Optrex Bloodshot Eye Drops

1. Name Of The Medicinal Product

Optrex Bloodshot Eye Drops

2. Qualitative And Quantitative Composition

Actives

Hamamelis water* BPC 12.5% v/v

Naphazoline hydrochloride EP 0.01% w/v

(*Synonyms. Distilled witch hazel, Witch hazel)

3. Pharmaceutical Form

Eye drops

4. Clinical Particulars

4.1 Therapeutic Indications

For temporary relief of redness of the eye due to minor eye irritations.

4.2 Posology And Method Of Administration

For topical application to the eye.

Adults, children over 12 years and the elderly:

Gently squeeze one to two drops into the corner of each eye. No more than 4 times daily.

Children under 12 years:

Not recommended.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Persons suffering from glaucoma, serious eye diseases or who have had previous eye surgery.

4.4 Special Warnings And Precautions For Use

Not to be used by contact lens wearers whilst wearing lenses.

If you are being treated for high blood pressure, depression, heart disease, diabetes or increased thyroid activity consult your doctor before using the drops.

Discard any eye drops remaining 28 days after opening the container.

Continued use of this product may increase redness of the eye.

If you experience eye pain, changes in vision or continued redness of the eye, or if the condition worsens or persists for more than 24 hours consult a doctor.

If you have any eye disease, suffer from glaucoma or have had eye surgery, do not use this product except under the advice and supervision of a doctor.

If the solution changes colour or becomes cloudy do not use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

May interact with other topically applied autonomic drugs used in the treatment of glaucoma. May interact with monoamine oxidase inhibitors and should not be used by patients receiving such treatment or within 14 days of ceasing therapy. May reverse the antihypertensive action of drugs used in the treatment of hypertension. There may be an increased risk of arrhythmias in patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

4.6 Pregnancy And Lactation

Although the safety of Optrex Red Eyes Eye Drops during pregnancy and lactation has not been established, it is unlikely that sufficient of the active ingredients will reach the foetus or the breast-fed infant to be harmful.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Transient irritation and stinging may occur. Following long term use a rebound secondary hyperaemia may occur.

4.9 Overdose

If applied in excessive quantities to the eye, it may give rise to irritation and stinging. Overdosage by mouth may cause nausea, headache, depression of the central nervous system with marked reduction of body temperature and symptoms of bradycardia, sweating, drowsiness and coma, particularly in children. In addition, may cause hypertension followed by rebound hypotension. Treatment of adverse effects should be symptomatic and supportive.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Naphazoline is a sympathomimetic amine with pronounced alpha adrenergic activity and as a consequence has vasoconstrictor activity.

Distilled witch hazel has astringent properties.

5.2 Pharmacokinetic Properties

Although there are no specific pharmacokinetic properties for this product, systematic absorption of naphazoline may take place following topical application.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerin

Boric acid

Borax

Disodium edetate

Benzalkonium chloride

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

a) Unopened: 24 months.

b) After first opening: 28 days.

6.4 Special Precautions For Storage

Store below 25°C.

Do not freeze.

6.5 Nature And Contents Of Container

A pigmented high density/low density polythene bottle having a polythene plug and wadless high density polyethylene tamper evident cap. Pack size is 10ml.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Optrex Limited

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL 00062/0024

9. Date Of First Authorisation/Renewal Of The Authorisation

11 April 1978 / 08 July 1997

10. Date Of Revision Of The Text

15/04/2008