Summary of Product Characteristics (SmPC) - Ear Wax Remover drops
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, solution.
A clear, colourless, viscous liquid, odourless or almost odourless.
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
Hypersensitivity to the active substance or to any of the excipients listed in 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. The dropper unit of this medicinal product contains latex rubber. May cause severe allergic reactions.
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 and lactation.
4.7 Effects on ability to drive and use machines
Docusate sodium has no or negligible influence on the ability to drive and use machines. However, if dizziness occurs, driving and using machines should be avoided.
4.8 Undesirable effects
Evaluation of undesirable effects is based on the following frequency information:
- Very common (≥ 1/10)
- Common ( ≥ 1/100 to < 1/10)
- Uncommon ( ≥ 1/1,000 to < 1/100)
- Rare ( ≥ 1/10,000 to < 1/1,000)
- Very rare (< 1/10,000)
- Not known (cannot be estimated from the available data)
Infections and infestations
Frequency not known: Otitis externa
Immune system disorders
Frequency not known: hypersensitivity/allergic reactions
Nervous system disorders
Frequency not known: Dizziness
Ear and labyrinth disorders
Frequency not known: Hypoacusis, ear pain, ear discomfort
Skin and subcutaneous tissue disorders
Frequency not known: Allergic skin reactions, contact dermatitis
General disorders and administration site conditions
Frequency not known: Application site reactions (e.g. irritation, pruritus, exfoliation, inflammation, pain, erythema).
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. By reporting side effects you can help provide more information on the safety of this medicine.
4.9 Overdose
Excess Ear Wax Remover Drops 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
Pharmacotherapeutic group: Other otologicals, ATC code: S02DC
Docusate sodium is a cerumenolytic substance; its emulsifying action softens the ear wax plug.
Ear wax is produced by the glands in the skin lining of the ear canal, and its purpose appears to be protective. Occasionally ear wax can build up and harden in the ear, causing problems if not removed. Excessive amounts of hardened ear wax can cause poor hearing, ringing in the ears or earache.
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.
Ear Wax Remover 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
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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons & Co (Druggists) Limited,
Gifford House,
Slaidburn Crescent,
Southport,
Merseyside,
PR9 9AL,
United Kingdom.
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
08/03/2024