Molcer Ear Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Molcer 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.
4.3. 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
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: Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Not applicable.
5.1 Pharmacodynamic properties
Docusate Sodium is an anionic surfactant. It has a direct action on hardened ear wax, gradually softening it.
5.2. 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.
6.6. 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
07/09/2015