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Ear Wax Remover Drops

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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