Boots Blocked Nose Relief 0.05% W/V Nasal Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Almus Decongestant Nasal Spray
Boots Blocked Nose Relief 0.05% w/v Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient %w/v
Oxymetazoline hydrochloride 0.05%
3 PHARMACEUTICAL FORM
Nasal Spray
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the fast relief of stuffy noses due to head colds and hayfever.
4.2 Posology and method of administration
Adults and children over 12 years 1-2 sprays up each nostril every 6-8 hours.
Children under 12 years
Not to be administered to children under 12 years.
Elderly
There is no need for dosage reduction in the elderly.
For nasal administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients, patients with cardiovascular disease, hyperthyroidism, angle closure glaucoma or prostatic enlargement.
4.4 Special warnings and precautions for use
Keep away from the eyes.
Not to be used for children under 12 years.
The spray should not be used in excess of the stated dosage nor for longer than seven days without medical advice.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
Boots Nasal Spray should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment.
4.6 Pregnancy and lactation
The safety of Boots Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during these periods.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasionally may cause local irritation and dryness of the mouth and throat. Prolonged use may cause rebound congestion and rhinitis medicamentosa.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overdosage may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Oxymetazoline hydrochloride is a sympathomimetic amine having vasoconstrictor properties which are utilised in the relief of nasal congestion.
5.2 Pharmacokinetic properties
Oxymetazoline enters tissues rapidly and local vasoconstriction is normally achieved within 5-10 minutes of intranasal administration. The full effect lasts for 5-6 hours and then gradually subsides over the next 6 hours. Plasma halflife is 5-8 days with 30% of any absorbed drug being excreted in the urine unchanged and 10% being excreted in the faeces.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Monosodium phosphate fine cryst
Disodium phosphate cryst Methyl hydroxybenzoate Cetrimide
Levomenthol natural Or Levomenthol synthetic Camphor racemic Eucalyptol
Alcohol 96% Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
A 22ml polypropylene bottle with a polythene plug and elongated nozzle dip tube fitted with a wadless polythene cap that fits the elongated nozzle.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/0292
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24 July 1989 / 19 March 1998
10
DATE OF REVISION OF THE TEXT
31st March 2015