Waxsol 0.5% w/v Ear Drops, Docusate sodium BP

WAXSOL Ear Drops, Docusate sodium BP 0.5% w/v

WAXSOL Ear Drops contain the following active ingredient:

Docusate Sodium BP 0.5% w/v.

Ear drops.

WAXSOL Ear Drops are indicated as an aid in the removal of ear wax.

Recommended dose and dosage schedules:

Adults (including the elderly): The application of ear drops sufficient to fill the affected ear on not more than two consecutive nights, prior to attending for syringing if this is necessary. If the problem persists patients should consult their doctor.

Children: As for adult dose.

Perforation of the ear drum or inflammation of the ear.

If pain or inflammation is experienced, treatment should be discontinued.

None known.

There is no evidence to suggest that Waxsol Ear Drops should not be used during pregnancy and lactation.

None known.

Immune system disorders: hypersensitivity/allergic reactions

Skin disorders: contact dermatitis and allergic skin reactions

General disorders: Application site reactions rarely including transient stinging or irritation may occur. Injuries or inflammation in the auditory canal may result in painful symptoms.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Excess WAXSOL may seep from the ear and treatment of any resulting adverse events, such as skin irritation should be symptomatic.

The so-called "wax" which often obstructs the external auditory meatus of the ear contains less than 50% of fatty matter derived from secretions of the sebaceous ceruminous glands. The majority of the wax consists of desquamated epithelium, foreign matter and shed hairs. This non-fatty material forms a matrix holding together the granules of fatty matter to form the ceruminous mass.

The addition of oils or solvents binds the mass more firmly together, but aqueous solutions, if they are able to penetrate the matrix, cause a disintegration of the ceruminous mass.

WAXSOL Ear Drops, because of their low surface tension and miscibility, rapidly penetrate the dry matrix of the ceruminous mass, reducing the solid material to a semi-solid debris. This can be syringed away readily, or in less severe or chronic cases, is ejected by normal physiological processes.

There are no available data on systemic absorption following instillation into the ear. However, any absorption which may occur is likely to be of an extremely low magnitude.

Although no toxicity studies via application to the ear are available, oral repeated dose toxicity studies with docusate sodium did not identify any clinically relevant information.

Glycerin

Phenonip (solution of esters of 4-hydroxybenzoic acid in phenoxetol)

Water

None known.

18 months

Store below 25☐

Amber glass bottle with a dropper applicator, containing 10 or 11 ml of WAXSOL solution.

The dropper applicator must be filled before dripping WAXSOL Ear Drops into the affected ear.

Mylan Products Ltd,

Station Close,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

PL 46302/0146

27/09/2006

17/04/2019

Legal Category: P

DOSIMETRY (IF APPLICABLE)

Not applicable.

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUITCALS (IF APPLICABLE)

Not applicable.