Monday, October 3, 2016

Care Decongestant Nasal Spray





1. Name Of The Medicinal Product



Oxymetazoline 0.05% w/v Nasal Spray



Care Decongestant Nasal Spray


2. Qualitative And Quantitative Composition



The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.



For excipients, see 6.1



3. Pharmaceutical Form



Nasal spray, solution



4. Clinical Particulars



4.1 Therapeutic Indications



Oxymetazoline Nasal Spray or Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.



4.2 Posology And Method Of Administration



Adults and Elderly



While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.



Children



Not recommended for children under 12 years of age.



4.3 Contraindications



Hypersensitivity to any component of the medicinal product.



Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment; patients suffering from porphyria, glaucoma, coronary artery disease, hypertension, hyperthyroidism or diabetes.



4.4 Special Warnings And Precautions For Use



If symptoms persist, consult your doctor. Prolonged use may result in rhinitis medicamentosa and should therefore be avoided. Treatment should be limited to a maximum of seven days. Keep all medicines safely away from children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



If you are taking other medicines, you should see your doctor for advice before taking this medicine.



4.6 Pregnancy And Lactation



The safety to use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.



4.7 Effects On Ability To Drive And Use Machines



None.



4.8 Undesirable Effects



This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that it may cause local skin reactions (e.g. contact dermatitis) and discolouration.



Benzalkonium chloride may cause local skin irritation.



4.9 Overdose



No statement.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants.



Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.



5.2 Pharmacokinetic Properties



When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 hours.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC



6. Pharmaceutical Particulars



6.1 List Of Excipients



Benzalkonium chloride



Thiomersal



Sodium chloride



Levomenthol



Cineole



Camphor



Methyl salicylate



Poloxamer 188



Sodium citrate (dihydrate) (E331)



Citric acid (anhydrous) (E330)



Purified water



6.2 Incompatibilities



None



6.3 Shelf Life



2 years



6.4 Special Precautions For Storage



None



6.5 Nature And Contents Of Container



White, low density polyethylene/polyethylene copolymer 15ml bottle.



White, high density polyethylene 15ml and 20ml bottle.



6.6 Special Precautions For Disposal And Other Handling



None



7. Marketing Authorisation Holder



Thornton & Ross Ltd



Linthwaite



Huddersfield



West Yorkshire



HD7 5QH



United Kingdom



8. Marketing Authorisation Number(S)



PL 00240/0343



9. Date Of First Authorisation/Renewal Of The Authorisation



24/01/2007



10. Date Of Revision Of The Text



20/12/2010



11 DOSIMETRY (IF APPLICABLE)


Not Applicable



12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)


Not Applicable




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