SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Molcer Ear Drops Lloyds Pharmacy Ear Drops

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Docusate Sodium BP 5.0% w/v

3.    PHARMACEUTICAL FORM

Solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the softening of ear wax, prior to syringing with warm water.

4.2.    Posology and Method of Administration

Adults, children and the elderly:

Lie on side with the affected ear uppermost. Fill the ear with Molcer Ear Drops using the dropper and remain in this position for a few minutes. Place a small plug of cotton wool in the ear before rising and leave the plug in until the next treatment. If both ears are affected repeat the procedure for the other ear. Do this for two nights and the wax will be soft and easily removed.

In difficult cases it may be necessary for you doctor to employ syringing with warm water to remove the wax after it has been softened.

Contra-indications

Tympanic perforation, Eczematous otitis extema, other inflammatory or infective conditions of the external auditory meatus.

4.4.    Special Warnings and Special Precautions For Use

Not applicable.

4.5.    Interaction with other Medicinal Products and other forms of Interaction

Not applicable.

4.6.    Pregnancy and Lactation

Not applicable.

4.7.    Effects on Ability to Drive and Use Machines

Not applicable.

4.8.    Undesirable Effects

Local hypersensitivity may occasionally occur.

4.9 Overdose

Not applicable.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Docusate Sodium is an anionic surfactant. It has a direct action on hardened ear wax, gradually softening it.

Pharmacokinetic Properties

Docusate Sodium acts directly on the hardened ear wax softening it over the period of a few days. There is negligible systemic absorption when used as directed.

5.3. Preclinical Safety Data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Propylene Glycol and Purified Water.

6.2.    Incompatibilities

Not applicable.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

Store between 4°C and 25°C.

6.5.    Nature and Contents of Container

Amber glass vial of 15ml supplied with dropper.

Instructions for Use/Handling

None

7 MARKETING AUTHORISATION HOLDER

Wallace Manufacturing Chemists Ltd.

Wallace House 51-53 Stert Street Abingdon

Oxfordshire OX14 3JF United Kingdom

8.    MARKETING AUTHORISATION NUMBERS

PL 0400/5019R

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

18 September 1990, 16 July 1996

10 DATE OF REVISION OF THE TEXT

17/04/2009