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

DATE OF REVISION OF THE TEXT

31^st March 2015