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Drug information

Simple eye ointment

OTC
Read time: 1 mins
Last updated: 08 Jul 2020
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Summary of product characteristics


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.


4.1. 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


5.1. 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.


6.1. 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

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

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Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).