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OPTREX SORE EYE DROPS

Active substance(s): HAMAMELIS WATER

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Optrex Sore Eye Drops

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active Distilled Witch Hazel BPC l3%v/v (Synonyms: Hamamelis Water, Witch Hazel)

3.

PHARMACEUTICAL FORM Eye Drops

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4.1

CLINICAL PARTICULARS
Therapeutic indications For the relief of minor eye irritations caused by dusty or smoky atmospheres, driving or close work.

4.2

Posology and method of administration For topical application into the eye. For adults, children and the elderly: Gently squeeze one or two drops into each eye. Use as often as required.

4.3

Contra-indications

Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use For external use only. Not suitable for use with hydrophilic (soft) contact lenses. Keep all medicines out of the sight and reach of children. Discard any eye drops remaining 28 days after opening the container.

4.5

Interactions with other medicaments and other forms of interaction No clinically significant drug interactions known.

4.6

Pregnancy and lactation The safety of Optrex Sore Eyes Eye Drops during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.

4.7

Effects on ability to drive and use machines No adverse effects known.

4.8

Undesirable effects Occasional hypersensitivity reactions.

4.9

Overdose In view of the size of the container, overdosage should not be a problem and any treatment should only be symptomatic.

5.

Pharmalogical Properties

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

Hamamelis water has cooling and astringent properties.

5.2

Pharmacokinetic properties Not available.

5.3

Preclinical safety data There are no preclinical safety data of relevance to the consumer.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients

Boric acid Borax Glycerin Benzalkonium chloride Purified water

6.2

Incompatibilities Not applicable.

6.3

Shelf Life a) b) Unopened: After first opening: 36 months 28 days

6.4

Special precautions for storage Store below 25C.

6.5

Nature and contents of container Polyethylene bottle with a polyethylene dropper plug and a tamper evident polyethylene cap. Pack sizes of 10ml and 18ml.

6.6

Instruction for use, handling and disposal None.

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MARKETING AUTHORISATION HOLDER
Optrex Limited 1 Thane Road West Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER PL 00062/5003R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 15 May 1987

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DATE OF REVISION OF THE TEXT
15/04/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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