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RINOCLENIL is a medicine that contains beclometasone dipropionate, an active substance belonging to the cortisone group, that reduces swelling and inflammation in the airways.RINOCLENIL is used to treat or prevent inflammation of the nose (rhinitis) due to allergies (both seasonal and perennial) or to vasomotor changes, which can cause: sneezing, runny nose, itching and blocked feeling in the nose, reduced sense of smell.
Do not take RINOCLENIL if:if you are allergic (hypersensitive) to beclometasone dipropionate or any ofthe other ingredients of this medicine (listed in section 6) or to any other medicines containing cortisone;you have tuberculosis or an infection due to viruses, located in the nose (local);you are pregnant or breast-feeding.RINOCLENIL is not suitable for children under 6 years of age. Warnings and precautionsTalk to your doctor before taking RINOCLENIL if:you are being treated with cortisone medicines; you have inflammation of your nose or nasal cavities as a whole (paranasal sinuses), due to micro-organisms;you have ulcers in your nose;you have had an injury or surgical operation to your nose.Be particularly careful if you are changing from treatment with cortisone medicines by systemic therapy (for example, tablets) to therapy with RINOCLENIL; this is particularly important if you have a change in adrenal gland function;if your symptoms worsen or your eyes becomewatery, itchy or red, due to severe allergy.
IN ALL THESE CASES, CONSULT YOUR DOCTOR WHO WILL PRESCRIBE A SUITABLETHERAPY FOR YOU.It is important that you take the dose of medicine indicated in this package leaflet or prescribed by your doctor, because using lower doses may cause your symptoms to get worse.Children and adolescentsIn children who use RINOCLENIL it is necessary to regularly measure their height since treatment for long periods with nasal cortisone medicines may give rise to slowing of growth. If this happens, talk to your doctor because it may be necessary to change the therapy.Other medicines and RINOCLENILTell your doctor or pharmacist if you are taking or have recently taken any other medicines. This is particularly important if you are using systemic (for example, tablets) or nasal medicines that contain cortisone, because this could increase the risk of a change in adrenal gland function (adrenal suppression).Pregnancy and breast-feedingIf you are pregnant or breast-feeding, do not take RINOCLENIL, unless your doctor specifically recommends it. Driving and using machinesRINOCLENIL does not affect the ability to drive or use machines.RINOCLENIL contains benzalkonium chloride, may cause bronchospas
Always take this medicine exactly as described in this leaflet or as your doctor orpharmacist has told you. Check with your doctor or pharmacist if you are not sure.Adults and children over 6 years of ageThe recommended dose is 2 puffs (200 micrograms) in each nostril, once a day. Once your symptoms have improved, the number of puffscan be reduced.In some cases, your doctor may also tell you to carry out 1 puff (100 micrograms) in each nostril, twice a day.The maximum dose must not exceed 4 puffs (400 micrograms) daily. Do not use RINOCLENIL for more than a month, unless yourdoctor tells you otherwise.Method of administrationTake RINOCLENIL by nose. Clean your nose thoroughly before administration to ensure successful delivery.To use this medicine correctly, consult the “How to use your nasal spray” section at the end of this package leaflet.If you take more RINOCLENIL than you shouldIf you accidentally take too much RINOCLENIL, the risk of having side effects is increased. If this happens, tell your doctor immediately, because appropriate measures may be necessary.
If you forget to take RINOCLENIL Continue normally with the therapy. Do not double the next dose.
Like all medicines, this medicine can cause side effects although not everybody gets them. The risk of side effects can be reduced by following the instructions in this package leaflet.
If you use RINOCLENIL, especially at high doses and/or over extended periods of time, you may notice: Common side effects (affectingup to 1 in 10people ) burning sensation, irritation (possible sensitisation), dry nose;Rare side effects (affectingup to 1 in 1,000people) nose bleed (epistaxis), perforation of the nasal septum, increased eye pressure with possible worsening of sight (glaucoma);Not known(frequency cannot be estimated from theavailable data)Adrenal suppression (with symptoms such as loss of appetite, low blood pressure, abdominal pain, weight loss, tiredness, headache, nausea, vomiting), weakening of the bones (osteoporosis), stomach ulcer or duodenal (peptic) ulcer.IF YOU NOTICE ONE OF THE EFFECTS LISTED ABOVE, STOP TAKING RINOCLENIL AND CONSULT YOUR DOCTOR IMMEDIATELY.In children and in adolescentswho take intranasal cortisone medicines, growth retardation has also been reported (unknown frequency)
Keep this medicine out of the reach and sight of children.Do not store above 30 oCDo not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This date refers to the product correctly stored in its unopened packaging.Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What RINOCLENIL containsThe active substance is beclometasone dipropionate.Each container contains 23.1 mg beclometasone dipropionate (each puff contains 100 micrograms).The other ingredients are polysorbate 20, microcrystalline cellulose and sodium carboxymethylcellulose, benzalkonium chloride, phenylethyl alcohol, dextrose (glucose) monohydrate, purified water.What RINOCLENIL looks like and contents of the packThis medicine is a suspension, available in a 30 ml bottle fitted with metering pump and nasal applicator. RINOCLENIL is sufficient for at least 200 puffs of 100 micrograms of beclometasone.
Marketing Authorisation Holder and ManufacturerChiesi Farmaceutici S.p.A. –Via Palermo, 26/A –43122 Parma (Italy).Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: -The National Pharmacovigilance and Drug Safety Centre (NPC)oFax:+966-11-205-7662oCall NPC at +966-11-2038222, Exts 2317-2356-2353-2354-2334-2340oTool Free Phone: 8002490000oE-mail: npc.drug@sfda.gov.saoWebsite: www.sfda.gov.sa/npc
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Prophylaxis and treatment of allergic seasonal and perennial rhinitis and vasomotor rhinitis.
Adults and children over 6 years: two actuations into each nostril once a day.In children, if deemed as suitable, an administration scheme in refracted doses can be maintained, with a single actuation per nostril twice a day. The onset of effect does not immediately occur and for a full therapeutic benefit it is advisable to regularly use the product and for several days.The product should not be administered to children aged under 6 years
Intranasal corticosteroids may cause systemic side effects, particularly if they are prescribed in high doses for extended periods of time.In all such instances treatment must be discontinued and an appropriate therapy commenced.These side effects are less probable than with oral corticosteroids and may vary from patient to patient and from one corticosteroid preparation to another.Possible systemic side effects include Cushing's Syndrome, Cushingoide features, adrenal suppression, inhibited growth in children and adolescents, reduction in bone mineral density, cataracts, glaucoma and, more rarely, a series of psychological or behavioural side effects that includes psychomotor hyperactivity, disturbed sleep, anxiety, depression and aggression (especially in children).It is recommended that the height of children who receive an extended treatment of intranasal corticosteroids be monitored regularly (see paragraph 4.8).It is suggested that paediatric patients who receive extended treatment with corticosteroids by nasal application should be checked regularly for normal growth.Although RINOCLENIL controls allergic rhinitis symptoms in the majority of cases, in some instances if the level of allergens is abnormally high a suitable additional therapy may be required, especially to control symptoms affecting the eyes.Replacing a systemic corticosteroidal therapy with a topical therapy (Rinoclenil) calls for prudence, particularly where there is reason to believe that the adrenal function has been compromised to some degree.In particularly sensitive patients or those who have a predisposition due to recent treatments with systemic steroids, or if doses of beclomethasone greater than those recommended are administered nasally, it is possible that systemic side effects might be produced (such as osteoporosis, peptic ulcers, or signs of secondary adrenal insufficiency).
Rinoclenil must not be used after a trauma to or surgical operation on the nose (until it has healed) or where there is nasal ulceration, unless prescribed by the doctor.Patients being treated with systemic corticosteroids must only use this product under the supervision of their doctor.Do not use this product for more than one month without consulting the doctor.Using topical corticosteroids for excessively long periods may cause the hypothalamic-pituitary-adrenal axis to be suppressed temporarily, resulting in secondary adrenal insufficiency.Any infection of the nasal passages and sinuses must be properly treated, although in themselves they are not a reason not to use Rinoclenil.
This product contains benzalkonium chloride, an irritant that can cause local reactions.Particularly when used for an extended period, benzalkonium chloride (BAC), which is contained in Rinoclenil as a preservative, can cause swelling of the nasal mucous membrane.If it is suspected that this reaction is taking place (due to persistent nasal congestion), a nasal medicine should be used that does not contain BAC.If a medicine for nasal use without BAC is not available, a different pharmaceutical form should be considered.
None known.
PregnancyThe product should only be administered to pregnant patients in the event of real need, under the direct supervision of a doctor.There is insufficient data available to confirm the safe use ofbeclomethasone dipropionate during pregnancy in humans.The administration of drugs during pregnancy should be considered only if the anticipated benefits to the mother outweigh the potential risks to the foetus.In reproductive studies in animals, it was only after high levels of systemic exposure that undesired side effects typical of strong corticosteroids were observed; nasal administration ensures a minimal systemic exposure.LactationNo studies have been carried out into the passage of beclomethasone dipropionate into breast milk.It is reasonable to assume that beclomethasone dipropionate is secreted in milk, but at the dose involved in nasal administration, it is improbable that it is present at significant levels in breast milk.Nevertheless the use of beclomethasone dipropionate during lactation calls for a careful assessment by the doctor of the risks and benefits to both the mother and the baby.
Rinoclenil does not affect the ability to drive and use machines
Systemic undesired effects are extremely unlikely due to the low doses used.Intranasal corticosteroids may cause systemic side effects, particularly if they are prescribed in high doses for extended periods of time.They may include the inhibiting of growth in children and adolescents.Nevertheless, particular care should be paid in the prolonged use of the product, keeping the patient under control in order to timely detect possible systemic effects (osteoporosis, peptic ulcer, signs of secondary renal failure). As for other nasal preparations, local burning, irritation, dryness and more seldom epistaxis might occur.Rare cases of nasal septum perforation have been reported after nasal applications of corticosteroids.
Rare cases of intraocular pressure increase or glaucoma have been associated to beclometasone dipropionate formulations for nasal application.In case of infection, a suitable therapy should be instituted.To report any side effect(s):The National Pharmacovigilance and Drug Safety Center (NPC)Fax +966-11-205-7662Call NPC at +966-11-2038222, Exts 2317-2356-2353-2354-2334-2340Tool Free Phone: 8002490000E-mail: npc.drug@sfda.gov.saWebsite: www.sfda.gov.sa/npc
Administration of high doses of beclometasone dipropionate within a short timeframe can bring about the suppression of hypothalamus-hypophysis-adrenal function. In this case, the dose of RINOCLENIL should be immediately reduced to the recommended one.
5.1Pharmacodynamic propertiesR01AD01Decongestants and other nasal preparations for topical use - CorticosteroidsRINOCLENIL contains beclometasone-17,21-dipropionate as active ingredient, a cortisonic drug with high topical antiinflammatory and antiallergic activity. Beclometasone dipropionate (BDP) is a synthetic corticosteroid for topical use only, with potent antiinflammatory activity, reduced mineralcorticoid activity and absence of significant systemic effects. In cutaneous vasoconstrictions tests according to McKenzie, BDP is 5000 times more active than hydrocortisone, 625 times than betametasone alcohol, 5 times than flucinolone acetonide and 1.39 than betametasone valerate. The producthas an intense and long-lasting antiinflammatory activity against the croton-oil-, carrageenine-, formalin- , white-egg- and dextran-induced oedema and against the foreign-body-induced granulomatous reaction with higher effectiveness than that of other corticosteroids. It shows no thymolytic, splenolytic or mineralcorticoid activity and does not inhibit the hypophysis-adrenal axis even after repeated administrations, if given at the recommended doses.
5.2Pharmacokinetic propertiesBDP administered by nasal application mainly deposits in the nostrils, therefore it is characterised by a high local activity that is not associatioted to any significant systemic effects.After inhalation, a part of the administered dose is swallowed and eliminated in the feces. The absorbed fraction in circulation is metablised by hepatic route to monopropionate and beclometasone alcohol, then excreted in the form of inactive metabolites in bile and urine.
By oral route, in rats and mice, the LD50values are higher than 3000 mg/kg.In rats and mice, exposures to concentrations of 149 mcg/dl for 9 minutes are well tolerated by nebulization; equally good was the tolerability in rats after nebulization of 51.6 mcg/dl of beclometasone dipropionate for 2 hours. Administration by inhalation to dogs, for one year, does not cause any suffering sign at the airways’ level at doses widely higher than the therapeutic ones.Beclometasone dipropionate administered by inhalation to rats, showed neither fetotoxic nor teratogenic effects at doses 10 times higher than the therapeutic ones.Preclinical data suggest that benzalkonium chloride is capable of producing a concentration and time dependent toxic effect on the vibrating cilia of the nasal mucosa epithelium, including irreversible immobility and that it may induce histopathological changes in the nasal mucosa
Polysorbate 20, microcrystalline cellulose and sodium carboxymethyl cellulose, benzalkonium chloride, phenyl ethyl alcohol, glucose (dextrose) monohydrate, purified water.
None known.
Do not store above 30°C
Immediate package: amber-coloured PET container, with metering pump and nasal applicator.Outer package: printed thin-cardboard box.Package: bottle providing at least 200 actuations
Vigorously shake the bottle before each administration. Moreocer, before starting therapy, remove the protecting cap (2), protecting ring (3) and fire more times the metering pump (4) in order to start the nebulization mechanism.Proceed as follows:1) Carry out a careful cleaning of the nose.2) Remove the protecting cap.3) Remove the side protecting ring, blocking the pump.4) Hold the bottle as reported in the figure. Actuate the metering pump more times in order to start thenebulization mechanism, up to obtain a visible puff.5) Introduce the nasal applicator into a nostril, closing the other one with a finger. Inspire and press at the same time the base of the nasal applicator, as shown in the figure. In this way, a single dose exactly metered is actuated. Repeat the same operation in the other nostril6) After use, close again with the protecting cap and ring.Should the actuator be obstructed, rinse it carefully with lukewarm water, without intervening on the hole with sharp objects.
