RINOCLENIL 100 µg/dose Nasal powder suspension Bottle/120 doses

Nasal spray suspension.
Spray bottle of 30 ml, containing 120 doses, with metering pump and nasal tip.

Per dose:

Beclomethasone dipropionate: 100 micrograms

Excipient with known effect: benzalkonium chloride.

Perennial or seasonal allergic rhinitis.

Chronic eosinophilic inflammatory rhinitis.

Nasal use.

1 spray delivers 100 micrograms of beclomethasone dipropionate.

Dosage

Adults:

The average daily dose is 400 micrograms per day, i.e. 1 spray in each nostril 2 times per day.

The dosage will be adapted to the clinical condition of the patient and should usually not exceed 1 mg per day (i.e. 5 sprays in each nostril per day).

In chronic forms, efforts should be made to gradually reduce the doses to 200 micrograms per day, i.e. one spray in each nostril once per day.

Children over 3 years:

The average daily dose is 200 to 400 micrograms per day (6 to 13 micrograms/kg/day), i.e. 1 spray in each nostril once or twice per day.

The dosage will be adapted to the patient's clinical condition and should not usually exceed 600 micrograms in children under 12 years (i.e. 3 sprays in each nostril per day).

In allergic rhinitis, the initiation and duration of treatment depend on allergen exposure.

Treatment will be continued while efforts are made to gradually lower the doses as soon as symptoms improve.

Method of administration

Shake the bottle vigorously before use.

Remove the cap and press 1-2 times into the air to prime.

Administer as follows:

1. Clean the nose thoroughly.
2. Remove the protective cap.
3. Remove the ring.
4. Press the sprayer several times until a fine mist is obtained.
5. Insert the nasal applicator into one nostril and close the other by pressing with a finger. Inhale while pressing on the base of the nasal applicator. This delivers a precise dose of active ingredient. Proceed in the same way in the other nostril.
6. After use, put the ring back on the bottle, along with the cap.

When using the medicine for the first time, or after a few days without having used it, remove the cap and press the sprayer several times until a fine mist is obtained.

If no mist comes out, do not try to unblock the sprayer opening with a pin or any other sharp object; instead, remove the tip by pulling it upwards and clean it by soaking it in hot water for a few minutes. Then rinse it under the tap and let it dry before reassembling it.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
• Haemostasis disorders, in particular epistaxis.
• Oro-buccal-nasal and ophthalmic infection due to herpes virus.

Special warnings

In children, in the case of prolonged treatment, vigilance is required regarding the risk of impact on growth.

The risk of systemic effects, adrenal cortical suppression and impact on growth is increased when corticosteroid therapy by the inhaled route or a fortiori systemic corticosteroid therapy.

Systemic effects may occur during long-term treatment with high doses of nasal corticosteroids. The risk of systemic impact nevertheless remains lower than with oral corticosteroids and may vary depending on individual susceptibility and on the composition of the corticosteroid product used. Possible systemic effects are: Cushing's syndrome or Cushingoid symptoms, skin thinning, subcutaneous haematomas, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma and, more rarely, psychological and behavioural disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (particularly in children).

Concomitant administration of nasal corticosteroids in patients receiving oral corticosteroid therapy long-term does not exempt from the necessary precautions when reducing oral corticosteroid doses. These will be reduced very gradually, and withdrawal must be carried out under careful medical supervision (watching for the appearance of signs of acute or subacute adrenal insufficiency) extending beyond the cessation of systemic corticosteroid therapy.

Local nasal administration of corticosteroids is not recommended in patients who have recently had an ulceration of the nasal septum, or who have undergone surgery or trauma to the nose, until healing is complete.

Due to the presence of benzalkonium chloride (preservative), this medicine may cause oedema of the nasal mucosa, particularly in the case of long-term use.

Visual disorders

Visual disturbances may occur with systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for cataract, glaucoma, or rarer lesions such as central serous chorioretinopathy, as described with systemic or local administration of corticosteroids.

Precautions for use

The patency of the nasal passages must be ensured for optimal diffusion of the product. Inform the patient and advise them to dry them by blowing their nose before instillation.

In case of major nasal obstruction, a detailed examination of the ENT area should be performed.

In cases of pulmonary tuberculosis or pulmonary fungal infection, the institution of close monitoring and appropriate treatment is required.

In the case of prolonged treatment, repeated examinations of the nasal mucosa are recommended (as an indication, approximately 2 months after starting treatment and then every 6 months) in order to assess any impact of corticosteroid therapy on the nasal mucosa. If atrophy of the nasal mucosa is observed, a reduction in topical corticosteroid doses should be considered.

Inform the patient that this is a regular treatment, and that a period of several days of treatment may be necessary before effects on rhinitis symptoms are observed.

Athletes should be made aware that this specialty contains an active substance that may induce a positive reaction in tests carried out during anti-doping controls.

The metabolism of beclometasone is less dependent on CYP3A than that of certain other corticosteroids, and interactions are generally unlikely; nevertheless, in case of concomitant use of potent CYP3A inhibitors (e.g. ritonavir, cobicistat), the possibility of systemic effects cannot be excluded and it is therefore advised to exercise caution and provide appropriate monitoring when these agents are used.

Pregnancy

In animals, experimentation has demonstrated a teratogenic effect, which varies according to species.

In humans, epidemiological studies have not detected any malformation risk associated with the intake of corticosteroids per os during the first trimester.

In chronic diseases requiring treatment throughout pregnancy, a slight intrauterine growth retardation is possible. Neonatal adrenal insufficiency has been exceptionally observed after high-dose corticosteroid therapy.

A period of clinical (weight, diuresis) and biological (blood glucose) monitoring of the newborn may be justified.

Consequently, this medicine may be prescribed during pregnancy if needed.

Breast-feeding

The passage of beclomethasone into milk has not been studied. Nevertheless, other corticosteroids are excreted in milk.

Available data appear to show good tolerance in children; however, the biological or clinical impact of long-term maternal treatment has not been evaluated to date.

Consequently, breastfeeding is possible during short-term treatment. During chronic treatment, as a precaution, breastfeeding should be avoided.

Local effects

Possibility of epistaxis, nasal irritation, dryness of the nasal mucosa.

Cases of nasal and pharyngeal infections with Candida albicans have been described during treatment with topical corticosteroids. In this case, it is preferable to discontinue nasal corticosteroid therapy and consider initiating appropriate treatment.

Rare cases of septal perforation as well as ocular hypertension have been reported with nasally administered corticosteroids.

Systemic effects

During long-term administration of beclomethasone, a systemic impact, in particular on growth in children, cannot be ruled out (see section Warnings and precautions). This risk is increased in case of concomitant administration of inhaled corticosteroid therapy or a fortiori systemic corticosteroid therapy.

The clinical impact, particularly in the long term, is not clearly established.

The risk of latent corticotropic insufficiency after prolonged administration should be considered in cases of intercurrent infection, trauma or surgical intervention.

Very rare frequency: cataract and glaucoma.

Frequency not known: blurred vision (see section Warnings and precautions)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions 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: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

Long-term overdosage could lead to hypothalamic-pituitary-adrenal suppression and, if prolonged, clinical signs of hypercorticism. These symptoms will disappear after discontinuation of treatment, which should be gradual.

Pharmacotherapeutic class: glucocorticoids for nasal use, ATC code: R01AD01 (R: Respiratory System).

Beclomethasone dipropionate administered nasally exerts an anti-inflammatory activity on the nasal mucosa.

Beclomethasone dipropionate, partly absorbed through the nasal mucosa and partly swallowed, is metabolised in the liver to beclomethasone monopropionate and beclomethasone alcohol, then excreted as inactive metabolites in bile and urine.

2 years.

No special precautions for storage.

See section Dosage and administration.