Simple Eye Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simple Eye Ointment B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Yellow Soft Paraffin 80%w/w
Liquid Paraffin 10%w.w
Wool Fat 10%w/w
3 PHARMACEUTICAL FORM
Eye ointment
It is a straw coloured, 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 morning and night, or as needed.
4.3 Contraindications
Simple Eye Ointment should not be used in patients with known 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.
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.
4.9 Overdose
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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
Discard tube 28 days after first opening
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
No special requirements
7 MARKETING AUTHORISATION HOLDER
Four Pharmaceuticals Limited
23 Upper Green Road
Tewin
Welwyn
Herts, AL6 OLE
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17248/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/06/2000 / 27/09/2005
10 DATE OF REVISION OF THE TEXT
27/09/2005