Rinoclenil Nasal Spray 100 Mcg Beclomethasone Dipropionate 200 Actuations

Beclometasone dipropionate based spray.

Therapeutic indications

Rinoclenil Spray is used in the prophylaxis and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• 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, making a single injection into 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 of age: the product should not be administered to children under 6 years of age.

Shake the bottle vigorously before each administration. Furthermore, before starting the therapy, it is advisable to remove the protective cap, the protective ring and operate the dosing pump several times to activate the nebulization mechanism. Proceed with the delivery as follows:

1. Carry out a thorough cleaning of the nose.
2. Remove the protective cap.
3. Laterally remove the protection ring that blocks the pump.
4. Hold the bottle between your fingers. To activate the spray mechanism, operate the dosing pump several times until a visible spray is obtained.
5. Place the nasal nozzle on one nostril, closing the other nostril with a finger. Breathe in and press the base of the nasal nozzle at the same time. In this way, an exactly dosed single dose of active ingredient is delivered. Repeat the same operation on the other nostril.
6. After use, replace the protective cap and protective ring. In case of occlusion of the dispenser, wash it carefully with lukewarm water, without intervening on the hole with sharp objects.

Overdose

Administration of large quantities of beclomethasone dipropionate over a short period of time may result in suppression of hypothalamic-pituitary-adrenal function. In this case, the dose of Rinoclenil should be reduced immediately to the recommended dose.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Local viral and tuberculous infections
• Contraindicated in children under 6 years of age.

Side effects

Systemic side effects are extremely unlikely due to the low doses used. Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. These can include growth retardation in children and adolescents. However, particular caution must be exercised in prolonged use of the product, keeping the patient under control in order to promptly reveal possible systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency). As with other nasal preparations, a burning sensation, irritation, dryness and more rarely epistaxis may occur locally. Rare cases of nasal septal perforation have been reported following nasal corticosteroid applications. Rare cases of increased intraocular pressure or glaucoma have been associated with nasal formulations of beclomethasone dipropionate. In case of infection, institute suitable therapy.

Pregnancy and breastfeeding

In pregnant women, the product should be administered in cases of real need, under the direct supervision of the doctor. There are insufficient data to establish the safety of beclomethasone dipropionate in human pregnancy. Drug administration during pregnancy should only be considered if the foreseeable benefits to the mother are greater than the potential risks to the fetus. In animal reproductive studies, only following high systemic exposures, the undesirable effects typical of potent corticosteroids were observed; nasal intake ensures minimal systemic exposure.

No specific studies related to the passage of beclomethasone dipropionate into breast milk have been performed. It is reasonable to assume that beclomethasone dipropionate is secreted in milk but, at nasal doses, significant levels in breast milk are unlikely. However, the use of beclomethasone dipropionate during breastfeeding requires careful consideration by the physician of the benefit-risk ratio for both mother and baby.

Special warnings

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. In any case, treatment must be suspended and appropriate therapy instituted. These effects are less likely to occur than with oral corticosteroid treatment and may vary in individual patients and between different corticosteroid preparations. Possible systemic effects include Cushing's syndrome, Cushingoid aspect, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, disturbances sleep, anxiety, depression or aggression (particularly in children). It is recommended that the height of children receiving prolonged intranasal corticosteroid treatment be regularly monitored.

In pediatric patients receiving prolonged treatment with nasal corticosteroids it is suggested to check for regular height gain. Although Rinoclenil controls the symptoms of allergic rhinitis in most cases, an abnormally high allergen stimulus may require appropriate adjunctive therapy in some cases, particularly to control ocular symptoms. The replacement of systemic corticosteroid therapy with topical therapy (Rinoclenil) requires caution, especially where there is reason to believe that there is some degree of impairment of adrenal function. Systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency) may occur in subjects particularly sensitive or predisposed due to recent therapies with systemic steroids, or if doses of beclomethasone by the nasal route are taken in excess of what is recommended, systemic effects may occur (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency). Rinoclenil should not be used after trauma or nose surgery (until healing) and in the presence of nasal ulcerations, unless prescribed by your doctor. In patients being treated with systemic corticosteroids the product should be administered under medical supervision.

Do not use for more than a month without consulting your doctor. Excessively prolonged use of topical corticosteroids can cause temporary suppression of the hypothalamic-pituitary-adrenal axis, resulting in secondary adrenal insufficiency. Infections of the nasal passages and sinuses must be treated appropriately, however they are not a specific contraindication to the use of Rinoclenil.

The product contains benzalkonium chloride, an irritant that can cause local reactions.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. No particular precautions for storage.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Rinoclenil Spray contain:

Active principle

Beclomethasone dipropionate 77 mg

Excipients

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