Boots Soothing Eye Drops

1. Name Of The Medicinal Product

Boots Soothing Eye Drops or Boots Eye Drops.

2. Qualitative And Quantitative Composition

Active ingredient	% v/v
Cetrimide Ph Eur	0.01 w
Hamamelis water BPC	5.0

3. Pharmaceutical Form

Sterile eye drops

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of minor eye irritations.

For topical application to the eye.

4.2 Posology And Method Of Administration

Adults, Elderly and Children

Tilt back the head, pull the lower eyelid and squeeze the bottle very gently so as to allow one or two drops to fall into the inner corner of the eye. Use night and morning and as required.

4.3 Contraindications

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. Discard any eye drops remaining one month after opening the container.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of this product during pregnancy and lactation has not been established but its use during these periods is not thought 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, overdosing should not be a problem and any treatment should only be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hamamelis water has astringent properties.

Cetrimide is a quaternary ammonium antiseptic with bactericidal activity against gram positive and some gram negative organisms.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Boric acid pdr Borax pdr Purified water

N/1 hydrochloric acid for sterile products N/1 sodium hydroxide for sterile products

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

Once opened 28 days.

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

A natural polythene, round, tamper-evident bottle fitted with a white polythene dropper plug and a white J-safe cap.

Pack size: 10ml

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/5237R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 31 August 1990

Date of Last Renewal: 23 July 1996

10. Date Of Revision Of The Text

November 2003