Summary of Product Characteristics (SmPC) - Molcer ear drops
1 NAME OF THE MEDICINAL PRODUCT
Molcer Ear Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate Sodium 5.0% w/v
Excipients with known effects:
Propylene Glycol
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear Drops, Solution
A water white liquid.
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 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Contraindicated for use in patients with the following conditions: Tympanic performance, Eczematous, otitis extema, other inflammatory or infective conditions of the external auditory meatus.
4.4 Special warnings and precautions for use
This medicine contains 468mg Propylene Glycol in each 1ml.
Propylene glycol may cause skin irritation.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
Molcer Ear Drops can be used during pregnancy and breast-feeding.
4.7 Effects on ability to drive and use machines
Molcer Ear Drops has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
System Organ Class | Very Common (≥1/10) | Common ≥1/100, < 1/10 | Uncommo n ≥1/1,000, <1/100 | Rare ≥1/10,000, <1/1000 | Very Rare <1/10,000 | Not known (cannot be estimated from available data) |
Immune system disorder | Hypersensitivity (local) |
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Emollients and Protectives ATC Code: D02AX
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 below 25°C.
6.5 Nature and contents of container
Amber glass vial of 15ml supplied with dropper.
6.6 Special precautions for disposal
None stated.
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
25/04/2023