Rinoclenil spray 100 mcg - rhinitis treatment 200 dispensations

Product Description

Rinoclenil 100mcg Spray

Composition

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

Excipients

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

Therapeutic indications

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

Contraindications

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

Dosage

Rinoclenil is for nasal administration only. Adults and children over 6 years: two sprays in each nostril once a day. In children, if deemed appropriate, a staggered administration schedule can be maintained, administering a single spray in each nostril twice a day. The onset of effect is not immediate, and for full therapeutic benefit, it is advisable to use the product regularly and for several days. Children under 6 years: the product should not be administered to children under 6 years of age. Instructions for use: Shake the bottle vigorously before each administration. Furthermore, before starting therapy, it is advisable to remove the protective cap and the protective ring and activate the dosing pump several times to activate the nebulization mechanism. Proceed with administration 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, press the dosing pump several times until a visible spray is obtained. 5) Place the nasal tip over one nostril, closing the other nostril with a finger. Inhale and simultaneously press the base of the nasal tip. This dispenses a single, precisely measured dose of the active ingredient. Repeat the same operation on the other nostril. 6) After use, replace the protective cap and protective ring. If the nozzle is blocked, rinse it thoroughly with warm water, without touching the hole with sharp objects.

Warnings and precautions

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses for prolonged periods. In any case, treatment should be discontinued 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 features, 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, sleep disorders, anxiety, depression, or aggression (particularly in children). It is recommended that the height of children receiving prolonged treatment with intranasal corticosteroids be regularly monitored (see section 4.8). In pediatric patients receiving prolonged treatment with nasal corticosteroids, regular height growth should be monitored. Although RINOCLENIL controls the symptoms of allergic rhinitis in most cases, an abnormally high allergen challenge may be associated with increased risk of allergic rhinitis. In some cases, appropriate additional therapy may be required, particularly to control ocular symptoms. Replacing systemic corticosteroid therapy with topical therapy (Rinoclenil) requires caution, especially when there is reason to suspect a degree of adrenal impairment. In particularly sensitive or predisposed subjects due to recent systemic steroid therapy, or if doses of nasal beclometasone in excess of those recommended, systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency) may occur. Rinoclenil should not be used after trauma or surgery to the nose (until healing) and in the presence of nasal ulcers, unless prescribed by a doctor. In patients being treated with systemic corticosteroids, the product must 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 systemic side effects. cause temporary suppression of the hypothalamic-pituitary-adrenal axis, resulting in secondary adrenal insufficiency. Nasal and sinus infections 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. cause bronchospasm.

Interactions

Not known.

Side effects

Systemic side effects are extremely unlikely due to the low doses used. Systemic effects may occur with intranasal corticosteroids, particularly if prescribed at high doses for prolonged periods. These may include growth retardation in children and adolescents. However, particular caution should be exercised with prolonged use of the product, monitoring the patient to promptly detect possible systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency). As with other nasal preparations, burning, 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. In case of infection, institute appropriate therapy.

Pregnancy and breastfeeding

Pregnancy: In pregnant women, the product should be administered only when strictly necessary, under the direct supervision of a physician. There are insufficient data to establish the safety of beclometasone dipropionate during human pregnancy. Administration of drugs during pregnancy should be considered only if the foreseeable benefits to the mother outweigh the potential risks to the fetus. In reproductive studies in animals, the undesirable effects typical of potent corticosteroids were observed only after high systemic exposure; administration via the nasal route ensures minimal systemic exposure. Breastfeeding: No specific studies have been performed on the passage of beclometasone dipropionate into breast milk. It is reasonable to assume that beclometasone dipropionate is secreted into breast milk, but at the doses used nasally, significant levels are unlikely to be present in breast milk. However, the use of beclometasone dipropionate during breastfeeding requires a careful assessment by the physician of the risk-benefit ratio for both mother and child.