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Drug information

Simple eye ointment

OTC
Read time: 1 mins
Last updated: 20 Feb 2019
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Summary of product characteristics


1. Name of the medicinal product

Simple Eye Ointment BP

Lubrifilm


2. Qualitative and quantitative composition

None


3. Pharmaceutical form

Eye Ointment.


4.1. Therapeutic indications

To lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, ophthalmic and non-ophthalmic surgery, sticky eyes and to soften crusts formed due to inflammation of the eye lids.


4.2. Posology and method of administration

Adults, the elderly and children.A thin line of the ointment to be placed along the inside of the lower eyelid.As this product contains no medicament it may be used as required.


4.3. Contraindications

Hypersensitivity to any of the components.Contact lenses should not be worn during the treatment period.


4.4. Special warnings and precautions for use

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 during 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 use machinery until their vision is clear.


4.8. Undesirable effects

None known.


4.9. Overdose

Unlikely


5.1. Pharmacodynamic properties

A medicament-free sterile preparation relying on its emollient action to exert an effect.


5.2. Pharmacokinetic properties

A simple combination of well known constituents with no reported incompatibilities.


5.3. Preclinical safety data

No additional data of relevance to the prescriber


6.1. List of excipients

Yellow Soft Paraffin BP/Ph EurAnhydrous Lanolin (Wool Fat) BP/Ph EurLiquid Paraffin BP/Ph Eur


6.2. Incompatibilities

None stated.


6.3. Shelf life

36 months (unopened)1 month (opened)


6.4. Special precautions for storage

None stated.


6.5. Nature and contents of container

4g collapsible polyethylene/aluminium foil laminate tubes with tamper evident caps. The product is supplied with patient leaflets and packed in a cardboard carton.


6.6. Special precautions for disposal and other handling

None stated.


7. Marketing authorisation holder

Martindale Pharmaceuticals Ltd

Bampton Road, Romford

RM3 8UG

United Kingdom


8. Marketing authorisation number(s)

PL 00156/0081


9. Date of first authorisation/renewal of the authorisation

27/06/2005


10. Date of revision of the text

02/2019

4.1 Therapeutic indications

To lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, ophthalmic and non-ophthalmic surgery, sticky eyes and to soften crusts formed due to inflammation of the eye lids.

4.2 Posology and method of administration

Adults, the elderly and children.A thin line of the ointment to be placed along the inside of the lower eyelid.As this product contains no medicament it may be used as required.

4.3 Contraindications

Hypersensitivity to any of the components.Contact lenses should not be worn during the treatment period.

4.4 Special warnings and precautions for use

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 during 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 use machinery until their vision is clear.

4.8 Undesirable effects

None known.

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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.

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Drug Licencing

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