Waxsol Ear Drops Ducosate Sodium Bp 0.5% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Waxsol Ear Drops, Ducosate sodium BP 0.5% w/v.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Waxsol Ear Drops contain the following active ingredient:
Ducosate sodium BP 0.5% w/v.
3 PHARMACEUTICAL FORM
Ear drops.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Waxsol Ear Drops are indicated as an aid in the removal of ear wax.
4.2 Posology and method of administration
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.
4.3 Contraindications
Perforation of the ear drum or 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 Pregnancy and lactation
There is no evidence to suggest that Waxsol Ear Drops should not be used during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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
4.9 Overdose
Excess WAXSOL may seep from the ear and treatment of any resulting adverse events, such as skin irritation, should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 matter to a semisolid debris. This can be syringed away readily, or in less severe or chronic cases, is ejected by normal physiological processes.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerin
Phenonip (solution of esters of 4-hydroxbenzoic acid in phenoxetol) Water
6.2 Incompatibilities
None known.
6.3 Shelf life
The shelf life is 3 years.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Amber glass bottle with a dropper applicator, containing 10 or 11ml of Waxsol solution.
6.6 Special precautions for disposal
The dropper applicator must be filled before dripping Waxsol Ear Drops into the affected ear.
7 MARKETING AUTHORISATION HOLDER
Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley
Bishop’s Stortford CM22 6PU
8 MARKETING AUTHORISATION NUMBER(S)
PL 15142/0243
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/09/2006
10 DATE OF REVISION OF THE TEXT
26/02/2014