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Simple Eye Ointment Bp

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Document: spc-doc_PL 17248-0001 change

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