Ear Wax Remover Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ear Wax Remover Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate Sodium BP 5.0% w/v
3 PHARMACEUTICAL FORM
Ear Drops
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the softening of ear wax to facilitate its removal.
4.2 Posology and method of administration
Adults:
Four drops to be instilled into the affected ear or ears twice daily for 2-3 days. The head should be inclined and the ear plugged with cotton wool, soaked in ear wax remover drops if necessary.
After 2-3 days the wax should be easy to remove.
Children:
The number of drops instilled may be reduced to the level required to fill the ear with solution.
Elderly:
No dosage adjustments are necessary.
4.3 Contraindications
Is contraindicated in patients with known hypersensitivity to the active or the excipients (see section 6.1)
Not to be used if the ear drum is known or suspected to be perforated; or if there is an inflammation of the ear.
4.4 Special warnings and precautions for use
If pain or inflammation is experienced, treatment should be discontinued.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
There is no evidence to suggest that ear wax remover drops should not be used during pregnancy.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Rarely, transient stinging or irritation may occur.
4.9 Overdose
Accidental ingestion of the whole bottle (500mg) may give rise to diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Docusate Sodium is an anionic wetting agent (surfactant), which is able to reduce the value of the surface tension of liquids. Because of the low surface tension and water miscibility of docusate sodium, it rapidly penetrates the dry matrix of the ceruminous mass, reducing the solid material to a semi-solid debris which can be syringed away readily or, in less severe and in chronic cases, is ejected by normal physiological processes.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyethylene Glycol 400 HSE
6.2 Incompatibilities
None known.
6.3 Shelf life
18 months
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Amber glass bottle with removable glass dropper unit.
6.6 Special precautions for disposal
Amber glass bottle with removable glass dropper unit.
7 MARKETING AUTHORISATION HOLDER
Bell Sons and Company (Druggists) Limited
Gifford House
Slaidburn Crescent
Southport
PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0108
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/01/2012
10 DATE OF REVISION OF THE TEXT
04/12/2013