RINOCLENIL SPRAY 200ER 100MCG

RINOCLENIL 100 mcg NASAL SPRAY, SOSPENSION

active ingredients

100 ml of suspension contain: Active ingredient: Beclometasone dipropionate 77 mg. Each spray dispenses 100 mcg of beclometasone dipropionate. Excipient with known effects: Benzalconio chloride 27 mg For the complete list of excipients, see paragraph 6.1

Excellent

Polysorbed 20, microcrystalline cellulose and sodium carboxylcellulose, benzalconio chloride, phenylethylene 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 ingredient or any of the excipients listed in paragraph 6.1. Local viral and tubercular infections. Contraindicated in children under 6 years of age.

Population

Rinoclenil should be administered exclusively by nasal means. Population Adults and children over 6 years: two issues in each nostril once a day. In children, if considered appropriate, a pattern of administration can be maintained in refracted doses, making only one delivery 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 should not be given to children under 6 years of age. Instructions for use Activate the bottle vigorously before each administration. Also before starting the therapy it is appropriate to remove the protective cap, the protection ring and operate multiple times the dosing pump to put the nebulization mechanism in place. Proceed to delivery in the following way: 1) Make careful cleaning of the nose. 2) Remove the protective cap. 3) Remove the protective ring that blocks the pump. 4) Handle the bottle between your fingers. To put the nebulization mechanism in place, operate the dosing pump several times until you get a visible spray. 5) Support the nasal spout on a nostril, closing the other nostril with a finger. Inhale and simultaneously press the base of the nasal spout. In this way a single dose exactly dose of active ingredient is delivered. Repeat the same operation on the other nostril. 6) After use, place the protective cap and the protection ring. In case of occlusion of the dispenser, wash it thoroughly with warm water, without intervening on the hole with pointed objects.

Conservation

No special precaution.

Warnings

Systemic effects can be found with intranasal corticosteroids, especially when prescribed at high doses for prolonged periods. In any case, it is necessary to suspend treatment and establish suitable therapy. Such effects occur with less probability than treatment with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Possible systemic effects include Cushing syndrome, Cushingoide appearance, adrenal suppression, growth delay in children and adolescents, reduction of bone mineral density, cataract, glaucoma and, more rarely, a series of psychological or behavioral effects that include, sleeping disorders, anxiety, depression or aggressiveness (particularly in children) or neurological hyperactivity as psychomotor hyperactivity. It is recommended to regularly monitor the height of children receiving prolonged treatment of intranasal corticosteroids (see paragraph 4.8). Although RINOCLENIL controls the symptoms of allergic rhinitis in most cases, an abnormally high stimulus of allergens may require in some cases an appropriate additional therapy in particular to control eye symptoms. Substitution of systemic corticosteroid therapy with the topical therapy (Rinoclenil) requires caution, especially where there is reason to believe that there is a certain degree of compromise of adrenal functionality. In subjects particularly sensitive or predisposed due to recent therapies with systemic steroids, or if doses of beclomethasone are taken over nasally than recommended, systemic effects ( osteoporosis, peptic ulcer, signs of secondary adrenal failure). Visual disturbances With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the evaluation of possible causes that may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic 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 the doctor. In patients in treatment with systemic corticosteroids, the product must be administered under medical supervision. Do not use it for more than a month without consulting your doctor. The excessively prolonged use of topical corticosteroids can cause temporary suppression of the hypothalamus-hypophysis-surrene axis, causing secondary adrenal failure. Nasal infections and paranasal breasts must be treated appropriately, however they do not constitute a specific contraindication to the use of Rinoclenil. Notices related to excipients The product contains benzalconio chloride, an irritant that can cause local reactions. Benzalconio chloride (BAC) contained as a preservative in Rinoclenil, especially when used for long periods, can cause a swelling of the nasal mucosa. If this reaction is suspected (persistent nasal congestion), it should be used, if possible, a nasal medication without BAC. If such nasal medications without BAC are not available, it will have to be considered another pharmaceutical form. It can cause bronchospasm.

Interactions

Beclometasone depends to a lesser extent on the metabolism of CYP3A than other corticosteroids and in general interactions are unlikely; however, since the possibility of systemic effects cannot be excluded with the concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat), it is recommended to pay attention and to properly monitor the use of such agents.

Effects

Systemic side effects are extremely unlikely due to low doses. Systemic effects can be found with intranasal corticosteroids, especially when prescribed at high doses for prolonged periods. These may include growth delay in children and adolescents. Particular caution should be placed, however, in the prolonged use of the product, keeping under control the patient in order to quickly reveal possible systemic effects ( osteoporosis, peptic ulcer, signs of secondary adrenal failure). As with other nasal preparations, locally there may be a sense of burning, irritation, dryness and more rarely epistaxis. Rare nasal septum perforation cases were reported as a result of nasal corticosteroid applications. Rare cases of increased intraocular pressure or glaucoma have been associated with formulations of dipropionate beclometasone for nasal application. Cases of unknown frequency blurred vision were observed (see also paragraph 4.4). In case of infection establish suitable therapy. Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

The administration of large quantities of dipropionate beclomethasone in a short period of time can determine the suppression of the hypothalamus-hypophysis-surrenal function. In this case, the dose of RINOCLENIL must be reduced immediately to the recommended dose.

In pregnant women the product should be administered in cases of actual need, under the direct control of the doctor. There is no sufficient data to establish the safety of use of beclometasone dipropionate in pregnancy in the human species. The administration of drugs during pregnancy should take into account only if the predictable benefits for the mother are greater than the potential risks for the fetus. In reproductive studies on the animal, only following high systemic exposures, the undesirable effects typical of powerful corticosteroids have been observed; nasal intake ensures minimal systemic exposure.

Food

Specific studies have not been carried out concerning the passage of beclometasone dipropionate into breast milk. It is reasonable to believe that dipropionate beclomethasone is secreted in milk but, at doses used by nasal means, significant levels in breast milk are unlikely. However, the use of dipropionate beclomethasone during breastfeeding requires careful assessment by the doctor of the risk-benefit ratio for both mother and child.

Source: Farmadati