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

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:

Docusate 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.

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 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.

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.

However, in cosmetic testing work, docusate sodium produced irritation under severe occluded conditions of a patch test and it has been cautioned that it is a cumulative irritant.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerin

Phenonip (solution of esters of 4-hydroxybenzoic 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 25ºC.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

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

18 June 2011

LEGAL CATEGORY

P

11. DOSIMETRY (IF APPLICABLE)

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUITCALS (IF APPLICABLE)

Not applicable.