitored (see section 4.8). Although RINOCLENIL controls the symptoms of allergic rhinitis in most cases, an abnormally high allergen stimulus may require in some cases appropriate additional therapy, particularly to control ocular symptoms. The replacement of systemic corticosteroid therapy with topical therapy (Rinoclenil) requires caution, especially if there is reason to believe that there is a certain degree of impairment of adrenal function. In subjects who are particularly sensitive or predisposed due to recent therapy with systemic steroids, or if doses of nasal beclometasone in excess of those recommended are taken, systemic effects may occur (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency). Visual disturbances Visual disturbances may be reported with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids. Rinoclenil should not be used after trauma or surgery to the nose (until healing) and in the presence of nasal ulcerations, unless prescribed by a doctor. In patients receiving systemic corticosteroids, the product should be administered under medical supervision. Do not use for more than one month without consulting a doctor. Excessively prolonged use of topical corticosteroids may cause temporary suppression of the hypothalamic-pituitary-adrenal axis, resulting in secondary adrenal insufficiency. Infections of the nasal passages and paranasal sinuses should be treated appropriately, however they do not constitute a specific contraindication to the use of Rinoclenil. Warnings relating to excipients The product contains benzalkonium chloride, an irritant that may cause local reactions. Benzalkonium chloride (BAC) contained as a preservative in Rinoclenil, especially when used for long periods, may cause swelling of the nasal mucosa. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without BAC should be used, if possible. If such nasal medicines without BAC are not available, another pharmaceutical form should be considered. May cause bronchospasm.

INTERACTIONS

Interactions Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - Which medicines or foods can modify the effect of Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays)?

Beclometasone is less dependent on CYP3A metabolism than other corticosteroids and, in general, interactions are unlikely; however, since the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, caution and appropriate monitoring of the use of such agents is recommended.

SIDE EFFECTS

Like all medicines, Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) can cause side effects - What are the side effects of Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays)?

Systemic side effects are extremely unlikely due to the low doses used. Systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses for prolonged periods. These may include growth retardation in children and adolescents. However, particular caution should be exercised in prolonged use of the product, with the patient being monitored in order to promptly reveal possible systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency). As with other nasal preparations, burning sensation, irritation, dryness and, more rarely, epistaxis may occur locally. Rare cases of perforation of the nasal septum have been reported following nasal applications of corticosteroids. Rare cases of increased intraocular pressure or glaucoma have been associated with nasal formulations of beclometasone dipropionate. Cases of blurred vision have been observed with an unknown frequency (see also section 4.4). In case of infection, institute appropriate therapy. 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse..

OVERDOSE

Overdose Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) - What are the risks of Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) in case of overdose?

Administration of large amounts of beclometasone dipropionate in a short period of time may result in suppression of hypothalamic-pituitary-adrenal function. In this case, the dose of RINOCLENIL must be immediately reduced to the recommended dose.

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 Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays).

Pregnancy In pregnant women, the product should be administered in cases of real need, under the direct supervision of a doctor. There are no or limited data on the use of beclometasone in pregnant women. The administration of drugs during pregnancy should be considered only if the foreseeable benefits for the mother are greater than the potential risks for the fetus. In reproductive studies in animals, the typical side effects of potent corticosteroids were observed only after high systemic exposure; nasal administration ensures minimal systemic exposure. Breastfeeding There is insufficient information on the excretion of beclometasone/metabolites in breast milk. It is reasonable to assume that beclometasone dipropionate is secreted in milk but, at the doses used by the nasal route, the presence of significant levels in breast milk is unlikely. However, the use of beclometasone dipropionate during breastfeeding requires a careful evaluation by the doctor of the risk-benefit ratio for both the mother and the child.

DRIVING AND USE OF MACHINERY

Taking Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) before driving or using machines - Does Rinoclenil 100 µg 30 ml nasal spray suspension (200 sprays) affect driving or using machines?

Rinoclenil does not alter the ability to drive vehicles or use machines.