Summary of Product Characteristics (SmPC) - Simple eye ointment
1 NAME OF THE MEDICINAL PRODUCT
Simple Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Simple Eye Ointment contains:
Yellow Soft Paraffin
Liquid Paraffin
Wool Fat
80%w/w 10%w.w 10%w/w
3 PHARMACEUTICAL FORM
Eye ointment
Smooth, straw coloured (yellow), translucent ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Simple Eye Ointment is a bland sterile preparation indicated for the softening of crusts in blepharitis, as a lubricant at night and to protect the ocular surface e.g. in keratitis, corneal conditions or during surgery.
4.2 Posology and method of administration
Apply a ribbon of ointment between the lower eyelid and the eye. As this product contains no medicament it may be used in the morning and night, or as required.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Discard tube 28 days after first opening. Contact lenses should not be worn during the treatment period.
To avoid contamination during use do not allow the nozzle tip to come in contact with any surface.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
Suitable for use in pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Application of the ointment will cause blurring of vision. Patients should not drive or operate machinery until their vision is clear.
4.8 Undesirable effects
Blurring of vision for 5 to 10 minutes after application.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Ophthalmologicals.
ATC code: S01 X.
A bland medicament free sterile ointment which exerts its effect as an emollient.
5.2 Pharmacokinetic properties
A combination of well recognised pharmaceutical constituents with no reported incompatibilities.
5.3 Preclinical safety data
No additional pre-clinical data of relevance to the prescriber is available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years (unopened)
1 month (opened)
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
LDPE aluminium laminate tube containing 4g sterile eye ointment.
6.6 Special precautions for disposal and other handling
No special requirements for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Tillomed Laboratories Ltd
220 Butterfield
Great Marlings
Luton, LU2 8DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 11311/0533
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/06/2000 / 27/09/2005
10 DATE OF REVISION OF THE TEXT
24/09/2018