BOOTS BLOCKED NOSE RELIEF 0.05% W/V NASAL SPRAY

Active substance: OXYMETAZOLINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.

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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24 July 1989 / 19 March 1998

10

DATE OF REVISION OF THE TEXT
21/09/2010

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)