- docusate sodium
This information is intended for use by health professionals
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.
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.
There is no evidence to suggest that WAXSOL Ear Drops should not be used during pregnancy and lactation.
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:
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.
Phenonip (solution of esters of 4-hydroxybenzoic acid in phenoxetol)
The shelf life is 3 years.
Store below 25°C.
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,
DOSIMETRY (IF APPLICABLE)
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUITCALS (IF APPLICABLE)
20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
+44 (0)1707 853000
+44 (0)1707 853 000