Active ingredients: Beclometasone (Beclometasone dipropionate)
Rinoclenil 100 micrograms nasal spray, suspension
Rinoclenil package inserts are available for pack sizes:- Rinoclenil 100 micrograms nasal spray, suspension
- Rinoclenil 50 micrograms nasal spray, suspension
Indications Why is Rinoclenil used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Nasal decongestant glucocorticoid for topical use.
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis.
Contraindications When Rinoclenil should not be used
Hypersensitivity to the active substance or to any of the excipients.
Local viral and tuberculous infections.
Contraindicated in children under 6 years of age.
Precautions for use What you need to know before you take Rinoclenil
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and exceptionally to the classic systemic undesirable effects of cortisone drugs. In any case it is necessary to suspend the treatment and institute a suitable therapy.
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.
It is important to take the dose of medication as directed in the package leaflet or as prescribed by your doctor. Only the dose recommended by your doctor should be used; the use of higher or lower doses can cause worsening of symptoms.
Interactions Which drugs or foods can modify the effect of Rinoclenil
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
There are no known interactions with other medicines.
Warnings It is important to know that:
RINOCLENIL should not be used after trauma or surgery to the nose (until healing) and in the presence of nasal ulcerations, unless prescribed by your doctor.
In patients receiving 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 paranasal sinuses must be treated appropriately, however they do not constitute a specific contraindication to the use of RINOCLENIL.
Systemic effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency) may occur in particularly sensitive subjects, or predisposed due to recent systemic steroid therapies, or if doses of beclomethasone nasally are taken in excess of what is recommended, systemic effects may occur (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency) .
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. In pregnancy and lactation, RINOCLENIL should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect you are pregnant or want to plan a maternity leave.
Effects on ability to drive and use machines
RINOCLENIL does not affect the ability to drive or use machines.
Important information about some of the excipients
The product contains benzalkonium chloride, an irritant which can cause local reactions.
Dose, Method and Time of Administration How to use Rinoclenil: Posology
RINOCLENIL should only be administered by the nasal route.
Adults and children over 6 years:
Two pumps into each nostril once a day.
In children, if deemed appropriate, a schedule of administration in divided doses can be maintained, making a single injection 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 for several days.
Children under the age of 6:
The product should not be given to children under 6 years of age.
Instructions for Use
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:
- Carry out a thorough cleaning of the nose.
- Remove the protective cap.
- Laterally remove the protection ring that blocks the pump.
- Hold the bottle as shown in the figure.To activate the spray mechanism, operate the dosing pump several times until a visible spray is obtained.
- Place the nasal nozzle on one nostril, closing the other nostril with a finger. Inhale and press the base of the nasal nozzle at the same time as shown in the figure. In this way an exactly metered single dose of active ingredient is dispensed. Repeat the same operation on the " other nostril.
- After use, replace the protective cap and the protective ring.
In case of occlusion of the dispenser, wash it carefully with lukewarm water, without intervening on the hole with sharp objects.
Overdose What to do if you have taken too much Rinoclenil
Administration of large quantities of beclomethasone dipropionate over a short period of time may result in suppression of hypothalamus-pituitary-adrenal function. In this case, the dose of RINOCLENIL should be reduced immediately to the recommended dose.
In case of accidental ingestion / intake of an excessive dose of RINOCLENIL, notify your doctor immediately or go to the nearest hospital.
IF IN ANY DOUBT ABOUT THE USE OF RINOCLENIL, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Rinoclenil
Like all medicines, RINOCLENIL can cause side effects, although not everybody gets them.
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 may occur locally, irritation, dryness and more rarely nosebleeds.
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.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Deadline "> Other information
COMPOSITION
100 ml of suspension contain:
- Active ingredient: Beclomethasone dipropionate 77 mg.
- Excipients: Polysorbate 20, microcrystalline cellulose and sodium carboxymethylcellulose, benzalkonium chloride, phenylethyl alcohol, dextrose (glucose) monohydrate, purified water.
PHARMACEUTICAL FORM AND CONTENT
Nasal spray, suspension. The contents of the pack are 1 bottle of 30 ml containing 200 puffs of 100 micrograms of beclomethasone dipropionate.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
RHINOCLENIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml of suspension contain:
Active ingredient: beclomethasone dipropionate 77 mg.
Each spray delivers 100 mcg of beclomethasone dipropionate.
Excipients:
Benzalkonium chloride 27 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM -
Nasal spray, suspension.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Prophylaxis and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis.
04.2 Posology and method of administration -
Rinoclenil should only be administered via the nose.
Adults and children over 6 years:
two pumps into each nostril once a day.
In children, if deemed appropriate, a schedule of administration in divided doses can be maintained, making a single injection 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 the age of 6:
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 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 dispensing as follows:
1) Carry out a thorough cleaning of the nose.
2) Remove the protective cap.
3) Sideways 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 your finger. Inhale and press the base of the nasal nozzle at the same time. In this way an exactly metered single dose of active ingredient is dispensed. Repeat the same operation on the other. nostril.
6) After use, replace the protective cap and the protective ring.
In case of occlusion of the dispenser, wash it carefully with lukewarm water, without intervening on the hole with sharp objects.
04.3 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.
04.4 Special warnings and appropriate precautions for use -
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).
Regular monitoring of the height of children receiving prolonged intranasal corticosteroid treatment is recommended (see section 4.8).
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 stimulus of allergens may require in some cases "appropriate adjunctive therapy in particular 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 individuals who are particularly sensitive or predisposed due to recent therapies with systemic steroids, or if doses of beclomethasone nasally are taken in excess of what is recommended.
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 receiving 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 paranasal sinuses must be treated appropriately, however they are not a specific contraindication to the use of Rinoclenil.
Warnings relating to excipients
The product contains benzalkonium chloride, an irritant which can cause local reactions.
Benzalkonium chloride (BAC) contained as a preservative in Rinoclenil, especially when used for long periods, can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a BAC-free nasal medicine should be used if possible. If such nasal medications without BAC are not available, another pharmaceutical form should be considered.
It can cause bronchospasm.
04.5 Interactions with other medicinal products and other forms of interaction -
Not known.
04.6 Pregnancy and breastfeeding -
Pregnancy
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.
Feeding time
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 doses used nasally, significant levels in breast milk are unlikely. However, the use of beclomethasone dipropionate during lactation requires a careful evaluation by the physician of the risk-benefit ratio for both mother and baby.
04.7 Effects on ability to drive and use machines -
Rinoclenil does not affect the ability to drive and use machines.
04.8 Undesirable 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 may occur locally, irritation, dryness and more rarely nosebleeds.
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.
04.9 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.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: nasal decongestants for topical use - corticosteroids.
ATC code: R01AD01.
Beclometasone dipropionate (BDP), the active ingredient of Rinoclenil, is a topical corticosteroid, characterized by an "intense anti-inflammatory and vasoconstrictive activity on the mucous membrane of the nasal passages.
BDP is a pro-drug with weak binding affinity for glucocorticoid receptors. It is hydrolyzed by esterases into the active metabolite beclomethasone-17-monopropionate (B-17-MP), which has a "high topical anti-inflammatory activity."
05.2 "Pharmacokinetic properties -
BDP administered nasally is deposited mainly in the nostrils, and is therefore characterized by high topical activity not associated with significant systemic effects.
After inhalation, part of the administered dose is swallowed and excreted in the faeces. The fraction absorbed into the circulation is metabolised by the liver to monopropionate and beclomethasone alcohol and subsequently excreted in the form of inactive metabolites in the bile and urine.
05.3 Preclinical safety data -
There is no information, deriving from preclinical data, of significant importance to the physician that has not already been reported in the other sections of the Summary of Product Characteristics, with the exception of those reported below on benzalkonium chloride.
Preclinical data suggest that benzalkonium chloride is capable of producing a toxic, concentration and time dependent effect on the vibrating cilia of the nasal mucosal epithelium, including irreversible immobility and may induce histopathological changes of the nasal mucosa.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Polysorbate 20, microcrystalline cellulose and sodium carboxymethyl cellulose, benzalkonium chloride, phenylethyl alcohol, dextrose (glucose) monohydrate, purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
No particular precautions.
06.5 Nature of the immediate packaging and contents of the package -
Amber colored polypropylene bottle, with metering pump and nasal applicator.
Each 30ml bottle contains at least 200 pumps of 100mcg beclomethasone dipropionate.
06.6 Instructions for use and handling -
No special instructions.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Chiesi Farmaceutici S.p.A. - Via Palermo, 26 / A - Parma
08.0 MARKETING AUTHORIZATION NUMBER -
Rinoclenil 100 mcg nasal spray, suspension - bottle of 200 sprays AIC n. 035799028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
04/04/2003
10.0 DATE OF REVISION OF THE TEXT -
July 2013
