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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